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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Trial Summary
Trial Overview
Inclusion Criteria

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
Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York 10032
Principal Investigator: Robert Sommer, MD
Phone: 212-342-0886
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Cincinnati Children's Hospital Medical Center
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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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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University of California at Los Angeles
Los Angeles, California 90095
310-825-4321
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Mount Sinai Hospital
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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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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Philadelphia, PA
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University of Utah
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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Salt Lake City, UT
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Children's Healthcare at Egleston
Atlanta, Georgia 30322
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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Children's Hospital Boston
Boston, Massachusetts 02115
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Atrium Health
208 East Boulevard
Charlotte, North Carolina 28203
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Charlotte, NC
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Children's Hospital of Michigan
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
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Texas Children's Hospital
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
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Riley Hospital for Children
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Nicklaus Children's Hospital
Miami, Florida 33155
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Miami, FL
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Phoenix Children's Hospital
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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Mayo Clinic Rochester
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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Children's Hospital and Regional Medical Center
Seattle, Washington 98105
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Seattle, WA
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