Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

Обзор

The design of this study is an intervention, randomized, controlled study and contains three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM group.

Вмешательства

• Процедура PVI
  PVI
• Процедура PWI
  PWI
• Процедура EGM
  EGM

Первичные конечные точки

• Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months [Срок оценки: 12 months]
• Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure [Срок оценки: 12 months]
• The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs. [Срок оценки: 12 months]
• Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs) [Срок оценки: 12 months]
• Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy [Срок оценки: 12 months]
• freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period. [Срок оценки: 12 months]
• Procedure time / Fluoroscopy time / ablation time [Срок оценки: 12 months]
• Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality. [Срок оценки: 12 months]
• Quality of life assessments during ≥12-month follow-up (AFEQT) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥18 years
• First-time ablation for persistent atrial fibrillation (PsAF)
• Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
• Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
• Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
• Ability and willingness to provide written informed consent
• Compliance with all study follow-up requirements

Критерии исключения

• Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
• Long-standing persistent AF: Continuous AF duration >3 years
• No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
• Contraindications to systemic anticoagulation
• Pregnancy
• Advanced renal or hepatic failure
• Severe valvular heart disease or cyanotic congenital heart disease
• Hypertrophic cardiomyopathy (HCM)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT07122336 · OAPWAF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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