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

NCT ID: NCT07095959

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-09-01

Brief 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.

Conditions

Atrial Fibrillation (AF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PFA-PVI + EIVOM group

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

Group Type: EXPERIMENTAL

vein of Marshall ethanol infusion

Intervention Type: 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

Intervention Type: PROCEDURE

Bilateral pulmonary vein antrum ablation using a pulsed field ablation

PFA-PVI group

PVI will be performed with PFA only

Group Type: ACTIVE_COMPARATOR

PVI using pulsed field ablation

Intervention Type: PROCEDURE

Bilateral pulmonary vein antrum ablation using a pulsed field ablation

Interventions

vein 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.

Intervention Type: PROCEDURE

PVI using pulsed field ablation

Bilateral pulmonary vein antrum ablation using a pulsed field ablation

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caihua Sang

Executive director of Arrhythmia center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Caihua Sang, MD

Role: CONTACT

sch9613070@sina.com

+86 010-81992280

Yiwei Lai

Role: CONTACT

yiweil0624@foxmail.com

Facility Contacts

Caihua Sang

Role: primary

sch9613070@sina.com

+86 010-81992280

Other Identifiers

MARVEL-PAF

Identifier Type: -

Identifier Source: org_study_id