Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Vektor Medical
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).
Description
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 ca…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 inpu…
Interventions
- ProcedurePulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.
- DevicevMap® + Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.
Locations (13)
- Arrhythmia Research Group - St. BernardsJonesboro, Arkansas
- BayCare Health SystemClearwater, Florida
- Baptist Health JacksonvilleJacksonville, Florida
- USF HealthTampa, Florida
- Piedmont Heart of AthensAthens, Georgia
- Piedmont Heart InstituteAtlanta, Georgia