Using ethanol infusion to improve atrial fibrillation ablation success

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

This study is testing if adding ethanol infusion to a specific heart procedure can help people with persistent atrial fibrillation have better outcomes and fewer heart rhythm problems after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06363604 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with symptomatic, non-valvular persistent atrial fibrillation that has not responded to at least one antiarrhythmic drug.

Not a fit: Patients with acute conditions, severe heart failure, or significant comorbidities such as uncontrolled malignancies or liver/kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the effectiveness of atrial fibrillation ablation, leading to better long-term outcomes for patients.

How similar studies have performed: While the specific combination of techniques in this trial may be novel, similar approaches in atrial fibrillation ablation have shown promising results in previous studies.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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.

Conditions Atrial Fibrillation