|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P040040 / PAS001 |
Date Original Protocol Accepted |
09/07/2007
|
Date Current Protocol Accepted |
09/07/2007
|
Study Name |
5 year long term (IDE)
|
Device Name |
AMPLATZER MUSCULAR VSD OCCLUDER
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Descriptive
|
Study Population |
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 will provide long-term follow-up of forty-three subjects from the premarket cohort that have been designated as High Risk.
|
Study Population |
This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
|
Sample Size |
43 patients, 21 sites
|
Key Study Endpoints |
Safety endpoints include adverse events.
|
Follow-up Visits and Length of Follow-up |
Annual office visits were required out to 5 years.
|
Interim or Final Data Summary |
Interim Results |
The study was terminated early due a low follow-up rate
|
Actual Number of Patients Enrolled |
43
|
Actual Number of Sites Enrolled |
38
|
Patient Follow-up Rate |
24%
|
Final Safety Findings |
A total of 35 overall events were reported in 20 of 43 subjects (46.5%). The most frequently reported event was hypotension which was reported in 11.6% of subjects (5 reports in 5 of 43 subjects).
|
Study Strengths & Weaknesses |
Strengths: Lessons learned on requesting for long term follow-up consent at tiem of IDE enrollment Weaknesses: Extremely low follow-up of the cohort.
|
Recommendations for Labeling Changes |
No labeling changes were recommended.
|