|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P020024 / PAS001 |
Date Original Protocol Accepted |
05/14/2003
|
Date Current Protocol Accepted |
05/14/2003
|
Study Name |
Long term
|
Device Name |
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Descriptive
|
Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This study was intended to evaluate long term safety and effectiveness issues that may not have been adequately addressed during the clinical investigation.
|
Study Population |
The AMPLATZER Duct Occluder is a percutaneous, transcatheter occlusion device and is indicated for the non-surgical closue of patent ductus arteriosus. The only requirement for enrollment into the Post-Approval Study was prior enrollment in the Phase II patent ductus arteriosus clinical investigation.
|
Sample Size |
435 patients. 20 sites
|
Key Study Endpoints |
No endpoints were specified.
|
Follow-up Visits and Length of Follow-up |
A follow-up visit at either five, six, or seven years was considered to be a "final" follow-up visit. If a subject has already completed a five year visit, they would not return for a six or seven year visit. However, a subject who missed their five year follow-up could be re-consented and seen after the five year window ends for a final follow-up at six or seven years. Subjects unwilling or unable to return for an office visit had the option of a phone interview.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
435 patients
|
Actual Number of Sites Enrolled |
20 sites
|
Patient Follow-up Rate |
35%
|
Final Safety Findings |
All remaining patients had demonstrated complete closure of the ductus.
|
Study Strengths & Weaknesses |
Strengths: It is very difficult to conduct long term follow-up in this pediatric population. Therefore, any attempt to gather long term data on this group is to be applauded. Weaknesses: Very poor follow-up.
|
Recommendations for Labeling Changes |
There were no recommendations for changes to the labeling based on the results of the post-approval study.
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