GORE® Septal Occluder European Union Clinical Evaluation

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01605851

Enrollment

150

Registered

2012-05-25

Start date

2012-05-31

Completion date

2014-04-30

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closure; Foramen Ovale

Keywords

PFO, closure

Brief summary

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).

Interventions

DEVICEClosure, Foramen Ovale

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects with a PFO less than or equal to 17mm

Design outcomes

Primary

Measure	Time frame	Description
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO	6 months	The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure

Secondary

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

Countries

Denmark, Germany, Italy, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026