NCT00581308 - Long-term Safety Study of the GORE® HELEX® Septal Occluder | Crick

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

215

Conditions

Septal Defect, Atrial

Interventions

GORE® HELEX® Septal OccluderDEVICE

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

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

Time frame: 36 months

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

Time frame: 60 months

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.

Time frame: 5 years