|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010031 S232/ PAS002 |
| Date Original Protocol Accepted |
04/04/2012
|
| Date Current Protocol Accepted |
01/10/2019
|
| Study Name |
REVERSE Product Surveillance Registry
|
| Device Name |
CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective cohort study
|
| Study Population |
All adult patients treated with a Medtronic CRT-D device, meeting the expanded indication with QRS duration < 150ms, enrolled into Medtronics Product Surveillance Registry.
|
| Sample Size |
216 investigation sites, 500 patients
|
| Key Study Endpoints |
To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure event or all cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
|
| Follow-up Visits and Length of Follow-up |
3 years, with the potential to be extended out to 5-years
every 6 months from implant through a minimum of 3-years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
155
|
| Actual Number of Sites Enrolled |
189
|
| Patient Follow-up Rate |
86.9%
|
| Final Safety Findings |
Of the 32 deaths reported, none were adjudicated to be system or procedure related. There were 39 reported heart failure events in 25
patients, of which 38 were adjudicated to be events and 35 were heart failure hospitalizations. The Kaplan Meier survival estimate at 5 years is
66.9%. This is primarily driven by the small sample size. The observed survival rate for the composite endpoint of heart failure event or allcause death was 77.4% at 3 years.
|
| Final Effect Findings |
N/A
|
| Study Strengths & Weaknesses |
The study estimated the 3-year survival probability of freedom from heart failure hospitalization/event or all-cause death. There were no
significant safety concerns of device use in the expanded patient population. There were very few deviations and a high follow up rate.
The study was limited by the number of enrollments and ultimate size of the analysis cohort.
|
| Recommendations for Labeling Changes |
Labeling will be updated with the clinical data available from the completed study
|
