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
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients who have undergone TAVI for severe aortic valve disease within the past 3 months

• Preserved left ventricular ejection fraction (LVEF ≥ 50%)

• Indications for pacemaker implantation according to guidelines, including :

• Third-degree atrioventricular (AV) block

• Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1

• Alternating left and right bundle branch block

• HV interval ≥ 70 ms during electrophysiological study

• Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI

• Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation

• Signed informed consent

• Patient affiliated with the national health insurance system

Locations
Other Locations
France
Brest University Hospital
NOT_YET_RECRUITING
Brest
Clermont Ferrand University Hospital
NOT_YET_RECRUITING
Clermont-ferrand
Nantes University Hospital
RECRUITING
Nantes
Poitiers University Hospital
NOT_YET_RECRUITING
Poitiers
Rennes University Hospital
NOT_YET_RECRUITING
Rennes
Rouen University Hospital
NOT_YET_RECRUITING
Rouen
Tours University Hospital
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Research and Innovation Departement of Nantes UH
bp-prom-regl@chu-nantes.fr
+33253482810
Backup
Damien MINOIS, M.D
damien.minois@chu-nantes.fr
+33244768742
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2029-11
Participants
Target number of participants: 266
Treatments
Experimental: LBAP : Left Bundle Area Pacing
Pacemaker implantation using left bundle branch area stimulation
Placebo_comparator: RVP : Right Ventricular Pacing
Right ventricular pacemaker implantation
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov