|
|
| General |
| Study Status |
Completed |
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
|
| 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 |
| Actual Number of Patients Enrolled |
1875
|
| Actual Number of Sites Enrolled |
76
|
| Patient Follow-up Rate |
Overall follow-up rate (within window patient contact rate) was 87.97%.
|
| Final Safety Findings |
iATP therapy is safe with low rates of arrythmia-related syncope and MVT acceleration resulting in shock.
The percentage of patients having arrhythmia-related syncope events where iATP therapy was used was 0.48% (9/1875).
The GEE-estimated rate for iATP associated MVT acceleration resulting in shock was 2.3% (95% CI: 1.5% - 3.5%).
|
| Final Effect Findings |
iATP is a highly effective therapy to treat MVT.
The GEE-estimated iATP success rate in the FVT zone was 89.7% (95% CI: 83.6% - 93.7%).
The GEE-estimated iATP success rate in the VT zone was 92.1% (95% CI: 89.0% - 94.4%).
The GEE-estimated iATP success rate in the VF zone was 72.8% (95% CI: 63.6% - 80.4%)
|
| Study Strengths & Weaknesses |
Strengths:
Reflects real world data as patients were managed per physician discretion and standard of care.
Collects patient characteristics and clinical outcomes through CRFs and device data through CareLink transmissions.
Weaknesses:
There was missing patient characteristics data likely due to standard of care and evolution of CRF development over years.
|
| Recommendations for Labeling Changes |
Recommend the labeling is updated to include the study results.
|
