Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation

Официальное название

Randomized Controlled Study of Atrial Posterior Wall Isolation (PWI) Assisted by Vein of Marshall Ethanol Infusion (VOMEI) and Pulmonary Vein Isolation in Persistent Atrial Fibrillation Ablation

Обзор

This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation.

Подробное описание

A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.

Group 1: VOMEI + PVI + linear ablation + PWI; Group 2: VOMEI + PVI +linear ablation. The major endpoint (efficacy endpoint) is the recurrence of atrial tachyarrhythmias between 3-12 months during follow-up. The secondary endpoint (safety endpoint) is the occurrence of procedural complications.

Вмешательства

• Процедура VOMEI + PVI + linear ablation of mitral isthmus
  The CS angiography is firstly performed to visualize the vein of Marshall. The ethanol infusion by anhydrous alcohol is then performed by using a guidewire and an OTW ballon. For radiofrequency catheter ablation, the standard procedure of pulmonary vein isolation is performed. All the enrolled persistent AF patients perform the routine linear ablation of mitral isthmus.
• Процедура Posterior wall isolation
  PWI is additionally performed for experimental group with linear ablation of LA roof and bottom line, and verified by mapping with a multielectrode catheter.

Первичные конечные точки

• Recurrence of atrial arrhythmias [Срок оценки: 3 and 12 months from the date of procedure]

Вторичные конечные точки (1)

• Procedural complications [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Between 18-85 years old;
• Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
• Prepared to undergo atrial fibrillation catheter ablation;
• Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.

Критерии исключения

• Presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months;
• On the heart transplant list;
• Life expectancy less than 1 year;
• With other bleeding disorders that cannot be treated with anticoagulation therapy;
• With left atrial thrombus;
• Heart failure with NYHA class III-IV or LVEF<40%;
• With uncontrolled malignant tumor;
• Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr<50%);
• History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
• Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.

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

• Xinhua Hospital, Shanghai Jiao Tong University — Шанхай

Публикации

• Chen M, Li C, Liao P, Cui X, Tian W, Wang Q, Sun J, Yang M, Luo L, Wu H, Li YG. Epidemiology, management, and outcomes of atrial fibrillation among 30 million citizens in Shanghai, China from 2015 to 2020: A medical insurance database study. Lancet Reg Health West Pac. 2022 May 3;23:100470. doi: 10.1016/j.lanwpc.2022.100470. eCollection 2022 Jun. PMID 35542895
• Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913. PMID 12968085
• Sun J, Chen M, Wang Q, Zhang PP, Li W, Zhang R, Mo BF, Han B, Li XJ, Du W, Zhao L, Wang H, Yang B, Wu Y, Cai X, Li C, Chen TZ, Li YG. Adding six short lines on pulmonary vein isolation circumferences reduces recurrence of paroxysmal atrial fibrillation: Results from a multicenter, single-blind, randomized trial. Heart Rhythm. 2022 Mar;19(3):344-351. doi: 10.1016/j.hrthm.2021.11.014. Epub 2021 Nov PMID 34775069
• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288. PMID 25946280
• Clarke JD, Piccini JP, Friedman DJ. The role of posterior wall isolation in catheter ablation of persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2567-2576. doi: 10.1111/jce.15164. Epub 2021 Jul 21. PMID 34258794
• Sugumar H, Thomas SP, Prabhu S, Voskoboinik A, Kistler PM. How to perform posterior wall isolation in catheter ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2018 Feb;29(2):345-352. doi: 10.1111/jce.13397. Epub 2017 Dec 26. PMID 29178497
• Cutler MJ, Johnson J, Abozguia K, Rowan S, Lewis W, Costantini O, Natale A, Ziv O. Impact of Voltage Mapping to Guide Whether to Perform Ablation of the Posterior Wall in Patients With Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2016 Jan;27(1):13-21. doi: 10.1111/jce.12830. Epub 2015 Oct 30. PMID 26515166
• Bai R, Di Biase L, Mohanty P, Trivedi C, Dello Russo A, Themistoclakis S, Casella M, Santarelli P, Fassini G, Santangeli P, Mohanty S, Rossillo A, Pelargonio G, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma CS, Tondo C, Natale A. Proven isolation of the pulmonary vein antrum with or without left atrial posterior wall isolation in patients with persistent atrial fibrillation. Heart Rhythm. PMID 26277862

Идентификаторы

NCT: NCT06363604 · XHEC-C-2023-128-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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