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

Launched by W.L.GORE & ASSOCIATES · Jan 28, 2019

Keywords

ClinConnect Summary

The REDUCE Post Approval Study is looking at a device called the GORE® CARDIOFORM Septal Occluder, which is used to help prevent strokes in patients who have a condition known as Patent Foramen Ovale (PFO). PFO is a small hole in the heart that can increase the risk of strokes. This study aims to ensure that the device is safe and effective for patients and to evaluate how well doctors are trained to use it.

To join the study, participants must have had a specific type of stroke called an embolic stroke of undetermined source within the last year and be diagnosed with PFO through special heart imaging tests. They also need to be able to take blood-thinning medication. The study is currently recruiting participants aged 18 and older, regardless of gender. Those who qualify will receive care related to the device and may help improve our understanding of how to best use it in everyday medical practice.

Gender

ALL

Eligibility criteria

• 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