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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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OSB Lead-Impella RP Pediatric Study


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General
Study Status Progress Inadequate
Application Number H140001 / PAS002
Date Current Protocol Accepted 01/23/2015
Study Name OSB Lead-Impella RP Pediatric Study
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description A retrospective, single-arm multicenter study
Study Population Description Pediatric patients with the right side heart failure supported with the Impella RP System.



Patients that meet all eligibility criteria

Sample Size 15 consecutive pediatric patients or all pediatric patients

supported with the Impella RP over a 5 year time period (whichever comes first) will be enrolled at a minimum of 5 participating clinical centers.

Data Collection Data collected in the PAS will be based on institutional standard of care. Data will be retrospectively collected throughout the study. Data must be collected on the case report forms. Source documents include, but are not limited to, death certificate, autopsy report, laboratory reports, operative report, echocardiograms, ultrasound report, angiograms, cardiac catheterization logs and cardiac catheterization reports, patient discharge report.

Primary:

Survival at 30 days post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer term therapy, including a heart transplant or an implant of a surgical RVAD.



Secondary:

Safety

Rates of the following major adverse events measured at hospital discharge or to induction of anesthesia to a longer term therapy (including a heart transplant or an implant of a surgical RVAD):

Death (any cause of death and cardiac death)

Major Bleeding

Hemolysis

Pulmonary Embolism



Survival only will be assessed at 30 days (± 10 days) and 180 days (± 30 days).



Other adverse events

Device failures and malfunctions will be retrospectively documented



Secondary Probable benefit

Improvement in hemodynamic parameters

Cardiac Index

Central Venous Pressure

LVAD flows after initiation of Impella RP support.



Major adverse events will be reviewed adjudicated and categorized by the Clinical Events Committee.

Follow-up Visits and Length of Follow-up 180 days post explant

Survival status will be assessed at 30 and 180 days post explant


OSB Lead-Impella RP Pediatric Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/24/2015 07/23/2015 On Time
one year report 01/23/2016 01/22/2016 On Time
18 month report 07/23/2016 07/22/2016 On Time
two year report 01/22/2017 01/23/2017 On Time
quarterly report 08/10/2017 08/10/2017 On Time
three year report 01/22/2018    
42 month report 07/23/2018    
four year report 01/22/2019    
66 month report 07/22/2019    
five year report 01/22/2020    
Final Report 04/22/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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