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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
German Heart Center
Berlin, Germany
University Medical Center of Freiburg
Freiburg im Breisgau, Germany
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure
Time frame: 6 months
Additional Clinical Success evaluated during the procedure and 6 months post-procedure
Technical Success, Procedure Success, Closure Success
Time frame: 6 months
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