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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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CentriMag FTW PAS


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General
Study Status Progress Adequate
Application Number P170038 / PAS001
Date Current Protocol Accepted 08/28/2020
Study Name CentriMag FTW PAS
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 PAS is a prospective, single-arm clinical investigation designed to evaluate the continued safety and effectiveness of the CentriMag Circulatory Support System for patients who fail-to-wean from CPB. The study is intended to assess whether post-approval use of the CentriMag PAS enrolling real-world subjects produces results that are comparable to those reported in the CentriMag Pivotal Clinical Study. The study will only involve new enrollees with new data collection.
Study Population Description Subjects greater than 18 years of age who have been implanted with a CentriMag Circulatory Support System due to failure-to-wean from cardiopulmonary bypass. Subjects or their legal representative must also have signed the Informed Consent Form.
Sample Size The PAS will enroll up to thirty-two (32) subjects. This is equal to the number of subjects enrolled in the CentriMag pivotal trial. Assuming a primary endpoint success rate of 67%, enrolling 32 subjects will give a power of 0.994 to reject the null hypothesis at an alpha of 0.025.
Data Collection The primary endpoint includes:

a) In patients who recover and do not go onto transplantation or a long-term device:

The proportion of subjects surviving to 30 days post CentriMag support or to hospital discharge (whichever is longer).

b) In patients who do not recover and are bridged to a transplant or a long-term system:

The proportion of subjects surviving to induction of anesthesia for surgery for transplant or a long-term device.



Secondary Endpoints:

Frequency and incidence of adverse events will be collected through 30 days post CentriMag support or hospital discharge (whichever is longer).

Frequency and incidence of adverse events will be collected through induction of anesthesia for surgery for subjects who are bridged to therapy requiring another surgical procedure.

Hemodynamic parameters will be collected at:

Baseline,

4 hours post CentriMag implant,

Daily during CentriMag support,

Prior to explant, induction of anesthesia for heart transplant, or long-term VAD

Follow-up Visits and Length of Follow-up Hospital discharge or 30 days post CentriMag support (whichever is longer)


CentriMag FTW PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/05/2020 06/04/2020 On Time
one year report 12/05/2020 12/02/2020 On Time
18 month report 06/05/2021 06/04/2021 On Time
two year report 12/05/2021    
three year report 12/05/2022    
four year report 12/05/2023    


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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