NCT00581308

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

February 7, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

December 20, 2007

Results QC Date

January 4, 2012

Last Update Submit

February 15, 2018

Conditions

Septal Defect, Atrial

Keywords

atrial septal defect, septal occluder, HELEX

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

GORE® HELEX® Septal Occluder

EXPERIMENTAL

Subjects who received a GORE® HELEX® Septal Occluder

Device: GORE® HELEX® Septal Occluder

Interventions

GORE® HELEX® Septal OccluderDEVICE

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

GORE® HELEX® Septal Occluder

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASD less than or equal to 18 mm.

You may not qualify if:

  • Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
  • Unable to accommodate device delivery catheter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Jay Donosky
Organization
W. L. Gore & Associates
jdonosky@wlgore.com
(800) 437-8181

Study Officials

  • Larry A Latson, MD

    Joe DiMaggio Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 27, 2007

Study Start

August 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2014

Last Updated

February 19, 2018

Results First Posted

February 7, 2012

Record last verified: 2018-02

Locations

US(1)