Status:
RECRUITING
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Lead Sponsor:
Vektor Medical
Collaborating Sponsors:
Veranex Switzerland SA
Veranex
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
22+ years
Phase:
NA
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) ...
Detailed Description
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 additi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT06935591
Start Date
June 27 2025
End Date
December 1 2027
Last Update
July 29 2025
Active Locations (8)
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1
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
2
USF Health
Tampa, Florida, United States, 33606
3
Indiana University
Indianapolis, Indiana, United States, 46202
4
Baptist Health Lexignton
Lexington, Kentucky, United States, 40503