GORE® Septal Occluder European Union Clinical Evaluation

April 22, 2014 updated by: W.L.Gore & Associates

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
  • Germany
      • Berlin, Germany
        • German Heart Center
      • Freiburg, Germany
        • University Medical Center of Freiburg
      • Heidelberg, Germany
        • Heidelberg University Hospital
      • Munich, Germany
        • German Heart Center
  • Italy
      • San Donato, Italy
        • Hospital Group of San Donato
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Subjects with a PFO less than or equal to 17mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Closure, Foramen Ovale
Patients undergoing device closure of PFO
Device: Closure, Foramen Ovale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Clinical Success evaluated during the procedure and 6 months post-procedure
Time Frame: 6 months
Technical Success, Procedure Success, Closure Success
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GSO 11-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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