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

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: NCT02985684
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Results First Posted : January 7, 2020
Last Update Posted : January 10, 2022
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)
Actual Enrollment : 125 participants
Allocation: N/A
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 : September 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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 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


Secondary Outcome Measures :
  1. Number of Subjects With Technical Success [ Time Frame: During procedure; median duration 67 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 ASD Occluder

  2. Number of Subjects With Procedure Success [ Time Frame: During procedure; median duration 67 minutes ]
    Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure

  3. Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE [ Time Frame: 30 days ]
    Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)

  4. Measured Residual Target Defect Size [ Time Frame: 6 months ]
    Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.

  5. Number of Subjects With Clinically Significant New Arrhythmia [ Time Frame: 6 months ]
    The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board

  6. Number of Subjects With Wire Frame Fracture [ Time Frame: 6 months ]
    Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-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.


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

Inclusion Criteria:

All responses must be Yes to be eligible:

  1. Patient has an ostium secundum ASD with evidence of left-to-right shunt and right ventricular volume overload.
  2. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing.
  3. Patient vasculature can accommodate the delivery system and procedural accessories.
  4. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure.
  5. Patient is judged by the implanting physician to have adequate septal rims to retain the study device.
  6. Patient (or legal guardian, if patient is a minor) will voluntarily sign a Patient Informed Consent Form (ICF) specific to the study. The Patient ICF must be reviewed and approved in a manner that complies with requirements of the hospital's Institutional Review Board (IRB).
  7. Patient (and legal guardian, if patient is a minor) is physically and mentally willing to comply with all study follow-up requirements through 36 months, including routinely scheduled diagnostic testing and physical examinations.

Exclusion Criteria:

All responses must be No to be eligible:

  1. Patient has significant known pre-existing electrophysiologic or structural cardiovascular defect, or other comorbidities that could elevate morbidity or mortality beyond what is common for ASD or would require surgical treatment within three (3) years of device placement. Examples include, but are not limited to, large ventricular septal defect, hypoplastic left heart syndrome, coarctation, univentricular heart or tricuspid atresia, pulmonary hypertension, coronary artery disease, valvular or myocardial dysfunction, and other congenital heart disease requiring surgical repair.
  2. Patient has systemic or inherited conditions that would significantly increase risk of major morbidity and mortality during the term of the study. Examples include endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any condition expected to result in significant deterioration of health within three (3) years of the index procedure.
  3. Patient has anatomy where the size or position of the occluder would interfere with other intracardiac or intravasculature structures, such as cardiac valves or pulmonary veins.
  4. Patient has active endocarditis, other infections producing bacteremia, or has known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
  5. Patient has known intracardiac thrombi.
  6. Patient has an uncontrolled arrhythmia with evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia while under rate control or atrial fibrillation while under rhythm control) or requires electrophysiology study or concomitant intervention with device placement.
  7. Patient is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure.
  8. Patient has a history of stroke resulting in a significant morbidity or disability.
  9. Patient is pregnant or lactating at time of screening.
  10. Patient has contraindication to antiplatelet and anticoagulant medications.
  11. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure.
  12. Patient has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device.

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


Locations
Show 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
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Study Protocol  [PDF] November 16, 2020
Statistical Analysis Plan  [PDF] February 27, 2017

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02985684    
Other Study ID Numbers: ASD 15-04
First Posted: December 7, 2016    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 10, 2022
Last Verified: December 2021
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
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