Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
Atrial Septal Defect
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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.

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.

Tracking Information

NCT #
NCT02985684
Collaborators
Not Provided
Investigators
Principal Investigator: Robert Sommer, MD Columbia University of New York Principal Investigator: Matthew Gillespie, MD Children's Hospital of Philadelphia