Long-term Safety Study of the GORE® HELEX® Septal Occluder

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

Detailed Description
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The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.

Official Title
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GORE® HELEX® Septal Occluder Post-Approval Study

Conditions
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Septal Defect, Atrial

Intervention / Treatment
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* Device: GORE® HELEX® Septal Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASD less than or equal to 18 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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Accepts Healthy Volunteers

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: GORE® HELEX® Septal Occluder<br>Subjects who received a GORE® HELEX® Septal Occluder | Device: GORE® HELEX® Septal Occluder<br>* Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of: Any major device/procedure adverse event Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. Clinically significant leak at the follow-up visit | 12 months | 
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of: Any major device/procedure adverse event Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. Clinically significant leak at the follow-up visit | 36 months | 
| Efficacy | A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of: Any major device/procedure adverse event Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. Clinically significant leak at the follow-up visit | 60 months | 
| Safety | A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial septal defect, septal occluder, HELEX