Atrial Fibrillation (AF)
Conditions
Keywords
Atrial Fibrillation, Pulmonary Vein Isolation, Ablation
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.
Interventions
PROCEDUREPulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.
DEVICEvMap® + Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.
Sponsors
Vektor Medical
Veranex Switzerland SA
Veranex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany, United States
Outcome results
None listed