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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Stroke, PFO - Patent Foramen Ovale

Intervention / Treatment
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* Device: PFO closure with GORE® CARDIOFORM Septal Occluder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GORE® CARDIOFORM Septal Occluder<br>Single Arm Commercially available GORE® CARDIOFORM Septal Occluder | Device: PFO closure with GORE® CARDIOFORM Septal Occluder<br>* PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) | Proportion of subjects with recurrent ischemic stroke post study device implant | 24 months | 
| Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint) | Device- or procedure- related serious adverse events post study device implant | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment | Complete PFO closure or a trivial or small residual shunt Proportion of subjects with complete PFO closure or a trivial or small residual shunt | 12 months | 
| Clinically Significant New Atrial Arrhythmia | Any new atrial fibrillation or flutter | 60 months | 
| Clinically Significant New Atrial Arrhythmia by Age | Any new atrial fibrillation or flutter in patients greater and less than 60 years of age | 60 months | 
| Residual Shunt Characterization via assessment of shunt in patients by Echo | Assessment of shunt in patients by Echo | 24 months | 
| Technical Success defined as successful delivery and retention of the GSO device based on physician reporting | Successful delivery and retention of the GSO device | Index procedure | 
| Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs) | Successful implantation of the GSO device with no reported in-hospital SAEs | Enrollment through discharge, approximately 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occluder, Patent Foramen Ovale, PFO, Stroke, Gore Septal Occluder