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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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Impella RP Pediatric Study


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General
Study Status Terminated
Application Number /
Requirement Number		 H140001 / PAS002
Date Original Protocol Accepted 01/23/2015
Date Current Protocol Accepted 01/23/2015
Study Name Impella RP Pediatric Study
Device Name IMPELLA RP SYSTEM
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 Objectives A retrospective, single-arm multicenter study
Study Population 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.
Key Study Endpoints 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


Impella RP Pediatric Study Reporting Schedule

Reporting 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


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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