Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-11-26

Brief Summary

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The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

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Detailed Description

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Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.

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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Test Device

ASD closure with the GORE® CARDIOFORM Septal Occluder

Group Type EXPERIMENTAL

GORE® CARDIOFORM Septal Occluder

Intervention Type DEVICE

Percutaneous Atrial Septal Defect Closure

Interventions

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GORE® CARDIOFORM Septal Occluder

Percutaneous Atrial Septal Defect Closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASD less than or equal to 17 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

No