NCT01605851CompletedNot Applicable
GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)
W.L.Gore & Associates9 sites in 5 countries150 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 9
- Primary Endpoint
- To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
Study Overview
Brief Summary
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with a PFO less than or equal to 17mm
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
Time Frame: 6 months
The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure
Secondary Outcomes
- Additional Clinical Success evaluated during the procedure and 6 months post-procedure(6 months)
Investigators
Study Sites (9)
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