GORE® Septal Occluder European Union Clinical Evaluation
Not Applicable
Completed
- Conditions
- Closure; Foramen Ovale
- Interventions
- Device: Closure, Foramen Ovale
- Registration Number
- NCT01605851
- Lead Sponsor
- W.L.Gore & Associates
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Closure, Foramen Ovale Closure, Foramen Ovale Patients undergoing device closure of PFO
- Primary Outcome Measures
Name Time Method To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO 6 months The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure
- Secondary Outcome Measures
Name Time Method Additional Clinical Success evaluated during the procedure and 6 months post-procedure 6 months Technical Success, Procedure Success, Closure Success
Trial Locations
- Locations (8)
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Leeds Teaching Hospitals
🇬🇧Leeds, United Kingdom
German Heart Center
🇩🇪Munich, Germany
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
University Medical Center of Freiburg
🇩🇪Freiburg, Germany
Heidelberg University Hospital
🇩🇪Heidelberg, Germany
Hospital Group of San Donato
🇮🇹San Donato, Italy