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
126 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
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
Official 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
- Have recent 12-lead electrogram data of atrial fibrillation recorded on approved systems in digital format
- Medical records confirm atrial fibrillation type, atrial characteristics, prior ablation details
- At least 22 years old at enrollment
- Indicated for an ablation procedure by the Investigator
- Able and willing to comply with study requirements and informed about the study nature
You will not qualify if you...
- Arrhythmias other than persistent or recurrent atrial fibrillation, including long-standing persistent AF lasting 1 year or more
- Unable to obtain acceptable ECG data before or during ablation procedure
- Participating in another clinical trial with investigational drugs or devices during this study
- Known or suspected medical conditions posing risk for study participation as judged by Investigator
- Pregnant at time of enrollment
- Prior pulmonary vein isolation with all four pulmonary veins confirmed isolated by voltage readings during index procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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