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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: VOMEI + PVI + linear ablation of mitral isthmus; Procedure: Posterior wall isolation

• Registration Number: NCT06363604
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VOMEI + PVI + linear ablation of mitral isthmus + PWI	VOMEI + PVI + linear ablation of mitral isthmus	Acquisition of left atrial posterior wall isolation by linear ablation of LA roof and bottom line, in addition to routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus.
VOMEI + PVI + linear ablation of mitral isthmus	VOMEI + PVI + linear ablation of mitral isthmus	Routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus. Left atrial posterior wall not isolated.
VOMEI + PVI + linear ablation of mitral isthmus + PWI	Posterior wall isolation	Acquisition of left atrial posterior wall isolation by linear ablation of LA roof and bottom line, in addition to routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus.

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial arrhythmias	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 Outcome Measures

Name	Time	Method
Procedural complications	through study completion, an average of 1 year	Safety endpoint: Occurrence of of atrioesophageal fistula, pulmonary vein stenosis, pericardial tamponade, phrenic nerve injury, and embolism

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China