Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation

Обзор

The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.

Вмешательства

• Процедура vein of Marshall ethanol infusion
  After PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM.
• Процедура PVI using pulsed field ablation
  Bilateral pulmonary vein antrum ablation using a pulsed field ablation

Первичные конечные точки

• Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period [Срок оценки: 12 months after procedure excluding the 2-month blanking period]

Вторичные конечные точки (6)

• Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period [Срок оценки: 12 months after procedure excluding the 2-months blanking period]
• Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period [Срок оценки: 12 months after procedure excluding the 2-months blanking period]
• Any atrial arrhythmias after multiple ablation with or without AADs [Срок оценки: 12 months after first procedure excluding the 2-months blanking period]
• AF burden [Срок оценки: 12 months after procedure excluding the 2-months blanking period]
• procedural complications [Срок оценки: 30 days after the procedure]
• Change in quality of life [Срок оценки: at baseline and 12 months after procedure]

Критерии участия

Критерии включения

• Age over 18 years;
• With symptomatic\* paroxysmal AF;
• Undergoing first AF ablation;
• At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
• Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.

• Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort

Критерии исключения

• Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation >7 days;
• Thrombosis in the heart cavity;
• Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
• Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
• Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
• Stroke or transient ischemic attacks (TIA) in the past 3 months;
• History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
• History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
• TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
• Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
• Other patients who were not suitable for enrollment in this study after the investigator's evaluation;

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

Китай · 1 центр

• Beijing Anzhen Hospital Affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT07095959 · MARVEL-PAF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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