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Completed

NCT Number: NCT01605851

GORE® Septal Occluder European Union Clinical Evaluation

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).

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Key information

Conditions

Closure; Foramen Ovale

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Subjects with a PFO less than or equal to 17mm

Treatment and study plan

Closure, Foramen Ovale

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Additional Clinical Success evaluated during the procedure and 6 months post-procedure

    Time frame: 6 months

    Technical Success, Procedure Success, Closure Success

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 25, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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