Clinical trials: Pacemaker
Left Bundle-Branch Block, Pacemaker DDD
Left Bundle Branch Area Mapping for Conduction System Pacing
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area.
- Trial name
- NCT05884359
- Testing
- 3D Electroanatomical Mapping (NavX)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
Atrial Fibrillation, Heart Failure
RAFT - Pace &Ablate
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Trial name
- RAFT-P&A RCT (NCT06299514)
- Testing
- Pace and Ablate, Medication
- Where
- 12 sites in Canada
- Volunteers
- 600 people
- Sponsor
- Habib Khan
Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Trial name
- Co-STAR (NCT04870424)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
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
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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
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
Defibrillators, Implantable, Follow-Up Studies
Remote Programming of Cardiac Implantable Electronic Device
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning.
- Conditions
- Defibrillators, Implantable, Follow-Up Studies, Pacemaker, Artificial, Telemedicine
- Trial name
- REACT (NCT05366660)
- Testing
- Interrogation/programming
- Where
- France
- Volunteers
- 110 people
- Sponsor
- University Hospital, Bordeaux
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Pacemaker, Implantable Cardioverter Defibrillator
Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device…
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy
- Trial name
- NCT06775691
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
Cardiac Pacemaker, Arrhythmias, Cardiac
The Leadless AV Versus DDD Pacing Study
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical…
- Conditions
- Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- LEAVE DDD (NCT05498376)
- Testing
- Conventional pacemaker DDD, Leadless pacemaker Micra AV
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrioventricular Block, Pacemaker
Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021.
- Trial name
- LBAP-TAVI (NCT07236489)
- Testing
- Pacemaker implantation using left bundle branch area stimulation, Right ventricular pacemaker implantation
- Where
- 7 sites in France
- Volunteers
- 266 people
- Sponsor
- Nantes University Hospital
Vascular Closure, Pacemaker Implantation
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker…
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Trial name
- PERCLOSE-LP (NCT06837870)
- Testing
- percutaneous suture mediated closure, Figure of Eight Suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
ICD, Pacemaker
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected CIED
The investigators tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices (CIED) who have lost continuous RM connectivity because their home monitor had become…
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring
- Trial name
- NCT07477964
- Testing
- Tailored Postcards
- Where
- United States
- Volunteers
- 1,312 people
- Sponsor
- San Francisco VA Health Care System
Atrial Arrhythmia, Atrial Tachycardia
ATrial Tachycardia PAcing Therapy in Congenital Heart
Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth.
- Conditions
- Atrial Arrhythmia, Atrial Tachycardia, Congenital Heart Disease, Pacemaker Re-Entrant Tachycardia
- Trial name
- AT-PATCH (NCT03209583)
- Testing
- Medtronic
- Where
- 15 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Ian Law
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Pacemaker DDD, Heart Block
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF).
- Trial name
- NCT05015660
- Testing
- Left bundle branch pacing lead, Right ventricular active fixation lead
- Where
- Canada
- Volunteers
- 1,300 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
ICD, Pacemaker
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring
- Trial name
- NCT07464834
- Testing
- Tailored Postcard
- Where
- United States
- Volunteers
- 2,726 people
- Sponsor
- San Francisco VA Health Care System
Pacemaker
A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not…
- Trial name
- FranceLEADLESS (NCT06262295)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- French Cardiology Society