Long-term Safety Study of the GORE® HELEX® Septal Occluder
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/29/2017 |
| Start Date: | August 2006 |
| End Date: | October 2014 |
GORE® HELEX® Septal Occluder Post-Approval Study
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).
HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
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.
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.
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.
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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