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RECRUITING
NCT06935591
NA

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

Sponsor: Vektor Medical

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

423

Start Date

2025-06-27

Completion Date

2027-12

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

PROCEDURE

Pulmonary Vein Isolation

Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.

DEVICE

vMap® + 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. 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

University of Toledo Medical Center

Toledo, Ohio, United States

Penn Presbyterian

Philadelphia, Pennsylvania, United States

German Heart Center

Munich, Germany