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

GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)

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.

Study Overview

• Status: Completed
• Conditions: Septal Defect, Atrial
• Intervention / Treatment: Device: GORE® CARDIOFORM Septal Occluder

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia, Children's Hospital Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Device; ASD closure with the GORE® CARDIOFORM Septal Occluder	Device: GORE® CARDIOFORM Septal Occluder; Percutaneous Atrial Septal Defect Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With 6-Month Composite Clinical Success	Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder; Safety Success:Freedom from any Serious Adverse Event (SAE) through 30 days post-procedureFreedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure; Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With 6-Month Closure Success	Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.	6 months
Number of Subjects With Technical Success	Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder	During procedure; median duration 68 minutes
Number of Subjects With Procedure Success	Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.	During procedure; median duration 68 minutes
Number of Subjects With 30-day SAE	Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure	30 days
Number of Subjects With 12-Month Closure Success	Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.	12 months
Number of Subjects With 36-Month Closure Success	Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.	36 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: D. Scott Lim, MD, University of Virginia, Children's Hospital Heart Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial; Foramen Ovale, Patent
• Other Study ID Numbers: GSO 10-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No