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CompletedNCT01605851Updated Apr 24, 2014

GORE® Septal Occluder European Union Clinical Evaluation

An interventional study of Closure, Foramen Ovale in Closure; Foramen Ovale, sponsored by W.L.Gore & Associates. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-24.

Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Closure; Foramen Ovale

Keywords

  • PFO
  • closure
03

In context

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 21 are open to participants now.

Browse W.L.Gore & Associates studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Subjects with a PFO less than or equal to 17mm

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Other
    Closure, Foramen Ovale

    Patients undergoing device closure of PFO

    Device: Closure, Foramen Ovale

Interventions

  • DeviceClosure, Foramen Ovale
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

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

    Technical Success, Procedure Success, Closure Success

    Time frame: 6 months

07

Study locations

9 sites
  • Aarhus University Hospital
    Aarhus, Denmark
  • Rigshospitalet
    Copenhagen, Denmark
  • German Heart Center
    Berlin, Germany
  • University Medical Center of Freiburg
    Freiburg im Breisgau, Germany
  • Heidelberg University Hospital
    Heidelberg, Germany
  • German Heart Center
    Munich, Germany
  • Hospital Group of San Donato
    San Donato, Italy
  • Karolinska University Hospital
    Stockholm, Sweden
  • Leeds Teaching Hospitals
    Leeds, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Jan 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2012
First posted
May 25, 2012
Start
May 2012
Primary completionActual
Jan 2014
CompletionActual
Apr 2014
Last update
Apr 24, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01605851
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
May 25, 2012
Start date
May 2012
Primary completion
Jan 2014
Completion
Apr 2014
Last update
Apr 24, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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