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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06935591
• Lead Sponsor: Vektor Medical

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) 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).

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 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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from AF	12 months post procedure	The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months.

Secondary Outcome Measures

Name	Time	Method
Freedom from AF and AT	12 months post procedure	Freedom from both AF and AT for subjects on and off antiarrhythmic drug (AAD) therapy at 12 months.
Total Procedure Time	Interventional Procedure	Defined as the time from completing intravascular access (successful placement of all vascular sheaths) to initiating hemostasis (time at which the first vascular sheath is removed from the subject).
Total vMap® Mapping Time	Interventional Procedure	Defined as time from entering the ECG and patient characteristics into the vMap® and ending with display of the 3-dimensional mapping result, prior to delivery of the first ablation.
AF Burden	12 months post procedure	AF burden as a proportion of time before versus after the ablation procedure, excluding the 'blanking period'.
Spontaneous AF Termination	Interventional Procedure	Proportion of subjects whose AF terminated spontaneously upon and after the first ablation lesion and before achieving hemostasis without cardioversion.
Total Fluoroscopy Dose	Interventional Procedure	Defined as the cumulative dose-area product (DAP) for the procedure.

Trial Locations

Locations (8)

Baptist Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

USF Health; 🇺🇸 Tampa, Florida, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Baptist Health Lexignton; 🇺🇸 Lexington, Kentucky, United States

Penn Presbyterian; 🇺🇸 Philadelphia, Pennsylvania, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

OhioHealth; 🇺🇸 Columbus, Ohio, United States

Catharina Ziekenhuis; 🇳🇱 Eindhoven, North Brabant, Netherlands