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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Champion Substudy

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Application Number P100045 / PAS002
Current Plan Approved 08/29/2014
Study Name OSB Lead-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)

OSB Lead-Champion Substudy Schedule

Report Schedule
Date Due
FDA Receipt
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 05/27/2017    
four year report 05/27/2018    
five year report 05/27/2019    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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