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

Recruiting

• Conditions: PFO - Patent Foramen Ovale; Stroke

• 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.

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Study Start: 2019-07-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2028-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 636

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Clinically 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
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 shunt

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

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