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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00581308
First received: December 20, 2007
Last updated: December 18, 2012
Last verified: December 2012
  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).


Condition Intervention Phase
Septal Defect, Atrial
Device: GORE® HELEX® Septal Occluder
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GORE® HELEX® Septal Occluder Post-Approval Study

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Clinical Success Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Total Time Under Fluoroscopy [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Secondary Outcome: Total Time Under Fluoroscopy [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Days in Hospital for Procedure [ Time Frame: Post Procedure ] [ Designated as safety issue: No ]
  • Secondary Outcome: Days in Hospital for Procedure [ Time Frame: Post Procedure ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: August 2006
Estimated Study Completion Date: August 2014
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00581308     History of Changes
Other Study ID Numbers: HLX 06-04
Study First Received: December 20, 2007
Results First Received: January 4, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014