Hybrid Ablation of Atrial Fibrillation in Heart Failure

Официальное название

A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure

Обзор

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure

Подробное описание

The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF and heart failure.

Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Вмешательства

• Устройство AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip
  Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation
• Устройство Endocardial Catheter Ablation
  Standard percutaneous endocardial catheter ablation of atrial fibrillation

Первичные конечные точки

• Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications [Срок оценки: Measured from the end of a 3-month blanking period at 12 and 24 months]

Вторичные конечные точки (9)

• Safety Endpoint [Срок оценки: Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure]
• Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications [Срок оценки: Measured from the end of a 3- month blanking period at 12 and 24 months]
• Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications) [Срок оценки: Measured from the end of a 3- month blanking period at 12 and 24 months]
• To assess left ventricular structural remodelling and change in ventricular function in response to either procedure [Срок оценки: Pre-procedure and at 12 and 24 months post-procedure]
• To assess left atrial remodelling in response to either technique. [Срок оценки: Pre-procedure and up to 12 and 24 months post-procedure]
• To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score) [Срок оценки: Pre-procedure and at 12 and 24 months post-procedure]
• To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class). [Срок оценки: Pre-procedure and at 12 and 24 months post-procedure]
• To evaluate the effects of the interventions on the patient's quality of life (EQ5D) [Срок оценки: Pre-procedure and at 12 and 24 months post-procedure]
• To evaluate the effects of the interventions on the patient's quality of life (AFEQT) [Срок оценки: Pre-procedure and at 12 and 24 months post-procedure]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Persistent or Long-standing Persistent AF
• Dilated left atrium (at least moderately dilated)
• Suitable for either procedure
• LVEF < 50%

Критерии исключения

• Not yet optimised from a medical or lifestyle perspective for AF or heart failure
• Unable to provide written consent
• Previous open-heart surgery
• Active infection, oesophageal ulcer stricture or oesophageal varices
• Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
• Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation
• Severe valvular heart disease
• Unstable coronary artery disease
• Uncontrolled ventricular arrhythmia
• Heart attack or stroke within the last 90 days
• Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months
• Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures

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

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 7 центров

• Ashford & St Peters Hospital NHS Trust — Chertsey
• Epsom General Hospital — Epsom
• Cromwell Hospital — London
• Royal Surrey County Hospital — London
• St Anthonys Hospital — London
• St Georges at Kingston Hospital — London
• St Georges University of London — London

Публикации

• Ahmed O, Behr ER, White S, Momin A, Kaba RA MBChB, FRCP. Convergent Hybrid Ablation Versus Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure: HALT AF Study Protocol and Rationale for a Multicenter Randomized Controlled Trial. J Am Heart Assoc. 2026 Jun 2;15(11):e047774. doi: 10.1161/JAHA.125.047774. Epub 2026 May 29. PMID 42216292

Идентификаторы

NCT: NCT05411614 · 2021.0137

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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