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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-Contined f/u of IDE pivotal cohort

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Application Number P130021 / PAS001
Current Plan Approved 02/17/2014
Study Name ODE Lead-Contined f/u of IDE pivotal 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® U.S. Pivotal Trial and received the Medtronic CoreValve® System (MCS).
Study Population Description Extreme risk subjects currently consented to and enrolled in the Medtronic U.S. Pivotal Trial, and implanted with the MCS.
Sample Size All subjects enrolled in the US Pivotal Trial, 656 iliofemoral and non-ilifemoral and 63 roll-in subjects in all sites (41).
Data Collection The investigational 12-month primary and secondary endpoints have been met and is the basis for FDA approval of the MCS. The following safety/effectiveness endpoints will characterize clinical outcomes 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 percutaneousadjusts, 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 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

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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