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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ODE Lead-Continued f/u of the premarket cohorts

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Application Number P130021 S002/ PAS001
Current Plan Approved 06/12/2014
Study Name ODE Lead-Continued f/u of the premarket cohorts
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extended follow-up study of all available subjects that were enrolled in the Medtronic CoreValve® U.S. Pivotal Trial and Continued Access Study who received the Medtronic CoreValve® System (MCS) or underwent surgical aortic valve replacement (SAVR).
Study Population Description High risk and extreme risk subjects currently consented to and enrolled in the Medtronic U.S. Pivotal Trial and Continued Access Study who received the MCS or underwent SAVR.
Sample Size All available subjects enrolled in the US Pivotal Trial, 394 subjects randomized to transcatheter aortic valve replacement (TAVR) and 401 subjects randomized to surgical aortic valve replacement (SAVR), and 76 roll-in subjects in all sites (up to 45) and approximately 2800 CAP subjects.
Data Collection The primary endpoint of all-cause mortality at 12 months in High Risk subjects is non-inferior to surgical aortic valve replacement (SAVR), has been met. Clinical outcomes will be characterized annually through 5 years.

The secondary endpoints through 12 months have been evaluated. The following secondary endpoints will characterize clinical outcomes annually through 5 years:

A. Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event rates via Kaplan-Meier. MACCE is defined as a composite of:

¿ all-cause death

¿ myocardial infarction (MI)

¿ all stroke, and

¿ reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

2. The occurrence of individual MACCE components event rates via Kaplan-Meier

3. Major Adverse Events (MAE) event rates via Kaplan-Meier

4. Conduction disturbance requiring permanent pacemaker implantation event rates via Kaplan-Meier

5. Change in NYHA class

6. Quality of Life (QoL) change using the following measures:

¿ Kansas City Cardiomyopathy Questionnaire (KCCQ)

¿ SF 12, and

¿ EuroQoL

7. Echocardiographic assessment of valve performance using the following measures:

¿ transvalvular mean gradient

¿ effective orifice area

¿ degree of aortic valve regurgitation (transvalvular and paravalvular)

8. Aortic valve disease hospitalization event rates via Kaplan-Meier

9. Cardiovascular deaths and valve-related deaths event rates via Kaplan-Meier

10.Strokes (of any severity) and TIAs event rates via Kaplan-Meier

11.Evidence of prosthetic valve dysfunction
Follow-up Visits and Length of Follow-up Annually through 5 years

ODE Lead-Continued f/u of the premarket cohorts Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 01/17/2015 11/28/2014 On Time
two year report 01/17/2016 11/27/2015 On Time
three year report 03/17/2017    
four year report 03/16/2018    
five year report 03/16/2019    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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