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)

• ClinicalTrials.gov Identifier: NCT03821129
• Recruitment Status: Recruiting
• First Posted: January 29, 2019
• Last Update Posted: August 12, 2021
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Tracking Information

• First Submitted Date: January 15, 2019
• First Posted Date: January 29, 2019
• Last Update Posted Date: August 12, 2021
• Actual Study Start Date: July 25, 2019
• Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Stroke
• PFO - Patent Foramen Ovale

Intervention

Device: PFO closure with GORE® CARDIOFORM Septal Occluder

PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

Study Arms

GORE® CARDIOFORM Septal Occluder

Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

Intervention: Device: PFO closure with GORE® CARDIOFORM Septal Occluder

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 28, 2019): 636
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2029
• Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tammy Delozier; 800-437-8181; GSO1801@wlgore.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03821129
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: W.L.Gore & Associates
• Study Sponsor: W.L.Gore & Associates
• Collaborators: Not Provided

Investigators

• 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