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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 : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date August 12, 2021
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 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
  • Clinically Significant New Atrial Arrhythmia [ Time Frame: 60 months ]
    Any new atrial fibrillation or flutter
  • 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
  • Residual Shunt Characterization via assessment of shunt in patients by Echo [ Time Frame: 24 months ]
    Assessment of shunt in patients by Echo
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • PFO - Patent Foramen Ovale
Intervention  ICMJE Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
Study Arms  ICMJE GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Intervention: Device: PFO closure with GORE® CARDIOFORM Septal Occluder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
636
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2029
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammy Delozier 800-437-8181 GSO1801@wlgore.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821129
Other Study ID Numbers  ICMJE GSO 18-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ignacio Inglessis, MD Interventional Cardiology Associates
Principal Investigator: John Volpi, MD Houston Methodist
PRS Account W.L.Gore & Associates
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP