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

W.L. Gore & Associates

Status: Completed

Conditions: Septal Defect, Atrial

Treatments: Device: GORE® HELEX® Septal Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581308

HLX 06-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 215 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 1 patient group

GORE® HELEX® Septal Occluder

Experimental group

Description:

Subjects who received a GORE® HELEX® Septal Occluder

Treatment:

Device: GORE® HELEX® Septal Occluder