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

NCT07471308 | Active Not Recruiting FDA Device

• 1 other identifier: CVFOLLOW-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PVI; PFA; AF; electrophysiology; cardiac ablation; catheter; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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.

  6 months

Secondary Outcomes (1)

• Secondary Objective

  6 months

Other Outcomes (1)

• Outcome

  6 months

Study Arms (3)

Cohort 1 - Continuous monitoring

Subject with continuous post-procedure monitoring, such as ILR, pacemaker, and CRT device

Device: AF Recurrence RIsk Assessment post pulmonary vein isolation

Cohort 2 - Transient monitoring

Subject with transient monitoring, such as Holter, and tracking devices

Device: AF Recurrence RIsk Assessment post pulmonary vein isolation

Cohort 3 - Punctual monitoring

Subject with punctual monitoring, such as reported symptoms during physician visit

Device: AF Recurrence RIsk Assessment post pulmonary vein isolation

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

Cohort 1 - Continuous monitoring; Cohort 2 - Transient monitoring; Cohort 3 - Punctual monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient EHR

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CathVision ApS: lead

Study Sites (1)

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 13, 2026
• Primary Completion: June 1, 2026
• Study Completion: August 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)