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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2029-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrioventricular Block Pacemaker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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LBAP : Left Bundle Area Pacing

Pacemaker implantation using left bundle branch area stimulation

Group Type EXPERIMENTAL

Pacemaker implantation using left bundle branch area stimulation

Intervention Type PROCEDURE

Pacemaker implantation using left bundle branch area stimulation

RVP : Right Ventricular Pacing

Right ventricular pacemaker implantation

Group Type PLACEBO_COMPARATOR

Right ventricular pacemaker implantation

Intervention Type PROCEDURE

Right ventricular pacemaker implantation

Interventions

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Pacemaker implantation using left bundle branch area stimulation

Intervention Type PROCEDURE

Right ventricular pacemaker implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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