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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).
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.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Arrhythmia Research Group - St. Bernards
Jonesboro, Arkansas, United States
BayCare Health System
Clearwater, Florida, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
USF Health
Tampa, Florida, United States
Piedmont Heart of Athens
Athens, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Baptist Health Lexignton
Lexington, Kentucky, United States
Westchester Medical Center
Valhalla, New York, United States
OhioHealth
Columbus, Ohio, United States
Start Date
June 27, 2025
Primary Completion Date
October 1, 2027
Completion Date
December 1, 2027
Last Updated
March 16, 2026
423
ESTIMATED participants
Pulmonary Vein Isolation
PROCEDURE
vMap® + Pulmonary Vein Isolation
DEVICE
Lead Sponsor
Vektor Medical
Collaborators
NCT07430007
NCT07272902
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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