AI-guided ECG mapping plus pulmonary vein isolation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-market, multicenter, randomized controlled study that assigns adults 1:1 to pulmonary vein isolation (PVI) alone or vMap®-guided mapping plus PVI. The vMap® system is a forward-solution computational 12-lead ECG mapping tool intended to identify non-pulmonary vein electrical drivers to guide additional ablation. Eligible subjects are adults (≥22 years) with persistent (not longstanding) or recurrent AF who have digitized 12-lead electrogram data available, and procedures are performed according to standard of care. The study compares clinical outcomes such as AF recurrence and need for repeat ablation between the two arms.

Why it matters

Who can join: the full rules

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.
6. Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

Where it's running

• Arrhythmia Research Group - St. Bernards
  Jonesboro, Arkansas, United States Recruiting
• BayCare Health System
  Clearwater, Florida, United States Recruiting
• Baptist Health Jacksonville
  Jacksonville, Florida, United States Recruiting
• USF Health
  Tampa, Florida, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.