RECRUITING

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

Description

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

Atrial Fibrillation (AF)
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Related Conditions:

Atrial Fibrillation (AF)

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Atrial Fibrillation (AF)
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Baptist Health Jacksonville, Jacksonville, Florida, United States, 32207

Tampa

USF Health, Tampa, Florida, United States, 33606

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Lexington

Baptist Health Lexignton, Lexington, Kentucky, United States, 40503

Valhalla

Westchester Medical Center, Valhalla, New York, United States, 10595

Columbus

OhioHealth, Columbus, Ohio, United States, 43202

Philadelphia

Penn Presbyterian, Philadelphia, Pennsylvania, United States, 19104-4238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
  • 2. 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.
  • 3. 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).
  • 4. Subject is ≥ 22 years of age at time of enrollment/consent.
  • 5. Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
  • 6. Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,
  • 1. 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).
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vektor Medical,

Study Record Dates

2027-12