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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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CAP Cohort and Low Risk Bicuspid RWU Surveillance


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General
Study Status Ongoing
Application Number /
Requirement Number		 P140031 S107/ PAS002
Date Original Protocol Accepted 07/22/2020
Date Current Protocol Accepted  
Study Name CAP Cohort and Low Risk Bicuspid RWU Surveillance
Device Name Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves
Clinical Trial Number(s) NCT02675114 
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Comprehensive/linked/registry-based surveillance. The objectives of the surveillance are to characterize the clinical outcomes of the CAP cohort annually through 10 years post implantation and to assess the real-world use of the commercial SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System to ensure that the device is used in appropriate circumstances, respectively.
Study Population The surveillance of the CAP cohort will consist of all living CAP patients who were enrolled at participating institutions, and the surveillance of the real-world use will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size All living CAP subjects and all consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Key Study Endpoints The clinical data through one (1) year will be collected through the TVT Registry; and the follow-up data from year 2 through year 10 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database. The surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-10 year post implantation.
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 CAP:
Bicuspid at 1 Year:
All-cause death: 0.0%
All stroke: 1.1%
Transient ischemic attack: 0.0%
Rehospitalization (Device or procedural related or heart failure): 7.1%
Aortic valve re-intervention (site reported): 1.0%
Life-threatening/major bleeding (site reported): 0%
Major vascular complications (site reported): 3.1%
New requirement for dialysis (site reported): 0%

LR RWU:
Bicuspid TVTR at 1 year:
All-cause mortality: 3.1%
All stroke (disabling and non-disabling): 2.3%
Life-threatening bleeding: 1.3%
Myocardial infarction: 0.4%
New requirement for dialysis: 0.2%
Transient ischemic attack (TIA): 0.6%
Major Vascular Complications: 0.8%
Aortic valve reintervention: 0.9%
New permanent pacemaker implantation (site reported): 8.3%
Prosthetic valve endocarditis (site reported): 0.4%
Prosthetic valve thrombosis (site reported): 0.6%
NYHA (% in class I/II): 97.3%
KCCQ (Mean Change from Baseline): 27.6
Transvalvular mean gradient: 13.6
Greater than or equal to Moderate PVL: 3.1%
Actual Number of Patients Enrolled CAP Cohort:
Bicuspid: A total of 98 subjects were enrolled, all of which were included in the valve implant population.

LR RWU:
Bicuspid TVTR: A total of 3,533 subjects were treated. Of these, 3,517 subjects were included in the VI population
Actual Number of Sites Enrolled CAP:
Bicuspid: 34

LR RWU:
Bicuspid TVTR: 531
Patient Follow-up Rate CAP:
Bicuspid at 1 year: 93.9%

LR RWU:
Bicuspid TVTR: Patient status known at 1 year: 61%


CAP Cohort and Low Risk Bicuspid RWU Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/01/2021 09/01/2021 On Time
2 year report 09/01/2022 09/01/2022 On Time
3 year report 09/01/2023 09/01/2023 On Time
4 year report 09/01/2024 08/30/2024 On Time
5 year report 09/01/2025    


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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