RECRUITING

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

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Conditions

StrokePFO - Patent Foramen OvaleOccluderPatent Foramen OvalePFOGore Septal Occluder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-07-25
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03821129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Patient is able to tolerate antiplatelet therapy
  4. * Note: Additional Inclusion Criteria may apply
  1. * History of or ongoing atrial fibrillation/flutter
  2. * 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)
  3. * Previous Myocardial Infarction
  4. * Rankin Scale sore greater than or equal to 3 at the time of procedure
  5. * Active infection that cannot be treated successfully prior to enrollment
  6. * Neurological deficits not due to stroke that may affect the patient's neurologic assessments
  7. * Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
  8. * Sensitivity or contraindication to all proposed medical treatments or any device components
  9. * Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
  10. * 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.
  11. * Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
  12. * Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
  13. * Note: Additional Exclusion Criteria may apply

Contacts and Locations

Study Contact

Tammy DeLozier
CONTACT
800-437-8181
GSO1801@wlgore.com

Study Locations (Sites)

St. Mary's Hospital
Tucson, Arizona, 85745
United States
Scripps Health La Jolla
La Jolla, California, 92037
United States
Loma Linda University Health
Loma Linda, California, 92354
United States
University of California - San Francisco
San Francisco, California, 94143
United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
United States
South Denver Cardiology Associates
Littleton, Colorado, 80120
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Naples Community Hospital
Naples, Florida, 34102
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Emory University
Atlanta, Georgia, 30322
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Northwestern University
Evanston, Illinois, 60208
United States
University of Iowa Hospitals & Clinic
Iowa City, Iowa, 52242
United States
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
West Des Moines, Iowa, 50266
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602
United States
University of Minnesota
Edina, Minnesota, 55435
United States
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Research Foundation SUNY Buffalo
Buffalo, New York, 14203
United States
Columbia University Medical Center/NYPH
New York, New York, 10032
United States
Atrium Health
Charlotte, North Carolina, 28203
United States
Providence Heart & Vascular Institute
Portland, Oregon, 97225
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Tennova Healthcare
Knoxville, Tennessee, 37934
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine-Houston
Houston, Texas, 77030
United States
The Methodist Hospital - Houston
Houston, Texas, 77030
United States
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
San Antonio, Texas, 78229
United States
St. Marks Hospital
Salt Lake City, Utah, 84124
United States
University of Utah
Salt Lake City, Utah, 84132
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23455
United States
University of Washington
Seattle, Washington, 98195
United States
Multicare Health Tacoma-Multicare Institute for Research & Innovation
Tacoma, Washington, 98405
United States
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-25
Study Completion Date2029-12

Study Record Updates

Study Start Date2019-07-25
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Occluder
  • Patent Foramen Ovale
  • PFO
  • Stroke
  • Gore Septal Occluder

Additional Relevant MeSH Terms

  • Stroke
  • PFO - Patent Foramen Ovale