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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821129
Other study ID # GSO 18-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 GOREĀ® 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

Study Design


Related Conditions & MeSH terms


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
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