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.
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
Single group
PFO closure with GORE® CARDIOFORM Septal Occluder
DevicePFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
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
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
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
Clinically Significant New Atrial Arrhythmia
Any new atrial fibrillation or flutter
Clinically Significant New Atrial Arrhythmia by Age
Any new atrial fibrillation or flutter in patients greater and less than 60 years of age
Residual Shunt Characterization via assessment of shunt in patients by Echo
Assessment of shunt in patients by Echo
Click on the lead sponsor to view all of their trials.
