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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
340
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.
Bilateral pulmonary vein antrum ablation using a pulsed field ablation
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAny atrial arrhythmias lasting ≥30s without AAD during 12 months after procedure excluding the 2-months blanking period
Time frame: 12 months after procedure excluding the 2-month blanking period
Any atrial arrhythmias lasting ≥30s with or without AAD during 12 months after procedure excluding the 2-months blanking period
Time frame: 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
Time frame: 12 months after procedure excluding the 2-months blanking period
Any atrial arrhythmias after multiple ablation with or without AADs
Time frame: 12 months after first procedure excluding the 2-months blanking period
AF burden
Total AF/AFL time devided by total monitoring time
Time frame: 12 months after procedure excluding the 2-months blanking period
procedural complications
Time frame: 30 days after the procedure
Change in quality of life
Assessed by AFEQT scale
Time frame: at baseline and 12 months after procedure
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