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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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Ovatio DR6550 Study

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Study Status Completed
Application Number P980049 S020/ PAS001
Date Current Protocol Accepted 04/28/2006
Study Name Ovatio DR6550 Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a 6-month, multi-center, single arm, prospective cohort study. All subjects in the study receive the device.
Study Population Description Study Population: Patients with an accepted indication for an implantable cardioverter defibrillator implant. Indication: The device is indicated for use in patients who are at high risk for sudden death due to ventricular tachyarrhythmia who have experienced at least one episode of cardiac arrest due to tachyarrhythmia or who have recurrent poorly tolerated, sustained ventricular tachycardia.
Sample Size 60 subjects at 5 sites
Data Collection Endpoints include incidence and nature of device related adverse events through 6 months follow-up (safety) and the percentage of patients with two successful reductions of ventricular fibrillation (VF) at 24Joules (10 Joules below maximum output) at implant (effectiveness).
Follow-up Visits and Length of Follow-up Patients will be evaluated at implant, 3 months, 6 months, and at unscheduled visits as needed for adverse events and effectiveness of device therapy.
Interim or Final Data Summary
Interim Safety Information There were 62 adverse events have been seen in 43 patients including 3 deaths. The deaths were not deemed device-related by the sponsor and were due to aspiration pneumonia/sepsis, pancytopenia, and renal disfunction (end-stage renal disease).
Actual Number of Patients Enrolled 5
Actual Number of Sites Enrolled 77 successful implants (85 enrolled)
Patient Follow-up Rate 84.4% (65 patients completed study of 77 implanted)
Final Safety Findings There were 12 applicable system complications in 8 patients for a 6-month system complication free rate of 89.6% (95% lower confidence bound: 85%). There were 4 deaths; none were device related. There were 12 serious, implant- or device-related events (complications) including: 2 pocket infections, 3 lead dislodgement/migrations, 1 non-conversion of ventricular tachycardia (VT) or ventricular fibrillation (VF), 3 lead losses of capture, 1 elevated pacing threshold, 1 pocket erosion, and 1 cardiac perforation. All were resolved within one day, except the 2 pocket infections which required explant of the device.
Final Effect Findings Two successful reductions of VF occurred in 72 of the 77 implanted patients (93.5%; 95% CI 89-98%). Four patients received 7 shocks for spontaneous VT or VF in the six months following implant. All had successful reductions of VT or VF. The sensitivity for correctly detecting and shocking induced VT or VF was 99.5%. The sensitivity for spontaneous VF was 100%. The sensitivity for spontaneous VT was 100%. And, the specificity for (correctly detecting and not shocking) supraventricular tachycardia or sinus tachycardia was 99.1%.
Study Strengths & Weaknesses The purpose of the study was to follow at least 60 patients for 6 months and to report on complications and successful shocks during that time. There was no stated hypothesis or specified maximum attrition rate. Thus, the results are descriptive and representative of the patients who completed the 6 month follow-up and not necessarily all patients who utilize this device.
Recommendations for Labeling Changes Yes

Ovatio DR6550 Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/27/2006 11/03/2006 Overdue/Received
1 year report 04/28/2007 04/27/2007 On Time
18 month report 10/27/2007 10/26/2007 On Time
2 year report 04/27/2008 04/18/2008 On Time
30 month report 10/27/2008 10/27/2008 On Time
3 year report 04/27/2009 04/29/2009 Overdue/Received
42 Month Report 10/27/2009 10/26/2009 On Time
Final Report 08/02/2010 08/02/2010 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

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

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