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Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

NCT01711983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-08-21

Study results available
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Summary

The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

Conditions

  • Septal Defect, Atrial

Interventions

DEVICE

GORE® CARDIOFORM Septal Occluder

Percutaneous Atrial Septal Defect Closure

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • D. Scott Lim, MD · University of Virginia, Children's Hospital Heart Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-11-26
Completion
2018-11-26

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 NCT01711983 on ClinicalTrials.gov