RecruitingNot ApplicableNCT06363604

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

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

260 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

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 Criteria10

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.

Interventions

PROCEDUREVOMEI + PVI + linear ablation of mitral isthmus

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.

PROCEDUREPosterior wall isolation

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