P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
Running, not enrolling
Conditions studied: Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
In brief
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.
Key facts
- Study ID
- NCT07471308
- Run by
- CathVision ApS
- People needed
- 300
- Starts
- 2026-04-13
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Valley Hospital — Paramus, New Jersey, United States
Full record on ClinicalTrials.gov
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