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Using a special device to close a heart opening to prevent strokes

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

Not applicable Interventional W.L.Gore & Associates · NCT03821129

This study is testing a special device to close a heart opening in people who have had a stroke to see if it can help prevent future strokes.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment636 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Locations45 sites (Tucson, Arizona and 44 other locations)
Trial IDNCT03821129 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the GORE® CARDIOFORM Septal Occluder in patients with a Patent Foramen Ovale (PFO) who have experienced an ischemic stroke. Up to 636 adult participants will be enrolled across 40 U.S. centers, with follow-up assessments at 1 month, 6 months, 12 months, and annually for up to 5 years post-implant. The study also aims to assess the quality of operator education and the transferability of trial experiences to a post-market setting.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with an ischemic stroke of undetermined source and confirmed PFO.

Not a fit: Patients with a history of atrial fibrillation or other significant cardiac or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients with PFO.

How similar studies have performed: Previous studies have shown promise in using similar occluder devices for PFO closure, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* 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
* Note: Additional Exclusion Criteria may apply

Where this trial is running

Tucson, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions StrokePFO - Patent Foramen OvaleOccluderPatent Foramen OvalePFOGore Septal Occluder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.