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

Vektor Medical · with Veranex Switzerland SA, Veranex · NCT06935591

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
423
US sites recruiting
10
Study start
June 27, 2025
Record last updated
March 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Pulmonary Vein Isolation; vMap® + Pulmonary Vein Isolation

Conditions: Atrial Fibrillation (AF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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,

Exclusion Criteria

  • 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.

Recruiting US locations

  • Arrhythmia Research Group - St. Bernards

    Jonesboro, AR 72401

    Site contact: Kayla Rubino · 870-935-6729 · krubino@dnairresearch.com

  • BayCare Health System

    Clearwater, FL 33759

    Site contact: Andrea Daigneault · 727-461-8510 · andrea.daigneault@baycare.org

  • Baptist Health Jacksonville

    Jacksonville, FL 32207

    Site contact: Smitha Gubbi · 904-202-7069 · smitha.gubbi@bmcjax.com

  • USF Health

    Tampa, FL 33606

    Site contact: Jacky He · 813-396-0410 · jackyhe@usf.edu

  • Piedmont Heart Institute

    Atlanta, GA 30309

    Site contact: Caryn Bernstein · 404-605-5688 · caryn.bernstein@piedmont.org

  • Indiana University

    Indianapolis, IN 46202

    Site contact: Collin Lamothe · 317-274-0963 · clamothe@iu.edu

  • Baptist Health Lexignton

    Lexington, KY 40503

    Site contact: Gwyndolyn Middleton · 859-260-4445 · gmiddlet@bhsi.com

  • Westchester Medical Center

    Valhalla, NY 10595

    Site contact: Corazon De La Pena · 914-493-2483 · corazon.delapena@wmchealth.org

  • OhioHealth

    Columbus, OH 43202

    Site contact: Reem Bekheet · 937-218-3542 · Reem.Bekheet@ohiohealth.com

  • Penn Presbyterian

    Philadelphia, PA 19104-4238

    Site contact: Katie Shoemaker · 215-662-8562 · katie.shoemaker@pennmedicine.upenn.edu