GORE® Septal Occluder European Union Clinical Evaluation

Closure; Foramen Ovale Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605851
• Other study ID #: GSO 11-05
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: April 22, 2014
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGermany: Ethics CommissionDenmark: Ethics CommitteeSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Subjects with a PFO less than or equal to 17mm

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Closure; Foramen Ovale

Intervention

Device:
• Closure, Foramen Ovale

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO	The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure	6 months	No
Secondary	Additional Clinical Success evaluated during the procedure and 6 months post-procedure	Technical Success, Procedure Success, Closure Success	6 months	No