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Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Sponsor: Nantes University Hospital
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
Conditions
Interventions
Pacemaker implantation using left bundle branch area stimulation
Pacemaker implantation using left bundle branch area stimulation
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