Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01711983
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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.

Condition or disease Intervention/treatment Phase
Septal Defect, Atrial Device: GORE® CARDIOFORM Septal Occluder Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 2012
Actual Primary Completion Date : November 26, 2018
Actual Study Completion Date : November 26, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Subjects With 6-Month Composite Clinical Success [ Time Frame: 6 months ]

    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


Secondary Outcome Measures :
  1. Number of Subjects With Technical Success [ Time Frame: During procedure; median duration 68 minutes ]
    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

  2. Number of Subjects With Procedure Success [ Time Frame: During procedure; median duration 68 minutes ]
    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.

  3. Number of Subjects With 30-day SAE [ Time Frame: 30 days ]
    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

  4. Number of Subjects With 6-Month Closure Success [ Time Frame: 6 months ]
    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.

  5. Number of Subjects With 12-Month Closure Success [ Time Frame: 12 months ]
    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.

  6. Number of Subjects With 36-Month Closure Success [ Time Frame: 36 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711983


Locations
Layout table for location information
United States, Virginia
University of Virginia, Children's Hospital Heart Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Layout table for investigator information
Principal Investigator: D. Scott Lim, MD University of Virginia, Children's Hospital Heart Center
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Layout table for additonal information
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01711983    
Other Study ID Numbers: GSO 10-09
First Posted: October 23, 2012    Key Record Dates
Results First Posted: August 21, 2020
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Septal Defects
Heart Septal Defects, Atrial
Foramen Ovale, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities