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

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Newly Enrolled Champion


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General
Study Status Progress Adequate
Application Number P100045 / PAS001
Date Current Protocol Accepted 02/14/2017
Study Name Newly Enrolled Champion
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 Design Description 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 Description 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.
Data Collection 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.


Newly Enrolled Champion 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

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