StrokeGSO-PFO PMSNCT05529901
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
An observational study of Stroke and PFO - Patent Foramen Ovale, run by W.L.Gore & Associates at 1 site in Japan.
Trial summary
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke
- What is being tested?
- GORE® CARDIOFORM Septal Occluder
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 3 Oct 2022to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.
Who may be able to join
- Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
- Diagnosed with a PFO
- Note: Additional Inclusion Criteria may apply
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Being tested
- GORE® CARDIOFORM Septal Occluder
- Medical subject headings
- Stroke, Foramen Ovale, Patent, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® CARDIOFORM Septal OccluderDevice
Patients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study
What is being measured
The primary outcome is the main question the study is designed to answer.
PFO Closure Rate
PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (<20).
Measured: 12 months
Rate of Conversion to surgical procedure
Rate of post-procedure conversion to surgical procedure will be calculated.
Measured: Discharge
Incidence rate of post-procedure ischemic stroke events
Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot.
Measured: 36 months
Device success
Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure.
Measured: 36 months
Incidence rate of post-procedure adverse events and/or device issues
Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated.
Measured: 36 months
Incidence rate of device- and procedure-related events within 30 days post procedure
Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start3 Oct 2022
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
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
- NCT05529901
- Sponsor's protocol ID
- JPS 21-08
- Acronym
- GSO-PFO PMS
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
- ClinicalTrials.gov ID
- NCT05529901
- Acronym / sponsor ID
- GSO-PFO PMS / JPS 21-08
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 7 Sep 2022 (actual)
- 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 purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.
Key inclusion criteria (3 listed)
- Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
- Diagnosed with a PFO
- Note: Additional Inclusion Criteria may apply
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| GORE® CARDIOFORM Septal OccluderPatients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study | Device | – |
Primary outcome
PFO Closure Rate
Time frame: 12 months
PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (<20).
Rate of Conversion to surgical procedure
Time frame: Discharge
Rate of post-procedure conversion to surgical procedure will be calculated.
Incidence rate of post-procedure ischemic stroke events
Time frame: 36 months
Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot.
Device success
Time frame: 36 months
Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure.
Incidence rate of post-procedure adverse events and/or device issues
Time frame: 36 months
Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated.
Incidence rate of device- and procedure-related events within 30 days post procedure
Time frame: 30 days
Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and PFO - Patent Foramen Ovale, run by W.L.Gore & Associates at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
This study is still under way. Results are not available in the source record yet.
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?
PFO Closure Rate (time frame: 12 months). The study lists 6 primary outcomes in all. 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 20 Nov 2025.