Post-Approval Studies (PAS) Database

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 RW Surveillance of Pts using Sodium Bicarb

General
Study Status	Study Pending
Application Number / Requirement Number	P170011 S035/ PAS001
Date Original Protocol Accepted	08/18/2022
Date Current Protocol Accepted	04/27/2023
Study Name	Impella RW Surveillance of Pts using Sodium Bicarb
Device Name	Impella RP System, Impella RP with SmartAssist System
General Study Protocol Parameters
Study Design	Comprehensive/Linked/RegistryBased Surveillance
Data Source	Sponsor Registry
Comparison Group	Concurrent & Historical Control
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	A multicenter, observational, records review study of routine clinical care. Subjects are from post-market cohorts and new enrollment.
Study Population	Device: The study will include up to 60 sites from the US. The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used. Comparator: The study will include up to 60 sites from the US. The population enrolled in this study are all subjects who received an Impella in which a heparin-based purge solution was used.
Sample Size	A sample size of 300 subjects is proposed for the study based on the following assumptions: Event rate 6% Target margin of error of +/-3% (the width of 95% confidence interval of 6%) While the sample size with the above assumptions is 275, the additional subjects ensure the target 3% margin of error for a potentially higher event rate in the all-comers population enrolled in the study. For Impella RP, the sample size will be the number of subjects available at the time the left-sided device population completes enrollment, up to 30 subjects. As the use of Impella RP is an order of magnitude less than the left-sided devices, a target margin of error is not feasible for this population.
Key Study Endpoints	1. Left-sided devices (Impella 2.5, Impella CP, Impella LD, Impella 5.0 and Impella 5.5): Hierarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus [Time Point: Discharge] 2. Impella RP: Hierarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) [Time Point: Discharge] 1. Bleeding, BARC greater than or equal to 3 [Time Point: Discharge] 2. For left-sided devices: Thrombotic events excluding LV thrombus, stroke and TIA [Time Point: Discharge] 3. For Impella RP: Thrombotic events excluding pulmonary thromboemboli and DVT [Time Point: Discharge]
Follow-up Visits and Length of Follow-up	Data will be collected, via records review, from the time of the index hospitalization where the subject received the Impella device through discharge

Impella RW Surveillance of Pts using Sodium Bicarb Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	04/19/2023	04/17/2023	On Time
final report	07/08/2024	07/08/2024	On Time

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background