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

Stroke Clinical Trial

— REDUCE PAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821129
• Other study ID #: GSO 18-01
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: Tammy DeLozier
• Phone: 800-437-8181
• Email: GSO1801[@]wlgore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 636
• Est. completion date: December 2029
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• PFO - Patent Foramen Ovale
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Research Foundation SUNY Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Minnesota	Edina	Minnesota
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Northwestern University	Evanston	Illinois
United States	Baylor College of Medicine-Houston	Houston	Texas
United States	The Methodist Hospital - Houston	Houston	Texas
United States	University of Iowa Hospitals & Clinic	Iowa City	Iowa
United States	Tennova Healthcare	Knoxville	Tennessee
United States	Scripps Health La Jolla	La Jolla	California
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	Loma Linda University Health	Loma Linda	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Aurora Health Care, Metro Inc.	Milwaukee	Wisconsin
United States	Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Naples Community Hospital	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Providence Heart & Vascular Institute	Portland	Oregon
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Covenant Medical Center, Inc.	Saginaw	Michigan
United States	St. Marks Hospital	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital	San Antonio	Texas
United States	University of California - San Francisco	San Francisco	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	University of Washington	Seattle	Washington
United States	Multicare Health Tacoma-Multicare Institute for Research & Innovation	Tacoma	Washington
United States	St. Mary's Hospital	Tucson	Arizona
United States	Catholic Health Initiatives- Iowa Corp dba Iowa Heart	West Des Moines	Iowa
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)	Proportion of subjects with recurrent ischemic stroke post study device implant	24 months
Primary	Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)	Device- or procedure- related serious adverse events post study device implant	30 days
Secondary	Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment	Complete PFO closure or a trivial or small residual shunt; Proportion of subjects with complete PFO closure or a trivial or small residual shunt	12 months
Secondary	Clinically Significant New Atrial Arrhythmia	Any new atrial fibrillation or flutter	60 months
Secondary	Clinically Significant New Atrial Arrhythmia by Age	Any new atrial fibrillation or flutter in patients greater and less than 60 years of age	60 months
Secondary	Residual Shunt Characterization via assessment of shunt in patients by Echo	Assessment of shunt in patients by Echo	24 months
Secondary	Technical Success defined as successful delivery and retention of the GSO device based on physician reporting	Successful delivery and retention of the GSO device	Index procedure
Secondary	Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)	Successful implantation of the GSO device with no reported in-hospital SAEs	Enrollment through discharge, approximately 1 day