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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two ablation techniques for people with paroxysmal atrial fibrillation (AF — a type of irregular heartbeat that comes and goes) who are having their first ablation procedure. It compares pulsed electric field (PEF) ablation alone versus PEF ablation combined with an injection of ethanol (alcohol) into a vein near the heart called the Marshall vein, which may improve long-term results. **You may be eligible if...** - You are over 18 years old - You have symptomatic paroxysmal AF (episodes that last less than 7 days and cause symptoms like palpitations, dizziness, or shortness of breath) - You have had at least one documented AF episode in the past 12 months - This is your first AF ablation procedure **You may NOT be eligible if...** - Your AF is persistent (lasting more than 7 days) rather than paroxysmal - You have a blood clot in the heart - You have a contraindication to blood thinners (e.g., history of heparin-induced thrombocytopenia) - Your AF is caused by a reversible cause (e.g., thyroid disease or electrolyte imbalance) - You had a heart attack or coronary procedure in the past 3 months - You had a stroke or TIA in the past 3 months - You have had prior heart surgery involving the left atrium, or you have severe valve disease, hypertrophic cardiomyopathy, or a very large left atrium - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT07095959


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