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

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ClinicalTrials.gov Identifier: NCT00581308
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2012
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Septal Defect, Atrial Device: GORE® HELEX® Septal Occluder Not Applicable

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  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GORE® HELEX® Septal Occluder Post-Approval Study
Study Start Date : August 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2014

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)



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581308


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Larry A Latson, MD Joe DiMaggio Children's Hospital

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00581308     History of Changes
Other Study ID Numbers: HLX 06-04
First Posted: December 27, 2007    Key Record Dates
Results First Posted: February 7, 2012
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by W.L.Gore & Associates:
atrial septal defect, septal occluder, HELEX

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities