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

April 14, 2026 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Finistère
      • Brest, Finistère, France, 29200
        • Recruiting
        • Brest University Hospital
        • Contact:
        • Principal Investigator:
          • Jacques MANSOURATI, UH Practitioner
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • Recruiting
        • Rennes University Hospital
        • Contact:
        • Principal Investigator:
          • Nathalie BEHAR, M.D
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Recruiting
        • Tours University Hospital
        • Contact:
        • Principal Investigator:
          • Arnaud BISSON, M.D
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Damien MINOIS, M.D
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63003
        • Not yet recruiting
        • Clermont Ferrand University Hospital
        • Contact:
        • Principal Investigator:
          • Romain ESCHALIER, UH Practitioner
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76031
        • Recruiting
        • Rouen University Hospital
        • Contact:
        • Principal Investigator:
          • Frédéric ANSELME, UH Practitioner
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Poitiers University Hospital
        • Contact:
        • Principal Investigator:
          • Rodrigue GARCIA, UH Practitioner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBAP : Left Bundle Area Pacing
Pacemaker implantation using left bundle branch area stimulation
Procedure: Pacemaker implantation using left bundle branch area stimulation
Pacemaker implantation using left bundle branch area stimulation
Placebo Comparator: RVP : Right Ventricular Pacing
Right ventricular pacemaker implantation
Procedure: Right ventricular pacemaker implantation
Right ventricular pacemaker implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of cardiovascular deaths
Time Frame: 24 months
24 months
number of hospitalizations for heart failure
Time Frame: 24 months
24 months
number of surgical reinterventions
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of the LBAP technique
Time Frame: 3, 12, and 24 months post-implantation
Verification of ECG effectiveness criteria: for the LBAP group: qR or rsR' appearance and for the RVP group: QS or rS aspect
3, 12, and 24 months post-implantation
comparison of immediate and long-term complications of the LBAP stimulation
Time Frame: 3, 12, and 24 months post-implantation
Adverse events such as: pneumothorax, infection of equipment, displacement of atrial catheter, lumen haematoma, venous thrombosis, pericardial effusion, reoperation, vascular complication, catheter-specific complications
3, 12, and 24 months post-implantation
ECG measurements
Time Frame: 3, 12, and 24 months post-implantation
QRS duration (ms)
3, 12, and 24 months post-implantation
left ventricular function (LVEF)
Time Frame: 3, 12, and 24 months post-implantation
3, 12, and 24 months post-implantation
left ventricular diameter
Time Frame: 3, 12, and 24 months post-implantation
3, 12, and 24 months post-implantation
creatinine levels
Time Frame: 3, 12, and 24 months post-implantation
3, 12, and 24 months post-implantation
GFR in CKD EPI
Time Frame: 3, 12, and 24 months post-implantation
3, 12, and 24 months post-implantation
Comparison of the occurrence of atrial fibrillation and ventricular tachycardia (non-sustained or sustained), based on pacemaker monitoring data.
Time Frame: 3, 12, and 24 months post-implantation
3, 12, and 24 months post-implantation
EQ-5D-5L questionnaire.
Time Frame: Baseline (inclusion), 3, 12, and 24 months post-treatment
Baseline (inclusion), 3, 12, and 24 months post-treatment
Evaluate the cost-effectiveness of left bundle branch area pacing versus standard therapy in this population using a cost-utility analysis.
Time Frame: 24 months post-implantation
This will be calculated from EQ-5D-5L utility scores.
24 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0610

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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