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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Atrioventricular Block; Pacemaker

Treatments: Procedure: Right ventricular pacemaker implantation; Procedure: Pacemaker implantation using left bundle branch area stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07236489

RC24_0610

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Left ventricular ejection fraction (LVEF) < 50% before TAVI
• Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
• Previously implanted pacemaker
• Patients under legal guardianship, curatorship, or judicial protection
• Participation in another interventional therapeutic clinical trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups, including a placebo group

LBAP : Left Bundle Area Pacing

Experimental group

Description:

Pacemaker implantation using left bundle branch area stimulation

Treatment:

Procedure: Pacemaker implantation using left bundle branch area stimulation

RVP : Right Ventricular Pacing

Placebo Comparator group

Description:

Right ventricular pacemaker implantation

Treatment:

Procedure: Right ventricular pacemaker implantation