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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010031 S232/ PAS001 |
| Date Original Protocol Accepted |
04/04/2012
|
| Date Current Protocol Accepted |
06/29/2012
|
| Study Name |
REVERSE NCDR ICD Registry Study
|
| Device Name |
CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective Cohort Study
|
| Study Population |
Patients meeting the expanded CRT-D indication criteria are eligible to participate the analysis cohort.
|
| Sample Size |
At least 1500 patients from US implanted with a Medtronic CRT-D device who meet the expanded indication criteria will be included in the analyses. A minimum of 500 patients with QRS duration will be included in the primary objective analysis.
|
| Key Study Endpoints |
5-year survival probability for patients implanted with a Medtronic CRT-D who meet the expanded indication criteria within percent precision.
|
| Follow-up Visits and Length of Follow-up |
5-years post-implant.
Reconciliation of mortality for patients identified through the NCDR® ICD Registry¿ will be completed monthly through 5-years post-implant.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
4639 patients
|
| Actual Number of Sites Enrolled |
N/A: Patients are identified through the American College of Cardiology’s National Cardiovascular Data Registry for implantable cardioverter defibrillators (ACC-NCDR ICD registry).
Mortality through five years will be tracked for this cohort using the National Death Index.
|
| Patient Follow-up Rate |
5 years post-implant
|
| Final Safety Findings |
Of the 4639 ICD Registry patients meeting expanded indication, a total of 799 deaths were identified. Of these deaths, 216 (27%) were female and 266 (33%) had narrow QRS (130 – 150 ms).
Based on this data, the sponsor reported a survival probability at 5 years of 77.2% (95% CI: 75.4% - 78.8%) as well as a significant difference in survival probability between male and female. Among female subjects 216 subjects died compared with 583 deaths for male subjects (hazard ratio: 0.73, 95% CI: 0.62-0.85, p < 0.0001). No significant difference in survival probability between the narrow QRS group and the group with wider QRS was also reported by the sponsor. Among narrow QRS subjects 266 subjects died compared with 533 deaths for the subjects with wider QRS (hazard ratio: 1.10, 95% CI: 0.95-1.28, p = 0.19).
|
| Final Effect Findings |
Please see "safety" findings.
|
| Study Strengths & Weaknesses |
The sponsor has collected sufficient data to address the primary objective of the study which was to estimate the 5-year survival probability for patients implanted with a Medtronic CRT-D meeting the expanded indication criteria within 3% precision. The Agency recommends that the sponsor update the labeling to incorporate the study findings.
|
| Recommendations for Labeling Changes |
FDA recommends that the sponsor update the labeling for these devices to reflect the long-term data from the Post Approval Study.
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