Skip to main content
OpenTrials
Completed

NCT Number: NCT00581308

Long-term Safety Study of the GORE® HELEX® Septal Occluder

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Septal Defect, Atrial Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GORE® HELEX® Septal Occluder

Device

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

Primary outcomes

  1. Efficacy

    Time frame: 12 months

    A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:

    • Any major device/procedure adverse event
    • Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.
    • Clinically significant leak at the follow-up visit

  2. Efficacy

    Time frame: 36 months

    A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.

    Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:

    • Any major device/procedure adverse event
    • Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.
    • Clinically significant leak at the follow-up visit

  3. Efficacy

    Time frame: 60 months

    A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure.

    Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of:

    • Any major device/procedure adverse event
    • Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group.
    • Clinically significant leak at the follow-up visit

  4. Safety

    Time frame: 5 years

    A calculation of the proportion of subjects experiencing one or more major device or procedure related adverse event(s) at 1, 2, 3, 4, and 5 years post procedure.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

GORE® HELEX® Septal Occluder Post-Approval Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2014
First posted
Dec 27, 2007
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.