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NCT Number: NCT07095959

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Caihua Sang

CONTACT

[email protected]

+86 010-81992280

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

vein of Marshall ethanol infusion

Procedure

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.

PVI using pulsed field ablation

Procedure

Bilateral pulmonary vein antrum ablation using a pulsed field ablation

Primary outcomes

  1. Any atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period

    Time frame: 12 months after procedure excluding the 2-month blanking period

Secondary outcomes

  1. Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period

    Time frame: 12 months after procedure excluding the 2-months blanking period

  2. Any atrial flutter/atrial tachycardia lasting ≥30s during 12 months after procedure excluding the 2-months blanking period

    Time frame: 12 months after procedure excluding the 2-months blanking period

  3. Any atrial arrhythmias after multiple ablation with or without AADs

    Time frame: 12 months after first procedure excluding the 2-months blanking period

  4. AF burden

    Time frame: 12 months after procedure excluding the 2-months blanking period

    Total AF/AFL time devided by total monitoring time

  5. procedural complications

    Time frame: 30 days after the procedure

  6. Change in quality of life

    Time frame: at baseline and 12 months after procedure

    Assessed by AFEQT scale

Study contacts

Contact information is provided by the study sponsor or research team.

Caihua Sang, MD

CONTACT

[email protected]

+86 010-81992280

Yiwei Lai

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: MARVEL-PAF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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