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Cleveland, Ohio 44195


Purpose:

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).


Study summary:

The GORE® HELEX® Septal Occluder is an approved medical device indicated for the transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of Approval Study. All subjects enrolled in this study will be followed for long-term safety and efficacy of the occluder device through 5 years.


Criteria:

Inclusion Criteria: - ASD less than or equal to 18 mm. Exclusion Criteria: - Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events. - Unable to accommodate device delivery catheter.


NCT ID:

NCT00581308


Primary Contact:

Principal Investigator
Larry A Latson, MD
Joe DiMaggio Children's Hospital


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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