Clinical trials: Complete Atrioventricular Block
Aortic Stenosis, Severe
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
- Trial name
- TAVHIS (NCT05714579)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 35 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Complete Heart Block, Second Degree Atrioventricular Block Möbitz Type II
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
- Trial name
- DEEP (NCT06474819)
- Testing
- Pacemaker implant
- Where
- 6 sites in Spain
- Volunteers
- 326 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Block Complete Heart, Atrial Fibrillation
International Ledless Pacemaker Registry
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
- Trial name
- i-LEAPER (NCT05528029)
- Testing
- Leadless Pacemaker (Micra)
- Where
- 12 sites in Belgium, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Luigi Sacco University Hospital
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
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara
Congenital Complete Heart Block, Cardiac Conduction Defect Progressive
Identification of Genetic Basis of Atrioventricular Conduction Defects: From Congenital Forms to Degenerative Forms
Identification of genes involved in congenital atrioventricular block and progressive Cardiac Conduction Disease.
- Trial name
- NCT02881671
- Testing
- genetic blood analysis
- Where
- 2 sites in France
- Volunteers
- 2,600 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Complete Heart Block
PECs Block for Pacemaker Insertion in Children
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial
- Trial name
- NCT04931693
- Testing
- paracetamol, modifiedPECs block
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Kasr El Aini Hospital
Sick Sinus Syndrome, Complete Heart Block
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or…
- Conditions
- Sick Sinus Syndrome, Complete Heart Block, Syncope, Chronic Systolic Heart Failure
- Trial name
- ENVELOPE (NCT02809131)
- Testing
- polymixin/bacitracin, cephalexin, or levofloxacin, or clindamycin, Saline
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Vanderbilt University Medical Center
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Trial name
- ZF-PMSC (NCT03118440)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity.
- Conditions
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- Trial name
- NCT01477658
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- University of Sao Paulo
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, 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
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
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
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.
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block (Disorder), Bradycardia
- Trial name
- ZF-PMDC (NCT03118427)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
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