Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study

Официальное название

Redo-Pulmonary Vein Isolation Using Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Atrial Fibrillation: A Multi-Centre Randomized Clinical Trial: The REDO-PIFPAF-PFA Study

Обзор

The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.

Подробное описание

In most patients, recurrence after ablation is caused by reconnection of previously isolated pulmonary veins (PV). However, atrial fibrillation (AF) recurrence may also result from progressive atrial remodelling, structural disease progression, and triggers originating outside the PVs. While there are multiple randomized controlled trials and clear recommendations for de novo ablations, there is a notable lack of studies and guideline recommendations for redo ablation procedures. Current practice therefore remains heterogeneous, and optimal lesion sets in the redo setting are not defined. The study aims to address this deficiency by undertaking a randomised comparison of two strategies that have already been adopted.

Вмешательства

• Процедура Pulmonary vein isolation with posterior wall ablation
  Redo-pulmonary vein isolation with left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.
• Процедура Pulmonary vein isolation without posterior wall ablation
  Redo-pulmonary vein isolation without left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

Первичные конечные точки

• Time to first recurrence of any atrial tachyarrhythmia day 61-365 [Срок оценки: Day 61-365 post-ablation]

Вторичные конечные точки (12)

• Treatment-emergent adverse events: Cardiac tamponade requiring drainage [Срок оценки: Day 0-90 post-ablation]
• Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours [Срок оценки: Day 0-90 post-ablation]
• Treatment-emergent adverse events: Serious vascular complication requiring intervention [Срок оценки: Day 0-90 post-ablation]
• Treatment-emergent adverse events: Stroke or TIA [Срок оценки: Day 0-90 post-ablation]
• Treatment-emergent adverse events: Atrioesophageal fistula [Срок оценки: Day 0-90 post-ablation]
• Treatment-emergent adverse events: Death [Срок оценки: Day 0-90 post-ablation]
• Total procedure time [Срок оценки: Day 0, during procedure]
• Total left atrial indwelling time [Срок оценки: Day 0, during procedure]
• Total fluoroscopy time [Срок оценки: Day 0, during procedure]
• Total radiation dose [Срок оценки: Day 0, during procedure]
• Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin [Срок оценки: Pre-procedural (day -1 or day 0) to day 1 post-ablation]
• Post-ablation 3D-EAM: Assessment of atrial low-voltage/scar [Срок оценки: Day 0, shortly after ablation]

Критерии участия

Критерии включения

• Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.
• Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.
• Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.
• Age ≥ 18 years at the time of informed consent.
• Written informed consent obtained prior to any study-related procedures.

Критерии исключения

• Previous LA surgery
• > 1 prior LA ablation
• LA ablation outside of the PVs in the first LA ablation
• LA diameter >60 mm in the parasternal long axis
• Patients in persistent AF lasting >3 years
• AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
• Pre-existing PV stenosis or PV stent
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• Prior mitral valve surgery
• Severe mitral regurgitation or moderate/severe mitral stenosis
• Myocardial infarction during the 3-month period preceding the consent date
• Ongoing triple antithrombotic/anticoagulation therapy
• Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/transcatheter aortic valve implantation procedure
• Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale)
• New York Heart Association (NYHA) class III or IV congestive heart failure
• Left ventricular ejection fraction (LVEF) <35%
• Hypertrophic cardiomyopathy or left septal wall thickness >1.5 cm
• Significant chronic kidney disease (eGFR <30 ml/min)
• Uncontrolled hyperthyroidism
• Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
• Ongoing systemic infections
• Cardiac amyloidosis
• Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
• Life expectancy less than one year per physician opinion
• Currently participating in any other clinical trial, which may confound the results of this trial.
• Unwilling or unable to comply fully with the study procedures and FU.

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

Швейцария · 5 центров

• University Hospital Basel — Basel
• Bern University Hospital — Bern
• University Hospital Lausanne — Lausanne
• Cantonal Hospital of St. Gallen — Sankt Gallen
• University Hospital Zurich, — Zurich

Идентификаторы

NCT: NCT07745543 · 2026-00465; kt25badertscher2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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