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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Recurrence of atrial arrhythmias
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Recurrence of atrial arrhythmias
Time Frame: 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)
Secondary Outcomes
- Procedural complications(through study completion, an average of 1 year)