GORE® Septal Occluder European Union Clinical Evaluation

NCT ID: NCT01605851

Last Updated: 2014-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Closure; Foramen Ovale

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closure, Foramen Ovale

Patients undergoing device closure of PFO

Group Type OTHER

Closure, Foramen Ovale

Intervention Type DEVICE

Interventions

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Closure, Foramen Ovale

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subjects with a PFO less than or equal to 17mm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

German Heart Center

Berlin, , Germany

Site Status

University Medical Center of Freiburg

Freiburg im Breisgau, , Germany

Site Status

Heidelberg University Hospital

Heidelberg, , Germany

Site Status

German Heart Center

Munich, , Germany

Site Status

Hospital Group of San Donato

San Donato, , Italy

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Leeds Teaching Hospitals

Leeds, , United Kingdom

Site Status

Countries

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Denmark Germany Italy Sweden United Kingdom

Other Identifiers

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GSO 11-05

Identifier Type: -

Identifier Source: org_study_id

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