Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Start Date
6/27/2025
Completion Date
12/1/2027
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).
Detailed 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 care practices.
Eligibility Criteria
Age Range: 22 years to No maximum
Interventions
Pulmonary Vein Isolation
vMap® + Pulmonary Vein Isolation
Conditions
Locations
Arrhythmia Research Group - St. Bernards
Jonesboro, Arkansas 72401
United States
BayCare Health System
Clearwater, Florida 33759
United States
Baptist Health Jacksonville
Jacksonville, Florida 32207
United States
USF Health
Tampa, Florida 33606
United States
Piedmont Heart of Athens
Athens, Georgia 30606
United States
Piedmont Heart Institute
Atlanta, Georgia 30309
United States
Indiana University
Indianapolis, Indiana 46202
United States
Baptist Health Lexignton
Lexington, Kentucky 40503
United States
Westchester Medical Center
Valhalla, New York 10595
United States
OhioHealth
Columbus, Ohio 43202
United States
University of Toledo Medical Center
Toledo, Ohio 43614
United States
Penn Presbyterian
Philadelphia, Pennsylvania 19104-4238
United States
German Heart Center
Munich, 80636
Germany