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
- Conditions
- PFO - Patent Foramen OvaleStroke
- Interventions
- Device: PFO closure with GORE® CARDIOFORM Septal Occluder
- Registration Number
- NCT03821129
- Lead Sponsor
- W.L.Gore & Associates
- Brief Summary
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.
- Detailed Description
A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 636
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GORE® CARDIOFORM Septal Occluder PFO closure with GORE® CARDIOFORM Septal Occluder Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment 12 months Complete PFO closure or a trivial or small residual shunt
Proportion of subjects with complete PFO closure or a trivial or small residual shuntClinically Significant New Atrial Arrhythmia 60 months Any new atrial fibrillation or flutter
Residual Shunt Characterization via assessment of shunt in patients by Echo 24 months Assessment of shunt in patients by Echo
Technical Success defined as successful delivery and retention of the GSO device based on physician reporting Index procedure Successful delivery and retention of the GSO device
Clinically Significant New Atrial Arrhythmia by Age 60 months Any new atrial fibrillation or flutter in patients greater and less than 60 years of age
Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs) Enrollment through discharge, approximately 1 day Successful implantation of the GSO device with no reported in-hospital SAEs
Trial Locations
- Locations (41)
St. Mary's Hospital
🇺🇸Tucson, Arizona, United States
Scripps Health La Jolla
🇺🇸La Jolla, California, United States
Loma Linda University Health
🇺🇸Loma Linda, California, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
University of Iowa Hospitals & Clinic
🇺🇸Iowa City, Iowa, United States
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
🇺🇸West Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Covenant Medical Center, Inc.
🇺🇸Saginaw, Michigan, United States
University of Minnesota
🇺🇸Edina, Minnesota, United States
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Research Foundation SUNY Buffalo
🇺🇸Buffalo, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Providence Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Tennova Healthcare
🇺🇸Knoxville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine-Houston
🇺🇸Houston, Texas, United States
The Methodist Hospital - Houston
🇺🇸Houston, Texas, United States
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
🇺🇸San Antonio, Texas, United States
Baylor Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
St. Marks Hospital
🇺🇸Salt Lake City, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Multicare Health Tacoma-Multicare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
Aurora Health Care, Metro Inc.
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Inc.
🇺🇸Milwaukee, Wisconsin, United States