Closure; Foramen OvaleNCT01605851
GORE® Septal Occluder European Union Clinical Evaluation
A study testing Closure, Foramen Ovale in people with Closure; Foramen Ovale, run by W.L.Gore & Associates at 9 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closure; Foramen Ovale
- What is being tested?
- Closure, Foramen Ovale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 5 countries
- Study dates
- May 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects with a PFO less than or equal to 17mm
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany4 sites
German Heart Center
Berlin
University Medical Center of Freiburg
Freiburg im Breisgau
Heidelberg University Hospital
Heidelberg
German Heart Center
Munich
About this study
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)
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).
- Conditions
- Closure; Foramen Ovale
- Being tested
- Closure, Foramen Ovale
- Keywords
- PFO, closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure, Foramen OvaleDevice
| Study group | Role | What they receive |
|---|---|---|
| Closure, Foramen Ovale | Other | Patients undergoing device closure of PFO Receives: Device: Closure, Foramen Ovale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Additional Clinical Success evaluated during the procedure and 6 months post-procedure
Technical Success, Procedure Success, Closure Success
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closure; Foramen OvaleStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605851
- Sponsor's protocol ID
- GSO 11-05
- Status last verified
- Apr 2014
- First submitted
- 18 May 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01605851
- Acronym / sponsor ID
- GSO 11-05
- Conditions
- Closure; Foramen Ovale
- Keywords
- PFO, closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closure, Foramen Ovale | Other | Device: Closure, Foramen OvalePatients undergoing device closure of PFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure, Foramen Ovale | Device | Closure, Foramen Ovale |
Primary outcome
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
1 secondary outcome
Additional Clinical Success evaluated during the procedure and 6 months post-procedure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure, Foramen Ovale in people with Closure; Foramen Ovale, run by W.L.Gore & Associates at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Denmark, Italy, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.