Clinical Trials Directory

Trials / Completed

CompletedNCT01605851

GORE® Septal Occluder European Union Clinical Evaluation

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
W.L.Gore & Associates · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEClosure, Foramen Ovale

Timeline

Start date
2012-05-01
Primary completion
2014-01-01
Completion
2014-04-01
First posted
2012-05-25
Last updated
2014-04-24

Locations

9 sites across 5 countries: Denmark, Germany, Italy, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT01605851. Inclusion in this directory is not an endorsement.