P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isola… (NCT07471308) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
United States300 participantsStarted 2026-04-13
Plain-language summary
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4.
Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients5. Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and Antiarrhythmic Drug management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation6. In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up7.
FOLLOW-AF is a retrospective, observational cohort study designed to validate the FollowGenius algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation.
The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.
Who can participate
Age range
21 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:
* Age ≥ 21 years
* Paroxysmal or persistent atrial fibrillation
* Underwent pulmonary vein isolation using pulse field ablation
* Patient record with pre-/post-ablation 12-lead ECGs and intra-procedural unipolar electrograms
Exclusion Criteria:
* Incomplete patient record:
* Lack of 12-leads ECG recording or intracardiac electrograms
* Lack of post-procedure follow-up assessment
* Follow-up was less than 6 months
* Cardiac recording data incomplete or not of sufficient quality
* Cardiac anatomical variation such as Left Common, or Right Accessory
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.