f Post-Approval Studies (PAS) Database
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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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Study Status Completed
Application Number /
Requirement Number
P140003 S008/ PAS001
Date Original Protocol Accepted 08/22/2017
Date Current Protocol Accepted 07/13/2021
Study Name Impella PROTECTED PCI PAS cVAD Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study design is a prospective and retrospective, multicenter, single-arm post-approval study (PAS) of use of the percutaneous Impella devices in elective or urgent high-risk percutaneous coronary intervention (PCI).
The study objective is to monitor post market safety and efficacy trends of the Impella 2.5 and CP devices in high-risk PCI patient population by assessing outcomes at discharge and outcomes at 90 days relative to a performance goal of 53%.
Study Population The study population will consist of adult patients (age = 22 years old) supported with the Impella 2.5 or Impella CP for the approved indication of elective or urgent high-risk PCI, who are enrolled in the cVAD registry at U.S. institutions (both IDE and non-IDE sites) after the PMA post market study approval. Patients will be enrolled consecutively without interruption at all participating sites, without preselection.
Sample Size Approximately 750 subjects at the cVAD registry sites will be treated to compare a composite rate of ten (10) major adverse events (MAE) at 90 days to the performance goal of 53%. This number was chosen to ensure enrollment of at least 369 subjects who are similar to the original PMA Impella 2.5 cohort in PROTECT II. The number of PROTECT II like patients needed (369) was chosen to provide a 90% power to reject the null hypothesis in favor of the alternative hypothesis with the assumption (from the PROTECT II data):
The true proportion of MAE (pPAS) at 90 days is 45%*;
Margin of 8%;
The Performance Goal is 53%;
The power of the study is 90%; and
The one-sided alpha error is 5%.
*Determined with the FDA based on the PROTECT II study results.
Key Study Endpoints Primary Endpoints:
A composite rate of the following intra-procedural and post-procedural major adverse events* (MAE) at 90 days post index procedure:
1. Death;
2. Myocardial infarction;
3. Stroke/TIA;
4. Repeat revascularization;
5. Need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia;
6. Acute renal dysfunction;
7. Increase in aortic insufficiency by more than one grade;
8. Severe hypotension defined as systolic blood pressure <90 mmHg for greater than or equal to 5 minutes requiring inotropic/pressor medications or IV fluid;
9. Cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion; and
10. Failure to achieve angiographic success defined as residual stenosis < 30% after stent implantation.
*Complete definitions of the components of the primary endpoint along with other adverse events are provided in the Appendix A of the study protocol.

Secondary Endpoints:
1. Improved hemodynamics post support initiation as compared to baseline, as measured by maximum increase in mean arterial pressure within 30 min of support initiation.
2. Improvement in LVEF at 90 days as compared to baseline.
3. Improvement in NYHA class at 90 days as compared to baseline.
Follow-up Visits and Length of Follow-up 1 year
Interim or Final Data Summary
Actual Number of Patients Enrolled 1237
Actual Number of Sites Enrolled 46
Patient Follow-up Rate 15.8% of patients missed 30 day follow up, 5.6% missed 90 day follow up, and 9.1% missed 1 year followed up.
Final Safety Findings The composite major adverse event (MAE) for the Protect II like cohort at 90 days was 25.6%, with a two sided confidence interval of 22.1%,
29.2%. Worst case scenario at 90 days is 42.6%, with a 39.0% - 46.1% 95% confidence interval. The Kaplan-Meier estimates of cumulative
MAE, Major adverse cardiac and cerebrovascular events (MACCE), and death reates are also below the 53% performance goal. At 90 days,
the Impella 2.5 cohort had a composite MAE rate of 17.7% and a composite MACCE rate of 12.1%. The Impella CP cohort had a
composite MAE rate of 25.2% and a composite MACCE rate of 16.2%. For the entire cohort, the rates were 23.6% and 15%, respectively.
Final Effect Findings The total cohort saw an improved mean LVEF at 90 days of 7.3% +/- 12.33, the Impella 2.5 cohort saw an improved mean LVEF at 90 days
of 13.3% +/- 15.13%, the Impella CP saw an improved mean LVEF of 6.3% +/- 11.68%. 4.5% decreased New York Heart Association class by
3 classes, 22.7% by 2 classes, 24.2% by 1 class, 40.9% saw no change, 6.1% increased by 1 class, 1.5% increased by 2 classes.
Study Strengths & Weaknesses Strengths: The study’s primary endpoint was the composite MAE at 90 days for the Protect II cohort. The MAE composite rate for this cohort
was 25.6%, with a two sided, 90% confidence interval of 22.1% and 29.2%. This meets the performance goal of 53%.
Weakness: The sponsor had difficulty with enrollment and follow up data collection throughout the study and data collection was paused due
to the COVID-19 Pandemic. The sponsor was able to complete enrollment with 90 day follow up data available through a waiver of
informed consent.
Recommendations for Labeling Changes A labeling change supplement will be requested.

Impella PROTECTED PCI PAS cVAD Registry Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/01/2017 03/23/2017 On Time
one year report 12/01/2017 12/01/2017 On Time
18 month report 06/01/2018 06/01/2018 On Time
two year report 01/11/2019 01/11/2019 On Time
33 month interim report 09/01/2019 08/29/2019 On Time
three year report 12/01/2019 11/29/2019 On Time
42 month report 05/31/2020 05/28/2020 On Time
four year report 11/30/2020 11/23/2020 On Time
final report 01/31/2022 01/31/2022 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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