RecruitingNot ApplicableNCT07095959

Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation

Sponsor

Beijing Anzhen Hospital

Enrollment

340 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

Summary

The Marvel-PAF trial is an investigator initiated, multi-center, open-label, randomized trial, which aims to compare the effectiveness of vein of Marshall in addition to pulmonary vein isolation using pulsed field ablation in the treatment of paroxysmal atrial fibrillation. The primary endpoint is any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age over 18 years;
With symptomatic\* paroxysmal AF;
Undergoing first AF ablation;
At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.
Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort

Exclusion Criteria11

Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
Thrombosis in the heart cavity;
Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
Stroke or transient ischemic attacks (TIA) in the past 3 months;
History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
Other patients who were not suitable for enrollment in this study after the investigator's evaluation;

Interventions

PROCEDUREvein of Marshall ethanol infusion

After PFA, the coronary sinus venography will be acquired in search of VOM ostium. Then an over-the-wire balloon will be sent into the VOM and deflated with 4-6 atm. Selective VOM venography will be performed, followed by injection of 10ml 95% ethanol into the VOM.

PROCEDUREPVI using pulsed field ablation

Bilateral pulmonary vein antrum ablation using a pulsed field ablation