|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P020024 S037/ PAS001 |
Date Original Protocol Accepted |
08/18/2013
|
Date Current Protocol Accepted |
11/08/2013
|
Study Name |
Continued F/u of the Premarket ADO II PAS
|
Device Name |
AMPLATZER DUCT OCCLUDER II
|
Clinical Trial Number(s) |
NCT00713700
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
To examine the long term safety and effectiveness of the ADO II through continued follow-up of the 178 subjects from the ADO II IDE study in whom device placement has occurred.
|
Study Population |
Subjects implanted with an ADO II device. No comparison group.
|
Sample Size |
A total of 178 subjects were enrolled in the ADO II IDE study and were implanted with the device.
|
Key Study Endpoints |
The primary ADO II PAS safety objective is to evaluate the rate of device serious adverse events (SAE) reported from the procedure through 5 years post-procedure.
|
Follow-up Visits and Length of Follow-up |
5 years post-procedure - annual visits
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
178 subjects implanted with the AMPLATZER Duct Occluder II constituted the post-approval study population
|
Actual Number of Sites Enrolled |
25 sites
|
Patient Follow-up Rate |
84.3% (150/178)
|
Final Safety Findings |
Freedom from device- and procedure-related serious adverse events through 5 years was 97.9% (95% CI: 94.4 – 99.2).
|
Final Effect Findings |
A total of 150 patients had their 60-month visits and 5 did not complete their echocardiograms. The rate of complete closure of the ductus arteriosus at 60 months post-procedure was 100% (145/145).
|
Study Strengths & Weaknesses |
The study had a low rate of attrition, thus minimizing selection bias. It also provided results on the long- term (5 years) safety and efficacy of the device. A weakness of this study is that it did not collect data on race and/or ethnicity.
|
Recommendations for Labeling Changes |
A labeling change is recommended to add the long-term safety and efficacy results from the pre-market cohort.
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