Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| PFA-PVI group | Active Comparator | PVI will be performed with PFA only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caihua Sang, MD | Contact | +86 010-81992280 | sch9613070@sina.com | |
| Yiwei Lai | Contact | yiweil0624@foxmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
Individual data will be shared only upon reasonable request to the principal investigator
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PVI using pulsed field ablation | Procedure | Bilateral pulmonary vein antrum ablation using a pulsed field ablation |
|
| 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 | Total AF/AFL time devided by total monitoring time | 12 months after procedure excluding the 2-months blanking period |
| procedural complications | 30 days after the procedure |
| Change in quality of life | Assessed by AFEQT scale | at baseline and 12 months after procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided