Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation (NCT07021313) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Netherlands378 participantsStarted 2025-06-30
Plain-language summary
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
* Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
* Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
Exclusion Criteria:
* Cerebrovascular accident (CVA) in the last 6 months
* More than moderate valvular disease that would require intervention
* Cardiac catheter/surgical intervention in the last 3 months or scheduled
* Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
* Left atrial appendage (LAA) closure in the past
* Mechanical mitral valve
* Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
* Renal disease with known eGFR\<45 ml
* Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm
* Known contra-indication for catheter ablation
* Known contra-indication for deep sedation or general anesthesia
* Known pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure.