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| Name | Class |
|---|---|
| Veranex Switzerland SA | INDUSTRY |
| Veranex | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vMap®+PVI | Experimental | Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation. |
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| PVI Alone | Active Comparator | Subjects in this arm will be treated with pulmonary vein isolation alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation | Procedure | Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF | The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months. | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF and AT | Freedom from both AF and AT for subjects on and off antiarrhythmic drug (AAD) therapy at 12 months. | 12 months post procedure |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluorscopy Time | Defined as the total time of fluoroscopy during procedure | 1Interventional Procedure |
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®):
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group - St. Bernards | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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.
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| vMap® + Pulmonary Vein Isolation | Device | Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation. |
|
| Interventional Procedure |
| 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. | Interventional Procedure |
| AF Burden | AF burden as a proportion of time before versus after the ablation procedure, excluding the 'blanking period'. | 12 months post procedure |
| Spontaneous AF Termination | Proportion of subjects whose AF terminated spontaneously upon and after the first ablation lesion and before achieving hemostasis without cardioversion. | Interventional Procedure |
| Total Fluoroscopy Dose | Defined as the cumulative dose-area product (DAP) for the procedure. | Interventional Procedure |
| BayCare Health System | Recruiting | Clearwater | Florida | 33759 | United States |
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| Baptist Health Jacksonville | Recruiting | Jacksonville | Florida | 32207 | United States |
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| USF Health | Recruiting | Tampa | Florida | 33606 | United States |
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| Piedmont Heart of Athens | Not yet recruiting | Athens | Georgia | 30606 | United States |
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| Piedmont Heart Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Baptist Health Lexignton | Recruiting | Lexington | Kentucky | 40503 | United States |
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| Westchester Medical Center | Recruiting | Valhalla | New York | 10595 | United States |
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| OhioHealth | Recruiting | Columbus | Ohio | 43202 | United States |
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| University of Toledo Medical Center | Not yet recruiting | Toledo | Ohio | 43614 | United States |
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| Penn Presbyterian | Recruiting | Philadelphia | Pennsylvania | 19104-4238 | United States |
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| German Heart Center | Recruiting | Munich | 80636 | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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