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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2014-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Septal Defect, Atrial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GORE® HELEX® Septal Occluder

Subjects who received a GORE® HELEX® Septal Occluder

Group Type EXPERIMENTAL

GORE® HELEX® Septal Occluder

Intervention Type DEVICE

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

Interventions

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GORE® HELEX® Septal Occluder

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes