NCT07095959Recruiting
Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 10 Jul 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07095959
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 31 Jul 2025 to the primary completion date, 10 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- 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
- Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
- TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
- Other patients who were not suitable for enrollment in this study after the investigator's evaluation;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.