Marshall vein ethanol injection plus pulsed-field pulmonary vein isolation for paroxysmal atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MARVEL-PAF trial randomizes adults with symptomatic paroxysmal atrial fibrillation undergoing their first ablation to either pulsed-field pulmonary vein isolation (PVI) alone or PVI plus ethanol infusion into the vein of Marshall. It is an open-label, randomized, investigator-initiated study with planned multi-center enrollment. The primary endpoint is any atrial arrhythmia lasting ≥30 seconds off antiarrhythmic drugs during 12 months after the procedure, excluding a 2-month blanking period. Patients receive standard procedural care with scheduled rhythm monitoring to detect recurrences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age over 18 years;
2. With symptomatic\* paroxysmal AF;
3. Undergoing first AF ablation;
4. At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
5. 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:

1. Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
2. Thrombosis in the heart cavity;
3. Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
4. Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
5. Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
6. Stroke or transient ischemic attacks (TIA) in the past 3 months;
7. History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
8. History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
9. TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
10. 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.);
11. Other patients who were not suitable for enrollment in this study after the investigator's evaluation;

Where it's running

• Beijing Anzhen Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Caihua Sang, MD
• Email: sch9613070@sina.com
• Phone: +86 010-81992280

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.