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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs

NCT02985684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-03-17

Study results available
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Summary

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

Conditions

  • Atrial Septal Defect

Interventions

DEVICE

GORE® CARDIOFORM ASD Occluder

Percutaneous Atrial Septal Defect Closure

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Robert Sommer, MD · Columbia University of New York

  • Matthew Gillespie, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2018-07-30
Completion
2022-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985684 on ClinicalTrials.gov