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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Septal Defect
• Intervention / Treatment: Device: GORE® CARDIOFORM ASD Occluder

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • Los Angeles, California, United States, 90095
      • University of California-Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80218
      • The Children's Hospital of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare at Egleston
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19014
      • Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98105
      • Children's Hospital & Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; ASD closure with the GORE® CARDIOFORM ASD Occluder	Device: GORE® CARDIOFORM ASD Occluder; Percutaneous Atrial Septal Defect Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With 6-Month Closure Success	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.	6 months
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: Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder; 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-procedureFreedom 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; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Technical Success	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	During procedure; median duration 67 minutes
Number of Subjects With Procedure Success	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	During procedure; median duration 67 minutes
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE	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)	30 days
Measured Residual Target Defect Size	Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.	6 months
Number of Subjects With Clinically Significant New Arrhythmia	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 months
Number of Subjects With Wire Frame Fracture	Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.	6 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Robert Sommer, MD, Columbia University of New York; Principal Investigator: Matthew Gillespie, MD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Qureshi AM, Sommer RJ, Morgan G, Paolillo JA, Gray RG, Love B, Goldstein BH, Sugeng L, Gillespie MJ; GORE ASSURED Clinical Trial Investigators. Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts. JACC Cardiovasc Interv. 2024 Oct 14;17(19):2274-2283. doi: 10.1016/j.jcin.2024.07.013. Epub 2024 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimated): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial
• Other Study ID Numbers: ASD 15-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes