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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-RWE Eval and Report


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General
Study Status Completed
Application Number P170011 / PAS002
Date Current Protocol Accepted 02/16/2018
Study Name Impella RP Pediatric-RWE Eval and Report
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description To monitor post-market approval safety and outcomes trends of the Impella RP device in pediatric patients with RV failure deemed to require hemodynamic support.

A single-arm multicenter registry study of patients from the premarket (i.e. the HDE Impella RP Pediatric Study) and newly treated patients after PMA approval. All data will be collected retrospectively after implant.
Study Population Description Pediatric patients aged 15-17 years old (BSA greater than or equal to 1.5m2) with right heart failure supported with the Impella RP System. Patients who meet all eligibility criteria.

There is no comparison group.
Sample Size Fifteen (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 The primary endpoint is survival rate at 30 days post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer term therapy, which includes a heart transplant or an implant of a surgical RVAD.

Secondary safety endpoints are the 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 death and cardiac), major bleeding, hemolysis, pulmonary embolism.

Additional adverse events to be collected are device malfunction and device failure.

Secondary effectiveness endpoints are improvement in the following hemodynamic parameters after Impella RP support through explant: cardiac index, central venous pressure, LVAD flow

Technical success will be assessed at exit from operating room

Survival only will be assessed at 30 days and 180 days.
Follow-up Visits and Length of Follow-up 180 days
Interim or Final Data Summary
Actual Number of Patients Enrolled One (1) patient with a protocol deviation in age cutoff treated at a non-participating site
Actual Number of Sites Enrolled One (1) non-participating site
Patient Follow-up Rate The one patient was captured in the firm’s commercial database, which contains limited data entered by the firm’s field clinical personnel and only covers the time period from Impella device insertion through Impella device removal. The patient was known to have survived to induction of anesthesia to a longer-term therapy.
Final Safety Findings No adverse events (death, major bleeding, hemolysis, and pulmonary embolism) were reported for the patient, to induction of anesthesia to a longer-term therapy.
Final Effect Findings The patient survived to induction of anesthesia to a longer term therapy (surgical RVAD). The patient’s central venous pressure (CVP) decreased from 28 mmHg to 19 mmHg on Impella RP support.
Study Strengths & Weaknesses The study was limited by the low enrollment (N=1) and limited dataset available.
Recommendations for Labeling Changes Yes


Impella RP Pediatric-RWE Eval and Report Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/21/2018 03/20/2018 On Time
one year report 09/20/2018 09/20/2018 On Time
18 month report 03/21/2019 03/20/2019 On Time
two year report 09/20/2019 09/20/2019 On Time
30 month report 03/20/2020 03/18/2020 On Time
Final Report 03/30/2021 10/01/2020 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

Additional Resources

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