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Recruiting Observational

One Year Pacing Dependency After TAVR

NCT06756282 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-11-13
Last updated
2025-01-03

Condition(s) studied

Patients Above 18 YearsPatient DischargePacing TherapyAortic Stenosis (Treated With TAVI)

Investigational drug(s) / intervention(s)

Pacemaker and defibrillator

Pacemaker and defibrillator: only patients with pacemaker implantation will be evaluated in the study

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: all patients who need a permanent pacemaker implantation after TAVR Exclusion Criteria: Patients who have already a pace maker before TAVR

Primary outcome measure(s)

  • pacing dependency at 1 year follow-up — 6 months
    pacing dependency is defined: 1. escape QRS rhythm \< 30 bpm 2. High degree atrioventricular block (paroxysmal or permanent) 3. Atrial fibrillation with escape rhythm \<40/min

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Montpellier Montpellier France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06756282 on ClinicalTrials.gov ↗ ← All trials in France