Tests a heart device to close a hole linked to stroke
Tests a septal occluder device to close a heart hole in adults with stroke.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Allentown, Ann Arbor, Atlanta, Boston, Buffalo, Charleston, Charlotte, Charlottesville, Chicago, Edina, Elk Grove Village, Evanston, Freehold, Houston, Iowa City, Jacksonville, Knoxville, La Jolla, Littleton, Loma Linda, Loveland, Milwaukee, Minneapolis, Naples, Nashville, New Haven, New York, Norfolk, Portland, Royal Oak, Saginaw, Salt Lake City, San Antonio, San Francisco, Santa Barbara, Tacoma, Tampa, Temple, Tucson, West Des Moines, and Weston, United StatesSee the 45 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT03821129, who can take part
Where in United States
- LeHigh Valley HospitalAllentown, United StatesTaking people
- University of MichiganAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesTaking people
- Research Foundation SUNY BuffaloBuffalo, United StatesTaking people
- Charleston Area Medical Center (CAMC)Charleston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Atrium HealthCharlotte, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of MinnesotaEdina, United StatesNo longer taking part
- Alexian Brothers Medical CenterElk Grove Village, United StatesNo longer taking part
- Northwestern UniversityEvanston, United StatesTaking people
- Jersey Shore University / Hackensack UMCFreehold, United StatesNo longer taking part
- Baylor College of Medicine, HoustonHouston, United StatesTaking people
- The Methodist Hospital - HoustonHouston, United StatesTaking people
- University of Iowa Hospitals & ClinicIowa City, United StatesTaking people
- Baptist Health - JacksonvilleJacksonville, United StatesTaking people
- Tennova HealthcareKnoxville, United StatesNo longer taking part
- Scripps Health La JollaLa Jolla, United StatesTaking people
- South Denver Cardiology AssociatesLittleton, United StatesTaking people
- Loma Linda University HealthLoma Linda, United StatesTaking people
- Medical Center of the RockiesLoveland, United StatesTaking people
- Aurora Health Care, Metro Inc.Milwaukee, United StatesTaking people
- Medical College of Wisconsin, IncMilwaukee, United StatesTaking people
- Minneapolis Heart Institute Foundation - Abbott Northwestern HospitalMinneapolis, United StatesTaking people
- Naples Community HospitalNaples, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Yale University School Of MedicineNew Haven, United StatesTaking people
- Columbia University Medical Center/NYPHNew York, United StatesNo longer taking part
- Sentara Cardiovascular Research InstituteNorfolk, United StatesNo longer taking part
- Providence Heart & Vascular InstitutePortland, United StatesTaking people
- William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
- Covenant Medical Center, Inc.Saginaw, United StatesNo longer taking part
- St. Marks HospitalSalt Lake City, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- Methodist Healthcare Systems of San Antonio d/b/a Methodist HospitalSan Antonio, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesTaking people
- Santa Barbara Cottage HospitalSanta Barbara, United StatesTaking people
- Multicare Health Tacoma-Multicare Institute for Research & InnovationTacoma, United StatesTaking people
- University of SF (Tampa General Hospital)Tampa, United StatesTaking people
- Baylor Scott & White Memorial HospitalTemple, United StatesTaking people
- St. Mary's HospitalTucson, United StatesNo longer taking part
- Catholic Health Initiatives- Iowa Corp dba Iowa HeartWest Des Moines, United StatesTaking people
- Cleveland Clinic FloridaWeston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT03821129
- Record updated
- 30 July 2026
- Original description
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.Read full original descriptionShow less
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
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
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; Note: Additional Inclusion Criteria may apply.
Exclusion: Previous Myocardial Infarction; Active infection that cannot be treated successfully prior to enrollment; Need for concomitant procedure(s) that may confound detection of adverse events related to device placement; History of or ongoing atrial fibrillation/flutter; 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; 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; 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); Rankin Scale sore greater than or equal to 3 at the time of 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; Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder; Note: Additional Exclusion Criteria may apply.