Clinical trials: Atrioventricular Block
Bradycardia, Heart Failure
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant…
- Conditions
- Bradycardia, Heart Failure, Pacemaker-Induced Cardiomyopathy, Conduction Block, Atrioventricular
- Trial name
- LEAP-CAR (NCT05910866)
- Testing
- Left bundle branch area pacing (LBBAP), Right ventricular pacing (RVP)
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Heart Block AV
Micra AV Tracking During Exercise Testing
The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates. Participation in research studies is voluntary.
- Trial name
- NCT05966168
- Testing
- Medtronic Micra AV Device
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Duke University
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Sinus Node Disease
To Pace or Not to Pace in Sinus Node Disease
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing.
- Trial name
- OPTIMIST (NCT02485093)
- Testing
- Septal ventricular pacing, VIP
- Where
- France
- Volunteers
- 215 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacing, Pacing-Induced Cardiomyopathy
LVSP vs RVP in Patients With AV Conduction Disorders
Rationale: Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving.
- Conditions
- Cardiac Pacing, Pacing-Induced Cardiomyopathy, Conduction System Pacing, Left Ventricular Septal Pacing
- Trial name
- LEAP (NCT04595487)
- Testing
- Left ventricular septal pacing, Right ventricular pacing
- Where
- 13 sites in Belgium, Czechia and 5 more
- Volunteers
- 470 people
- Sponsor
- Maastricht University
Atrioventricular Conduction Block
Micra Atrial TRacking Using A Ventricular AccELerometer 2
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal…
- Trial name
- MARVEL2 (NCT03752151)
- Testing
- MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
- Where
- 12 sites in United States, Austria and 6 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmias, Arrhythmias
Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects.
- Conditions
- Bradyarrhythmias, Arrhythmias, Atrioventricular Block, Ventricular Dysfunction
- Trial name
- SAFE-LVPACE (NCT01717469)
- Testing
- Left ventricular pacing through coronary sinus tributaries (Attain StarFix), Right ventricular pacing (Medtronic)
- Where
- Brazil
- Volunteers
- 12 people
- Sponsor
- University of Sao Paulo
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Bradycardia; Sick Sinus Syndrome, AV Block
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
- Trial name
- NCT00156741
- Testing
- Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
- Where
- 30 sites in Austria, Czechia and 9 more
- Volunteers
- 150 people
- Sponsor
- Medtronic BRC
Pacemaker DDD, Atrioventricular Block
Risk of Pacing-induced Cardiomyopathy
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
- Conditions
- Pacemaker DDD, Atrioventricular Block, Pacing-Induced Cardiomyopathy
- Trial name
- NCT04269733
- Testing
- Right ventricular pacing
- Where
- Denmark
- Volunteers
- 153 people
- Sponsor
- Aalborg University Hospital
Atrioventricular Block, Pacing Therapy
Central Haemodynamics and Pacing for AV Block
A randomized, single-blind study comparing two pacing strategies in patients with atrioventricular block requiring permanent pacemaker implantation.
- Conditions
- Atrioventricular Block, Pacing Therapy, Right Ventricular Pacing, Conduction System Pacing
- Trial name
- PACE-CCQ (NCT07276490)
- Testing
- Right ventricular pacing, Conduction system pacing
- Where
- 2 sites in Estonia
- Volunteers
- 124 people
- Sponsor
- University of Tartu
Atrioventricular Block, Cardiac Surgery
OPTImizing Lead Placement in Patients Requiring Pacemaker After Cardiac Surgery
Conventional right ventricular pacing has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Trial name
- OPTI-PACS (NCT07795541)
- Testing
- Left bundle branch area pacing, Conventional pacing strategy
- Volunteers
- 110 people
- Sponsor
- Sahlgrenska University Hospital
Bradycardia, Heart Block
Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT07802119
- Testing
- Aveir VR Leadless Pacemaker
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Min Shen
Symptomatic Aortic Valve Stenosis
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study.
- Trial name
- NCT01801098
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Atrioventricular Block, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing in AVB Patients
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony.
- Trial name
- NCT03851315
- Testing
- permanent left bundle branch area pacing
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Fu Wai Hospital, Beijing, China
Heart Failure, Heart Failure With Reduced Ejection Fraction
Left vs Left Randomized Clinical Trial
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality)…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB
- Trial name
- NCT05650658
- Testing
- His/LBBP, BiVP
- Where
- 71 sites in United States, Canada
- Volunteers
- 2,136 people
- Sponsor
- Baylor College of Medicine
Block Complete Heart, Atrial Fibrillation (AF)
Closed-Loop Stimulation in Left Bundle Branch Area Pacing
This prospective, single-center, crossover study evaluated the effects of closed-loop stimulation (CLS) compared with conventional accelerometer-based rate-adaptive pacing (VVIR) in patients with permanent atrial fibrillation…
- Conditions
- Block Complete Heart, Atrial Fibrillation (AF), Chronotropic Incompetence
- Trial name
- NCT07812935
- Testing
- Closed-Loop Stimulation, Accelerometer-Based VVIR Pacing
- Where
- Poland
- Volunteers
- 33 people
- Sponsor
- Bartlomiej Wrobel
Atrioventricular Block
RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied…
- Trial name
- ITALIA (NCT07279870)
- Testing
- Conduction System Pacing (CSP), Right Ventricular (RV) Pacing
- Where
- 14 sites in Italy
- Volunteers
- 1,260 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hypertension Resistant to Conventional Therapy, Bradycardia
Moderato System: A Double-Blind Randomized Trial Ver 1.1
The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02837445
- Testing
- PHC ON, PHC OFF
- Where
- 12 sites in Austria, Belgium and 5 more
- Volunteers
- 70 people
- Sponsor
- BackBeat Medical Inc
Sick Sinus Syndrome, Atrioventricular Block
Taiwan Registry for Leadless Pacemaker
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.
- Trial name
- NCT04926792
- Testing
- Leadless Pacemaker
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital