Clinical trials: Pacemaker, open to volunteers
Temporary Cardio-neural Pacing, Pacemaker Implantation
Cardioneural Temporary Pacing to Achieve Autonomic Modulation
Atrial fibrillation (AF) is the most common arrhythmia, with a lifetime risk of 1 in 3-5. In cases of rapid ventricular rate, patients often experience low blood pressure, making standard rate and rhythm control medications…
- Trial name
- NCT07247422
- Testing
- Temporary cardio-neural pacing
- Where
- Hong Kong
- Volunteers
- 33 people
- Sponsor
- Chinese University of Hong Kong
Symptomatic Bradycardia, Cognitive Function
PACE Cognition Proof-of-Concept Study
This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.
- Conditions
- Symptomatic Bradycardia, Cognitive Function, Pacemaker, Health Status
- Trial name
- NCT07769424
- Testing
- Physiologic Pacemaker Programming, Standard Pacemaker Programming
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- University of Minnesota
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
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Leadless Pacemaker, Left Atrial Appendage Occlusion
Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in selected patients. Implantation is performed with a large caliber delivery catheter.
- Trial name
- NCT06702865
- Where
- Hong Kong
- Volunteers
- 47 people
- Sponsor
- Chinese University of Hong Kong
Leadless Pacemaker, Same-day Discharge
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g.
- Trial name
- VAMPIRE (NCT06455566)
- Testing
- Leadless pacemaker implantation through right internal jugular vein
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen
Heart Failure, Bradycardia
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart…
- Trial name
- OPTPACE-HF (NCT07563153)
- Testing
- Adjustment of the pacemaker/ICDs lower rate limit (LRL), Conventional lower rate (60bpm)
- Where
- South Korea
- Volunteers
- 106 people
- Sponsor
- Samsung Medical Center
Cardiac Implantable Electronic Device Infection
Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.
- Trial name
- CIEDOUT (NCT06323668)
- Testing
- Cardiac implantable electronic device extraction
- Where
- Denmark
- Volunteers
- 180 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Pacing-Induced Cardiomyopathy, Heart Failure
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing…
- Trial name
- PROTECT-UP (NCT06052475)
- Testing
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing), Continued RV Pacing (Right Ventricular Pacing)
- Where
- 12 sites in United Kingdom
- Volunteers
- 155 people
- Sponsor
- Imperial College London
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
Patient Safety
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.
- Trial name
- Veteran CIEDs (NCT05062434)
- Testing
- Academic detailing and audit and feedback intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
Heart Failure and Reduced Ejection Fraction, Dyssynchrony
Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat…
- Trial name
- RIPCORD-CRT (NCT07430553)
- Testing
- Biventricular pacing, Conduction system pacing, Left bundle optimised cardiac resynchronisation therapy
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
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