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

NCT06935591 | Recruiting FDA Device

• 1 other identifier: 23-VM-1001
• Study Type: interventional
• Target: 423
• Locations: 2 countries
• Sites: 13

Brief 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).

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Pulmonary Vein Isolation; Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF

  The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months.

  12 months post procedure

Secondary Outcomes (6)

• Freedom from AF and AT

  12 months post procedure

• Total Procedure Time

  Interventional Procedure

• Total vMap® Mapping Time

  Interventional Procedure

• AF Burden

  12 months post procedure

• Spontaneous AF Termination

  Interventional Procedure

Other Outcomes (1)

• Total Fluorscopy Time

  1Interventional Procedure

Study Arms (2)

vMap®+PVI

EXPERIMENTAL

Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.

Device: vMap® + Pulmonary Vein Isolation

PVI Alone

ACTIVE COMPARATOR

Subjects in this arm will be treated with pulmonary vein isolation alone.

Procedure: Pulmonary Vein Isolation

Interventions

Pulmonary Vein Isolation PROCEDURE

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

PVI Alone

vMap® + Pulmonary Vein Isolation DEVICE

Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.

vMap®+PVI

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
• 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.
• 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).
• Subject is ≥ 22 years of age at time of enrollment/consent.
• Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
• Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,

You may not qualify if:

• 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).
• 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.
• 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.
• 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.
• Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
• Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

Sponsors & Collaborators

• Vektor Medical: lead
• Veranex Switzerland SA: collaborator
• Veranex: collaborator

Study Sites (13)

Arrhythmia Research Group - St. Bernards

Jonesboro, Arkansas, 72401, United States

RECRUITING

BayCare Health System

Clearwater, Florida, 33759, United States

RECRUITING

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

USF Health

Tampa, Florida, 33606, United States

RECRUITING

Piedmont Heart of Athens

Athens, Georgia, 30606, United States

NOT YET RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Baptist Health Lexignton

Lexington, Kentucky, 40503, United States

RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

OhioHealth

Columbus, Ohio, 43202, United States

RECRUITING

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

NOT YET RECRUITING

Penn Presbyterian

Philadelphia, Pennsylvania, 19104-4238, United States

RECRUITING

German Heart Center

Munich, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 20, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (12); DE (1)