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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050006 / PAS001 |
| Date Original Protocol Accepted |
08/11/2006
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| Date Current Protocol Accepted |
12/13/2006
|
| Study Name |
GORE HELEX
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| Device Name |
GORE HELEX SEPTAL OCCLUDER
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| 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 is prospective cohort study. The study population consists of two different cohorts: 1) Continued Access Study of the GORE HELEX Septal Occluder and 2) Post-Approval Study of the GORE HELEX Septal Occluder (CA-PAS Subjects HLX 06-04).
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| Study Population |
The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects. This study will enroll approximately 200 subjects, including subjects from the Icontinued Access Study, who have been successfully implanted.
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| Sample Size |
200 patients, 19 sites
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| Key Study Endpoints |
Composite Clinical Success is evaluated at 12 months and is defined as a subject with the targeted defect assessed by TTE as being either completely occluded or the residual shunt is clinically insignificant, with an absence of repeat procedure to the target ASD, and absence of any major complication.
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| Follow-up Visits and Length of Follow-up |
The safety endpoints defined above will be evaluated annually through 5 years post procedure. The efficacy endpoints defined above will be evaluated at year 1, 3, and 5 post-procedure.During Year 2 and Year 4 of long-term follow-up, the site will contact the subject (or legal guardian if subject is a minor) by telephone to evaluate their status. During Year 3 and Year 5 of long-term follow-up, the site will schedule subject for a follow-up visit. Follow-up visit will include physical examination, ECG, and echocardiogram. A fluoroscopy exam without contrast will be conducted at Year 5.
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| Interim or Final Data Summary |
| Interim Results |
No unanticipated adverse events have been reported to date. There have been no new Major Adverse Events reported during this reporting period. Clinically successful defect closure (Complete Occlusion or Clinically Insignificant Leak) was observed in 97.8% (43/44) of subjects evaluated at 12 months post procedure by the Echocardiographic Core Lab. Of the echo core lab reviews available for the 16 subjects at 36 months post procedure, clinically successful defect closure was observed in 100.0%. Of the 17 echo core lab reviews available for the 17 subjects at 60 months post procedure, clinically successful defect closure also was observed in 100.0%. Clinical Success was achieved in 85.0% (17/20) of subjects evaluated at 60 month post procedure. Three subjects were considered clinical failures. These are the same three (3) subjects identified at the 12 month post procedure interval. Clinical Success has been determined in 20 (40.0%) of the 50 evaluable subjects at the 60 month follow-up interval. Of the 30 subjects not evaluated, 15 were lost to follow-up and 15 have not completed Echo Core Lab evaluations of residual defect status (pending or missing).
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| Actual Number of Patients Enrolled |
Continued Access Study: 50
PAS: 215
|
| Actual Number of Sites Enrolled |
Continued Access Study: 13
Post-approval Study (PAS): 21 sites
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| Patient Follow-up Rate |
Continued Access Study: 70% PAS: 76%
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| Final Safety Findings |
Continued Access Study:
Major adverse events were reported in 6.0% (3/50) of subjects. These included 2 device embolizations in the first 24 hours post-procedure and 1 wire frame fracture. All of these major adverse events were device-related and occurred within 12 months.
PAS:
Major adverse events (MAEs) were reported in 4.7% (10/215) of subjects through the 60-month follow- up. Out of 8 device-related MAEs, there were 2 device embolizations within the first 30 days post- procedure and 5 device removals (4 due to fracture and 1 due to device malposition).
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| Final Effect Findings |
Continued Access Study:
Clinically successful defect closure was observed in 91.5% (43/47), 84.2% (16/19), and 87.5% (21/24) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.
PAS:
Clinically successful defect closure was observed in 95.0% (171/180), 92.5% (123/133), and 94.1% (143/152) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.
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| Study Strengths & Weaknesses |
Continued Access Study: The 50 subjects in this study provided safety and efficacy data in support of the PMA approval for the Gore Helex septal occluder. Subjects in this study had to be re-consented for longer-term follow-up. Many of the subjects missed the 36-month follow-up and consequently, this information was not available for analysis. This also impacted the overall study follow-up. Analysis presented showed no evidence of selection bias introduced in the study due to loss-to-follow-up. This study shows the initial results of the long-term performance of this device.
PAS:
The results of this study provide long-term safety and effectiveness data for the Gore Helex septal occluder. Although patient follow-up was 76%, only 4% shy of the protocol defined expectations, a sensitivity analysis showed no evidence of selection bias. Further, the data demonstrated that over 90% of the patients implanted with the investigational device maintained composite clinical success through
60 months.
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| Recommendations for Labeling Changes |
It is not recommended because W.L. Gore & Associates, Inc. ceased the production of the GORE HELEX Septal Occluder.
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