Clinical trials: Atrioventricular Heart-block
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
Post Pacemaker Implantation Patients
Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation.
- Trial name
- NCT03303872
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Yonsei University
AV Block
Danish Randomized Trial on Leadless vs Transvenous Pacing
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block.
- Trial name
- DANVERS (NCT05856799)
- Testing
- Leadless Micra AV Transcatheter Pacing System, Transvenous Azure XT DR dual chamber pacemaker
- Where
- 2 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- University of Aarhus
Congenital Heart Block, Neonatal Lupus
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving…
- Conditions
- Congenital Heart Block, Neonatal Lupus, Atrioventricular Nodal Dysfunction, Myocardial Injury
- Trial name
- NCT00007358
- Testing
- Dexamethasone or other corticosteroid
- Where
- 4 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Atrioventricular Block, Second and Third Degree, Heart Failure
Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT…
- Conditions
- Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing
- Trial name
- NCT05553626
- Testing
- Left bundle branch pacing, Bi-ventricular pacing
- Where
- China
- Volunteers
- 160 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrioventricular Block
Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block
OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years.
- Trial name
- OptimPacing (NCT04624763)
- Testing
- Left bundle branch pacing, Right ventricular pacing
- Where
- China
- Volunteers
- 683 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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.
Atrioventricular Block, Second and Third Degree
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic…
- Trial name
- PACE-4-TAVI (NCT05966675)
- Testing
- conduction system pacing, right ventricular or biventricular pacing
- Where
- Poland
- Volunteers
- 500 people
- Sponsor
- Medical University of Silesia
Aortic Valve Stenosis
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery.
- Trial name
- TAVISTIM (NCT02337140)
- Testing
- Pacemaker SORIN Group KORA DR, transcatheter aortic valve implantation (TAVI)
- Where
- France
- Volunteers
- 165 people
- Sponsor
- University Hospital, Montpellier
Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction
Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and…
- Trial name
- CLOSE-AV (NCT07314008)
- Testing
- LBBAP, MVP
- Where
- South Korea
- Volunteers
- 440 people
- Sponsor
- Asan Medical Center
Atrioventricular Block, Pacing-Induced Cardiomyopathy
Conduction System Pacing to Prevent Pacing-Induced Cardiomyopathy
The purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with…
- Conditions
- Atrioventricular Block, Pacing-Induced Cardiomyopathy, Cardiac Pacing, Artificial
- Trial name
- PRESERVE-CSP (NCT07831655)
- Testing
- Conduction System Pacing, Right Ventricular Apical Pacing
- Where
- Spain
- Volunteers
- 116 people
- Sponsor
- Germans Trias i Pujol Hospital
Sjogren's Syndrome, Neonatal Systemic Lupus Erythematosus
Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor
The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their…
- Conditions
- Sjogren's Syndrome, Neonatal Systemic Lupus Erythematosus, Fetal Heart Block Complete
- Trial name
- NCT02920346
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- University of Colorado, Denver
Sinus Bradycardia, Atrioventricular Block
Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart
Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia is one of the largest pediatric heart transplant centers in the world, averaging 25 transplants per year, and providing ongoing care to…
- Trial name
- NCT02462941
- Testing
- Adenosine, Cardiac catheterization
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Columbia University
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Sick Sinus Syndrome, AV-Block
Left Ventricular Function and Remodelling During Permanent Pacing
1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure.
- Trial name
- NCT00228241
- Testing
- AAI vs. DDD vs. BIV pacing in different patients groups
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aarhus University Hospital Skejby
Complete AV Block, Sick Sinus Syndrome
Left Ventricular Pacing to Avoid Cardiac Enlargement Study
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients…
- Trial name
- LVPACE (NCT01302717)
- Testing
- LV pacing, RV pacing
- Where
- 2 sites in South Korea
- Sponsor
- Seoul National University Hospital
First Degree Atrioventricular Block
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the…
- Trial name
- REAL-CRT (NCT02150538)
- Testing
- Cardiac resynchronization therapy pacemaker, Dual chamber pacemaker
- Where
- Italy
- Volunteers
- 164 people
- Sponsor
- Gianluca Botto
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