Atrial Septal DefectASSUREDNCT02985684
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
A study testing GORE® CARDIOFORM ASD Occluder in people with Atrial Septal Defect, run by W.L.Gore & Associates at 22 sites in United States.
Trial summary
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- GORE® CARDIOFORM ASD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 22 sitesUnited States
- Study dates
- 10 Mar 2017to 29 Sep 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare at Egleston
Atlanta, Georgia, 30322
The Children's Hospital of Colorado
Aurora, Colorado, 80218
Massachusetts General Hospital
Boston, Massachusetts, 02114
Children's Hospital Boston
Boston, Massachusetts, 02115
Atrium Health
Charlotte, North Carolina, 28203
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Michigan
Detroit, Michigan, 48201
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of California-Los Angeles
Los Angeles, California, 90095
Nicklaus Children's Hospital
Miami, Florida, 33155
Yale University School of Medicine
New Haven, Connecticut, 06520
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84113
Children's Hospital & Regional Medical Center
Seattle, Washington, 98105
About this study
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
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Read the 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.
- Conditions
- Atrial Septal Defect
- Being tested
- GORE® CARDIOFORM ASD Occluder
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® CARDIOFORM ASD OccluderDevice
Percutaneous Atrial Septal Defect Closure
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | ASD closure with the GORE® CARDIOFORM ASD Occluder Receives: Device: GORE® CARDIOFORM ASD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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-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
- Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion30 Jul 2018
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Sommer, MD, Principal investigator, Columbia University of New YorkMatthew Gillespie, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985684
- Sponsor's protocol ID
- ASD 15-04
- Acronym
- ASSURED
- Status last verified
- Jun 2023
- First submitted
- 28 Nov 2016
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 39297855