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

Septal Defect, Atrial Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711983
• Other study ID #: GSO 10-09
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: November 26, 2018

Study information

• Verified date: August 2020
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Septal Defect, Atrial

Intervention

Device:
• GORE® CARDIOFORM Septal Occluder
Percutaneous Atrial Septal Defect Closure

Locations

Country	Name	City	State
United States	University of Virginia, Children's Hospital Heart Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-procedure; Freedom 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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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