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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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Abiocor Artificial Heart

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Study Status Other
Application Number H040006 / PAS001
Date Current Protocol Accepted 09/05/2006
Study Name Abiocor Artificial Heart
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective multi-center single armed study. The goal of the study is to continue to gather clinical data on the AbioCor to permit the continued assessment of its clinical performance while in clinical use.
Study Population Description Study Population: Patients in severe biventricular heart failure and who are not transplant candidates; not supportable by a left ventricular assist device alone; are less than 75 years old; require multiple inotropic support; not treatable by left ventricular assist device destination therapy; not weanable from biventricular support, if applicable. Indication: Biventricular heart failure.
Sample Size 25 patients, 10 sites
Data Collection The following outcomes will be assessed: 1) Adverse events: including neurologic events, infection, bleeding, renal dysfunction, liver dysfunction, thrombosis, and respiratory events, 2) Quality of life using the Kansas City Cardiomyopathy Questionnaire and the EuroQol will be administered on a monthly basis while in the hospital and every three months after discharge from the hospital, 3) Characterization of patient activity and interaction with family will be monitored by the patient caregiver, 4) CVA events due to thromboembolism, 5) Discharge history to hotel, intermediary facility, or home, and readmission to hospital, 6) Functional status instruments, including distance walked and ventilatory oxygen uptake measurements, and 7) Neurological assessment, including NIH stroke scale, modified Rankin scale, and a battery of cognitive function tests
Follow-up Visits and Length of Follow-up Post-discharge, patients will be contacted every three months. Patients will be followed until death (while on the device) or other outcome (e.g. elective termination by family, device malfunction, etc).

Abiocor Artificial Heart Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/06/2007 03/09/2007 Overdue/Received
1 year report 09/05/2007 09/06/2007 Overdue/Received
18 month report 03/05/2008 04/21/2008 Overdue/Received
2 year report 09/04/2008 09/04/2008 On Time
30 month report 03/05/2009 03/26/2009 Overdue/Received
3 year report 09/04/2009 09/08/2009 Overdue/Received
42 month report 03/05/2010 03/05/2010 On Time
4 year report 11/03/2010 11/04/2010 Overdue/Received
54 month report 03/04/2011 03/04/2011 On Time
5 year report 09/04/2011 09/07/2011 Overdue/Received
66 month report 04/27/2012 04/27/2012 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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