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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100045 / PAS002 |
| Date Original Protocol Accepted |
05/28/2014
|
| Date Current Protocol Accepted |
02/14/2017
|
| Study Name |
Champion Substudy
|
| Device Name |
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this sub-study is to confirm the postmarket safety and effectiveness of the CardioMEMS¿ HF System to premarket. This is a prospective, multi-center, open-label trial conducted in the US.
|
| Study Population |
The sub-study patient population will consist of patients selected by an independent committee from the PAS (Main Cohort) who are optimally managed and are clinically similar to the Control group in the CHAMPION study based on pre- enrollment data. The independent committee will identify these patients from the main cohort with NYHA Class III HF who have experienced a HF hospitalization within the past
12 months.
|
| Sample Size |
A minimum of 256 patients will be selected by the independent committee for inclusion in the sub-study
|
| Key Study Endpoints |
Primary safety endpoints will be evaluated at 2 years:
1) Freedom from device/system related complications
2) Freedom from pressure sensor failure
The primary effectiveness objective is to demonstrate that there is not a worsening in HF hospitalization rate at 1 year in the sub-study compared to the 1 year HF hospitalization rate in the CHAMPION study Control group (Part 1).
|
| Follow-up Visits and Length of Follow-up |
2 years
Implanted subjects will be evaluated at Month 1 (± 7 days) and at Months 6, 12, 18, and 24 (± 30 days)
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 1200 subjects were enrolled. Additionally, 387 patients were selected by the independent committee for inclusion in the sub-study
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| Actual Number of Sites Enrolled |
This study was conducted in 104 centers.
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| Patient Follow-up Rate |
The follow-up rate was 96.3% (684/710) at 24-months.
|
| Final Safety Findings |
The primary safety outcomes for this study are 1) freedom from device/system related complications (DSRC) at 24 months and 2) freedom from pressure sensor failure at 24 months. For freedom from DSRCs at 24 months, the results show that freedom from DSRCs at 24 months was 99.6% (1209/1214) with a lower confidence bound of 99.0%, thus allowing the null hypothesis to be rejected. For freedom from pressure sensor failure at 24 months, the results show that freedom from pressure sensor failure at 24 months was 99.9% with a lower confidence bound of 99.5%, thus allowing the null hypothesis to be rejected.
|
| Final Effect Findings |
The primary effectiveness endpoint for this study compares the annualized HFH rate including recurrent events at 12 months post implant with the rate including recurrent events 12 months prior to implant. The HFH rate prior to sensor implant was 1.249 HFHs per patient year. After sensor implant, the rate of HFHs was reduced to 0.535 HFHs per patient year. This is a reduction of 57% in HFHs after treatment using the CardioMEMS sensor.
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| Study Strengths & Weaknesses |
Data from the CardioMEMs PAS demonstrates clinically meaningful benefits that include a reduction in the rate of HFH and clinically relevant improvement in quality of life. In CardioMEMs PAS there was a significant reduction of 57% in the HFH rate at 12 months. This result was similar in males and females. There was no significant difference in HFH amongst any of the subgroup analysis. A limitation of the CardioMEMs PAS single arm design is that there is no direct competitor provided within the study population for outcomes. However, results from the CardioMEMs PAS are supported by results from the CHAMPION trial and the MEMS-HF study.
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| Recommendations for Labeling Changes |
Yes
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