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NCT Number: NCT07236489

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.

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Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pacemaker Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest University Hospital, Brest, Finistère, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacemaker implantation using left bundle branch area stimulation

Procedure

Pacemaker implantation using left bundle branch area stimulation

Right ventricular pacemaker implantation

Procedure

Right ventricular pacemaker implantation

Primary outcomes

  1. number of cardiovascular deaths

    Time frame: 24 months

  2. number of hospitalizations for heart failure

    Time frame: 24 months

  3. number of surgical reinterventions

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. 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. ECG measurements

    Time frame: 3, 12, and 24 months post-implantation

    QRS duration (ms)

  4. left ventricular function (LVEF)

    Time frame: 3, 12, and 24 months post-implantation

  5. left ventricular diameter

    Time frame: 3, 12, and 24 months post-implantation

  6. creatinine levels

    Time frame: 3, 12, and 24 months post-implantation

  7. GFR in CKD EPI

    Time frame: 3, 12, and 24 months post-implantation

  8. 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

  9. EQ-5D-5L questionnaire.

    Time frame: Baseline (inclusion), 3, 12, and 24 months post-treatment

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Damien MINOIS, M.D

CONTACT

[email protected]

+33244768742

Research and Innovation Departement of Nantes UH

CONTACT

[email protected]

+33253482810

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: LBAP-TAVI

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 19, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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