PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study (NCT07621003) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
264 participantsStarted 2026-07-01
Plain-language summary
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\<3 years) compared to usual care, defined as OMT.
Who can participate
Age range
18 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:
* Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation
* First diagnosis of AF within the last 36 months
* At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device
* No prior catheter ablation for AF
Exclusion Criteria:
* Persistent AF \>3 years or longstanding persistent AF
* Previous AF-Ablation
* Ongoing continuous AAD therapy with Amiodarone at baseline
* History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy
* Left Atrial Volume Index (LAVI) \> 50mL/m2
* Severe mitral regurgitation
* Contraindications to anticoagulation therapy
* Severe pulmonary or renal disease
* Pregnancy, active cancer disease
* Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)
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.