Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Trial ID: NCT06935591
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-06-27
Completion date: 2027-12
Sponsor: Vektor Medical
Collaborators: Veranex Switzerland SA; Veranex
Conditions: Atrial Fibrillation (AF)
Interventions: Pulmonary Vein Isolation; vMap® + Pulmonary Vein Isolation
Locations: Arrhythmia Research Group - St. Bernards; BayCare Health System; Baptist Health Jacksonville; USF Health; Piedmont Heart of Athens; Piedmont Heart Institute; Indiana University; Baptist Health Lexignton; Westchester Medical Center; OhioHealth; University of Toledo Medical Center; Penn Presbyterian; German Heart Center
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Germany
Enrollment: 423
Age range: 22 Years - None
Sex: ALL

Summary:
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults.

Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).

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.

Outcomes:
Freedom from AF