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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs (ASSURED)

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ClinicalTrials.gov Identifier: NCT02985684
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)

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

Detailed Description:
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation outcomes for devices indicated for ASD closure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GORE® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : July 30, 2018
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device
Attempted implantation of GORE® CARDIOFORM ASD Occluder
Device: GORE® CARDIOFORM ASD Occluder
Percutaneous Atrial Septal Defect Closure




Primary Outcome Measures :
  1. 6-Month Closure Success [ Time Frame: 6 months ]
    Among subjects with technical success, the proportion of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.

  2. 6-Month Composite Clinical Success [ Time Frame: 6 months ]

    Among subjects with attempted study device closure, the proportion 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 ASD Occluder
    2. Safety Success:

      • Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) 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 (180 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



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

Inclusion Criteria:

  • Appropriate ASD anatomy Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  • Absence of concurrent cardiac conditions that could elevate morbidity/mortality beyond what is common for ASD Note: Additional Exclusion Criteria may apply

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): NCT02985684


Contacts
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Contact: Heather Aguilar 800-437-8181 haguilar@wlgore.com

  Show 22 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Robert Sommer, MD Columbia University of New York
Principal Investigator: Matthew Gillespie, MD Children's Hospital of Philadelphia

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02985684     History of Changes
Other Study ID Numbers: ASD 15-04
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities