Clinical trial NCT06935591: Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Official title: Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Pulmonary Vein Isolation
Ablation
Lead sponsor: Vektor Medical
Sponsor class: INDUSTRY
Collaborators: name: Veranex Switzerland SA
First posted: 2025-04-20
Enrollment: 384
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from AF
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Freedom from AF and AT
timeFrame: 12 months post procedure
measure: Total Procedure Time
timeFrame: Interventional Procedure
measure: Total vMap® Mapping Time
timeFrame: Interventional Procedure
measure: AF Burden
timeFrame: 12 months post procedure
measure: Spontaneous AF Termination
timeFrame: Interventional Procedure
measure: Total Fluoroscopy Dose
timeFrame: Interventional Procedure
Other outcomes:
measure: Total Fluorscopy Time
timeFrame: 1Interventional Procedure
Locations:
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexignton
state: Kentucky
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian
state: Pennsylvania
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: North Brabant
Study officials:
References: