GORE® Septal Occluder European Union Clinical Evaluation

W.L. Gore & Associates

Status: Completed

Conditions: Closure; Foramen Ovale

Treatments: Device: Closure, Foramen Ovale

Study type: Interventional

Funder types: Industry

Identifiers

NCT01605851

GSO 11-05

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Subjects with a PFO less than or equal to 17mm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Closure, Foramen Ovale

Other group

Description:

Patients undergoing device closure of PFO

Treatment:

Device: Closure, Foramen Ovale