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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00581308
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2012
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Septal Defect, Atrial Device: GORE® HELEX® Septal Occluder

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 Design

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
Primary Completion Date : October 2009
Study Completion Date : October 2014
Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. Clinical Success Endpoint [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Secondary Analyses Will be Performed on All Patients Enrolled With a Device Implanted, Regardless of Meeting Inclusion / Exclusion Criteria or Anatomic Suitability Criteria, Using Data From All Visit Evaluations. [ Time Frame: 1 year postprocedure ]
  2. Total Time Under Fluoroscopy [ Time Frame: Procedure ]
  3. Secondary Outcome: Total Time Under Fluoroscopy [ Time Frame: Procedure ]
  4. Days in Hospital for Procedure [ Time Frame: Post Procedure ]
  5. Secondary Outcome: Days in Hospital for Procedure [ Time Frame: Post Procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
Contacts and Locations

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
More Information

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: October 27, 2017
Last Verified: September 2017

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