HVP_GORE PFO GSO 18-01 REDUCE

HVP 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

HVP GOREĀ® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for
Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study.

Key Inclusion Criteria:

1. 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.
2. 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.
3. Patient is able to tolerate antiplatelet therapy
4. Note: Additional Inclusion Criteria may apply

Key Exclusion Criteria:

1. History of or ongoing atrial fibrillation/flutter
2. 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)
3. Previous Myocardial Infarction
4. Rankin Scale sore greater than or equal to 3 at the time of procedure
5. Active infection that cannot be treated successfully prior to enrollment


**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
N/A
NCT03821129
Heart and Vascular
Interventional Cardiology
Brandon Jones, M.D.
W.L. Gore and Associates, Inc.
Sarah Grant
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center