|
|
| 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 1234 devices from 1229 patients, 947 spontaneous episodes were collected in one of the ventricular tachycardia zones (VT, VF, FVT), where one or more ATP therapies were delivered, and EGM was available. Of 947 episodes, 181 spontaneous episodes in the FVT zone were treated with iATP. As of the cutoff date, 0 episodes have been adjudicated by ERC.
There have been 22 syncope events reported, and 20 were adjudicated as syncope by the CEC. Due to the early phase of the study, 0 have been adjudicated by the ERC.
There have been 50 reported patient deaths. 0 of the deaths were device-related.
Effectiveness Results
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.
|
| Actual Number of Patients Enrolled |
1229
|
| Actual Number of Sites Enrolled |
68
|
| Patient Follow-up Rate |
91.11%
|
