Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Last updated on July 2021Recruitment
- 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