Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation (MARVEL-PAF)

Capital Medical University

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: vein of Marshall ethanol infusion; Procedure: PVI using pulsed field ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07095959

MARVEL-PAF

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

PFA-PVI + EIVOM group

Experimental group

Description:

PVI will be performed with PFA first, then EIVOM will be performed to achieve potential cardiac autonomous nerve modulation while reinforce LPV isolation.

Treatment:

Procedure: PVI using pulsed field ablation

Procedure: vein of Marshall ethanol infusion

PFA-PVI group

Active Comparator group

Description:

PVI will be performed with PFA only

Treatment:

Procedure: PVI using pulsed field ablation