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NCT06935591NARecruiting

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

Vektor Medical

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

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.

Interventions

PROCEDURE

Pulmonary Vein Isolation

DEVICE

vMap® + Pulmonary Vein Isolation

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Conditions

Atrial Fibrillation (AF)

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