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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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Impella RP-RWE Eval and Reporting


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General
Study Status Progress Adequate
Application Number P170011 / PAS001
Date Current Protocol Accepted 05/21/2019
Study Name Impella RP-RWE Eval and Reporting
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
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 The objective is to monitor post market safety and efficacy trends of the Impella system used to treat patients = 18 years old with right heart failure.

Observational, prospective/retrospective, multicenter, single arm, registry surveillance of newly treated subjects. Patients will be treated according to standard of care and per institution guidelines.
Study Population Description All patients age greater than or equal to 18 years old, who received Impella RP catheters for the treatment of RV dysfunction post LVAD implantation, post myocardial infarction and post open heart surgery, after PMA post market approval and were enrolled in the cVAD registry.
Sample Size A minimum of sixty (60) newly treated patients enrolled at participating US cVAD Registry sites (44 US sites). The sample size is similar to the total sample size of 60 subjects evaluated in the PMA.



The study subjects will be divided in the following groups:

Checklist group - A minimum enrollment of 30 subjects who would have met inclusion/exclusion criteria for the premarket clinical studies, which includes at least 10 subjects that will be similar to premarket Cohort A and at least 10 subjects similar to premarket Cohort B



Real world use group - A minimum enrollment of 30 “all-comers” subjects who would not have met inclusion/exclusion criteria for the premarket studies.



Enrollment of “all-comers” subjects must continue until the full enrollment of the checklist group is completed.

Data Collection Primary Endpoint



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.



The primary endpoint will be reported for all patients, for each cohort treated: a) Patients that develop RVF post LVAD implantation, and b) Patients that develop RVF post myocardial infarction or postcardiotomy; and for each subgroup: checklist group and real world use group.



Secondary endpoints

Technical success-

defined as successful device implant and positioning for hemodynamic support, and patient alive for transport from the operating room or catheterization lab)

During Support through device Explant the following secondary endpoints will be assessed: Central venous pressure, Cardiac index, LVAD flow and device malfunction

At 30 days or discharge the secondary endpoints to be assessed are death, bleeding hemolysis and pulmonary embolism

Additional data to be collected at 30 days, 90 days and 1 year include patient status, major cardiac and cerebrovascular adverse events (MACCE) and cardiac related readmission
Follow-up Visits and Length of Follow-up 1 year; 30 days, 90 days and 1 year post Impella RP explant.
Interim or Final Data Summary
Interim Safety Information Seventy-two (72) subjects were enrolled as of database closure date January 10, 2020. Enrollment requirements have been met for the following sub-cohorts: Checklist-Group Cohort B, and Real-world Use Group (both cohorts). Enrollment will continue until Checklist Group Cohort A has reached 10 subjects (currently three subjects are enrolled).

Enrollment by subgroups was as follows:

Checklist Group Total: 25 subjects enrolled

Checklist Group Cohort A: 3 subjects enrolled

Checklist Group Cohort B: 22 subjects enrolled

Real-world Use Group Total: 47 subjects enrolled

Real-world Use Group Cohort A: 9 subjects enrolled

Real-world Use Group Cohort B: 38 subjects enrolled



Twenty-three (23) sites are open with IRB approval to enroll subjects.



Survival rate

Survival at 30 days post device explant or discharge, or to induction of anesthesia to a longer-term therapy was 32% (23/72).

For the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies (i.e., Checklist Group), the survival rate was 68% (17/25). For the subgroup of PAS patients who would not have qualified for the premarket clinical studies (i.e.,Real-World Use Group, the survival rate was 13% (6/47).



Secondary endpoints

Effectiveness



Overall Technical Success rate was 94% (68/72) defined as successful device implant and positioning for hemodynamic support, and patient alive for transport from the operating room or catheterization lab.



Overall Patient Success (i.e., the primary endpoint) rate was 35% (25/72); subjects who were discharged alive, but without follow-up to 30 days post explant or alive to induction of anesthesia to a longer term therapy, were assumed alive at 30 days post explant.



Safety

Adverse events/device malfunction rates at 30 days or discharge were Device Malfunction; 6% (4/72)



Death prior to 30 days post device explant or discharge; 68% (49/72



Bleeding considered life-threatening, disabling or major; 15% (11/72)



Hemolysis; 8% (6/72)



Pulmonary embolism; 0% (0/72)



Follow-up Rate:

Of the 23 subjects alive at discharge, ten (10) subjects consented for follow-up at 30 days, 90 days and one year post-explant. The 13 other subjects did not consent for follow-up. Of eligible subjects, ten (10) out of ten (10) completed follow-up at 30 days, nine (9) out of ten (10) completed follow-up at 90 days, and five (5) out of eight (8) completed follow-up at one year.



Strengths and Weaknesses:

Only 43% (10/23) of subjects discharged alive consented for follow-up at 30 days, 90 days and 1 year.


Impella RP-RWE Eval and Reporting 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 10/20/2018 10/18/2018 On Time
18 month report 03/21/2019 03/14/2019 On Time
two year report 09/20/2019 09/20/2019 On Time
30 month report 03/20/2020 03/18/2020 On Time
three year report 09/20/2020 09/18/2020 On Time
42 month report 03/20/2021    
Final Report 07/20/2022    


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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