NCT07236489

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrioventricular Block
• Pacemaker

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-25
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2025-11-19
• Last updated: 2026-04-15

Locations

7 sites across 1 country: France