Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Vektor Medical · with Veranex Switzerland SA, Veranex · NCT06935591
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
Similar studies in Arkansas
All heart & blood pressure studies in Arkansas →- RecruitingHealthy volunteers
BoxX-NoAF Clinical Trial
AtriCure, Inc.
- Location
- Jonesboro, AR + 30 other US sites
- Eligibility basics
- Ages 65+
- Recruiting
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Boston Scientific Corporation
- Location
- Jonesboro, AR + 9 other US sites
- Eligibility basics
- Ages 18+
- Recruiting
Prevail Global Study
Medtronic Vascular
- Location
- Little Rock, AR + 53 other US sites
- Eligibility basics
- Ages 18+
- Recruiting
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
Boston Scientific Corporation
- Location
- Jonesboro, AR + 46 other US sites
- Eligibility basics
- Ages 18+