|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000039 / PAS001 |
| Date Original Protocol Accepted |
12/05/2001
|
| Date Current Protocol Accepted |
08/16/2007
|
| Study Name |
Long term
|
| Device Name |
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical 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 is a prospective, non-randomized, multi-site clinical study design. The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients implanted with the AMPLATZER Septal Occluder.
|
| Study Population |
Study Population: Patients implanted with the AMPLATZER Septal Occluder device. Indication: The AMPLATZER Septal Occluder device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.
|
| Sample Size |
256 patients, 33 sites
|
| Key Study Endpoints |
The objective of the study was to assess the safety and effectiveness of the Amplatzer Septal Occluder device. The safety endpoints includes: 1) The incidence of System-Related Adverse Events by patient. System-Related and 2) Adverse Events are defined in the Definitions Section. The effectiveness endpoing include the percentage of patients for whom Closure Success was achieved.
|
| Follow-up Visits and Length of Follow-up |
Patients enrolled in the study will be evaluated pre-procedure, at implant post device deployment, pre-discharge, and at one month, one year, and two years post-implant. Patient data will be obtained at the time of visit and/or if appropriate through a telephone interview. A follow-up visit at the site is required for the pre-procedure, at implant post device deployment, pre-discharge and one month visits.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1,000 subjects
|
| Actual Number of Sites Enrolled |
50 sites
|
| Patient Follow-up Rate |
At two years the follow-up rate was 93.1% (931/1000).
|
| Final Safety Findings |
Primary Endpoint:
Hemodynamic compromise related to the device at two years: 0.65% (6/928, upper bound of exact 95%
CI: 1.40%). This rate is below the performance goal was 1.65%.
Rate of hemodynamic compromise related to the device: 35 per 10,000 subject-years.
Co-Primary Safety Endpoint:
Device- or delivery system-related adverse events at two years: 6.56% (61/930, 95% CI: 5.05% - 8.35%)
Three subjects developed cardiac erosions during the two years of the study (0.3% (3/1000) or 15 per
10,000 subject-years).
Secondary Endpoint #1:
Hemodynamic compromise event rates by size (appropriate or under/oversized) at 2 years:
-Appropriate: 0.19% (1/518)
-Under/oversized: 1.4% (5/356)
Secondary Endpoint #2:
Hemodynamic compromise by high/low implanting physicians:
-High implanting: 0.33% (1/307)
-Low implanting: 0.69% (4/583)
|
| Final Effect Findings |
Co-Primary Effectiveness Endpoint
Closure success at two years: 97.87% (966/987, 95% CI: 96.8% - 98.7%)
|
| Study Strengths & Weaknesses |
This study met its performance goal and had a large sample size. The study also had a low rate of attrition, thus minimizing selection bias. However, this study was not designed adequately to detect rare adverse events, such as cardiac erosion. Postmarket surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act is being conducted to address safety concern related to erosion events (PS130046).
|
| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term (2 years) postmarket performance of the device.
|
