Clinical trial NCT01711983: Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
Official title: GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septal Defect, Atrial
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* ASD less than or equal to 17 mm.

Exclusion Criteria:

* Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
* Unable to accommodate device delivery catheter.

Primary outcomes:
measure: Number of Subjects With 6-Month Composite Clinical Success
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects With Technical Success
timeFrame: During procedure; median duration 68 minutes
measure: Number of Subjects With Procedure Success
timeFrame: During procedure; median duration 68 minutes
measure: Number of Subjects With 30-day SAE
timeFrame: 30 days
measure: Number of Subjects With 6-Month Closure Success
timeFrame: 6 months
measure: Number of Subjects With 12-Month Closure Success
timeFrame: 12 months
measure: Number of Subjects With 36-Month Closure Success
timeFrame: 36 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Children's Hospital Heart Center
state: Virginia
Study officials:
affiliation: University of Virginia, Children's Hospital Heart Center
name: D. Scott Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: