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

This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation [vMap®+PVI]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.

Inclusion criteria

• Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
• 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.
• 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).
• Subject is ≥ 22 years of age at time of enrollment/consent.
• Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
• Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,

Exclusion criteria

• 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).
• 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.
• 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.
• 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.
• Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
• Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.