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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Champion Substudy


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General
Study Status Progress Adequate
Application Number P100045 / PAS002
Date Current Protocol Accepted 02/14/2017
Study Name Champion Substudy
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 Design Description 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 Description 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
Data Collection 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
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.
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.
Recommendations for Labeling Changes Yes


Champion Substudy Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/26/2014 02/09/2015 Overdue/Received
one year report 05/28/2015 06/04/2015 Overdue/Received
18 month report 11/26/2015 12/02/2015 Overdue/Received
two year report 06/26/2016 06/17/2016 On Time
three year report 06/26/2017 06/23/2017 On Time
four year report 06/26/2018 06/25/2018 On Time
five year report 06/26/2019 06/24/2019 On Time
final report 06/26/2020 04/24/2020 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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