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

February 15, 2018 updated by: W.L.Gore & Associates

GORE® HELEX® Septal Occluder Post-Approval Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GORE® HELEX® Septal Occluder
Subjects who received a GORE® HELEX® Septal Occluder
Device: GORE® HELEX® Septal Occluder
Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
36 months
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
60 months
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX 06-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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