Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

Обзор

The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation

Вмешательства

• Процедура left bundle branch of His pacing
  left bundle branch of His pacing
• Процедура right ventricular pacing
  right ventricular pacing

Первичные конечные точки

• Maximum Oxygen Consumption (VO2 max) in mL/min/kg. [Срок оценки: 18 months]

Вторичные конечные точки (5)

• walking test distance covered [Срок оценки: 18 months]
• echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time) [Срок оценки: 18 months]
• Determination of NT pro BNP or BNP [Срок оценки: 18 months]
• Physical component of quality-of-life scale (SF-36) [Срок оценки: 18 months]
• Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP [Срок оценки: 18 months]

Критерии участия

Критерии включения

1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).

5\) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form

Критерии исключения

• Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale < 5).
• LVEF < 40% at inclusion
• Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
• Patient participating in another interventional trial
• Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
• Pregnant, parturient or breast-feeding women, or those without proven contraception

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de CAEN — Caen

Идентификаторы

NCT: NCT06061978 · 2021/0379/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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