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

NCT01711983 | Completed Results DMC

• 1 other identifier: GSO 10-09
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septal Defect, Atrial

Outcome Measures

Primary Outcomes (1)

• 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: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder 2. 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 3. 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 Outcomes (6)

• Number of Subjects With Technical Success

  During procedure; median duration 68 minutes

• Number of Subjects With Procedure Success

  During procedure; median duration 68 minutes

• Number of Subjects With 30-day SAE

  30 days

• Number of Subjects With 6-Month Closure Success

  6 months

• Number of Subjects With 12-Month Closure Success

  12 months

Study Arms (1)

Test Device

EXPERIMENTAL

ASD closure with the GORE® CARDIOFORM Septal Occluder

Device: GORE® CARDIOFORM Septal Occluder

Interventions

GORE® CARDIOFORM Septal Occluder DEVICE

Percutaneous Atrial Septal Defect Closure

Test Device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASD less than or equal to 17 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

University of Virginia, Children's Hospital Heart Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Bryan Randall
• Organization: W. L. Gore & Associates

BRandall@WLGore.com

928-864-4832

Study Officials

• D. Scott Lim, MD

  University of Virginia, Children's Hospital Heart Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: October 11, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: August 21, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)