Actively Recruiting

All Genders
NCT06756282

One Year Pacing Dependency After TAVR

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

Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and two-thirds of patients who required a permanent pace maker implantation post TAVR were not found to be dependent at subsequent follow-up. This study aims to evaluate a cohort of patients permanently implanted with a pacemaker post-TAVR for high-grade conductive disorders and to describe the prevalence of effective pacemaker stimulation at 1 year follow-up. Secondary objectives include the evaluation of the prevalence of effective stimulation 3 months after implantation of the pace maker , description of the types of conductive disorders associated with atrial and/or ventricular stimulation, description of the initial indication for pacemaker implantation, description of the characteristics of the population with or without stimulation dependency. The objective is to better rationalize indication of permanent stimulation after TAVI

CONDITIONS

Official Title

One Year Pacing Dependency After TAVR

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who require a permanent pacemaker implantation after TAVR
Not Eligible

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

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Research Team

F

Florence Leclercq, PUPH

CONTACT

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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