|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220012 / PAS001 |
| Date Original Protocol Accepted |
10/20/2023
|
| Date Current Protocol Accepted |
04/24/2024
|
| Study Name |
Enlighten PAS
|
| Device Name |
Aurora EV-ICD System
|
| Clinical Trial Number(s) |
NCT04060680
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Out of 805 subjects enrolled, 786 underwent an implant attempt, with 756 of them successfully implanted. Of those 756 patients, 285 (27.0%) required lead repositioning. Among those, 104 were due to atrial oversensing, 108 were due to suboptimal R-wave sensing, 59 implant attempts had both atrial oversensing and suboptimal R-wave sensing, and 4 had an unknown reason. Additionally, 124 (16.1%) implant attempts required re-tunneling and of those, 22 were due to atrial oversensing, 61 due to suboptimal R-wave sensing, 36 related to both, and 1 was unknown relation.
210 adverse events were reported in 163 patients, 193 were fully adjudicated by the CEC. Among the adjudicated events, 187 were deemed to be related to the EV-ICD system and/or EV-ICD procedure. Of the 193 fully adjudicated events for the 805 patients enrolled 58 were classified as major complications, 64 are serious, 142 are system related, and 93 are procedure related. None were unanticipated.
79 patients had 277 fully adjudicated episodes, of which 64 were inappropriate shocks, 16 were inappropriate ATP events, and 1 was inappropriate ATP and shock.
Effectiveness Results:
Regarding electrical performance, the most common pacing vector testing was Ring 1 to Coil 2 with a mean of 5.4V. Pacing capture threshold (PCT) at implant was consistent as enrollment increased. PCT was not measured at 6 or 12 months. Sensing at 12 months was similar to pivotal study. The average impedance remains consistent.
Among the 786 patients with an implant attempt, 710 had defibrillation testing at the time of the implant with 701 patients having a reported minimum energy where defibrillation was successful.
|
| Actual Number of Patients Enrolled |
805
|
| Actual Number of Sites Enrolled |
133
|
| Patient Follow-up Rate |
At the time of the visit cutoff date, 358 out of the expected 484 patient contacts were completed for the 6-month visit window, 117 out of the expected 169 patient contacts were completed for the 12-month visit window, and 34 out of the expected 34 patient contacts were completed for the 18-month visit window. The mean follow-up time for the 756 patients with a successful implant enrolled by the visit cutoff date of June 13, 2025, was 4.5 months.
|
| Final Effect Findings |
N/A
|
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