GORE HELEX Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO)
The goal of this trial is to demonstrate that patent foramen ovale (PFO) closure with the GORE HELEX Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.
You may be eligible to participate in this study if you:
Are 18-60 years of age
Have a presence of cryptogenic ischemic stroke or TIA with MRI (or CT) evidence of a presumably embolic infarction verified by a neurologist within 180 days prior to randomization
Have a presence of patent foramen ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during valsalva maneuver
You will be excluded from this study if you:
Have had a previous myocardial infarction
Are pregnant or intend to become pregnant during study period
Have other comorbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, and severe CNS disease, severe disability that would increase the risk of mortality or morbidity above what is typical for the treatment
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.