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

Part of paid clinical trials in Paramus, New Jersey.

Sponsor
CathVision ApS
Study ID
NCT07471308
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Apr 13, 2026
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Cohort 1 - Continuous monitoring
    Subject with continuous post-procedure monitoring, such as ILR, pacemaker, and CRT device
  • Arm: Cohort 2 - Transient monitoring
    Subject with transient monitoring, such as Holter, and tracking devices
  • Arm: Cohort 3 - Punctual monitoring
    Subject with punctual monitoring, such as reported symptoms during physician visit

Primary Outcome Measure

Primary Objective [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Valley HospitalParamusNew Jersey07652-

Find similar trials in Paramus, NJ

By research site
The Valley Hospital· Paramus, NJ

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