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)
Sponsor study identifier
interventional
150
5 countries
9
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 18, 2012
Actual (reported)May 25, 2012
Actual (reported)January 2014
Actual (reported)April 2014
Actual (reported)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
6 months
Additional Clinical Success evaluated during the procedure and 6 months post-procedure
6 months
Patients undergoing device closure of PFO
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
German Heart Center
Berlin, Germany
University Medical Center of Freiburg
Freiburg im Breisgau, Germany
Heidelberg University Hospital
Heidelberg, Germany
German Heart Center
Munich, Germany
Hospital Group of San Donato
San Donato, Italy
150 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2012
First Posted
May 25, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Karolinska University Hospital
Stockholm, Sweden
Leeds Teaching Hospitals
Leeds, United Kingdom
Primary Completion
January 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
April 24, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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