Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07236489

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

Led by Nantes University Hospital · Updated on 2026-04-15

266

Participants Needed

7

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
  • Preserved left ventricular ejection fraction (LVEF 250%)
  • 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 270 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Brest University Hospital

Brest, Finistère, France, 29200

Actively Recruiting

2

Rennes University Hospital

Rennes, Ille-et-Vilaine, France, 35033

Actively Recruiting

3

Tours University Hospital

Tours, Indre-et-Loire, France, 37044

Actively Recruiting

4

Nantes University Hospital

Nantes, Loire-Atlantique, France, 44093

Actively Recruiting

5

Clermont Ferrand University Hospital

Clermont-Ferrand, Puy-de-Dôme, France, 63003

Not Yet Recruiting

6

Rouen University Hospital

Rouen, Seine-Maritime, France, 76031

Actively Recruiting

7

Poitiers University Hospital

Poitiers, Vienne, France, 86021

Actively Recruiting

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Research Team

R

Research and Innovation Departement of Nantes UH

CONTACT

D

Damien MINOIS, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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