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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Recurrence of atrial arrhythmias
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Recurrence of atrial arrhythmias
时间窗: 3 and 12 months from the date of procedure
Efficacy endpoint: Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (sustaining more than 30s)
次要结局
- Procedural complications(through study completion, an average of 1 year)