One Year Pacing Dependency After TAVR

NCT06756282 | Recruiting

• 1 other identifier: 2024-09-137
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Patients Above 18 Years; Patient Discharge; Pacing Therapy; Aortic Stenosis (Treated With TAVI)

Keywords

transcatheter aortic valve replacement (TAVR); permanent pacing; conductive disorders; pacing dependency

Outcome Measures

Primary Outcomes (1)

• pacing dependency at 1 year follow-up

  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

  6 months

Study Arms (1)

Patients who need permanent pace maker implantation after TAVR

patients with high degree conductive disorders after TAVR who required pacemaker implantation before discharge the study will evaluated pacing dependency at one year (main objective) and the profile of patients with pacing dependency (type of initial conductive disorder, clinical characteristics)

Procedure: Pacemaker and defibrillator

Interventions

Pacemaker and defibrillator PROCEDURE

only patients with pacemaker implantation will be evaluated in the study

Patients who need permanent pace maker implantation after TAVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have TAVR and who are considered to need permanent pacemaker implantation before hospital discharge relating to high degree, symptomatic or not, conductive disorders

You may qualify if:

• all patients who need a permanent pacemaker implantation after TAVR

You may not qualify if:

• Patients who have already a pace maker before TAVR

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Biotronik France: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Florence Leclercq, PUPH

CONTACT

0467336189; f-leclercq@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 1, 2025
• Study Start: November 13, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 13, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

FR (1)