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NOT YET RECRUITING
NCT07471308

P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation

Sponsor: CathVision ApS

View on ClinicalTrials.gov

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.

Official title: Validation of an Algorithm Designed to Predict the Recurrence of AF After Pulmonary Vein Isolation Using P-wave Duration and Procedural Unipolar Atrial Local Potential Measurements

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-04

Completion Date

2026-08

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

AF Recurrence RIsk Assessment post pulmonary vein isolation

AF Recurrence RIsk Assessment post pulmonary vein isolation based on PWD and Residual Local Potentials

Locations (1)

The Valley Hospital

Paramus, New Jersey, United States