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

NCT07471308 · tracked via the Priya Life Science USA tracker

Sponsor

CathVision ApS

Phase

Observational

Started

2026-04-13

Last updated

2026-10-20

Condition(s) studied

Atrial Fibrillation (AF)Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA SystemAtrial Fibrillation (Paroxysmal)Pulmonary Vein Isolation

Investigational drug(s) / intervention(s)

AF Recurrence RIsk Assessment post pulmonary vein isolation

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

Study 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.

Eligibility

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Primary Objective — 6 months
Evaluate predictive performance of a novel prognostic algorithm (called FollowGenius) combining p-wave duration and procedural unipolar atrial local potential measurements in predicting recurrence of AF after pulmonary vein isolation using PFA.

Trial sites (1)

Facility	City	Region	Status
The Valley Hospital	Paramus	New Jersey

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07471308 on ClinicalTrials.gov ↗ ← All trials in the USA