GORE® Septal Occluder European Union Clinical Evaluation
NCT01605851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2014-04-24
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).
Conditions
- Closure; Foramen Ovale
Interventions
- DEVICE
-
Closure, Foramen Ovale
Sponsors & Collaborators
-
W.L.Gore & Associates
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2014-01-31
- Completion
- 2014-04-30
Countries
- Denmark
- Germany
- Italy
- Sweden
- United Kingdom
Study Locations
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