Actively Recruiting
Pacing Dependence at 1 Year Follow-up in Patients Implanted With a Pacemaker After TAVR: a Multicenter Observational Study
Led by University Hospital, Montpellier · Updated on 2025-01-03
90
Participants Needed
1
Research Sites
106 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 have had a transcatheter aortic valve replacement (TAVR) and subsequently required permanent pacemaker implantation due to high-grade conduction disorders. This observational study aims to evaluate how many of these patients remain dependent on their pacemaker stimulation one year after implantation. The study also explores the types of conduction disorders involved, the initial reasons for pacemaker implantation, and the characteristics of patients who do or do not depend on pacing over time. The study focuses on patients who needed pacemakers implanted after their TAVR procedure. Researchers will observe these patients without altering their treatment. They will assess effective pacemaker stimulation at 3 months and 1 year after implantation. The study will also document serious clinical events such as mortality, stroke, heart failure, rehospitalizations for cardiac causes, and pacemaker-related complications during follow-up. Participants will be monitored through clinical evaluations and electrocardiogram (ECG) assessments to determine pacing dependency and cardiac status over time. The main outcome measured is pacing dependency at one year post-implantation. The study aims to provide clearer guidance on when permanent pacemaker implantation is truly needed after TAVR. The total participation duration includes follow-up assessments at 3 months and 12 months after pacemaker implantation.
CONDITIONS
Brief Title
One Year Pacing Dependency After TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients who need a permanent pacemaker implantation after TAVR
You will not qualify if you...
- Patients who already have a pacemaker before TAVR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who have received a pacemaker after TAVR are observed to evaluate pacing dependency and clinical events.
Assessments at 3 months and 12 months after pacemaker implantation
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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