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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Posterior wall isolation; Procedure: VOMEI + PVI + linear ablation of mitral isthmus

Study type: Interventional

Funder types: Other

Identifiers

NCT06363604

XHEC-C-2023-128-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

VOMEI + PVI + linear ablation of mitral isthmus + PWI

Experimental group

Description:

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.

Treatment:

Procedure: VOMEI + PVI + linear ablation of mitral isthmus

Procedure: Posterior wall isolation

VOMEI + PVI + linear ablation of mitral isthmus

Active Comparator group

Description:

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.

Treatment:

Procedure: VOMEI + PVI + linear ablation of mitral isthmus