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RECRUITING
NCT07236489
NA

Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality. Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing. The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.

Official title: Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2025-11-25

Completion Date

2029-11

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

PROCEDURE

Pacemaker implantation using left bundle branch area stimulation

Pacemaker implantation using left bundle branch area stimulation

PROCEDURE

Right ventricular pacemaker implantation

Right ventricular pacemaker implantation

Locations (7)

Brest University Hospital

Brest, Finistère, France

Rennes University Hospital

Rennes, Ille-et-Vilaine, France

Tours University Hospital

Tours, Indre-et-Loire, France

Nantes University Hospital

Nantes, Loire-Atlantique, France

Clermont Ferrand University Hospital

Clermont-Ferrand, Puy-de-Dôme, France

Rouen University Hospital

Rouen, Seine-Maritime, France

Poitiers University Hospital

Poitiers, Vienne, France