AI-guided ECG mapping plus pulmonary vein isolation for atrial fibrillation

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

This trial tests whether adding the vMap® AI 12-lead ECG mapping system to standard pulmonary vein isolation helps adults with persistent or recurrent atrial fibrillation have better outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 423 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Vektor Medical (Industry-sponsored)
• Locations: 13 sites (Jonesboro, Arkansas and 12 other locations)
• Trial ID: NCT06935591 on ClinicalTrials.gov

What this trial studies

This is a post-market, multicenter, randomized controlled study that assigns adults 1:1 to pulmonary vein isolation (PVI) alone or vMap®-guided mapping plus PVI. The vMap® system is a forward-solution computational 12-lead ECG mapping tool intended to identify non-pulmonary vein electrical drivers to guide additional ablation. Eligible subjects are adults (≥22 years) with persistent (not longstanding) or recurrent AF who have digitized 12-lead electrogram data available, and procedures are performed according to standard of care. The study compares clinical outcomes such as AF recurrence and need for repeat ablation between the two arms.

Who should consider this trial

Good fit: Adults aged 22 or older with persistent (not longstanding) or recurrent atrial fibrillation who are indicated for ablation and have digitized 12-lead ECG/electrogram recordings are the ideal candidates.

Not a fit: Patients without adequate digitized 12-lead ECG recordings, those with longstanding persistent AF, or those not eligible for ablation are unlikely to receive benefit from this mapping approach.

Why it matters

Potential benefit: If successful, the approach could reduce AF recurrence and the need for repeat ablation by identifying and targeting non-pulmonary vein drivers.

How similar studies have performed: Prior pilot and observational work on ECG-based and rotor-targeting mapping approaches has shown mixed but promising signals, so the vMap® approach is relatively novel with limited conclusive evidence to date.

Eligibility criteria

Inclusion Criteria:

1. Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
2. Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format.
3. The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):

   * Atrial fibrillation type
   * Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s).
4. Subject is ≥ 22 years of age at time of enrollment/consent.
5. Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
6. Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,

Exclusion Criteria:

1. Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis).
2. Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads.
3. Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation.
4. Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.
5. Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
6. Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

Where this trial is running

Jonesboro, Arkansas and 12 other locations

• Arrhythmia Research Group - St. Bernards — Jonesboro, Arkansas, United States (Recruiting)
• BayCare Health System — Clearwater, Florida, United States (Recruiting)
• Baptist Health Jacksonville — Jacksonville, Florida, United States (Recruiting)
• USF Health — Tampa, Florida, United States (Recruiting)
• Piedmont Heart of Athens — Athens, Georgia, United States (Not_yet_recruiting)
• Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• Baptist Health Lexignton — Lexington, Kentucky, United States (Recruiting)
• Westchester Medical Center — Valhalla, New York, United States (Recruiting)
• OhioHealth — Columbus, Ohio, United States (Recruiting)
• University of Toledo Medical Center — Toledo, Ohio, United States (Not_yet_recruiting)
• Penn Presbyterian — Philadelphia, Pennsylvania, United States (Recruiting)
• German Heart Center — Munich, Germany (Recruiting)

Conditions Atrial Fibrillation; Pulmonary Vein Isolation; Ablation