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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.