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Clinical Trial Summary

The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.


Clinical Trial Description

Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01711983
Study type Interventional
Source W.L.Gore & Associates
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date November 26, 2018

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Withdrawn NCT04395027 - Iatrogenic Atrial Septal Defect Study (iASD) Phase 3
Enrolling by invitation NCT05025475 - Stitch Closure of PFO and Septal Repair (STITCH) N/A
Completed NCT00581308 - Long-term Safety Study of the GORE® HELEX® Septal Occluder N/A