Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary Vein Isolation, vMap® + Pulmonary Vein Isolation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
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.
Interventions
- Procedure Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care. - Device vMap® + Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.
Primary outcome measures
- Freedom from AF [Time frame: 12 months post procedure]
Secondary outcome measures (6)
- Freedom from AF and AT [Time frame: 12 months post procedure]
- Total Procedure Time [Time frame: Interventional Procedure]
- Total vMap® Mapping Time [Time frame: Interventional Procedure]
- AF Burden [Time frame: 12 months post procedure]
- Spontaneous AF Termination [Time frame: Interventional Procedure]
- Total Fluoroscopy Dose [Time frame: Interventional Procedure]
Eligibility criteria
Inclusion criteria
- Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
- 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.
- 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).
- Subject is ≥ 22 years of age at time of enrollment/consent.
- Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
- Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,
Exclusion criteria
- 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).
- 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.
- 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.
- 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.
- Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
- Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 12 centers
- Arrhythmia Research Group - St. Bernards — Jonesboro
- BayCare Health System — Clearwater
- Baptist Health Jacksonville — Jacksonville
- USF Health — Tampa
- Piedmont Heart of Athens — Athens
- Piedmont Heart Institute — Atlanta
- Indiana University — Indianapolis
- Baptist Health Lexignton — Lexington
- … and 4 more centers
Germany · 1 center
- German Heart Center — Munich
Identifiers
NCT: NCT06935591 · 23-VM-1001