Back to resultsLong-term Safety Study of the GORE® HELEX® Septal Occluder
Primary Purpose
Septal Defect, Atrial
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE® HELEX® Septal Occluder
Sponsored by
About this trial
This is an interventional treatment trial for Septal Defect, Atrial focused on measuring atrial septal defect, septal occluder, HELEX
Eligibility 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.
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GORE® HELEX® Septal Occluder
Arm Description
Subjects who received a GORE® HELEX® Septal Occluder
Outcomes
Primary Outcome Measures
Efficacy
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
Efficacy
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
Efficacy
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
Safety
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00581308
First Posted
December 20, 2007
Last Updated
February 15, 2018
Sponsor
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT00581308
Brief Title
Long-term Safety Study of the GORE® HELEX® Septal Occluder
Official Title
GORE® HELEX® Septal Occluder Post-Approval Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septal Defect, Atrial
Keywords
atrial septal defect, septal occluder, HELEX
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE® HELEX® Septal Occluder
Arm Type
Experimental
Arm Description
Subjects who received a GORE® HELEX® Septal Occluder
Intervention Type
Device
Intervention Name(s)
GORE® HELEX® Septal Occluder
Intervention Description
Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)
Primary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
12 months
Title
Efficacy
Description
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
Time Frame
36 months
Title
Efficacy
Description
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
Time Frame
60 months
Title
Safety
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry A Latson, MD
Organizational Affiliation
Joe DiMaggio Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
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