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NCT07471308Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
10 Mar 2026
Start date
13 Apr 2026
Primary completion date
31 Aug 2026
Lead sponsor
CathVision ApS
NCT number
NCT07471308

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 13 Apr 2026 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cardiac recording data incomplete or not of sufficient quality
  • Cardiac anatomical variation such as Left Common, or Right Accessory

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Valley Hospital
Coordinator of this site? Confirm its status
ParamusUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.