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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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Long Term


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General
Application Number P060027 / PAS001
Current Plan Approved 10/31/2008
Study Name Long Term
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 Design Description 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 Description 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
Data Collection 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.
Final Study Results
Interim Safety Information To date, there are 5 deaths in 92 enrolled patients. Four deaths were deemed by the sponsor to be related to heart failure (one each related to sepsis and congestive heart failure, end-stage congestive heart failure, advanced class IV heart failure, and cerebral vascular accident). One was not heart-failure related, but due to cardiac arrest due to renal failure and sepsis. There have been 8 complications in 5 patients: 3 were related to the implant procedure, 2 were related to the RA lead, 1 was related to the LV lead, and 2 were related to the RV lead. There have been 14 observations in 11 patients: 5 were related to the implant procedure, 2 to the RV lead, and 7 to the LV lead. Six of the LV lead observations were diaphragmatic stimulation and the other was an elevated pacing threshold.


Long Term Schedule

Report 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

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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