Actively Recruiting
Pacing Dependence One Year After Pacemaker Implantation Post-TAVR A Multicenter Observational Study on Conduction Disorders and Pacemaker Use
Led by University Hospital, Montpellier · Updated on 2025-01-03
90
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
B
Biotronik France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients who receive a permanent pacemaker after undergoing transcatheter aortic valve replacement (TAVR), a procedure used to treat aortic stenosis. The study focuses on understanding how many of these patients remain dependent on their pacemaker one year after implantation. Previous findings suggest that conduction problems caused by TAVR may improve over time, and many patients who initially need a pacemaker may not be dependent on it later. The goal is to better understand when permanent pacemaker use is truly necessary after TAVR. The study involves patients who have had a pacemaker implanted following TAVR. Researchers will evaluate the effectiveness of pacemaker stimulation at 3 months and 1 year after implantation. They will also describe the types of conduction disorders linked to atrial or ventricular pacing, the initial reasons for pacemaker use, and differences between patients who are pacemaker-dependent and those who are not. The study will monitor serious clinical events such as mortality, stroke, heart failure, rehospitalization, and device-related complications during follow-up. Participants will be observed over the course of one year, with assessments focusing on pacemaker use and heart conduction status. Data on clinical events and patient characteristics will be collected to understand the long-term effects and outcomes of pacemaker implantation after TAVR. This study aims to provide clearer guidance on when permanent pacing is needed, potentially improving patient care and reducing unnecessary pacemaker use.
CONDITIONS
Official Title
One Year Pacing Dependency After TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who require a permanent pacemaker implantation after TAVR
You will not qualify if you...
- Patients who had a pacemaker before undergoing TAVR
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Montpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
F
Florence Leclercq, PUPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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