GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients

Not Applicable

Completed

Interventions: Device: Septal Occluder Device
Drug: Antiplatelet Medical Therapy

Brief Summary: The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM 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.

A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.

Recruitment & Eligibility

Inclusion Criteria

Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
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.
Absence of an identifiable source of thromboembolism in the systemic circulation
No evidence of a hypercoagulable state
Note: Additional Inclusion Criteria may apply

Exclusion Criteria

Other co-morbidities 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, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
Previous Myocardial Infarction
Active infection that cannot be treated successfully prior to randomization
Sensitivity or contraindication to all proposed medical treatments
Pregnancy or intent on becoming pregnant through 24-months after randomization
Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be > 18mm
Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / 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

Arm && Interventions

Group	Intervention	Description
Device Closure	Septal Occluder Device	PFO closure with study septal occluder device plus antiplatelet medical therapy
Device Closure	Antiplatelet Medical Therapy	PFO closure with study septal occluder device plus antiplatelet medical therapy
Medical Management	Antiplatelet Medical Therapy	Antiplatelet medical therapy alone

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)	24 months	A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)	24 months	Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days. An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Effective Closure in Test (Device) Arm	24 months	Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up. Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles).
Number of Subjects With Study-related Serious Adverse Events	24 months	Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site