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Набор скоро начнётся NCT07245147

REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention

Без фазы С лечением Atrial Fibrillation (AF) AV Node Ablation Left Bundle Branch Pacing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Redo AF Ablation, Pace and Ablate.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation (AF), AV Node Ablation, Left Bundle Branch Pacing. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Обзор

The goal of this randomized open-label clinical trial is to evaluate two different strategies for the treatment of recurrent atrial fibrillation (AF) after AF ablation. Patients who have symptomatic, drug-refractory recurrence of AF will be randomized to either a redo AF ablation vs conduction system pacing with AV node ablation. Patients will need to have undergone at least 1 prior AF ablation to be considered eligible for the study. The current trial is a vanguard study of 16 patients and will determine the feasibility of enrolment, compare changes in quality of life, and inform the design of the definitive REDO AF trial.

Подробное описание

Recurrence rates after atrial fibrillation (AF) ablation procedures are high at approximately 50% at 18 months and are associated with procedural risk as well as with significant costs. There is limited guidance on how best to treat those who recur post AF ablation. The combination of pacemaker implantation and atrioventricular node ablation (AVNA), so-called "pace-and-ablate" strategy, is an alternative treatment in patients who are at high risk of AF recurrence, especially since the recent introduction of left bundle branch pacing (LBBP). LBBP is a type of pacing strategy that captures the intrinsic conduction system and preserves normal physiological ventricular activation. The REDO-AF Trial will compare a strategy of pace-and-ablate therapy with LBBP + AVNA as compared to a strategy of redo AF ablation in medically refractory patients presenting with recurrent symptomatic AF post AF ablation. We hypothesize that a pace-and-ablate strategy will result in reduction in cardiovascular hospitalizations, procedural complications and an improvement in quality of life (QOL). The definitive research question of the REDO-AF trial is: Can a strategy of LBBP combined with AVNA in patients with recurrent, symptomatic, drug-refractory AF after previous AF ablation(s), who remain at high risk of recurrence, lead to a reduction in cardiovascular hospitalizations, reduction in procedure or device-related complications, and a greater improvement in QOL as compared to a subsequent (redo) AF ablation.

Вмешательства

  • Процедура Redo AF Ablation
    Redo AF Ablation as per operator discretion
  • Процедура Pace and Ablate
    Left bundle branch pacing with AV node ablation

Первичные конечные точки

  • Cardiac Hospitalization [Срок оценки: 1 year]
  • Quality of Life Improvements [Срок оценки: 1 year]
  • Feasibility of Enrolment [Срок оценки: 1 year]
  • Procedural and Device-Related Complications not requiring a hospitalization [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • One or more prior left atrial (LA) ablation procedure(s) for AF
  • Symptomatic AF/atypical atrial flutter/atrial tachycardia with failure of or intolerance to medical rate or rhythm control therapy, that is detected at >2 months post most recent LA ablation procedure
  • Either a LA volume index on any prior echo of >= 45ml/m2 or LA diameter >= 50mm OR a HATCH score >=2 (where 1 point is given for each for hypertension, Age>75, COPD, and 2 points for each of stroke/TIA, or HF (defined as signs or symptoms of pulmonary edema and may include HFrEF or HFpEF)
  • Be considered suitable for both treatment strategies of redo ablation and pacemaker and AV node ablation
  • Willingness to participate, complete the QOL questionnaires and ability to sign informed consent

Критерии исключения

  • Severe valvular disease defined by echo criteria
  • Myocardial infarction, stroke, or coronary revascularization within the previous 3 months
  • LVEF <40% or need for an ICD
  • Life expectancy <24 months
  • Lack of capacity to consent

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
Лечение

Центры проведения

Канада · 1 центр
  • McGill University Health Center — Montreal

Идентификаторы

NCT: NCT07245147 · MP-37-2025-11136

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗