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

Septal Defect, Atrial Clinical Trial

Official title:

GORE® HELEX® Septal Occluder Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581308
• Other study ID #: HLX 06-04
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: February 15, 2018
• Start date: August 2006
• Est. completion date: October 2014

Study information

• Verified date: February 2018
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Atrial
• Septal Defect, Atrial

Intervention

Device:
• GORE® HELEX® Septal Occluder
Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

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