Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/26/2018
Start Date:March 10, 2017
End Date:January 2022
Contact:Heather Aguilar
Email:haguilar@wlgore.com
Phone:800-437-8181

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GORE® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study

Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous
closure of ostium secundum atrial septal defects (ASDs)

This is a prospective, multicenter, single-arm clinical study comparing outcomes with the
GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation
outcomes for devices indicated for ASD closure.

Inclusion Criteria:

- Appropriate ASD anatomy Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

- Absence of concurrent cardiac conditions that could elevate morbidity/mortality beyond
what is common for ASD Note: Additional Exclusion Criteria may apply
We found this trial at
22
sites
Atlanta, Georgia 30322
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Boston, Massachusetts 02115
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208 East Boulevard
Charlotte, North Carolina 28203
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Miami, Florida 33155
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10032
Principal Investigator: Robert Sommer, MD
Phone: 212-342-0886
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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