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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Scripps Health La Jolla
  La Jolla, California, United States Recruiting
• Loma Linda University Health
  Loma Linda, California, United States Recruiting
• University of California - San Francisco
  San Francisco, California, United States Recruiting
• Santa Barbara Cottage Hospital
  Santa Barbara, California, United States Recruiting
• South Denver Cardiology Associates
  Littleton, Colorado, United States Recruiting
• Medical Center of the Rockies
  Loveland, Colorado, United States Recruiting

Study contacts

• Study coordinator: Tammy DeLozier
• Email: GSO1801@wlgore.com
• Phone: 800-437-8181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.