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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine260 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

260

Conditions

Atrial Fibrillation

Interventions

VOMEI + PVI + linear ablation of mitral isthmusPROCEDURE

The CS angiography is firstly performed to visualize the vein of Marshall. The ethanol infusion by anhydrous alcohol is then performed by using a guidewire and an OTW ballon. For radiofrequency catheter ablation, the standard procedure of pulmonary vein isolation is performed. All the enrolled persistent AF patients perform the routine linear ablation of mitral isthmus.

Posterior wall isolationPROCEDURE

PWI is additionally performed for experimental group with linear ablation of LA roof and bottom line, and verified by mapping with a multielectrode catheter.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Recurrence of atrial arrhythmias

Efficacy endpoint: Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (sustaining more than 30s)

Time frame: 3 and 12 months from the date of procedure

Secondary Outcomes

Procedural complications

Safety endpoint: Occurrence of of atrioesophageal fistula, pulmonary vein stenosis, pericardial tamponade, phrenic nerve injury, and embolism

Time frame: through study completion, an average of 1 year

Central Contacts

Yichi YU, Dr.

CONTACT

+8613585563975 yuyichi@xinhuamed.com.cn

Data from ClinicalTrials.gov

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