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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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Continued f/u of the premarket cohort


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General
Study Status Completed
Application Number P130021 S010/ PAS001
Study Name Continued f/u of the premarket cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of all living subjects who were enrolled under the IDE in Registry 6: TAV-in-SAV. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects who were enrolled in the ¿TAV-in-SAV¿ Registry
Sample Size All living subjects.
Data Collection The safety and effectiveness endpoints include all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), change in functional status and quality of life, conduction disturbance requiring permanent pacemaker implantation, echocardiographic assessment, and valve dysfunction.
Follow-up Visits and Length of Follow-up 5 years
All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure.
Interim or Final Data Summary
Actual Number of Patients Enrolled 232
Actual Number of Sites Enrolled 38
Patient Follow-up Rate The follow-up rate through 5 years was approximately 88%
Final Safety Findings The Kaplan-Meier rates of CEC-adjudicated safety outcomes at 5 years are summarized as follows:

All-cause mortality or major stroke: 47.2%
All-cause mortality: 46.8% (29.8% cardiovascular mortality)
Valve-related death: 4.7%
All stroke: 9.8% (6.7% major stroke)
Aortic valve rehospitalization: 31%
Reintervention: 5.9%
Major adverse cardiovascular and cerebrovascular event (MACCE): 51.7%
Bleeding: 34.7%
New permanent pacemaker: 24%
Final Effect Findings Key effectiveness outcomes are summarized as follows, in subjects who were evaluated for each outcome measure at the 5-year visit:

NYHA Classification: There was improvement in NYHA classification from baseline to 5-years. The mean change compared to baseline at 5 years was -1.4 +/- 0.9 (n=78).
KCCQ: Improvement was observed in both overall and clinical summary scores through five years. The change in KCCQ overall summary score at 5 years compared to baseline was 27.6 +- 23.3 (n=80).
Valve Performance Outcomes:
Mean gradient decreased from 37.84 +/- 18.03 at baseline to 15.62 +/- 8.79 at 30 days. At 5-years, the overall mean gradient was 14.12 + 9.81 mmHg (n=72).
Mean effective orifice area (EOA) increased from 1.02 +/- 0.61 cm2 at baseline to 1.45 +/- 0.63 cm2 at 30 days. At 5 years, the EOA was 1.57 0.70 cm2 (n=62).
At 5 years, 93.2% of subjects with available echocardiographic data (n=74) had mild or less total aortic regurgitation (AR).

Study Strengths & Weaknesses This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the Medtronic CoreValve System in patients with symptomatic severe aortic stenosis with predicted operative mortality or serious, irreversible morbidity risk of greater than or equal to 50% at 30 days who received a transcatheter implantation of the CoreValve System in a failed surgical prosthetic aortic valve (TAV-in-SAV). Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvements shown for key effectiveness endpoints from baseline to 5 years. However, Echocardiography Corelab and Quality of Life compliance rates at 5 years are low (53-70%). The incomplete data may impact the ability to interpret and draw conclusions from the results.
Recommendations for Labeling Changes The labeling is recommended to be updated to reflect the 5 year findings of the study and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.


Continued f/u of the premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/29/2016 11/27/2015 On Time
two year report 01/17/2017 01/18/2017 Overdue/Received
three year report 01/17/2018 01/18/2018 Overdue/Received
four year report 01/17/2019 01/17/2019 On Time
five year report 01/17/2020 01/16/2020 On Time
final report 04/30/2021 04/28/2021 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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