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

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

This trial will test whether injecting ethanol into the vein of Marshall in addition to pulsed-field pulmonary vein isolation reduces return of atrial fibrillation in adults with symptomatic paroxysmal AF undergoing their first ablation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07095959 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with symptomatic paroxysmal AF who are undergoing their first AF ablation, have at least one documented AF episode >30 seconds in the past 12 months, and can consent to randomization and follow-up are ideal candidates.

Not a fit: Patients with persistent AF (>7 days), intracardiac thrombus, contraindications to anticoagulation, transient/reversible AF from non-cardiac causes, or other protocol exclusions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding Marshall vein ethanol infusion could lower AF recurrence rates and reduce the need for repeat ablation.

How similar studies have performed: Previous studies have reported benefit from vein-of-Marshall ethanol infusion when added to radiofrequency PVI, but combining it with pulsed-field ablation is less established.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Caihua Sang, MD

Conditions Atrial Fibrillation