Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
NCT07095959 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340
Last updated 2025-08-07
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)
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
PVI using pulsed field ablation
Bilateral pulmonary vein antrum ablation using a pulsed field ablation
Sponsors & Collaborators
-
Beijing Anzhen Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2027-07-10
- Completion
- 2027-09-01
Countries
- China
Study Locations
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