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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 7 центров

• 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

Идентификаторы

NCT: NCT07236489 · RC24_0610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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