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GORE® Septal Occluder European Union Clinical Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605851
First Posted: May 25, 2012
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
W.L.Gore & Associates
  Purpose
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).

Condition Intervention
Closure; Foramen Ovale Device: Closure, Foramen Ovale

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO [ Time Frame: 6 months ]
    The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure


Secondary Outcome Measures:
  • Additional Clinical Success evaluated during the procedure and 6 months post-procedure [ Time Frame: 6 months ]
    Technical Success, Procedure Success, Closure Success


Enrollment: 150
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Closure, Foramen Ovale
Patients undergoing device closure of PFO
Device: Closure, Foramen Ovale

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Subjects with a PFO less than or equal to 17mm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605851


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Germany
German Heart Center
Berlin, Germany
University Medical Center of Freiburg
Freiburg, Germany
Heidelberg University Hospital
Heidelberg, Germany
German Heart Center
Munich, Germany
Italy
Hospital Group of San Donato
San Donato, Italy
Sweden
Karolinska University Hospital
Stockholm, Sweden
United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
Sponsors and Collaborators
W.L.Gore & Associates
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01605851     History of Changes
Other Study ID Numbers: GSO 11-05
First Submitted: May 18, 2012
First Posted: May 25, 2012
Last Update Posted: April 24, 2014
Last Verified: April 2014

Keywords provided by W.L.Gore & Associates:
PFO
closure