GORE® Septal Occluder European Union Clinical Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01605851
First received: May 18, 2012
Last updated: April 22, 2014
Last verified: April 2014
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subjects with a PFO less than or equal to 17mm

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01605851     History of Changes
Other Study ID Numbers: GSO 11-05
Study First Received: May 18, 2012
Last Updated: April 22, 2014
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
Denmark: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 21, 2014