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 |
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)
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.
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
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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 At Nationwide Children’s, we are creating the future of pediatric health care....
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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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 Since its start in 1855 as the nation's first hospital devoted...
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University of Utah Research is a major component in the life of the U benefiting...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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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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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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