Actively Recruiting

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ID06756282

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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients who need a permanent pacemaker implantation after TAVR
Not Eligible

You will not qualify if you...

  • Patients who already have a pacemaker before TAVR

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

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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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