BradycardiaGENTLE-PACENCT05896592
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
A study testing Invasive electrophysiological study, Extracardiac vagal stimulation and Cardioneuroablation in people with Bradycardia and Syncope, run by 4th Military Clinical Hospital with Polyclinic, Poland at 2 sites in Poland.
Trial summary
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bradycardia, Syncope
- What is being tested?
- Invasive electrophysiological study, Extracardiac vagal stimulation and Cardioneuroablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Aug 2024to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
Who cannot join
- Own heart rate <30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
Show all 15Show fewer
- History of ablation procedures
- Congenital heart defects
- Congenital atrioventricular block
- Neuromuscular and neurodegenerative diseases
- Indications for expanding the pacemaker system to ICD/CRT-D
- Pregnancy
- Renal insufficiency with GFR <30 ml/min/1.73m2
- Age below 18 and above 65 years
- HAS-BLED score >/= 3 points
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Silesia
Katowice, Silesian Voivodeship, 40-055
Jacek Bednarek, PhD, kbigosinska@sum.edu.pl
- Recruiting
Mazowiecki Specialist Hospital
Radom, Masovian Voivodeship, 26-617
Sebastian Stec, Professor, smstec@wp.pl
About this study
Official title: A Multicenter, Randomized, Double-blind, Research Study comparinG the Efficacy and Safety of cardioneuroablaTion vs Permanent Pacing in Patients With an implantabLE PACEmaker for Symptomatic Bradycardia.
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM). Although PM remains the main therapeutic approach for most patients with SND/AVB, long-term PM therapy can be associated with various limitations, complications, and the need for device and electrode replacement. There is increasing evidence for the effectiveness of an alternative approach to functional bradycardia associated with excessive vagal activation - cardioneuroablation (CNA). The method leads to the alleviation or complete resolution of bradycardia symptoms, as well as reflex syncope, providing an opportunity to discontinue PM therapy.
Primary aims
Read more
1.Evaluation of the efficacy and safety of CNA as a therapy allowing for discontinuation of PM therapy in patients with SND or AVB.
Secondary aims
- Evaluation of the efficacy and safety of CNA as a therapy allowing for the optimization of PM therapy in patients with SND and AVB.
- Development of a diagnostic algorithm allowing for the identification of patients with SND and/or AVB suitable for CNA and discontinuation of PM and TLE therapy.
- In addition, blood samples will be collected for future analysis and biobanking.
Methodology
Inclusion criteria
- Patients up to 50 years old who underwent pacemaker implantation due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
Exclusion criteria
- Own heart rate <30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
- History of ablation procedures
- Congenital heart defects
- Congenital atrioventricular block
- Neuromuscular and neurodegenerative diseases
- Indications for expanding the pacemaker system to ICD/CRT-D
- Pregnancy
- Renal insufficiency with GFR <30 ml/min/1.73m2
- Age below 18 and above 65 years
- HAS-BLED score >/= 3 points
Randomization, study scheme Qualified patients will be randomly assigned (1:1:1) to group 1 undergoing first-stage invasive electrophysiology study (EPS), extracardiac vagus nerve stimulation (ECVS) and CNA with continued PM therapy and implantable loop recorder (ILR) implantation, to group 2 undergoing first-stage EPS and ECVS with continued PM therapy, ILR implantation, and no CNA, and to group 3 where patients will undergo observation only for the entire study. The follow-up time will be 18 months. Groups 1 and 2 will be blinded. Two months after the first invasive procedure, the secondary endpoint-stimulation rate in all groups will be assessed. In addition, a non-invasive evaluation of the efficacy of CNA and the incidence of syncope (MAS) and collapse (paraMAS) will take place in group 1, as well as an evaluation of the pacing percentage. After another month during the second hospitalization, the following will be performed: EPS and ECVS, and repeat CNA if ECVS does not show full parasympathetic cardiac denervation. In group 2, after 2 months, non-invasive tests will also be performed to assess and presence of MAS, paraMAS symptoms, and to assess pacing rates. After another month, during the second hospitalization, the following will be performed: EPS, ECVS and CNA. Group 1 and 2 patients will have their pacemaker set to VVI/AAI 30/min. Group 3 patients will then be evaluated for pacing rates and MAS, paraMAS symptoms. At the third visit, one month after the second invasive procedure in group 1 and 2 patients, the pacing percentage will be assessed. Patients with zero pacing percentage PM will be put on ODO/OVO/OAO-pacing off mode. Patients with a pacing percentage greater than zero PM will be set to their optimal mode. A pacing percentage of <0.1% will be treated as 0%, which will be confirmed in the ILR control. For the next 12 months, patients will be observed. During this period, at the next 4 visits repeated every 3 months, groups 1 and 2 will undergo a non-invasive assessment of CNA efficacy and bradycardia symptoms, while group 3 will be evaluated for MAS, paraMAS and pacing percentage assessment. At the 7th visit, the qualification of patients in groups 1 and 2 for discontinuation of continued pacing treatment will take place, with possible qualification for TLE.
Justification Early and late results of a new strategy which is CNA, indicate the possibility of developing an new approach that allows patients with functional bradycardia to decide whether to discontinue or optimize PM therapy. However, standardized approaches based on noninvasive and invasive techniques have not yet been validated and evaluated in a prospective, multicenter, randomized, controlled trial with long-term remote follow-up, including ILR.
Read the detailed description
Visit 1- Screening, recruitment, randomization.
- ECG, PM check, NIEPS
- change the stimulation mode to DDD 50/min, AV 220ms/ VVI 50/min/ AAI 50/min
- atropine test
- laboratory tests: complete blood count, creatinine, AST, ALT, TSH, fT3, fT4, NT-proBNP, beta-HCG, K
- analysis of inclusion and exclusion criteria
Hospitalization 1-1 month from randomization Group 1- EPS, ECVS, CNA, ILR implantation Group 2- EPS, ECVS, ILR implantation Group 3- observation
Visit 2-3 months after randomization
Group 1 and 2:
- History of MAS and paraMAS symptoms and the consequences of the procedures performed.
- PM control with the assessment of the percentage of stimulation. Change settings and check PM - to assess the efficiency of own rhythm, patients will then have their pacemaker reprogrammed in DDD 50/min mode with AV 220ms or VVI 50/min. or AAI 50/min.
- ECG
- NIEPS
- 24-hour Holter ECG monitoring
- ILR control
Group 3 observation:
- History of MAS and paraMAS symptoms.
- PM control with the assessment of the percentage of stimulation.
Hospitalization 2-4 months from randomization Group 1 - EPS, ECVS, redo CNA if required Group 2 - EPS, ECVS, CNA Group 1 and 2 patients will have their pacemaker set to VVI/AAI 30/min. For patients of Groups 1 and 2 in whom the CNA proved to be ineffective, the PM will be programmed in the optimal mode for them.
Visit 3-6 months after randomization
Group 1 and 2:
- History of MAS and paraMAS symptoms and the consequences of the procedures performed.
- PM control with the evaluation of the percentage of stimulation. Changing settings and checking PM- to assess the efficiency of your own rhythm
- ECG
- NIEPS
- 24 hour Holter ECG monitoring
- ILR control Patients from groups 1 and 2, whose percentage of stimulation in PM control will be 0%, will have their PM reprogrammed to ODO/OVO/OAO - pacing off.
Group 3 observation:
- History of MAS and paraMAS symptoms.
- PM control with the assessment of the percentage of stimulation.
Visits 4, 5, 6 - consecutively 9, 12, 15 months after randomization
Groups 1 and 2:
- Anamnesis for possible symptoms of bradycardia and undesirable effects of the procedure.
- PM control
- ECG
- NIEPS
- 24-hour Holter ECG monitoring
- ILR control Patients in Groups 1 and 2 who experience symptoms of bradycardia correlated with bradycardia recorded in the ILR will resume pacing in the optimal mode for them.
During these visits, patients in Group 3 and Groups 1 and 2 who had their pacing restored/optimized will be interviewed for possible MAS and paraMAS symptoms, perform a physical examination, and check the PM with assessment of pacing percentage and pacing mode optimization.
Visit 7 - ending the study - 18 months from randomization.
Group 1 and 2:
- Anamnesis for possible symptoms of bradycardia and undesirable effects of the procedure.
- PM control
- ECG
- NIEPS
- Atropine test
- 24-hour Holter ECG monitoring
- ILR control Patients from groups 1 and 2 without symptoms of bradycardia and without asymptomatic bradycardia <40/min recorded in the ILR, after assessment by the EP-HEART TEAM (a council of two cardiologist specialists), will be qualified for the end of permanent pacing therapy. Those patients with a low risk of TLE will be qualified for TLE.
During this visit, Group 3 and Group 1 and 2 patients with previously pacing restored/optimized will be interviewed for possible MAS and paraMAS symptoms, perform a physical examination and PM check with assessment of pacing percentage and pacing mode optimisation.
The ILR will be left in place until the battery runs out or will be removed sooner at the patient's request.
- Conditions
- Bradycardia, Syncope
- Being tested
- Invasive electrophysiological study, Extracardiac vagal stimulation, Cardioneuroablation, Redo cardioneuroablation, Implantation of the implantable loop recorder
- Keywords
- cardioneuroablarion, functional bradycardia, pacemaker treatment discontinuation
- Medical subject headings
- Bradycardia, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive electrophysiological studyDiagnostic test
Also called EPS
Invasive electrophysiological study consists in inserting two electrodes into the heart through femoral vein puncture into the right atrium and right ventricle. Then the following measurements are taken: SNRT- sinus rhythm recovery time, cSNRT- corrected sinus rhythm recovery time, Wenckebach point, AH and HV time and HRV-rhythm variability after SNRT measurement. The examination will be performed under general anesthesia.
Extracardiac vagal stimulationDiagnostic test
Also called ECVS
Extracardiac vagal stimulation consists in leading the electrode through the puncture of the femoral vein, successively to both internal jugular veins and stimulating the vagus nerve at the level of its cranial orifice and lower at the level of the angle of the mandible. Stimulation is performed using the Extra-Cardiac Autonomic NeuroStimulatorPachon.
Induction of a sinus pause or AV block during vagal stimulation is considered a positive test result. Absence of sinus pause and AV block during vagal stimulation indicates parasympathetic denervation of the heart. The examination is performed under general anesthesia.
CardioneuroablationProcedure or surgery
Also called CNA
CNA consists in complete parasympathetic denervation of the heart or in its deep neuromodulation by destroying the postganglionic nerve fibers of the vagus nerve, located in the epicardium in the vicinity of the pulmonary veins to the left atrium and in the area of the interatrial septum. It consists in inserting the electrode into the left atrium through puncture of the femoral vein, and then the interatrial septum, and performing ablation in the vicinity of the pulmonary vein orifices and on the interatrial septum at the level of the mitral annulus. Then the electrode is withdrawn into the right atrium and subsequent applications are made in the area of the coronary sinus opening and the roof of the right atrium and the upper part of the interatrial septum. The procedure is performed under general anesthesia. In group 1, CNA will be performed 1 month after randomization. In group 2, CNA will be performed 4 months after randomization.
Redo cardioneuroablationProcedure or surgery
Also called redo CNA
It consists in re-performing the CNA if full parasympathetic parasympathetic denervation of the heart is not confirmed by ECVS.
Implantation of the implantable loop recorderProcedure or surgery
Also called ILR implantation
Implantation of the implantable loop recorder consists in subcutaneous implantation of the ECG loop recorder in the sternum area.
Pacemaker checkDiagnostic test
Also called PM check
It consists in evaluating the reliability of the PM system. And the assessment of pacing percentage and recorded arrhythmias. After successful cardioneuroablation in groups 1 and 2, 4 months after randomization, the PM will be programmed to the VVI 30/min mode and after 6 months to the OAO/OVO mode. In group 3 patients and in the case of unsuccessful cardioneuroablation, the pacemaker will be set to the optimal mode for the patient. During the PM control, a non-invasive electrophysiological study (NIEPS) is also performed, in which the SNRT, cSNRT, Wenckebach point and HRV after SNRT measurement are assessed. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization.
Implantable loop recorder checkDiagnostic test
Also called ILR check
Assessment of arrhythmias recorded in the ILR. The procedure will be repeated at subsequent visits 3, 4, 6, 9, 12, 15, 18 months after randomization.
Holter ECGDiagnostic test
24 hour ECG recording. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization.
AnamnesisDiagnostic test
Medical history assessing symptoms of bradycardia, MAS, paraMAS and complications of performed procedures. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 will undergo EPS, ECVS, CNA with continuation of PM therapy and ILR implantation. Two months later pacing rate, will be assessed. In addition, there will be a non-invasive assessment of the effectiveness of CNA. After another month, EPS and ECVS will be performed and a re-CNA if the ECVS does not show full parasympathetic denervation of the heart. The pacemaker will be set to VVI or AAI 30/min. One month after the second invasive procedure, the pacing rate will be assessed. Patients with zero percentage of PM stimulation will be set to ODO/OVO/OAO-stimulation off mode. Patients will be monitored for the next 12 months. During the next 4 visits repeated every 3 months, patients in this group will undergo non-invasive assessment of the effectiveness of CNA and symptoms of bradycardia. At the 7th visit, patients in this group will be qualified to discontinue of the cardiac pacing treatment, with possible qualification for TLE. Receives: Diagnostic Test: Invasive electrophysiological study; Diagnostic Test: Extracardiac vagal stimulation; Procedure: Cardioneuroablation; Procedure: Redo cardioneuroablation; Procedure: Implantation of the implantable loop recorder; Diagnostic Test: Pacemaker check; Diagnostic Test: Implantable loop recorder check; Diagnostic Test: Holter ECG; Diagnostic Test: Anamnesis |
| Group 2 | Experimental | Group 2 will undergo EPS and ECVS with continuation of PM therapy, ILR implantation, without CNA. Two months later pacing rate, will be assessed. After another month, EPS, ECVS and CNA will be made. The pacemaker will be set to VVI or AAI 30/min. One month after the second invasive procedure, patients in this group will have their pacing rate assessed. Patients with zero percentage of PM stimulation will be set to ODO/OVO/OAO-stimulation off mode. Patients will be monitored for the next 12 months. During next 4 visits repeated every 3 months, patients in this group will undergo a non-invasive assessment of the effectiveness of CNA and symptoms of bradycardia. At the 7th visit, the qualification for discontinuation of cardiac pacing treatment will take place, with possible qualification for TLE. Receives: Diagnostic Test: Invasive electrophysiological study; Diagnostic Test: Extracardiac vagal stimulation; Procedure: Cardioneuroablation; Procedure: Implantation of the implantable loop recorder; Diagnostic Test: Pacemaker check; Diagnostic Test: Implantable loop recorder check; Diagnostic Test: Holter ECG; Diagnostic Test: Anamnesis |
| Group 3 | Active comparator | Group 3 patients will only be observed for the duration of the study. The observation period will be 18 months. At subsequent visits 1, 3, 4, 6, 9, 12, 15 months after randomization, they will be assessed for the presence of MAS, paraMAS and assessment of the percentage of stimulation. Receives: Diagnostic Test: Pacemaker check; Diagnostic Test: Anamnesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoints- Composite endpoint
Composite endpoint including:
- occurrence of non-traumatic loss of consciousness
- occurrence of symptoms of presyncope state
- determination in the loop recorder recording of events of asymptomatic bradycardia requiring permanent cardiac pacing, understood as:
- type II degree atrioventricular block and/or
- atrioventricular block of 2:1 or higher order and/or
- sinus bradycardia <40/min during the patient's wakefulness
- sinus pause >3 seconds during the patient's wakefulness
- cardiac pacing despite the PM setting in AAI/VVI mode 30/min after the second intervention.
Measured: 18 months
Primary safety endpoints- Composite endpoint
Composite endpoint including:
- death from any cause
- peri-procedural damage to cardiac or vascular structures requiring surgical intervention not resulting in death
- ischemic stroke not terminated by death
- symptomatic damage to the pulmonary veins
- symptomatic injury to the phrenic nerve
- de-electrode device-related infective endocarditis
- device lodge infection
- electrode dysfunction requiring electrode replacement
- BARC grade 2, 3 bleeding during postoperative anticoagulant therapy
Measured: 18 months
Secondary outcomes (22)
Secondary efficacy endpoint
Occurrence of non-traumatic loss of consciousness
Measured: 18 months
Secondary efficacy endpoint
Occurrence of syncope in the course of documented bradyarrhythmia
Measured: 18 months
Secondary efficacy endpoint
Occurrence of symptoms of pre-fainting state
Measured: 18 months
Secondary efficacy endpoint
Occurrence of presyncope in the course of documented bradyarrhythmia
Measured: 18 months
Secondary efficacy endpoint
Determination in the loop recorder recording of events of asymptomatic bradycardia requiring permanent pacing of the heart, understood as:
- atrioventricular block type II and/or
- atrioventricular block of 2:1 or higher order and/or
- sinus bradycardia <40/min during the patient's wakefulness
- sinus pause >3 seconds during the patient's wakefulness
- cardiac pacing despite the PM setting in AAI/VVI mode 30/min after the second intervention.
Measured: 18 months
Secondary efficacy endpoint
Disabling permanent cardiac pacing at visit 3
Measured: 18 months
Secondary efficacy endpoint
Demonstration of a statistically significant lower pacing rate in the group of patients undergoing CNA vs patients who continued PM therapy without CAN
Measured: 18 months
Secondary efficacy endpoint
Qualification for removal of PM and TLE system
Measured: 18 months
Secondary safety endpoint
Death from any cause
Measured: 18 months
Secondary safety endpoint
Peri-procedural damage to cardiac or vascular structures requiring surgical intervention not resulting in death
Measured: 18 months
Secondary safety endpoint
Ischemic stroke not terminated by death
Measured: 18 months
Secondary safety endpoint
Symptomatic pulmonary venous injury
Measured: 18 months
Secondary safety endpoint
Symptomatic phrenic nerve injury
Measured: 18 months
Secondary safety endpoint
Asymptomatic phrenic nerve injury
Measured: 18 months
Secondary safety endpoint
Electrodermal infective endocarditis
Measured: 18 months
Secondary safety endpoint
PM implantation site infection
Measured: 18 months
Secondary safety endpoint
Electrode dysfunction
Measured: 18 months
Secondary safety endpoint
Occurrence of atrial tachyarrhythmias
Measured: 18 months
Secondary safety endpoint
Development of symptoms of heart failure
Measured: 18 months
Secondary safety endpoint
Symptoms of inadequate sinus tachycardia
Measured: 18 months
Secondary safety endpoint
Hospitalization for any reason
Measured: 18 months
Secondary safety endpoint
BARC grade 2, 3 bleeding during postoperative anticoagulant therapy
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Przemysław Skoczyński, 4th Military Clinical Hospital with Polyclinic, Poland
- Investigators
- Przemyslaw Skoczynski, PhD, Principal investigator, 4th Military Clinical Hospital with Polyclinic, PolandDariusz Jagielski, PhD, Study director, 4th Military Clinical Hospital with Polyclinic, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896592
- Sponsor's protocol ID
- 03/2023
- Acronym
- GENTLE-PACE
- Status last verified
- Dec 2023
- First submitted
- 21 May 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
PubMed 34455430Rudbeck-Resdal J, Christiansen MK, Johansen JB, Nielsen JC, Bundgaard H, Jensen HK. Aetiologies and temporal trends of atrioventricular block in young patients: a 20-year nationwide study. Europace. 2019 Nov 1;21(11):1710-1716. doi: 10.1093/europace/euz206.
PubMed 31424500Chung MK, Fagerlin A, Wang PJ, Ajayi TB, Allen LA, Baykaner T, Benjamin EJ, Branda M, Cavanaugh KL, Chen LY, Crossley GH, Delaney RK, Eckhardt LL, Grady KL, Hargraves IG, True Hills M, Kalscheur MM, Kramer DB, Kunneman M, Lampert R, Langford AT, Lewis KB, Lu Y, Mandrola JM, Martinez K, Matlock DD, McCarthy SR, Montori VM, Noseworthy PA, Orland KM, Ozanne E, Passman R, Pundi K, Roden DM, Saarel EV, Schmidt MM, Sears SF, Stacey D, Stafford RS, Steinberg BA, Youn Wass S, Wright JM. Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management. Circ Arrhythm Electrophysiol. 2021 Dec;14(12):e007958. doi: 10.1161/CIRCEP.121.007958. Epub 2021 Dec 6.
PubMed 34865518Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.
PubMed 15670960Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.
PubMed 21712276Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.
PubMed 36114133Tulecki L, Polewczyk A, Jachec W, Nowosielecka D, Tomkow K, Stefanczyk P, Kosior J, Duda K, Polewczyk M, Kutarski A. A Study of Major and Minor Complications of 1500 Transvenous Lead Extraction Procedures Performed with Optimal Safety at Two High-Volume Referral Centers. Int J Environ Res Public Health. 2021 Oct 3;18(19):10416. doi: 10.3390/ijerph181910416.
PubMed 34639716Sidhu BS, Gould J, Bunce C, Elliott M, Mehta V, Kennergren C, Butter C, Deharo JC, Kutarski A, Maggioni AP, Auricchio A, Kuck KH, Blomstrom-Lundqvist C, Bongiorni MG, Rinaldi CA; ELECTRa Investigators Group. The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis. Europace. 2020 Nov 1;22(11):1718-1728. doi: 10.1093/europace/euaa131.
PubMed 32688392
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Research Study comparinG the Efficacy and Safety of cardioneuroablaTion vs Permanent Pacing in Patients With an implantabLE PACEmaker for Symptomatic Bradycardia.
- ClinicalTrials.gov ID
- NCT05896592
- Acronym / sponsor ID
- GENTLE-PACE / 03/2023
- Conditions
- Bradycardia, Syncope
- Keywords
- cardioneuroablarion, functional bradycardia, pacemaker treatment discontinuation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, PolandUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM). Although PM remains the main therapeutic approach for most patients with SND/AVB, long-term PM therapy can be associated with various limitations, complications, and the need for device and electrode replacement. There is increasing evidence for the effectiveness of an alternative approach to functional bradycardia associated with excessive vagal activation - cardioneuroablation (CNA). The method leads to the alleviation or complete resolution of bradycardia symptoms, as well as reflex syncope, providing an opportunity to discontinue PM therapy.
Primary aims
1.Evaluation of the efficacy and safety of CNA as a therapy allowing for discontinuation of PM therapy in patients with SND or AVB.
Secondary aims
- Evaluation of the efficacy and safety of CNA as a therapy allowing for the optimization of PM therapy in patients with SND and AVB.
- Development of a diagnostic algorithm allowing for the identification of patients with SND and/or AVB suitable for CNA and discontinuation of PM and TLE therapy.
- In addition, blood samples will be collected for future analysis and biobanking.
Methodology
Inclusion criteria
- Patients up to 50 years old who underwent pacemaker implantation due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
Exclusion criteria
- Own heart rate <30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
- History of ablation procedures
- Congenital heart defects
- Congenital atrioventricular block
- Neuromuscular and neurodegenerative diseases
- Indications for expanding the pacemaker system to ICD/CRT-D
- Pregnancy
- Renal insufficiency with GFR <30 ml/min/1.73m2
- Age below 18 and above 65 years
- HAS-BLED score >/= 3 points
Randomization, study scheme Qualified patients will be randomly assigned (1:1:1) to group 1 undergoing first-stage invasive electrophysiology study (EPS), extracardiac vagus nerve stimulation (ECVS) and CNA with continued PM therapy and implantable loop recorder (ILR) implantation, to group 2 undergoing first-stage EPS and ECVS with continued PM therapy, ILR implantation, and no CNA, and to group 3 where patients will undergo observation only for the entire study. The follow-up time will be 18 months. Groups 1 and 2 will be blinded. Two months after the first invasive procedure, the secondary endpoint-stimulation rate in all groups will be assessed. In addition, a non-invasive evaluation of the efficacy of CNA and the incidence of syncope (MAS) and collapse (paraMAS) will take place in group 1, as well as an evaluation of the pacing percentage. After another month during the second hospitalization, the following will be performed: EPS and ECVS, and repeat CNA if ECVS does not show full parasympathetic cardiac denervation. In group 2, after 2 months, non-invasive tests will also be performed to assess and presence of MAS, paraMAS symptoms, and to assess pacing rates. After another month, during the second hospitalization, the following will be performed: EPS, ECVS and CNA. Group 1 and 2 patients will have their pacemaker set to VVI/AAI 30/min. Group 3 patients will then be evaluated for pacing rates and MAS, paraMAS symptoms. At the third visit, one month after the second invasive procedure in group 1 and 2 patients, the pacing percentage will be assessed. Patients with zero pacing percentage PM will be put on ODO/OVO/OAO-pacing off mode. Patients with a pacing percentage greater than zero PM will be set to their optimal mode. A pacing percentage of <0.1% will be treated as 0%, which will be confirmed in the ILR control. For the next 12 months, patients will be observed. During this period, at the next 4 visits repeated every 3 months, groups 1 and 2 will undergo a non-invasive assessment of CNA efficacy and bradycardia symptoms, while group 3 will be evaluated for MAS, paraMAS and pacing percentage assessment. At the 7th visit, the qualification of patients in groups 1 and 2 for discontinuation of continued pacing treatment will take place, with possible qualification for TLE.
Justification Early and late results of a new strategy which is CNA, indicate the possibility of developing an new approach that allows patients with functional bradycardia to decide whether to discontinue or optimize PM therapy. However, standardized approaches based on noninvasive and invasive techniques have not yet been validated and evaluated in a prospective, multicenter, randomized, controlled trial with long-term remote follow-up, including ILR.
Detailed description
Visit 1- Screening, recruitment, randomization.
- ECG, PM check, NIEPS
- change the stimulation mode to DDD 50/min, AV 220ms/ VVI 50/min/ AAI 50/min
- atropine test
- laboratory tests: complete blood count, creatinine, AST, ALT, TSH, fT3, fT4, NT-proBNP, beta-HCG, K
- analysis of inclusion and exclusion criteria
Hospitalization 1-1 month from randomization Group 1- EPS, ECVS, CNA, ILR implantation Group 2- EPS, ECVS, ILR implantation Group 3- observation
Visit 2-3 months after randomization
Group 1 and 2:
- History of MAS and paraMAS symptoms and the consequences of the procedures performed.
- PM control with the assessment of the percentage of stimulation. Change settings and check PM - to assess the efficiency of own rhythm, patients will then have their pacemaker reprogrammed in DDD 50/min mode with AV 220ms or VVI 50/min. or AAI 50/min.
- ECG
- NIEPS
- 24-hour Holter ECG monitoring
- ILR control
Group 3 observation:
- History of MAS and paraMAS symptoms.
- PM control with the assessment of the percentage of stimulation.
Hospitalization 2-4 months from randomization Group 1 - EPS, ECVS, redo CNA if required Group 2 - EPS, ECVS, CNA Group 1 and 2 patients will have their pacemaker set to VVI/AAI 30/min. For patients of Groups 1 and 2 in whom the CNA proved to be ineffective, the PM will be programmed in the optimal mode for them.
Visit 3-6 months after randomization
Group 1 and 2:
- History of MAS and paraMAS symptoms and the consequences of the procedures performed.
- PM control with the evaluation of the percentage of stimulation. Changing settings and checking PM- to assess the efficiency of your own rhythm
- ECG
- NIEPS
- 24 hour Holter ECG monitoring
- ILR control Patients from groups 1 and 2, whose percentage of stimulation in PM control will be 0%, will have their PM reprogrammed to ODO/OVO/OAO - pacing off.
Group 3 observation:
- History of MAS and paraMAS symptoms.
- PM control with the assessment of the percentage of stimulation.
Visits 4, 5, 6 - consecutively 9, 12, 15 months after randomization
Groups 1 and 2:
- Anamnesis for possible symptoms of bradycardia and undesirable effects of the procedure.
- PM control
- ECG
- NIEPS
- 24-hour Holter ECG monitoring
- ILR control Patients in Groups 1 and 2 who experience symptoms of bradycardia correlated with bradycardia recorded in the ILR will resume pacing in the optimal mode for them.
During these visits, patients in Group 3 and Groups 1 and 2 who had their pacing restored/optimized will be interviewed for possible MAS and paraMAS symptoms, perform a physical examination, and check the PM with assessment of pacing percentage and pacing mode optimization.
Visit 7 - ending the study - 18 months from randomization.
Group 1 and 2:
- Anamnesis for possible symptoms of bradycardia and undesirable effects of the procedure.
- PM control
- ECG
- NIEPS
- Atropine test
- 24-hour Holter ECG monitoring
- ILR control Patients from groups 1 and 2 without symptoms of bradycardia and without asymptomatic bradycardia <40/min recorded in the ILR, after assessment by the EP-HEART TEAM (a council of two cardiologist specialists), will be qualified for the end of permanent pacing therapy. Those patients with a low risk of TLE will be qualified for TLE.
During this visit, Group 3 and Group 1 and 2 patients with previously pacing restored/optimized will be interviewed for possible MAS and paraMAS symptoms, perform a physical examination and PM check with assessment of pacing percentage and pacing mode optimisation.
The ILR will be left in place until the battery runs out or will be removed sooner at the patient's request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: Invasive electrophysiological study, Diagnostic Test: Extracardiac vagal stimulation, Procedure: Cardioneuroablation, Procedure: Redo cardioneuroablation, Procedure: Implantation of the implantable loop recorder, Diagnostic Test: Pacemaker check, Diagnostic Test: Implantable loop recorder check, Diagnostic Test: Holter ECG, Diagnostic Test: AnamnesisGroup 1 will undergo EPS, ECVS, CNA with continuation of PM therapy and ILR implantation. Two months later pacing rate, will be assessed. In addition, there will be a non-invasive assessment of the effectiveness of CNA. After another month, EPS and ECVS will be performed and a re-CNA if the ECVS does not show full parasympathetic denervation of the heart. The pacemaker will be set to VVI or AAI 30/min. One month after the second invasive procedure, the pacing rate will be assessed. Patients with zero percentage of PM stimulation will be set to ODO/OVO/OAO-stimulation off mode. Patients will be monitored for the next 12 months. During the next 4 visits repeated every 3 months, patients in this group will undergo non-invasive assessment of the effectiveness of CNA and symptoms of bradycardia. At the 7th visit, patients in this group will be qualified to discontinue of the cardiac pacing treatment, with possible qualification for TLE. |
| Group 2 | Experimental | Diagnostic Test: Invasive electrophysiological study, Diagnostic Test: Extracardiac vagal stimulation, Procedure: Cardioneuroablation, Procedure: Implantation of the implantable loop recorder, Diagnostic Test: Pacemaker check, Diagnostic Test: Implantable loop recorder check, Diagnostic Test: Holter ECG, Diagnostic Test: AnamnesisGroup 2 will undergo EPS and ECVS with continuation of PM therapy, ILR implantation, without CNA. Two months later pacing rate, will be assessed. After another month, EPS, ECVS and CNA will be made. The pacemaker will be set to VVI or AAI 30/min. One month after the second invasive procedure, patients in this group will have their pacing rate assessed. Patients with zero percentage of PM stimulation will be set to ODO/OVO/OAO-stimulation off mode. Patients will be monitored for the next 12 months. During next 4 visits repeated every 3 months, patients in this group will undergo a non-invasive assessment of the effectiveness of CNA and symptoms of bradycardia. At the 7th visit, the qualification for discontinuation of cardiac pacing treatment will take place, with possible qualification for TLE. |
| Group 3 | Active comparator | Diagnostic Test: Pacemaker check, Diagnostic Test: AnamnesisGroup 3 patients will only be observed for the duration of the study. The observation period will be 18 months. At subsequent visits 1, 3, 4, 6, 9, 12, 15 months after randomization, they will be assessed for the presence of MAS, paraMAS and assessment of the percentage of stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
Key exclusion criteria (15 listed)
- Own heart rate <30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive electrophysiological studyAlso: EPSInvasive electrophysiological study consists in inserting two electrodes into the heart through femoral vein puncture into the right atrium and right ventricle. Then the following measurements are taken: SNRT- sinus rhythm recovery time, cSNRT- corrected sinus rhythm recovery time, Wenckebach point, AH and HV time and HRV-rhythm variability after SNRT measurement. The examination will be performed under general anesthesia. | Diagnostic test | Group 1, Group 2 |
| Extracardiac vagal stimulationAlso: ECVSExtracardiac vagal stimulation consists in leading the electrode through the puncture of the femoral vein, successively to both internal jugular veins and stimulating the vagus nerve at the level of its cranial orifice and lower at the level of the angle of the mandible. Stimulation is performed using the Extra-Cardiac Autonomic NeuroStimulatorPachon. Induction of a sinus pause or AV block during vagal stimulation is considered a positive test result. Absence of sinus pause and AV block during vagal stimulation indicates parasympathetic denervation of the heart. The examination is performed under general anesthesia. | Diagnostic test | Group 1, Group 2 |
| CardioneuroablationAlso: CNACNA consists in complete parasympathetic denervation of the heart or in its deep neuromodulation by destroying the postganglionic nerve fibers of the vagus nerve, located in the epicardium in the vicinity of the pulmonary veins to the left atrium and in the area of the interatrial septum. It consists in inserting the electrode into the left atrium through puncture of the femoral vein, and then the interatrial septum, and performing ablation in the vicinity of the pulmonary vein orifices and on the interatrial septum at the level of the mitral annulus. Then the electrode is withdrawn into the right atrium and subsequent applications are made in the area of the coronary sinus opening and the roof of the right atrium and the upper part of the interatrial septum. The procedure is performed under general anesthesia. In group 1, CNA will be performed 1 month after randomization. In group 2, CNA will be performed 4 months after randomization. | Procedure or surgery | Group 1, Group 2 |
| Redo cardioneuroablationAlso: redo CNAIt consists in re-performing the CNA if full parasympathetic parasympathetic denervation of the heart is not confirmed by ECVS. | Procedure or surgery | Group 1 |
| Implantation of the implantable loop recorderAlso: ILR implantationImplantation of the implantable loop recorder consists in subcutaneous implantation of the ECG loop recorder in the sternum area. | Procedure or surgery | Group 1, Group 2 |
| Pacemaker checkAlso: PM checkIt consists in evaluating the reliability of the PM system. And the assessment of pacing percentage and recorded arrhythmias. After successful cardioneuroablation in groups 1 and 2, 4 months after randomization, the PM will be programmed to the VVI 30/min mode and after 6 months to the OAO/OVO mode. In group 3 patients and in the case of unsuccessful cardioneuroablation, the pacemaker will be set to the optimal mode for the patient. During the PM control, a non-invasive electrophysiological study (NIEPS) is also performed, in which the SNRT, cSNRT, Wenckebach point and HRV after SNRT measurement are assessed. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization. | Diagnostic test | Group 1, Group 2, Group 3 |
| Implantable loop recorder checkAlso: ILR checkAssessment of arrhythmias recorded in the ILR. The procedure will be repeated at subsequent visits 3, 4, 6, 9, 12, 15, 18 months after randomization. | Diagnostic test | Group 1, Group 2 |
| Holter ECG24 hour ECG recording. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization. | Diagnostic test | Group 1, Group 2 |
| AnamnesisMedical history assessing symptoms of bradycardia, MAS, paraMAS and complications of performed procedures. The procedure will be repeated at subsequent visits 1, 3, 4, 6, 9, 12, 15, 18 months after randomization. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Primary efficacy endpoints- Composite endpoint
Time frame: 18 months
Composite endpoint including: * occurrence of non-traumatic loss of consciousness * occurrence of symptoms of presyncope state * determination in the loop recorder recording of events of asymptomatic bradycardia requiring permanent cardiac pacing, understood as: 1. type II degree atrioventricular block and/or 2. atrioventricular block of 2:1 or higher order and/or 3. sinus bradycardia <40/min during the patient's wakefulness 4. sinus pause >3 seconds during the patient's wakefulness 5. cardiac pacing despite the PM setting in AAI/VVI mode 30/min after the second intervention.
Primary safety endpoints- Composite endpoint
Time frame: 18 months
Composite endpoint including: * death from any cause * peri-procedural damage to cardiac or vascular structures requiring surgical intervention not resulting in death * ischemic stroke not terminated by death * symptomatic damage to the pulmonary veins * symptomatic injury to the phrenic nerve * de-electrode device-related infective endocarditis * device lodge infection * electrode dysfunction requiring electrode replacement * BARC grade 2, 3 bleeding during postoperative anticoagulant therapy
22 secondary outcomes
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary efficacy endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Secondary safety endpoint
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 34455430Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
- Results publication: PubMed 31424500Rudbeck-Resdal J, Christiansen MK, Johansen JB, Nielsen JC, Bundgaard H, Jensen HK. Aetiologies and temporal trends of atrioventricular block in young patients: a 20-year nationwide study. Europace. 2019 Nov 1;21(11):1710-1716. doi: 10.1093/europace/euz206.
- Results publication: PubMed 34865518Chung MK, Fagerlin A, Wang PJ, Ajayi TB, Allen LA, Baykaner T, Benjamin EJ, Branda M, Cavanaugh KL, Chen LY, Crossley GH, Delaney RK, Eckhardt LL, Grady KL, Hargraves IG, True Hills M, Kalscheur MM, Kramer DB, Kunneman M, Lampert R, Langford AT, Lewis KB, Lu Y, Mandrola JM, Martinez K, Matlock DD, McCarthy SR, Montori VM, Noseworthy PA, Orland KM, Ozanne E, Passman R, Pundi K, Roden DM, Saarel EV, Schmidt MM, Sears SF, Stacey D, Stafford RS, Steinberg BA, Youn Wass S, Wright JM. Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management. Circ Arrhythm Electrophysiol. 2021 Dec;14(12):e007958. doi: 10.1161/CIRCEP.121.007958. Epub 2021 Dec 6.
- Results publication: PubMed 15670960Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.
- Results publication: PubMed 21712276Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.
- Results publication: PubMed 36114133Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.
- Results publication: PubMed 34639716Tulecki L, Polewczyk A, Jachec W, Nowosielecka D, Tomkow K, Stefanczyk P, Kosior J, Duda K, Polewczyk M, Kutarski A. A Study of Major and Minor Complications of 1500 Transvenous Lead Extraction Procedures Performed with Optimal Safety at Two High-Volume Referral Centers. Int J Environ Res Public Health. 2021 Oct 3;18(19):10416. doi: 10.3390/ijerph181910416.
- Results publication: PubMed 32688392Sidhu BS, Gould J, Bunce C, Elliott M, Mehta V, Kennergren C, Butter C, Deharo JC, Kutarski A, Maggioni AP, Auricchio A, Kuck KH, Blomstrom-Lundqvist C, Bongiorni MG, Rinaldi CA; ELECTRa Investigators Group. The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis. Europace. 2020 Nov 1;22(11):1718-1728. doi: 10.1093/europace/euaa131.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Przemyslaw Skoczynski, PhD principal investigator
4th Military Clinical Hospital with Polyclinic, Poland
Dariusz Jagielski, PhD study director
4th Military Clinical Hospital with Polyclinic, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive electrophysiological study, Extracardiac vagal stimulation and Cardioneuroablation in people with Bradycardia and Syncope, run by 4th Military Clinical Hospital with Polyclinic, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Przemyslaw Skoczynski, PhD (48602753043, przemyslaw.skoczynski@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoints- Composite endpoint (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896592, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.