Actively Recruiting
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Led by Vektor Medical · Updated on 2026-03-16
423
Participants Needed
13
Research Sites
8 weeks
Total Duration
On this page
Sponsors
V
Vektor Medical
Lead Sponsor
V
Veranex Switzerland SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Vektor Computational ECG Mapping System (vMap4) combined with pulmonary vein isolation (PVI) compared to PVI alone for treating adults with persistent or recurrent atrial fibrillation (AF). This post-market, prospective, multi-center randomized clinical study aims to compare clinical outcomes in patients undergoing ablation procedures for AF using either standard care or the vMap4 system, which is FDA-cleared and commercially available. Participants will be randomly assigned to one of two groups: one group will receive PVI alone, while the other will undergo ablation guided by the vMap4 system in addition to PVI. Both groups follow standard ablation procedures, with the vMap4 system used to identify and map electrical drivers of AF to plan the ablation. The study evaluates these two approaches to understand differences in treatment outcomes. During the study, participants will be monitored for one year after their procedure to assess freedom from atrial fibrillation. Researchers will collect data on procedure time, mapping duration, AF burden, spontaneous AF termination, and fluoroscopy dose. Participants will follow up with study visits and evaluations in line with the protocol to measure these outcomes and monitor safety throughout the 12-month period.
CONDITIONS
Brief Title
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with persistent (not longstanding) or recurrent atrial fibrillation (AF)
- Have recent 12-lead electrogram data of AF recorded on an approved electrogram or ECG system in digitized format
- Able to provide data on atrial fibrillation type and atrial characteristics including geometry, Utah classification, prior ablation modality, and lesion locations
- Age 22 years or older at enrollment
- Indicated for an ablation procedure by the Investigator
- Able and willing to comply with study protocol and informed about study nature
You will not qualify if you...
- Have arrhythmias other than persistent or recurring AF, including long-standing persistent AF lasting 1 year or more
- Unable to obtain or have poor quality ECG data prior to or during ablation procedure
- Participating in another clinical trial with investigational drug or device during this study
- Have a medical condition that may increase risk for participation as judged by the Investigator
- Pregnant as confirmed by standard pre-surgery practice
- Previously had pulmonary vein isolation with all four veins confirmed isolated by voltage readings during this procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure care
Participants receive treatment for atrial fibrillation with pulmonary vein isolation, either alone or with the use of the vMap® system for mapping.
1 procedure visit (in-person)
Duration - Up to 12 months post procedure
Participants are monitored for freedom from atrial fibrillation and other outcomes for up to 12 months after the procedure.
Regular follow-up visits depending on clinical practice
Trial Site Locations
Total: 13 locations
1
Arrhythmia Research Group - St. Bernards
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
BayCare Health System
Clearwater, Florida, United States, 33759
Actively Recruiting
3
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
4
USF Health
Tampa, Florida, United States, 33606
Actively Recruiting
5
Piedmont Heart of Athens
Athens, Georgia, United States, 30606
Not Yet Recruiting
6
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Baptist Health Lexignton
Lexington, Kentucky, United States, 40503
Actively Recruiting
9
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
10
OhioHealth
Columbus, Ohio, United States, 43202
Actively Recruiting
11
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
Not Yet Recruiting
12
Penn Presbyterian
Philadelphia, Pennsylvania, United States, 19104-4238
Actively Recruiting
13
German Heart Center
Munich, Germany, 80636
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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