Clinical trials: Atrioventricular Block
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
Patients Implanted With a Pacemaker
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
- Trial name
- NATURE (NCT00531037)
- Where
- 129 sites in United States, Belgium and 9 more
- Volunteers
- 1,440 people
- Sponsor
- LivaNova
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
Sinus Node Dysfunction, Bradycardia
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA).
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Trial name
- BIO-CONDUCT (NCT06540079)
- Testing
- Solia CSP S lead
- Where
- 10 sites in United States
- Volunteers
- 192 people
- Sponsor
- Biotronik, Inc.
Bradycardia, A-V Block
PV Loops With CNT in Multiple Pacing Sites
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV.
- Trial name
- CS-07 (NCT05345925)
- Testing
- Moderato
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- BackBeat Medical Inc
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arhythmia, Atrioventricular Heart-block
Observation of ImageReady™ MR Conditional Pacing System in China
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
- Conditions
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome
- Trial name
- NCT02636712
- Testing
- ImageReady™ MR Conditional Pacing System
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Atrioventricular Block, Ventricular Dysfunction
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of…
- Trial name
- NCT00187278
- Testing
- Biventricular Pacing, RV Pacing
- Where
- Germany
- Volunteers
- 1,833 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
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
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova
Atrioventricular Block
Biventricular Alternative Pacing
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
- Trial name
- BETTER (NCT00559143)
- Testing
- Biventricular Pacing (DDD(R)- BiV)
- Where
- Greece
- Volunteers
- 38 people
- Sponsor
- Medtronic Hellas Medical Devices ΑEE
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
Sick Sinus Syndrome, AV Block
HBP Device EGM Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac…
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Trial name
- NCT03564860
- Testing
- Device data collection
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrioventricular Block
BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area.
- Conditions
- Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
- Trial name
- BIO-CONDUCT (NCT05251363)
- Testing
- Solia S lead
- Where
- 14 sites in United States
- Volunteers
- 194 people
- Sponsor
- Biotronik, Inc.