Sinus Node DysfunctionSANOKNCT05196126
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
A study testing Permament pacemaker implantation and Cardioneuroablation in people with Sinus Node Dysfunction, run by Stec, Sebastian, MD, PhD, FESC at 4 sites in Poland.
Trial summary
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinus Node Dysfunction
- What is being tested?
- Permament pacemaker implantation and Cardioneuroablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesPoland
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, 18-75 years
- Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
- Optimization of chronic disease treatment
- Ability to provide informed consent to participate in the study
- Ability to understand patient information.
Who cannot join
- Contraindications to invasive and noninvasive procedures used in the study
- Uncontrolled endocrine and systemic disorders
- Persistent atrial fibrillation
- Dilated cardiomyopathy
- Severe congenital heart valve disease or cardiomyopathy
- Functional NYHA class III/IV
Show all 24Show fewer
- Left ventricular ejection fraction <35%
- Left atrial diameter >50 mm
- Previous catheter ablation
- Contraindications to anticoagulant treatment
- Contraindications to catheter ablation
- Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
- Contraindications to noninvasive tests
- Pregnancy and lactation
- Previous cardiac surgery
- Implanted pacemaker device
- Neck and chest abnormalities
- Myocardial infarction in the previous 6 months
- Percutaneous coronary intervention in the previous 3 months
- Estimated survival <24 months
- Participation in another drug or medical device program
- Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
- Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS)
- Severe obesity (body mass index ≥40 kg/m2 )
Trial locations and contacts
4 sites in 1 country.
Poland4 sites, 4 recruiting
- Not yet recruiting
Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
Ostrowiec Świętokrzyski, 27-400
Janusz Sledz, MD, +48 602535589, januszsledz@onet.eu
Janusz Sledz, MD
- Recruiting
Medical Center SABAMED
Rzeszów
Agnieszka Reichert, MD, +48 69365129, agarei@mp.pl
Agnieszka Reichert, MD
- Recruiting
Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint
Sanok, 38-500
Antoni Wileczek, MD, +48 663517874, antoniwileczek@gmail.com
Sebastian Stec, MD, PhD
- Not yet recruiting
Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
Wroclaw, 50-07
Adrianna Szalonka, BA, +48 535502175, ada.szalonka@interia.pl
Dariusz Jagielski, MD PhD
About this study
Official title: Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers.
Read the detailed description
All patients meeting the inclusion criteria and not meeting the exclusion criteria will be invited to participate in the study. The patient will receive an informed consent form describing the study protocol. After speaking to the investigator and receiving detailed answers to all questions, the patient will sign the written informed consent form to participate in the study or will choose to opt out of randomization and to be included in the registry only.
Premenopausal women who will provide consent to participate in the study will undergo a pregnancy test before any invasive procedure. During the 12-month study duration, the use of effective contraception is recommended.
The patient will be asked to complete the questionnaires on bradycardia symptoms and quality of life (QOL).
Any patient included in the study will be randomized into group A or group B. Patients included in the registry (group C) will undergo patient-tailored interventions and treatments through shared decision-making with a possibility of permanent cardiac pacing (subgroup CA), vagal nerve stimulation (VNS) according to the protocol and cardioneuroablation (subgroup CB), as well as observation (subgroup CO).
- Conditions
- Sinus Node Dysfunction
- Being tested
- Permament pacemaker implantation, Cardioneuroablation
- Keywords
- cardioneuroablation, pacemaker, sinus node dysfunction, bradycardia, extracardiac vagal nerve stimulation, ECG monitoring, quality of life
- Medical subject headings
- Sick Sinus Syndrome, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permament pacemaker implantationProcedure or surgery
PM implantation
CardioneuroablationProcedure or surgery
Also called Extracardiac vagal nerve stimulation
Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A - PACEMAKER | Active comparator | According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation. Receives: Procedure: Permament pacemaker implantation |
| Group B - CARDIONEUROABLATION | Experimental | According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified. Receives: Procedure: Cardioneuroablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences.
Measured: 6 months
Number of Participants with Pacemaker Implantation at 6 months
Number of participants with PM implantation at 6 months
Measured: 6 monhts
Secondary outcomes (8)
Number of Events of Procedural Complications
Procedural Complications (death, stroke, myocardial infarction, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm (0-6 month changes)
Measured: 0-6 months
Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation
Number of participants with post-ablation inducibility of sinus arrest and/or AV block in pre- and post- procedural extracardiac Vagal Nerve stimulation
Measured: 1 day (peri-procedural)
Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire
EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health, 0 indicating the worst health status.
Measured: 0, 3, 6, 9, 12 months
Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire
SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability.
Measured: 0, 3, 6, 9, 12 months
Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)
MFIS is a validated, standardized, 21-item questionnaire, which provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Total scores range from 0-84. The lower the score the less fatigue, the higher the score the more fatigue impairs physical, cognitive, and psychosocial functioning.
Measured: 0, 6, 12 months
Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)
HADS-M is a validated, standardized 16-item questionnaire to evaluate the association between anxiety and depression and the degree of illness acceptance in patients. Total scores range from 0-64. Higher scores indicate a greater degree of anxiety or depression.
Measured: 0, 6, 12 months
Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)
The ESS score is a standardized, validated 8-item questionnaire (with scores 0-3 each). The total score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Measured: 0, 6, 12 months
Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)
AIS-8 is a standardized, validated questionnaire assessing 8 factors related to nocturnal sleep and daytime dysfunction, which are rated on a 0-3 scale. The sleep is evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. Higher score indicates more sleep disturbances.
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jun 2022
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stec, Sebastian, MD, PhD, FESC
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Principal investigator, Sebastian Stec, Stec, Sebastian, MD, PhD, FESC
- Investigators
- Sebastian Stec, MD, PhD, Study chair, Medical Center SABAMED Medicans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196126
- Sponsor's protocol ID
- SANOK
- Acronym
- SANOK
- Status last verified
- Mar 2023
- First submitted
- 14 Oct 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05196126
- Acronym / sponsor ID
- SANOK / SANOK
- Conditions
- Sinus Node Dysfunction
- Keywords
- cardioneuroablation, pacemaker, sinus node dysfunction, bradycardia, extracardiac vagal nerve stimulation, ECG monitoring, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stec, Sebastian, MD, PhD, FESCUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Jan 2022 (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.
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers.
Detailed description
All patients meeting the inclusion criteria and not meeting the exclusion criteria will be invited to participate in the study. The patient will receive an informed consent form describing the study protocol. After speaking to the investigator and receiving detailed answers to all questions, the patient will sign the written informed consent form to participate in the study or will choose to opt out of randomization and to be included in the registry only.
Premenopausal women who will provide consent to participate in the study will undergo a pregnancy test before any invasive procedure. During the 12-month study duration, the use of effective contraception is recommended.
The patient will be asked to complete the questionnaires on bradycardia symptoms and quality of life (QOL).
Any patient included in the study will be randomized into group A or group B. Patients included in the registry (group C) will undergo patient-tailored interventions and treatments through shared decision-making with a possibility of permanent cardiac pacing (subgroup CA), vagal nerve stimulation (VNS) according to the protocol and cardioneuroablation (subgroup CB), as well as observation (subgroup CO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - PACEMAKER | Active comparator | Procedure: Permament pacemaker implantationAccording with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation. |
| Group B - CARDIONEUROABLATION | Experimental | Procedure: CardioneuroablationAccording with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age, 18-75 years
- Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
- Optimization of chronic disease treatment
- Ability to provide informed consent to participate in the study
- Ability to understand patient information.
Key exclusion criteria (24 listed)
- Contraindications to invasive and noninvasive procedures used in the study
- Uncontrolled endocrine and systemic disorders
- Persistent atrial fibrillation
- Dilated cardiomyopathy
- Severe congenital heart valve disease or cardiomyopathy
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 |
|---|---|---|
| Permament pacemaker implantationPM implantation | Procedure or surgery | Group A - PACEMAKER |
| CardioneuroablationAlso: Extracardiac vagal nerve stimulationBiatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia. | Procedure or surgery | Group B - CARDIONEUROABLATION |
Primary outcome
Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
Time frame: 6 months
Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences.
Number of Participants with Pacemaker Implantation at 6 months
Time frame: 6 monhts
Number of participants with PM implantation at 6 months
8 secondary outcomes
Number of Events of Procedural Complications
Time frame: 0-6 months
Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation
Time frame: 1 day (peri-procedural)
Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire
Time frame: 0, 3, 6, 9, 12 months
Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire
Time frame: 0, 3, 6, 9, 12 months
Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)
Time frame: 0, 6, 12 months
Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)
Time frame: 0, 6, 12 months
Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)
Time frame: 0, 6, 12 months
Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)
Time frame: 0, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sebastian Stec, MD, PhD study chair
Medical Center SABAMED Medicans
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permament pacemaker implantation and Cardioneuroablation in people with Sinus Node Dysfunction, run by Stec, Sebastian, MD, PhD, FESC at 4 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 5 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Stec, MD, PhD (+48600298022, smstec@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months (time frame: 6 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?
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 7 Mar 2023.