Using ethanol infusion to improve atrial fibrillation ablation success

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) in improving the success rate of ablation for persistent atrial fibrillation (AF). A total of 260 participants will be randomly assigned to two groups: one receiving VOMEI along with PWI and linear ablation, and the other receiving VOMEI with linear ablation only. The primary goal is to assess the recurrence of atrial tachyarrhythmias within 3 to 12 months post-procedure, while secondary outcomes will focus on procedural safety and complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. 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;
2. On the heart transplant list;
3. Life expectancy less than 1 year;
4. With other bleeding disorders that cannot be treated with anticoagulation therapy;
5. With left atrial thrombus;
6. Heart failure with NYHA class III-IV or LVEF\<40%;
7. With uncontrolled malignant tumor;
8. Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%);
9. History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
10. Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.

Where it's running

• Xinhua Hospital, Shanghai Jiao Tong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yigang LI, Dr. — Xinhua Hospital, Shanghai Jiaotong University School of Medicine
• Study coordinator: Yichi YU, Dr.
• Email: yuyichi@xinhuamed.com.cn
• Phone: +8613585563975

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.