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Completed

NCT Number: NCT01711983

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

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.

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Key information

Conditions

Septal Defect, Atrial Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia, Children's Hospital Heart Center

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GORE® CARDIOFORM Septal Occluder

Device

Percutaneous Atrial Septal Defect Closure

Primary outcomes

  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:

    • 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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2012
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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