Atrial fibrillation Irregular heartbeat
Conditions
Interventions
Vektor Computational ECG Mapping System (referenced as “vMap®” or “vMap® system” or “vMap® device”, Vektor Medical)
Sponsors
Vektor Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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, Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, or CardioCard) 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), 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, and has signed the IRB-approved informed consent form.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is the achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from both AF and AT for subjects on and off antiarrhythmic drug (AAD) therapy at 12 months.Total procedure time, 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, 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 as a proportion of time before versus after the ablation procedure, excluding the ‘blanking period’. | — |
Countries
Germany, Netherlands, United States
Contacts
Public ContactPB Barry
Vektor Medical, Inc.
Outcome results
None listed