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Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 25, 2025
Primary Completion Date
November 1, 2029
Completion Date
November 1, 2029
Last Updated
December 15, 2025
266
ESTIMATED participants
Pacemaker implantation using left bundle branch area stimulation
PROCEDURE
Right ventricular pacemaker implantation
PROCEDURE
Lead Sponsor
Nantes University Hospital
NCT05884359
NCT03475498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07196397