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
Phase: NA
Conditions: Atrial Septal Defect
Sponsor: W.L.Gore & Associates

GORE® CARDIOFORM ASD Occluder 
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STUDY SUMMARY 
Study 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 
Protocol Number 
ASD 15-04 - Revision 6 (06 Jan 2021)
 
IDE Number 
G160218 
Study Device 
GORE® CARDIOFORM ASD Occluder 
Sponsor 
W. L. Gore & Associates, Inc.
Medical Products Division
4250 West Kiltie Lane
Flagstaff, AZ 86005
Telephone: 800-437-8181
Facsimile: 928-864-4957
Study Design 
Prospective, multicenter, single-arm comparison to performance goals 
derived from clinical study outcomes for devices indicated for ASD closure 
Study Objective 
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD 
Occluder in the percutaneous closure of ostium secundum atrial septal 
defects (ASDs) 
Study Endpoints 
Primary Endpoints 
Co-Primary Endpoint 1: 6-Month Closure Success is defined as a clinical 
residual defect status of occluded or clinically insignificant as determined by 
the Echo Core Lab at the 6-month evaluation among subjects with technical 
success. 
Co-Primary Endpoint 2: Composite Clinical Success is evaluated at 6 months 
after index procedure among subjects with attempted study device closure 
and is defined as satisfying all of the following criteria: 
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 Echocardiography Core
Lab at the 6-month evaluation
Secondary Endpoints 
•
Technical Success
•
Procedure Success

 
GORE® CARDIOFORM ASD Occluder  
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• 
Long-term Composite Clinical Success 
• 
Long-term Closure Success 
• 
Safety Outcomes  
• 
Clinically Significant New Arrhythmia 
Subject Population 
• 
No age limitations 
• 
Patients with ostium secundum ASD measuring 8-35 mm by stop-balloon 
sizing 
• 
Inter-atrial shunting with evidence of right heart volume overload, 
demonstrating the need for septal defect closure 
• 
Absence of concurrent cardiac conditions that could elevate 
morbidity/mortality beyond what is common for ASD 
Number of Subjects 
• 
Training Cases: First 2 subjects per site 
• 
Pivotal Phase: 125 subjects (non-training) 
• 
Continued Access Phase: up to 535 subjects (non-training) 
• 
Total Study Enrollment: up to 704 subjects 
Number of Sites 
Up to 22 sites in the U.S.  
Coordination Principal 
Investigator 
Matthew Gillespie, MD 
Division of Cardiology 
The Children's Hospital of Philadelphia  
Room 6NE42, Main Bldg 
34th & Civic Center BLVD 
Philadelphia, PA 19104 
National Principal Investigator, Pediatric 
 
Robert Sommer, MD 
Center for Interventional Vascular Therapy 
Columbia University Medical Center 
627 West 165th Street, 5th floor Room 512 
New York, NY 10032 
National Principal Investigator, Adult 
Significant Inclusion 
Criteria 
• 
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 ICF specific to the study. The Patient ICF must be reviewed and 

 
GORE® CARDIOFORM ASD Occluder  
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approved in a manner that complies with requirements of the hospital’s 
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. 
Significant Exclusion 
Criteria 
 
• 
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 intravascular 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. 
Expected Time to  
Complete Enrollment 
Pivotal Phase: Enrollment Completion: 12 months  
Continued Access: Enrollment Completion: 18-24 months 

 
GORE® CARDIOFORM ASD Occluder  
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Expected Time of each  
Study Subject to  
Complete the Study 
36 months 
Study Duration  
Total Study Duration: 5.5 years 
Schedule of Events 
Screening Assessments (within 6 months of procedure) 
• 
Physical exam 
• 
Electrocardiogram (ECG)  
• 
Echocardiogram (TTE or TEE) 
Pre-Study Procedure (within 90 days of procedure) 
• 
Echocardiogram (TTE)  
Procedure 
• 
Physical exam 
• 
Stop-flow balloon sizing of defect 
• 
Echocardiogram (TEE, TTE or ICE) 
• 
Fluoroscopy 
Pre-Discharge 
• 
Electrocardiogram (ECG) 
• 
Echocardiogram (TTE)  
30 days and 6 months: 
• 
Physical exam 
• 
Electrocardiogram (ECG)  
• 
Echocardiogram (TTE) 
• 
Fluoroscopy (6 months for all Subjects) 
Long-term follow-up at 12 months and 36 months included: 
• 
Physical exam 
• 
Electrocardiogram (ECG) 
• 
Echocardiogram (TTE) 
• 
Fluoroscopy (36 months for all Subjects) 
A telephone follow-up occurred at 24 months 
Additional Information 
Echocardiography Core Lab, Independent Data Review Board (IDRB)