Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs

Not Applicable

Completed

Conditions: Atrial Septal Defect

Interventions: Device: GORE® CARDIOFORM ASD Occluder

Registration Number: NCT02985684

Lead Sponsor: 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)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	GORE® CARDIOFORM ASD Occluder	ASD closure with the GORE® CARDIOFORM ASD Occluder

Primary Outcome Measures

Name	Time	Method
Number of Subjects With 6-Month Composite Clinical Success	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
Number of Subjects With 6-Month Closure Success	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.

Secondary Outcome Measures

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

Trial Locations

Locations (22): Nicklaus Children's Hospital
🇺🇸
Miami, Florida, United States
Children's Healthcare at Egleston
🇺🇸
Atlanta, Georgia, United States
Riley Hospital for Children
🇺🇸
Indianapolis, Indiana, United States
Texas Children's Hospital
🇺🇸
Houston, Texas, United States
Children's Hospital & Regional Medical Center
🇺🇸
Seattle, Washington, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Children's Hospital Boston
🇺🇸
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Phoenix Children's Hospital
🇺🇸
Phoenix, Arizona, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
The Children's Hospital of Colorado
🇺🇸
Aurora, Colorado, United States
University of California-Los Angeles
🇺🇸
Los Angeles, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
🇺🇸
Rochester, Minnesota, United States
Children's Hospital of Michigan
🇺🇸
Detroit, Michigan, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸
New York, New York, United States
Atrium Health
🇺🇸
Charlotte, North Carolina, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States