|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P010031 S674/ PAS001 |
Date Original Protocol Accepted |
04/23/2020
|
Date Current Protocol Accepted |
04/26/2024
|
Study Name |
iATP PAS
|
Device Name |
Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt HF Quad CRT-D MRI SureScan (DTPB2QQ and DTPB2Ql); Cobalt HF CRT-D MRI SureScan (DTPB2D4 and DTPB2Dl); Crome HF Quad CRT-D MRI SureScan (DTPC2QQ and DTPC2Q1); and Crome HF CRT-D MRI SureScan (DTPC2D4 and DTPC2Dl) Implantable Pulse Generators with Cardiac Resynchronization Therapy; and Cobalt Crome Application Software Model D00U005
|
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
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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.
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Actual Number of Patients Enrolled |
1229
|
Actual Number of Sites Enrolled |
68
|
Patient Follow-up Rate |
91.11%
|