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GORE® CARDIOFORM Septal Occluder for Stroke Prevention in PFO

This study is looking at how safe and effective the GORE® CARDIOFORM Septal Occluder is for people who have had a stroke and also have a Patent Foramen Ovale (PFO). A PFO is a small opening between the upper chambers of the heart that didn't close completely after birth. The GORE® CARDIOFORM Septal Occluder is a device used to close this opening. To join, you must be between 18 and 70 years old, have had an ischemic stroke (a stroke caused by a blood clot) within the last year, and have a PFO confirmed by specific heart tests. The study will measure how many people have another stroke after getting the device and how many experience serious problems related to the device or procedure. The study's current status is unclear.

Study design
This interventional study plans to enroll up to 636 adult participants at up to 40 centers in the U.S.
What's involved
You would have follow-up visits at 1 month, 6 months, 12 months, and annually for up to 5 years after the device is implanted.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after the device implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03821129

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Recruiting
NAAges 18–70InterventionalPrevention
W.L.Gore & Associates
~636 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:PFO closure with GORE® CARDIOFORM Septal Occluder

At a glance

Recruiting sites
31 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
Measured over 24 months
+1 more outcome measured

Conditions

Stroke
PFO - Patent Foramen Ovale

Explore related trials

Patent Foramen OvaleStroke

NCT03821129

Where you'd take part

This study runs at 45 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atrium Health

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Baylor College of Medicine-Houston

    Houston, Texasstudy coordinator listed

    Recruiting

  • Baylor Scott & White Memorial Hospital

    Temple, Texasstudy coordinator listed

    Recruiting

  • Catholic Health Initiatives- Iowa Corp dba Iowa Heart

    West Des Moines, Iowastudy coordinator listed

    Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvaniastudy coordinator listed

    Recruiting

  • Loma Linda University Health

    Loma Linda, Californiastudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Tammy DeLozier
[email protected]
800-437-8181
Email the study team

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Eligibility criteria

Inclusion

Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
Patient is able to tolerate antiplatelet therapy

Exclusion

History of or ongoing atrial fibrillation/flutter
Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \<40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)
Previous Myocardial Infarction
Rankin Scale sore greater than or equal to 3 at the time of procedure
Active infection that cannot be treated successfully prior to enrollment
Neurological deficits not due to stroke that may affect the patient's neurologic assessments
Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
Sensitivity or contraindication to all proposed medical treatments or any device components
Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.
Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
Need for concomitant procedure(s) that may confound detection of adverse events related to device placement

What this trial measures

  • Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)24 months

    Proportion of subjects with recurrent ischemic stroke post study device implant

  • Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)30 days

    Device- or procedure- related serious adverse events post study device implant