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

Official 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

Overview

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.

Interventions

• Procedure Pacemaker implantation using left bundle branch area stimulation
  Pacemaker implantation using left bundle branch area stimulation
• Procedure Right ventricular pacemaker implantation
  Right ventricular pacemaker implantation

Primary outcome measures

• number of cardiovascular deaths [Time frame: 24 months]
• number of hospitalizations for heart failure [Time frame: 24 months]
• number of surgical reinterventions [Time frame: 24 months]

Secondary outcome measures (10)

• success rate of the LBAP technique [Time frame: 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]
• ECG measurements [Time frame: 3, 12, and 24 months post-implantation]
• left ventricular function (LVEF) [Time frame: 3, 12, and 24 months post-implantation]
• left ventricular diameter [Time frame: 3, 12, and 24 months post-implantation]
• creatinine levels [Time frame: 3, 12, and 24 months post-implantation]
• GFR in CKD EPI [Time frame: 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]
• EQ-5D-5L questionnaire. [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 7 centers

• Brest University Hospital — Brest
• Rennes University Hospital — Rennes
• Tours University Hospital — Tours
• Nantes University Hospital — Nantes
• Clermont Ferrand University Hospital — Clermont-Ferrand
• Rouen University Hospital — Rouen
• Poitiers University Hospital — Poitiers

Identifiers

NCT: NCT07236489 · RC24_0610

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗