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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P040040 / PAS002 |
| Date Original Protocol Accepted |
09/07/2007
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| Date Current Protocol Accepted |
03/18/2016
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| Study Name |
Post Approval Study
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| Device Name |
AMPLATZER MUSCULAR VSD OCCLUDER
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21,
All Pediatric Patients: 0-21 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, non-randomized, multi-site clinical study.
The primary safety objective is to evaluate the proportion of subjects experiencing a major (serious) adverse event within 12 months of the procedure.
The effectiveness objective is to evaluate the proportion of subjects whom experience technical success, closure success, and acute procedure success.
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| 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. Eligible patients can be enrolled retrospectively.
The comparison group is the Historical Control.
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| Sample Size |
One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional sites in Europe and Canada.
If subject follow-up drops below 80%, additional subjects will be enrolled to ensure a final population of 80 subjects either meet a defined endpoint or are followed for five years.
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| Key Study Endpoints |
Primary safety endpoint:
Any major (serious) adverse event within 12 months of the procedure. A serious adverse event is defined as any untoward medical occurrence that:
results in death;
is a life-threatening adverse event;
requires inpatient hospitalization or prolongation of existing hospitalization;
results in persistent or significant disability/incapacity; or
is a medically significant event.
Primary effectiveness endpoints:
Technical Success
Acute Procedure Success
Shunt Closure Success at 12 months
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| Follow-up Visits and Length of Follow-up |
Each study subject receiving a device will be followed for 60 months post-procedure, unless the device is explanted.
Follow-up assessments will be conducted at 30 days, 6 months , one year, and annually until the five-year visit is complete.
If the delivery system enters the subject’s body in an attempt to place a device but no device is implanted during the initial procedure, the subject will be discontinued from the study after a 30-day adverse event collection period.
If the device explant occurs before the 12-month visit and a SAE is associated with the device explant, the subject will be discontinued on the date the device is explanted. (In this case, the subject is considered a failure for all endpoints except Technical Success.)
If a device explant is not associated with a SAE, the subject will continue to be followed through the 12-month visit. The subject will then be discontinued at the 12-month visit. If a subject has a device explanted after the 12-month visit, the subject will be discontinued on the date of the explant procedure.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 92 subjects were enrolled into the study.
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| Actual Number of Sites Enrolled |
28 sites in the United States and Canada.
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| Patient Follow-up Rate |
All subjects have completed the 5-year follow-up visit. The percentage of subjects that covered each follow up visit are presented below:
1 year - 96.4%
2 year - 90.2%
3 year - 86.3%
4 year - 94.7%
5 year - 96.1
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| Final Safety Findings |
The point estimate for the primary safety endpoint was, 52.2% (47/90), with a 97.5% upper confidence bound of 62.9%, which met the performance goal of 63.2%.
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| Final Effect Findings |
The point estimate for Technical Success for prospectively enrolled subjects was 93.8%, with a 97.5% lower confidence bound of 86.0%, which exceeded the performance goal of 64.0%. Acute Procedure Success and Shunt Closure Success estimates were 78% and 94.4%, respectively. The 97.5% lower confidence bound for Acute Procedure Success was 68.1%, surpassing the performance goal of 61.3%. Shunt Closure Success had a 95% lower confidence bound of 87.7%, which exceeded the performance goal of 58.7%.
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| Study Strengths & Weaknesses |
Study strengths: Long-term follow-up post 5-year implant.
Weaknesses: This was a single arm non-randomized study.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add the long-term safety and efficacy results from this study.
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