Septal Defect, Atrial Clinical Trial
Official title:
GORE® HELEX® Septal Occluder Post-Approval Study
Verified date | February 2018 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 215 |
Est. completion date | October 2014 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
12 months | |
Primary | 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 |
36 months | |
Primary | 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 |
60 months | |
Primary | 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. | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01711983 -
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
|
N/A | |
Enrolling by invitation |
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Stitch Closure of PFO and Septal Repair
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N/A | |
Withdrawn |
NCT04395027 -
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Phase 3 | |
Enrolling by invitation |
NCT05025475 -
Stitch Closure of PFO and Septal Repair (STITCH)
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N/A |