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

NCT07471308 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-15

No results posted yet for this 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.

Conditions

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

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

Sponsors & Collaborators

  • CathVision ApS

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471308 on ClinicalTrials.gov