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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 premarket cohort


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General
Study Status Progress Adequate
Application Number P130021 S025/ PAS001
Date Current Protocol Accepted  
Study Name Continued f/u of 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 72 enrolled; 60 received an attempted implant
Actual Number of Sites Enrolled 10
Patient Follow-up Rate The follow-up rate through 5 years was approximately 75%. Compliance with visit assessments (e.g., NYHA Classification, KCCQ) ranged from 69% to 72% of subjects who completed the 5Y follow-up visit, and compliance with echocardiographic imaging assessments were approximately 63% of subjects who attended the final 5-year visit.
Final Safety Findings The Kaplan-Meier rates of CEC-adjudicated safety outcomes at 5 years are summarized as follows: - All-cause mortality: 45.9% (29.8% cardiovascular mortality) - All stroke: 14.6% (6.3% disabling stroke) - Vascular Complications: 3.3% - Bleeding: 22.8% (13.2% life-threatening or disabling) - Acute kidney injury: 0.0% - Myocardial infarction: 13.9% - New permanent pacemaker: 35.7% - Valve thrombosis: 2.1% - Valve endocarditis: 2.8% - Valve-related dysfunction requiring repeat procedure: 2.8% - Coronary artery obstruction: 0.0%
Final Effect Findings Key effectiveness outcomes are summarized as follows, in subjects who were evaluated for each outcome measure at the 5-year visit (unless otherwise noted): • NYHA Classification: Improvement in NYHA classification was maintained through 5 years. The mean change compared to baseline at 5 years was -1.1 +/- 0.8 (n=23), and 91% of the remaining 23 subjects were Class I/II. • KCCQ: Clinically significant 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 17.0
+/- 22.9 (n=22) • Valve Performance Outcomes: o Mean effective orifice area (EOA) increased from 0.8 +/- 0.2 cm2 at baseline to 2.6 +/- 0.7 cm2 at 30 days. At 5 years, the EOA was 2.6 +/- 0.7 cm2 (n=20) o Overall, mean gradient decreased from 41.5 +/- 10.3 mmHg at baseline to 6.3 +/- 3.2 mmHg at 30 days. At 5 years, the overall mean gradient was 8.3 +/- 5.6 mmHg (n=20). o At 5 years, 100% of subjects with available echocardiographic data (n=20) had mild or less total aortic regurgitation (AR). o At 5 years, 100% of subjects with available echocardiographic data (n=20) had mild or less paravalvular AR.
Study Strengths & Weaknesses This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the CoreValve Evolut 34R valve in patients with severe symptomatic aortic stenosis at high or greater surgical risk. Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvement in quality of life outcomes and hemodynamic performance. The lack of completion of some assessments of interest including NYHA Classification, KCCQ, and echocardiographic imaging at the 5-year study visit presents challenges to the interpretability of longer-term effectiveness outcomes. The missing data is in part related to challenges with in-person visits during the COVID-19 pandemic. Additionally, it should be noted that some subjects withdrew or were lost to follow-up in this study. Incomplete follow-up may also lead to biased longer-term results.
Recommendations for Labeling Changes Complete longer-term follow-up data warrants inclusion into the labeling for the device and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.


Continued f/u of premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/17/2017 01/18/2017 Overdue/Received
2 year report 01/17/2018 01/18/2018 Overdue/Received
3 year report 01/17/2019 01/17/2019 On Time
4 year report 01/17/2020 01/16/2020 On Time
5 year report 01/17/2021 01/15/2021 On Time
final report 04/30/2022 04/28/2022 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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