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 (REDUCE PAS)

  • STATUS
    Recruiting
  • sponsor
    W.L.Gore & Associates
Updated on 18 October 2021

Summary

The GORE GSO 18-01 study is a Post Approval Study assessing the safety and effectiveness of the GORE Septal Occluder device as observed in the REDUCE pivotal IDE study, evaluating the quality of operator education and training and transferability of trial experience to a post-market setting.

Description

  • Condition: Stroke, Patent Foramen Ovale 
  • Device: PFO closure with GORE® CARDIOFORM Septal Occluder
  • Clinical Trial Identifier: NCT03821129

Details
Condition Occlusions, Stroke
Clinical Study IdentifierTX276527
SponsorW.L.Gore & Associates
Last Modified on18 October 2021

Eligibility

Yes No Not Sure

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
resence 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

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
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
Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.)
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