Clinical Trial: Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: W.L.Gore & Associates

Current Primary Outcome: Clinical Success [ Time Frame: 6 months ]

The primary endpoint for the study is composite Clinical Success defined as satisfying all the following criteria: Successful deployment and retention (at conclusion of index procedure) of a GORE® Septal Occluder; Freedom from any Serious Adverse Event (SAE) through 30 days post procedure and freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through the 6-month follow-up evaluation; A clinical residual defect status of completely occluded or clinically insignificant residual shunt at 6-month evaluation as determined by the Echo Core Lab.


Original Primary Outcome:

Current Secondary Outcome:

  • Technical Success [ Time Frame: immediate post-implant ]
    Successful deployment and retention of a GORE® Septal Occluder device at the conclusion of the index procedure.
  • Procedure Success [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of less than 24 hours. ]
    Technical Success with the GORE® Septal Occluder and greater than or equal to 2mm residual shunt of the target ASD at conclusion of the index procedure.
  • Closure Success (Efficacy) [ Time Frame: evaluated at 6 months, 12 months, and 36 months post index procedure. ]
    Technical Success and measured residual defect status of occluded/trivial.
  • Safety [ Time Frame: evaluated at 6 months, 12 months, and 36 months post index procedure. ]
    A calculation of the proportion of subjects experiencing one or more Serious Adverse Event(s) (SAE) in the first 30 days post index procedure and/or a device event (embolization, device removal, reintervention after completion of index procedure) through 6 months, 12 months, and 36 months post index procedure.


Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: October 11, 2012
Date Started: October 2012
Date Completion: October 2018
Last Updated: January 16, 2017
Last Verified: January 2017