RecruitingNot ApplicableNCT06935591

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


Sponsor

Vektor Medical

Enrollment

423 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence (AI) to improve the process of mapping and ablating (destroying) abnormal heart tissue in patients with atrial fibrillation (AFib) — an irregular heartbeat originating from areas outside the pulmonary veins. AI is used to help identify the exact source of the irregular signals so doctors can target them more precisely. **You may be eligible if...** - You have atrial fibrillation that does not originate from the pulmonary veins (non-pulmonary vein triggers) - You are scheduled for a cardiac ablation procedure - You are an adult in stable enough health for the procedure **You may NOT be eligible if...** - You have significant structural heart disease that makes ablation unsafe - You have uncontrolled bleeding disorders or are on blood thinners that cannot be managed - You have active infections or other conditions making the procedure high risk - You have had multiple prior ablation procedures without success Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. 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

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NCT06935591


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