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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)

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ClinicalTrials.gov Identifier: NCT03821129
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Condition or disease Intervention/treatment Phase
Stroke PFO - Patent Foramen Ovale Device: PFO closure with GORE® CARDIOFORM Septal Occluder Not Applicable

Detailed Description:
A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 636 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2028

Arm Intervention/treatment
GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke




Primary Outcome Measures :
  1. Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) [ Time Frame: 24 months ]
    Proportion of subjects with recurrent ischemic stroke post study device implant

  2. Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint) [ Time Frame: 30 days ]
    Device- or procedure- related serious adverse events post study device implant


Secondary Outcome Measures :
  1. Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment [ Time Frame: 12 months ]

    Complete PFO closure or a trivial or small residual shunt

    Proportion of subjects with complete PFO closure or a trivial or small residual shunt


  2. Clinically Significant New Atrial Arrhythmia [ Time Frame: 60 months ]
    Any new atrial fibrillation or flutter

  3. Clinically Significant New Atrial Arrhythmia by Age [ Time Frame: 60 months ]
    Any new atrial fibrillation or flutter in patients greater and less than 60 years of age

  4. Residual Shunt Characterization via assessment of shunt in patients by Echo [ Time Frame: 24 months ]
    Assessment of shunt in patients by Echo

  5. Technical Success defined as successful delivery and retention of the GSO device based on physician reporting [ Time Frame: Index procedure ]
    Successful delivery and retention of the GSO device

  6. Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs) [ Time Frame: Enrollment through discharge, approximately 1 day ]
    Successful implantation of the GSO device with no reported in-hospital SAEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821129


Contacts
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Contact: Jennie Wurgler 800-437-8181 GSO1801@wlgore.com

  Show 37 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT03821129     History of Changes
Other Study ID Numbers: GSO 18-01
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by W.L.Gore & Associates:
Occluder
Patent Foramen Ovale
PFO
Stroke
Gore Septal Occluder
Additional relevant MeSH terms:
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Stroke
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities