Clinical Trial: Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)

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

Current Primary Outcome:

  • 6-Month Closure Success [ Time Frame: 6 months ]
    Among subjects with technical success, the proportion of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
  • 6-Month Composite Clinical Success [ Time Frame: 6 months ]

    Among subjects with attempted study device closure, the proportion of subjects who satisfy all of the following components:

    1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder

    2. Safety Success:

      • Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure
      • Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure
    3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: W.L.Gore & Associates

Dates:
Date Received: November 28, 2016
Date Started: March 10, 2017
Date Completion: January 2022
Last Updated: April 5, 2017
Last Verified: April 2017