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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) of 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 continued access cohort


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General
Study Status Revised/Replaced Study
Application Number P130021 / PAS002
Date Current Protocol Accepted 02/17/2014
Study Name ODE Lead-Continued f/u of continued access cohort
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 Design Description A longitudinal observational clinical trial following subjects that were enrolled in the Medtronic CoreValve® Continued Access Study (CAS) and received the Medtronic CoreValve® System (MCS).

Not a hypothesis driven study.
Study Population Description Extreme risk subjects currently consented to and enrolled in the Medtronic U.S. CAS Protocol, and implanted with the MCS.
Sample Size All subjects enrolled in the CoreValve® Continued Access Study (approximately 2250, including both ilio-femoral and non-ilio-femoral implant access) at all sites (up to 45).
Data Collection Primary endpoints: all-cause death or major stroke at 6 months and annually through 5 years.

Secondary endpoints: The following endpoints will be assessed at 1 month, 6 months, and annually through 5 years:

1. 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

¿ EuroQoL7. 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 viaKaplan-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




Contact Us
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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