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

NCT07095959 | Recruiting DMC

• 1 other identifier: MARVEL-PAF
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

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

  12 months after procedure excluding the 2-month blanking period

Secondary Outcomes (6)

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

  12 months after procedure excluding the 2-months blanking period

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

  12 months after procedure excluding the 2-months blanking period

• Any atrial arrhythmias after multiple ablation with or without AADs

  12 months after first procedure excluding the 2-months blanking period

• AF burden

  12 months after procedure excluding the 2-months blanking period

• procedural complications

  30 days after the procedure

Study Arms (2)

PFA-PVI + EIVOM group

EXPERIMENTAL

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

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

PFA-PVI group

ACTIVE COMPARATOR

PVI will be performed with PFA only

Procedure: PVI using pulsed field ablation

Interventions

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.

PFA-PVI + EIVOM group

PVI using pulsed field ablation PROCEDURE

Bilateral pulmonary vein antrum ablation using a pulsed field ablation

PFA-PVI + EIVOM group; PFA-PVI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caihua Sang, MD

CONTACT

+86 010-81992280; sch9613070@sina.com

Yiwei Lai

CONTACT

yiweil0624@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive director of Arrhythmia center

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 31, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)