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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P980016 S713/ PAS001 |
| Date Original Protocol Accepted |
04/23/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
iATP PAS
|
| Device Name |
Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DDPC3D4 and DDPC3Dl); Cobalt XT VR MRI SureScan (DVPA2D4 and DVPA2D1); Cobalt VR MRI SureScan (DVPB3D4 and DVPB3Dl); and Crome VR MRI SureScan (DVPC3D4 and DVPC3Dl) Implantable Cardioverter Defibrillators
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To further characterize iATP effectiveness in real world clinical practice to pace-terminate VT. The study is a global, non-randomized, prospective post-market surveillance study.
|
| Study Population |
Subjects with an implanted Cobalt ICD or CRT-D with iATP enabled and enrolled in the Medtronic CareLink Network.
|
| Sample Size |
Approximately 2200 patients will be enrolled to review 241 eligible episodes.
|
| Key Study Endpoints |
To demonstrate the effectiveness performance of iATP in the fast VT (FVT) zone is acceptable, i.e. iATP success rate is greater than 60%.
Secondary objectives:
To demonstrate the effectiveness performance of iATP in the FVT zone exceeds expectations, i.e., iATP success rate is greater than 70%
To characterize arrhythmia-related syncope events
To characterize unnecessary and inappropriate shocks
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
On 1548 devices from 1540 patients, 1398 spontaneous episodes were collected in one of the ventricular tachycardia zones (VT, VF, FVT), where one or more ATP (traditional ATP/iATP) therapies were delivered, and EGM was available. Of 1398 episodes, 233 spontaneous episodes in the FVT zone were treated with iATP. As of the cut-off date, 0 episodes have been adjudicated by ERC. There have been 35 syncope events reported to Medtronic for the PAS and 29 have been adjudicated as syncope by the CEC. As of the cut-off date, there are 0 episodes that have been adjudicated by the ERC. There have been 69 reported patient deaths. Only deaths that occur during device follow-up time, from implant to date of device inactivation, are reported. 39 reported as cardiac deaths per investigator classification. There are 4 deaths pending CEC adjudication. There were 0 device-related deaths.
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| Actual Number of Patients Enrolled |
1540
|
| Actual Number of Sites Enrolled |
71
|
| Patient Follow-up Rate |
85.49%
|
| Final Effect Findings |
The sponsor stated the number of VT/VF episodes treated by iATP, but the ERC has not adjudicated any events yet due to the early stage of the study. No key effectiveness findings available yet.
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