Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs (ASSURED)

Trial Purpose and Description

Evaluate the safety and efficacy of the GOREĀ® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs).

Gender: Both


Eligibility Criteria

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

W.L. Gore & Associates, Inc.

Dates: 07/11/2017 - 12/31/2021

Last Updated: 07/12/2017

Study HIC#: 2000020129

Get Involved

For more information about this study, contact:
Amanda Catucci
203-785-6947
amanda.catucci@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Jeremy David Asnes

Principal Investigator

Sub-Investigators