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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Anzhen Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Caihua Sang, MD
sch9613070@sina.com
+86 010-81992280
Backup
Yiwei Lai
yiweil0624@foxmail.com
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 340
Treatments
Experimental: 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.
Active_comparator: PFA-PVI group
PVI will be performed with PFA only
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov