f Post-Approval Studies (PAS) Database
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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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Long Term


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General
Study Status Other
Application Number /
Requirement Number		 P060027 / PAS001
Date Original Protocol Accepted 10/31/2008
Date Current Protocol Accepted 10/31/2008
Study Name Long Term
Device Name OVATIO CRT SYSTEM
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The post-approval study is a 5-year, multi-center, single arm, prospective and retrospective cohort study. All subjects in the study receive the device.
Study Population Study population same as approved product. Indication for use: Ovatio cardiac resynchronization therapy is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized New York Heart Association Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. Situs over-the-wire is designed to pace the left ventricle through a coronary vein. It is intended to be used in conjunction with ELA Medical cardiac resynchronization therapy pulse generators.
Sample Size 2260 subjects, 20 sites
Key Study Endpoints Endpoints include complication free rate at 5 years, individual adverse event rates through 5 years, and system complication free rate at 6 months.
Follow-up Visits and Length of Follow-up Scheduled follow-up occurs at discharge, one month, 6 months, and every 6 months thereafter, for five years post-implant. Unscheduled visits may occur for adverse events. At each scheduled visit, patients are queried regarding adverse events and device interrogation is performed.


Long Term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Fatigue Test Report 06/02/2008 06/02/2008 On Time
6 Month Report 04/13/2009 05/01/2009 Overdue/Received
1 Year Report 10/30/2009 10/30/2009 On Time
18 Month Report 04/13/2010 04/14/2010 Overdue/Received
2 Year Report 10/15/2010 10/20/2010 Overdue/Received
30 month report 04/13/2011 04/14/2011 Overdue/Received
3 Year Report 10/14/2011 10/14/2011 On Time
42 month report 04/13/2012 04/13/2012 On Time
4 Year Report 10/15/2012 10/15/2012 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

Additional Resources

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