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

Using ECG Mapping for Treating Irregular Heartbeats

M
Mithilesh Das

Primary Investigator

Enrolling By Invitation
22 years - 100 years
All
Phase N/A
30 participants needed
1 Location

Brief description of study

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).

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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 addition to pulmonary vein isolation [vMap®+PVI]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.
 

 

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atrial Fibrillation, AF
  • Age: 22 years - 100 years
  • Gender: All

Inclusion 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,

Exclusion Criteria:

  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.

This study investigates the treatment of Atrial Fibrillation (AF), a condition where the heart beats in an irregular and often rapid manner. The purpose of this study is to compare two different methods for treating AF: using a mapping system called vMap in addition to pulmonary vein isolation (PVI), and using PVI alone. Participants will be randomly assigned to one of these two study arms to see which method is more effective.

Participants in the study will undergo an ablation procedure, which is a treatment that uses heat or cold to destroy tissue in the heart that causes irregular heartbeats. In the treatment arm, the vMap system will be used to help plan the ablation procedure by mapping the heart's electrical activity. The control arm will undergo the standard ablation procedure with PVI alone.

  • Who can participate: Adults 22 years and older with ongoing or returning atrial fibrillation can join. They need recent 12-lead ECG data and must be eligible for an ablation procedure.
  • Study details: Participants will be placed in a group to receive either the investigational mapping system with their ablation or the standard procedure. The investigational system helps plan the ablation by mapping heart activity.
Updated on 23 Sep 2025. Study ID: KIC-VEKTOR-IMPROVED-AF, 28120
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only