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Compares treatment options for Atrial Fibrillation (AF)
Official title Marshall Vein Ethanol Infusion in Addition to Pulsed Electric Field Ablation Versus Pulsed Electric Field Ablation Alone for Paroxysmal Atrial Fibrillation
ClinicalTrials.gov ID: NCT07095959
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
- 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;
See the full eligibility 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.
- Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort
- Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
- 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;
- 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;
- TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
- 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...
- Other patients who were not suitable for enrollment in this study after the investigator's evaluation;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.