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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Cont F/u Low Risk Premarket Cohort

General
Study Status	Ongoing
Application Number / Requirement Number	P130021 S076/ PAS001
Date Original Protocol Accepted	08/17/2020
Date Current Protocol Accepted
Study Name	Cont F/u Low Risk Premarket Cohort
Device Name	Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
Clinical Trial Number(s)	NCT02701283
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	Continued follow-up of all 148 subjects who were enrolled in the Bicuspid Registry under IDE G160022. The objective of this study is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population	All living subjects who were enrolled in the Bicuspid Registry.
Sample Size	148
Key Study Endpoints	All-cause mortality, all stroke (disabling and nondisabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.
Follow-up Visits and Length of Follow-up	10 years. All subjects are followed annually through 10 years post procedure.
Interim or Final Data Summary
Interim Results	Safety Results At 4 years: All-cause mortality: 5.7% All stroke (disabling and nondisabling): 6.8% Life-threatening bleeding: 4.7% Acute kidney injury at stage 2 or 3: 0% Coronary artery obstruction requiring intervention: 0.7% Major vascular complication: 1.3% Valve-related dysfunction requiring repeat procedure: 3.8% New permanent pacemaker implantation: 21.2% Prosthetic valve endocarditis: 2.1% Prosthetic valve thrombosis: 1.3% Effectiveness Results At 4 years: NYHA classification (change from baseline): 75% improved KCCQ overall summary score (change from baseline): 22.0 Mean Gradient: 9.94 mmHg Mean Effective Orifice Area: 2.17 cm2 Total Aortic Regurgitation (greater than or equal to moderate): 0.8%
Actual Number of Patients Enrolled	150 attempted implants
Actual Number of Sites Enrolled	25
Patient Follow-up Rate	89% at 4 years

Cont F/u Low Risk Premarket Cohort Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	03/31/2021	03/30/2021	On Time
2 year report	03/31/2022	03/23/2022	On Time
3 year report	03/31/2023	03/27/2023	On Time
4 year report	03/31/2024	03/25/2024	On Time
5 year report	03/31/2025
6 year report	03/31/2026
7 year report	03/31/2027
8 year report	03/31/2028
9 year report	03/31/2029
10 year report	03/31/2030

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