|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980049 S020/ PAS001 |
| Date Original Protocol Accepted |
04/28/2006
|
| Date Current Protocol Accepted |
04/28/2006
|
| Study Name |
Ovatio DR6550 Study
|
| Device Name |
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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 Results |
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
|
