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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100045 / PAS001 |
| Date Original Protocol Accepted |
05/28/2014
|
| Date Current Protocol Accepted |
02/14/2017
|
| Study Name |
Newly Enrolled Champion
|
| 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 |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objectives are to confirm the safety and effectiveness of the CardioMEMS HF System in subjects with New York Heart Association (NYHA) Class III heart failure (HF) (a minimum of 35% of enrolled patients are to be women) who experienced a heart failure hospitalization in the previous year. The purpose of the sub study was to evaluate the use of CardioMEMS HF system in patients with NYHA Class
III heart failure who are optimally managed in are clinically similar to the Control group and the CHAMPION study based on pre-enrollment data.
|
| Study Population |
Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past
12 months. At least 35% of the enrolled patients will be women.
|
| Sample Size |
1,200 enrolled (at least 420 women) at no more than 150 sites. The sponsor states that the 2-year attrition rate in CHAMPION was 49.1%
(228/550). At least 35% of the enrolled patients will be women (206 completing the trial) and this data is based on the proportion seen
premarket. This sample size of 206 female patients for gender evaluation will provide greater than 90% power to meet the goal for
effectiveness and greater than 90% power to detect a difference as small as 0.06 from the null proportion rate of 0.90 for safety.
|
| Key Study Endpoints |
Primary Safety Endpoints: 1) Freedom from device/system related complications (DSRC) over 2 years in study compared to the objective
performance criterion (OPC) used in the CHAMPION trial; 2) Freedom from Pressure Sensor Failure over 2 years in study compared to the OPC
used in the CHAMPION trial.
Primary Effectiveness Endpoint: Heart failure (HF) hospitalization rate over 1 year in study compared to the HF hospitalization rate in the year
prior to enrollment.
Substudy
Same Primary Safety Endpoints
Effectiveness Endpoint: 1 year HFH rate in PAS study compared to the 1-year HFH rate in the randomized portion of the CHAMPION study
Control cohort.
|
| Follow-up Visits and Length of Follow-up |
All subjects were followed until completion of their 24 month visit or withdrawal from the study.
|
| 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.
|
| 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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