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
CathVision ApS
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.
Description
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.3 Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for symptomatic AF.4 Historically, this has been achieved using radiofrequency and thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceAF Recurrence RIsk Assessment post pulmonary vein isolation
AF Recurrence RIsk Assessment post pulmonary vein isolation based on PWD and Residual Local Potentials
Location
- The Valley HospitalParamus, New Jersey