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
1 other identifier
interventional
125
1 country
22
Brief Summary
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedStudy Start
First participant enrolled
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedResults Posted
Study results publicly available
January 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2022
CompletedMarch 17, 2026
June 1, 2023
1.4 years
November 28, 2016
November 7, 2019
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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: 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
6 months
Secondary Outcomes (6)
Number of Subjects With Technical Success
During procedure; median duration 67 minutes
Number of Subjects With Procedure Success
During procedure; median duration 67 minutes
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
30 days
Measured Residual Target Defect Size
6 months
Number of Subjects With Clinically Significant New Arrhythmia
6 months
- +1 more secondary outcomes
Study Arms (1)
Device
EXPERIMENTALASD closure with the GORE® CARDIOFORM ASD Occluder
Interventions
Eligibility Criteria
You may qualify if:
- All responses must be Yes to be eligible:
- Patient has an ostium secundum ASD with evidence of left-to-right shunt and right ventricular volume overload.
- Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing.
- Patient vasculature can accommodate the delivery system and procedural accessories.
- Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure.
- Patient is judged by the implanting physician to have adequate septal rims to retain the study device.
- 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).
- 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.
You may not qualify if:
- All responses must be No to be eligible:
- 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.
- 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.
- 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.
- 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.
- Patient has known intracardiac thrombi.
- 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.
- Patient is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure.
- Patient has a history of stroke resulting in a significant morbidity or disability.
- Patient is pregnant or lactating at time of screening.
- Patient has contraindication to antiplatelet and anticoagulant medications.
- Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure.
- Patient has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of California-Los Angeles
Los Angeles, California, 90095, United States
The Children's Hospital of Colorado
Aurora, Colorado, 80218, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Children's Healthcare at Egleston
Atlanta, Georgia, 30322, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Atrium Health
Charlotte, North Carolina, 28203, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Children's Hospital & Regional Medical Center
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 39297855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bryan Randall
- Organization
- W. L. Gore & Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sommer, MD
Columbia University of New York
- PRINCIPAL INVESTIGATOR
Matthew Gillespie, MD
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 7, 2016
Study Start
March 10, 2017
Primary Completion
July 30, 2018
Study Completion
September 29, 2022
Last Updated
March 17, 2026
Results First Posted
January 7, 2020
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share