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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs — ASSURED  

Atrial Septal Defect Clinical Trial

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 (ASDs) - The Gore ASSURED Clinical Study

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02985684
Study type Interventional
Source W.L.Gore & Associates
Contact
Status Completed
Phase N/A
Start date March 10, 2017
Completion date September 29, 2022
View Details
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