Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

Study Overview
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Brief Summary
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The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

Detailed Description
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Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.

Official Title
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GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)

Conditions
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Septal Defect, Atrial

Intervention / Treatment
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* Device: GORE® CARDIOFORM Septal Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASD less than or equal to 17 mm. Exclusion Criteria: Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events. Unable to accommodate device delivery catheter.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Device<br>ASD closure with the GORE® CARDIOFORM Septal Occluder | Device: GORE® CARDIOFORM Septal Occluder<br>* Percutaneous Atrial Septal Defect Closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With 6-Month Composite Clinical Success | Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder Safety Success: Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Technical Success | Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder | During procedure; median duration 68 minutes | 
| Number of Subjects With Procedure Success | Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure. | During procedure; median duration 68 minutes | 
| Number of Subjects With 30-day SAE | Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure | 30 days | 
| Number of Subjects With 6-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation. | 6 months | 
| Number of Subjects With 12-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation. | 12 months | 
| Number of Subjects With 36-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation. | 36 months |