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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130046 / PSS001 |
| Date Original Plan Accepted |
06/20/2014
|
| Date Current Plan Accepted |
02/10/2017
|
| Study Name |
ADVANCE ASO
|
| Device Name |
Amplatzer
|
| Root Document Number |
P000039
|
| General Study Protocol Parameters |
| Study Design |
Case Control Study
|
| Data Source |
Other Data Source
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| 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 |
The manufacturer used data from a published study to fulfill the postmarket surveillance (522) order (McElhinney et al. Circulation.2016;133:1738-1746). The study was a matched case-control study conducted to evaluate relative risk factors for cardiac erosion after ASD closure with an Amplatzer Septal Occluder (cases).
|
| Study Population |
Cases: all erosions events reported to St. Jude Medical after ASD closure with an Amplatzer Septal Occluder reported through 2014. These erosion events were identified through product surveillance complaints, the prospective post-approval study (PAS), and monitoring of the MAUDE database and the published literature.
Controls: Subjects were selected from the post-approval study (P000039/PAS1).
|
| Sample Size |
125 cases and 250 controls matched by age and gender
|
| Key Study Endpoints |
Primary endpoint: Cardiac erosion
An Erosion Board determined whether the event is likely to be attributable to erosion and adjudicates on certain technical, anatomic, and other aspects of the case.
|
| Follow-up Visits and Length of Follow-up |
Retrospective data collection of erosion cases.
Prospective data collection of PAS controls.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
125 cases and 250 controls matched by age and gender. Of these cases, 59 were from the US (47%). Controls were selected from the Amplatzer US Post-Approval Study (P000039, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_ id=89977&c_id=168).
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| Actual Number of Sites Enrolled |
Cases were identified through product surveillance complaints, the prospective PAS, and monitoring of the MAUDE database and the published literature.
Controls: The Amplatzer US Post-Approval Study (P000039) enrolled 50 US sites.
|
| Patient Followup Rate |
Not applicable for a case-control study
|
| Final Safety Findings |
A total of 125 erosions were reported between 2002 and 2014. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age =17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon- sized atrial septal defect (ASD) diameter, Amplatzer septal occluder device size, and device size–ASD diameter difference, and smaller weight:device size ratio were associated with erosion.
The risk factors associated with erosion identified in multivariable analysis were:
• deficiency of the aortic or superior vena cava rims,
• balloon size diameter >5 mm larger than static ASD diameter, and
• low patient weight to device size ratio.
|
| Final Effectiveness Findings |
Not applicable
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| Study Strengths and Weaknesses |
One strength of the study is that it used all the clinical and imaging data from all the erosion cases the sponsor had available between 2002 and 2014. This is a strength given that cardiac erosion is a rare event. Another strength is the selection of controls subjects from a prospective post-approval study (P000039). The study data confirmed the association between aortic rim deficiency and cardiac erosion. It also identified additional risk factors for cardiac erosion: deficiency of the superior vena cava rim, a balloon size diameter device >5 mm larger than static ASD diameter, and low patient weight to: device size ratio. Limitations of the study include missing data on clinical variables for cases (such as location of the erosion, ASD details) and echocardiographic variables for both cases and controls (such as short-axis aortic rim thin information) which potentially affected the statistical power of the study to detect additional risk factors. In addition, half of the cases were implanted in an earlier time-period than the controls. This introduced bias but the authors did not identified differences in the characteristics of the erosion patients during the 2 time periods.
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| Recommendations for Labeling Changes |
The manufacturer was asked to submit a labeling update to include the results from the McElhinney et al. case-control study (Circulation.2016;133:1738-1746).
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