GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
Phase: NA
Conditions: Septal Defect, Atrial
Sponsor: W.L.Gore & Associates

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CONFIDENTIAL INFORMATION
 Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
GORE® Septal Occluder Clinical Study: A Study to evaluate safety and efficacy in the 
treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs)  
Protocol Number: 
GSO 10-09 
Original Protocol: 
26 June 2012 
Amendment Date: 
22 August 2014 
W. L. Gore & Associates, Inc. 
Medical Products Division 
4250 West Kiltie Lane 
Flagstaff, AZ  86005 
Telephone:   800-437-8181 
Facsimile:     928-864-4957 

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Study Information 
Study Title 
GORE® Septal Occluder Clinical Study: A Study to evaluate safety and 
efficacy in the treatment of transcatheter closure of ostium secundum 
atrial septal defects (ASDs)  
Protocol Number 
GSO 10-09 
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, mulitcenter, single-arm, clinical study comparing the 
GORE® Septal Occluder to outcomes from previous GORE® HELEX 
Septal Occluder clinical studies. 
Study Objective 
To evaluate the safety and efficacy of the GORE® Septal Occluder in 
the treatment of percutaneous, transcatheter closure of ostium 
secundum atrial septal defects (ASDs). 
Study Endpoints 
Primary Endpoint 
Composite Clinical Success evaluated at 6 months post-procedure 
Secondary Endpoints 

Technical Success

Procedure Success

Closure Success

Safety
Patient Population 
Patients with: 

ostium secundum atrial septal defects of ≤17 mm measured by
stop flow balloon sizing

evidence of right ventricular volume overload

absence of concurrent cardiac defect(s) that could elevate
morbidity/mortality beyond what is common for ASD (e.g. Large
ventricular septal defect, hypoplastic left heart syndrome,
coarctation, arrhythmias requiring electrophysiology or concurrent
intervention with device placement)
Number of Sites 
Up to 21 sites 
Enrollment 
400 total subjects in following phases: 
         50 Pivotal 
         350 Continued Access 
         Post Approval (if required) 
Study Duration  
Enrollment Duration: 
Pivotal Phase:  7 months 
Continued Access Phase:  12-20 months 
Post Approval Phase:  (if required post PMA approval) 

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Pivotal Study Duration: 13-16 months 
Overall Study Duration: 5-6 years based on 36 months follow up for 
enrolled subjects 
Pre-Enrollment 
Evaluation 
Pre-procedural exam performed within 6 months of procedure that 
must include: 
◘confirmation of ASD by TTE or TEE
◘estimated defect size ≤17mm
◘ECG
Subjects will be considered enrolled when the GORE® Septal Occluder 
device is introduced into the anatomy of the subject. 
Follow-Up Evaluations 
Subjects successfully enrolled in the study will be examined at 30 
days and 6 months after the procedure. Each visit will include: 
◘physical exam
◘ECG
◘TTE
◘Fluoroscopy-En face and lateral views (6 months)*
Long term follow-up will be performed at 12, 24 and 36 months. The 
12 and 36 month visits will include: 
◘physical exam
◘ECG
◘TTE
◘Fluoroscopy-En face and lateral views (36 months)*
The 24 month visit by telephone follow-up questionnaire. 
* Refer to Section 5.4.8 for details.
Echocardiographic 
Core Laboratories 
Craig Fleishman, MD, FACC, FASE 
Director, Non-Invasive Cardiac Imaging 
Arnold Palmer Hospital for Children 
Orlando FL 
Ricardo Pignatelli, MD 
Assistant Professor Pediatrics 
Texas Children's Hospital  
Baylor College of Medicine 
Pediatric Cardiology 
Houston TX 
Study Clinical Monitor 
Theorem Clinical Research 
Telephone: 800.290.5766 
www.theoremclinical.com 
IDE or PMA Number  
G110161  

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LIST OF ABBREVIATIONS 
AE
Adverse Event
ASD 
Atrial Septal Defect 
CD
Compact Disc
CDMS 
Clinical Data Management System 
CFR 
Code of Federal Regulations 
Cm
Centimeter
CRF 
Case Report Form 
CRO 
Contract Research Organization 
ECG
Electrocardiogram
eCRF 
Electronic Case Report Form 
ePTFE
expanded polytetrafluoroethylene
FDA 
Food and Drug Administration 
Fr 
French Catheter Scale 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
ICE
Intracardiac Echocardiography
IDE
Investigational Device Exemption
IDR 
Independent Data Reviewer 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
mm
Millimeter
O.D.
Outer diameter
PAS 
Post Approval Study 
PMA
Pre-Market Approval
Qp:Qs ratio 
systemic blood flow (Qs) is proportional to the pulmonary blood 
flow (Qp); this ratio is used in the measurement of physiologic 
shunt 
SAE  
Serious Adverse Event 
TEE  
Transesophageal Echocardiography 
TIA 
Transient Ischemic Attack 
TTE
Transthoracic Echocardiography
UADE  
Unanticipated Adverse Device Effect 

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TABLE OF CONTENTS 
1.0 
INTRODUCTION ........................................................................................... 7 
1.1 
DEVICE DESCRIPTION .............................................................................. 7 
1.2 
GORE® SEPTAL OCCLUDER DELIVERY SYSTEM ............................................... 8 
2.0 
STUDY OBJECTIVES ..................................................................................... 9 
2.1 
PRIMARY OBJECTIVE ................................................................................ 9 
3.0 
STUDY DESIGN ........................................................................................... 9 
3.1 
DESCRIPTION OF STUDY DESIGN ................................................................. 9 
STUDY SCHEMA ............................................................................................ 10 
3.2 
STUDY ENDPOINTS ............................................................................... 10 
4.0 
DESCRIPTION OF POPULATION ................................................................... 12 
4.1 
INCLUSION CRITERIA ............................................................................. 12 
4.2 
EXCLUSION CRITERIA ............................................................................. 13 
5.0 
STUDY PROCEDURES AND EVALUATIONS ................................................... 14 
5.1 
STUDY EVALUATIONS SCHEMA ................................................................. 14 
5.2 
SCHEDULE OF EVENTS ........................................................................... 15 
5.3 
INFORMED CONSENT PROCESS ................................................................. 16 
5.4 
SCREENING/PRE-TREATMENT, ENROLLMENT, PROCEDURE, AND FOLLOW-UP .......... 16 
5.5 
SUBJECT WITHDRAWAL FROM THE CLINICAL STUDY ......................................... 21 
5.6 
SUBJECT LOST TO FOLLOW-UP ................................................................. 21 
5.7 
SUBJECT STUDY COMPLETION .................................................................. 22 
5.8 
EXPLANT PROCEDURES .......................................................................... 22 
6.0 
CLINICAL STUDY ADMINISTRATION ............................................................ 22 
6.1 
TRAINING ........................................................................................... 22 
6.2 
DEVICE ACCOUNTABILITY AND STORAGE ...................................................... 22 
6.3 
CORE LABORATORY ............................................................................... 23 
6.4 
STUDY MONITORING ............................................................................. 23 
6.5 
PROTOCOL DEVIATIONS ......................................................................... 24 
6.6 
PROTOCOL AMENDMENTS ....................................................................... 24 
6.7 
SPONSOR REPRESENTATIVES ................................................................... 24 
6.8 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA ..................................... 24 
6.9 
STUDY RECORDS RETENTION ................................................................... 25 
6.10 PUBLICATION PLAN ............................................................................... 26 
7.0 
DATA COLLECTION AND SUBMISSION ........................................................ 26 
7.1 
DATA COLLECTION METHODS .................................................................. 26 

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7.2 
DATA CLARIFICATION AND CORRECTION....................................................... 27 
7.3 
CRF COMPLETION SCHEDULE .................................................................. 27 
8.0 
RISK ASSESSMENT ................................................................................... 27 
8.1 
MINIMIZATION OF RISKS......................................................................... 28 
8.2 
SUMMARY OF EXPECTED BENEFITS ............................................................ 29 
9.0 
ADVERSE EVENTS AND SAFETY MONITORING ............................................. 29 
9.1 
ANTICIPATED ADVERSE EVENTS ................................................................ 29 
9.2 
UNANTICIPATED ADVERSE DEVICE EFFECTS .................................................. 30 
9.3 
ADVERSE EVENT RELATIONSHIP ................................................................ 30 
9.4 
SERIOUS ADVERSE EVENTS ..................................................................... 30 
9.5 
ADVERSE EVENT SEVERITY ...................................................................... 31 
9.6 
ADVERSE EVENT DATA COLLECTION ........................................................... 31 
9.7 
ADVERSE EVENT CODING ........................................................................ 32 
9.8 
INDEPENDENT DATA REVIEW .................................................................... 32 
10.0 
STATISTICAL ANALYSIS ............................................................................. 32 
10.1 PRIMARY STUDY HYPOTHESES ................................................................. 32 
10.2 SAMPLE SIZE ASSUMPTIONS ................................................................... 33 
10.3 NON-INFERIORITY MARGIN ...................................................................... 34 
10.4 SAMPLE SIZE DETERMINATION ................................................................. 34 
10.5 STUDY ENROLLMENT ............................................................................. 35 
10.6 DATA ANALYSIS ................................................................................... 35 
11.0 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................ 37 
11.1 STATEMENT OF COMPLIANCE ................................................................... 37 
11.2 COMPLIANCE RESPONSIBILITIES ............................................................... 38 
11.3 SUBJECT INFORMED CONSENT .................................................................. 38 
11.4 INDEPENDENT ETHICAL REVIEW ................................................................ 39 
11.5 CONFLICT OF INTEREST ........................................................................... 39 
11.6 CONFIDENTIALITY ................................................................................. 39 
12.0 
REFERENCES ............................................................................................. 40 

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Introduction 
W. L. Gore & Associates, Inc., has developed an atrial septal defect (ASD) 
closure device, the GORE® Septal Occluder. This minimally invasive occluder 
device is intended to effectively repair ostium secundum ASDs.  
Ostium secundum atrial septal defects present as a persistent 
communication between the atria and are a common congenital cardiac 
anomaly accounting for approximately 10% of all congenital heart disease. 
They are one of the most common congenital heart defects to present in 
adulthood. Untreated, ASDs produce right heart volume overload and 
progressive impairment over time, including reduced aerobic capacity, atrial 
dysrhythmias, congestive heart failure, pulmonary hypertension, and 
potential paradoxical embolism. In the U.S. alone it is estimated that 
approximately 10,000 new patients per year can be expected to have an ASD. 
Successful surgical repair of ASD has been performed for 50 years with 
continued improvement in technique and outcomes. King and Mills reported 
the first transcatheter closure of ASD in 1976, but the delivery system was 
quite large and impractical, especially for younger patients. With time, 
improvements in design concepts and materials discoveries have led to 
improved results in transcatheter closure systems. Several devices are now 
available commercially for transcatheter ASD closure. 
The primary objective of the GORE® Septal Occluder Study is to evaluate the 
safety and efficacy of the occluder device in the treatment of transcatheter 
closure of ostium secundum atrial septal defects (ASDs). The data obtained in 
this study will evaluate this next generation device as compared to outcomes 
of prior studies conducted with the GORE® HELEX® Septal Occluder. 
Device Description 
GORE® Septal Occluder 
The GORE® Septal Occluder consists of an implantable occluder and a 
catheter delivery system. The occluder is comprised of five platinum-filled 
nickel-titanium (Nitinol) wires which form a frame covered with expanded 
polytetrafluoroethylene (ePTFE). The ePTFE is treated with a hydrophilic 
coating to facilitate echocardiographic imaging of the occluder and 
surrounding tissue during implantation. When fully deployed, the occluder 
assumes a configuration (see Figure 1) to prevent shunting of blood between 
the right and left atria.  

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The occluder is configured in nominal diameters of 15, 20, 25, and 30mm.  
The occluder is delivered using conventional catheter delivery techniques and 
may be delivered with the aid of a 0.035" guidewire, or smaller, if necessary.   
Figure 1: GORE® Septal Occluder 
GORE® Septal Occluder Delivery System 
The delivery system consists of a 75 cm working length 10 Fr (O.D.) delivery 
catheter, a control catheter, and a mandrel coupled to a handle (Figure 2). The 
handle facilitates loading, deployment, and locking of the occluder. The 
handle also allows repositioning and retrieval of the occluder via the retrieval 
cord, if necessary.  
The catheter delivery system for the GORE® Septal Occluder is a catheter and 
handle assembly composed of four primary components.  
•
Delivery Catheter: Delivers the occluder to the treatment site.
•
Control Catheter: Advances/retracts the occluder at the treatment
site.
•
Mandrel: Supports the Nitinol frame and the locking mechanism of
the occluder.
•
Handle: Facilitates simple push/pull motions for occluder loading,
deployment, and locking.
The catheter components are arranged coaxially and are coupled to the 
handle mechanism. The handle moves the catheter components separately or 
in combination to facilitate simple push/pull motions for occluder loading, 
deployment, and locking.  The retrieval cord attaches the proximal eyelet of 
the occluder to the control catheter and facilitates occluder retrieval after lock 

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release, if necessary.  A flexible flushing port is attached to the handle to 
permit convenient device flushing prior to implant.  
Figure 2: GORE® Septal Occluder Handle Delivery System 
Study Objectives 
Primary Objective 
The primary objective of this study is to evaluate the safety and effectiveness 
of the GORE® Septal Occluder when used for percutaneous, transcatheter 
closure of ostium secundum atrial septal defects (ASDs). 
Study Design 
Description of Study Design  
This is a prospective, multicenter, single arm, clinical study comparing 
outcomes with the GORE® Septal Occluder to outcomes from previous GORE® 
HELEX® Septal Occluder clinical studies. 
This study will enroll 150 - 400 subjects from a maximum of 21 sites.  
Enrollment will occur in three phases – Pivotal (50 subjects), Continued 
Access (100 - 350 subjects), and Post Approval (if required).  Each phase will 
enroll sequentially (see Study Schema).  Criteria for initiation of each phase of 
enrollment are presented in Section 10.5. 
All enrolled subjects will be followed through the 36-month, post index 
procedure follow-up.  The study primary endpoint, composite Clinical 

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Success, will be evaluated at 6 months post index procedure.  The analysis in 
support of pre-market approval submission will occur when the 50 Pivotal 
subjects have completed 6-month follow-up evaluations.  The final, primary 
endpoint analysis of Clinical Success will occur when all enrolled subjects 
have completed 36-month follow-up evaluations. 
Study Schema 
Study Endpoints 
Primary Endpoint  
The primary endpoint for the study is composite Clinical Success 
evaluated at 6 months post index procedure and is defined as satisfying 
all the following criteria: 
1. Successful deployment and retention (at conclusion of index
procedure) of a GORE® Septal Occluder
2. Freedom from:
o
any Serious Adverse Event (SAE) through 30 days post
procedure
o
device events (post-procedure embolization, device
removal, or other device reintervention) from completion of
the implant procedure through the 6-month follow-up
evaluation
3.
A clinical residual defect status of completely occluded or
clinically insignificant residual shunt at 6-month evaluation as
determined by the Echo Core Lab (see Section 3.2.3)
 
Secondary Endpoints 
Technical Success: Successful deployment and retention of a GORE® 
Septal Occluder device at the conclusion of the index procedure. 
Pivotal  
Phase 
(50 subjects) 
Continued 
Access 
Phase 
(100 - 350 
subjects) 
Post Approval 
Phase 
(if required) 
Overall 
Study Cohort 
(150-400 
subjects) 
Analysis #1 ― To support 
Continued Access Phase: 
50 enrolled subjects with 1-month 
follow-up 
Analysis #2 ― To support PMA 
submission: 
50 enrolled subjects with 6-month 
follow-up 
Analysis #3 ― Final hypothesis 
analysis: 
All enrolled subjects with 36-
month follow-up 

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Procedure Success:  Technical Success with the GORE® Septal Occluder 
and ≤2mm residual shunt of the target ASD at conclusion of the index 
procedure. 
Closure Success (Efficacy): Technical Success and measured residual 
defect status of occluded/trivial, evaluated at 6 months, 12 months, 
and 36 months post index procedure. 
Safety: A calculation of the proportion of subjects experiencing one or 
more Serious Adverse Event(s) (SAE) in the first 30 days post index 
procedure and/or a device event (embolization, device removal, 
reintervention after completion of index procedure) through 6 months, 
12 months, and 36 months post index procedure. 
Study Definitions 
Clinical Residual Defect Status – categories defined based on clinical 
characteristics of the residual shunt at study follow-up intervals as 
determined by the echocardiography core lab: 
1. Completely Occluded, defined as absence of residual shunt
2. Clinically Insignificant Residual Shunt, defined as all of the
following:
a. Residual shunt is hemodynamically insignificant based on
any of the following characteristics:
i. Normalization of ventricular septal motion
ii. Significant decrease in right ventricular size as
determined by comparison of equivalent parasternal
and apical images of the right ventricle pre- and
post-device placement
b. No clinical sequelae related to the leak
3. Clinically Significant Residual Shunt, defined as any of the
following:
a. A residual left to right shunt or right heart volume overload
that would likely require repeat intervention
b. Clinical sequelae related to the leak
c. Hemodynamically significant, defined as failure to meet
criteria for hemodynamically insignificant detailed above
Measured Residual Defect Status – If present, residual defect size 
should be measured at post-implant, pre-discharge and all subsequent 
follow up evaluations. During the Core Lab analysis, the categories will 
be defined based on measured size of the target ASD residual shunt and 
compared to the guideline below:  
1. Occluded = absence of residual shunt
2. Trivial = >0 to ≤2mm residual shunt

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3. Moderate = >2 to ≤4 mm residual shunt
4. Large = >4 mm residual shunt
Description of Population 
Subjects with an ostium secundum ASD having a stop flow balloon diameter 
of less than or equal to 17 mm may be enrolled.  Baseline variables are 
assessed by means of physical examination, electrocardiogram (ECG), and 
transthoracic or transesophageal echocardiography (TTE or TEE).   
Subjects with additional cardiac conditions requiring surgery at the time of 
ASD closure or anticipated within three (3) years of enrollment are not 
permitted in the study due to possible confounding adverse events. Overall 
health, age and other underlying conditions should be considered prior to 
patient enrollment. 
Only patients who meet all of the Inclusion Criteria and none of the Exclusion 
Criteria will be enrolled. 
Inclusion Criteria  
All responses must be Yes to be eligible. 
1. Patient has an ostium secundum ASD with evidence of right
ventricular volume overload.
2. Patient has a defect size of ≤17 mm as measured directly by stop
flow balloon sizing.
3. Patient vasculature is able to accommodate the delivery system
and/or procedural accessories.
4. Patient is able to accommodate TEE or ICE probe for implant
procedure.
5. Patient is judged to have adequate septal rims to retain the device.
6. Patient (or legal guardian, if subject is a minor) must voluntarily
sign a Patient Informed Consent Form specific to the study.  The
Patient Informed Consent Form must be reviewed and approved in
a manner that complies with requirements of the hospital’s
Institutional Review Board.
7. Patient (and legal guardian, if patient is a minor) must be
physically and mentally willing to comply with all study follow-up

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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,
structural cardiovascular defect, or other comorbidities that could
elevate morbidity/mortality beyond what is common for ASD or
that is expected to 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, arrhythmias
requiring electrophysiology study, or intervention concurrent with
device placement.
2. Patient has systemic or inherited conditions that would
significantly increase subject risk of major morbidity and mortality
during the term of the study.  Examples would be endocarditis,
cancer, degenerative neuromuscular disorder, cardiomyopathy, or
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 in 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 one (or more) known intracardiac thrombi.
6. Patient has an uncontrolled arrhythmia.
7. Patient has a history of stroke resulting in a significant morbidity or
disability.
8. Patient is pregnant or lactating at time of enrollment.
9. Patient has contraindication to antiplatelet therapy.
10. Patient has a pulmonary artery systolic pressure greater than half
the systemic systolic arterial pressure unless the indexed
pulmonary arteriolar resistance is <5 Woods units.
11. Patient has multiple defects based on screening imaging and stop
flow balloon sizing that would require placement of >1 device.

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Study Procedures and Evaluations 
Study Evaluations Schema 
No GORE® Septal Occluder Attempt
(Patient Not Enrolled)
GORE® Septal Occluder Attempted
(Patient Enrolled as Study Subject)
Follow-up:
30 days, 6, 12, 24, 36 months
(calculated from index 
procedure )
- Physical Exam
- ECG
- Echo (TTE,TEE,ICE)
- Fluoroscopy (6 and 36 
months)*
- other as necessary
- Telephone Follow -up (24
month only)
Continue F/U until completion or 
discontinuation
* See details in Section 5.4.8
Eligibility Screening and Consent
Evaluate patient elig bility
Obtain informed consent
Screening Evaluations and CRFs :
- Demographics /Medical History
- Physical Exam
- Echo Evaluation (TTE,TEE,ICE)
Patient is Screen Failure
Complete CRFs:
- All Screening CRFs
- Demographics 
- Eligibility and Enrollment
No Additional F/U required
Includes subjects who have :
- Alternative Occluder implant
- No ASD Closure
Follow-up:
30 days (calculated from index 
procedure )
Complete CRFs:
- All Screening and Procedure 
CRFs
- Telephone Follow -up
- Completion/Discontinuation
UNSUCCESSFUL
GORE® Septal Occluder
Implant
SUCCESSFUL
GORE® Septal Occluder 
Implant
Subjects who have GORE Septal Occluder Removal or 
Embolization after completion of index procedure :
- If occurs within first 30 days post index procedure – complete follow-
up at 30 days post procedure and Completion /Discontinuation CRF.
- If occurs in beyond 30 days post index procedure – complete 
required CRFs . No additional study follow-up required .

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Schedule of Events 
The table below presents the procedures and evaluations for each protocol interval. 
Procedure / Evaluation 
Screening/ Pre-procedure  
(within 6 mo of index procedure) 
Procedure 
Pre-discharge 
Unsuccessful Implant – 30 
Days 
(day 30; + 14 days)
30 Days 
(day 30; + 14 days) 
6 Months 
(day 180: + 14 days) 
12 Months 
(day 365  + 60 days) 
24 Months 
(day 730; + 60 days) 
36 Months 
(day 1095 + 60 days) 
Screening  Evaluation and 
estimated defect size* (TTE, TEE 
or ICE) 
X
Patient Informed Consent & 
HIPAA 
X
Demographics and Medical 
History 
X
Physical Exam 
X 
X 
X 
X 
X 
X 
TTE/TEE/ICE 
(subcostal, parasternal, and 
apical 4-chamber views) 
X 
X
X 
X 
X
X
ECG 
X
X
X 
X 
X
X
Antiplatelet Therapy 
X 
X 
X 
X 
Telephone Questionnaire 
X
 
X
Assess Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
Fluoroscopy (without contrast; 
Enface and lateral views)** 
X**
X**
* performed within 6 months prior to index procedure
** Only if clinically indicated for certain subjects. Refer to Section 5.4.8 for details 

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Informed Consent Process 
All patients must provide informed consent, or assent for minors, prior to any 
study related procedures being performed. The case history (i.e. source 
documents/subject chart) for each subject must document that such 
informed consent was obtained. The patient, and authorized representative 
when applicable, must sign and date the informed consent form (ICF). The 
Investigator or designee must also sign the ICF. The patient will be provided 
with a copy of the signed and dated ICF and the original will be maintained at 
the Investigator site. 
Screening/Pre-treatment, Enrollment, Procedure, and Follow-up 
In all cases, the Investigator maintains exclusive responsibility for the 
inclusion and exclusion of any potential study participant(s). All patients 
presenting for treatment of ASD are evaluated for study participation based 
on the inclusion/exclusion criteria provided in this protocol. 
Screening /Pre-treatment Evaluation  
When the Investigator identifies a patient as a potential candidate for 
inclusion in the study, the necessary medical history, physical exam and 
inclusion/exclusion criteria are reviewed. If the patient meets the criteria 
for entry into the study, the Patient Informed Consent Form is 
administered. 
A screening evaluation is performed within six (6) months of procedure 
to identify initial suitability of defect closure. This pre-treatment patient 
evaluation will assess eligibility variables by means of physical 
examination, electrocardiogram (ECG) and transthoracic 
echocardiography (TTE),  transesophageal echocardiography (TEE) or 
other appropriate imaging to estimate static defect size of 17 mm or less 
may be enrolled. Peri-procedural antibiotics may be prescribed at the 
discretion of the Investigator. 
Subjects with additional cardiac conditions anticipated to require 
surgery within three (3) years of enrollment are not permitted in the 
study. In addition, no concurrent intervention(s) should be performed 
during the occluder procedure. 
Screen Failure 
Patients who consent to participate in the study, but who are 
determined to not have suitable anatomy and no GORE® Septal Occluder 
implant or placement is attempted, will be considered screen failures 
and will not be followed in this study (see Study Schema, Section 5.1). 
No post-procedure study follow-up or contact will be required for these 

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patients. Screen failures will be recorded on the appropriate case report 
form (CRF) in the EDC system. 
Enrollment 
A subject is considered enrolled into the clinical study when the GORE® 
Septal Occluder device is introduced into the anatomy of the subject.  
Subjects who enroll in the trial and have a successful implant should be 
followed through 36 months post index procedure (see Study Schema, 
Section 5.1).  
Transcatheter Procedure 
Subjects will be consented to the GORE® Septal Occluder Study prior to 
transcatheter procedure. 
Subjects will undergo placement of the GORE® Septal Occluder via a 
transcatheter procedure. During the transcatheter procedure either 
transesophageal echocardiography (TEE) or intracardiac 
echocardiography (ICE) will be performed with general anesthesia or 
conscious sedation based on the institution or Investigator’s general 
practice. These are acceptable testing modalities during the 
transcatheter procedure. Procedure time begins upon venous 
cannulation and procedure time ends upon removal of the final catheter. 
At that time, under general anesthesia or conscious sedation and by 
utilizing transesophageal echocardiography (TEE) or intracardiac 
echocardiography (ICE), either TEE or ICE static sizing and stop flow 
balloon sizing of the defect takes place. Static and stop flow balloon 
defect sizing of 17 mm or less and cardiac anatomy will determine final 
patient suitability and the appropriate device size for closure of the 
defect. 
Data will be recorded to characterize the procedure. 
5.4.4.1 
Recommended Procedure Technique (Instructions for Use) 
Detailed Instructions for Use for placement of the GORE® Septal 
Occluder may be found in the GORE® Septal Occluder package as well 
as in Study Regulatory Binder. 
The following recommendations should be considered when choosing 
the appropriate GORE® Septal Occluder for the subject: 
1. The selected occluder nominal diameter should be in a range
reflecting 1.75 times the stop flow diameter of the defect (1.75:1
ratio of device nominal diameter-to-defect diameter).
2. The defect should be evaluated to ensure there are adequate
septal rims to retain the device.

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3. The occluder size and position should be evaluated to ensure no
interference with other intracardiac or intravavular structures, such
as cardiac valves or pulmonary veins.
4. If successful deployment cannot be achieved after three (3)
attempts, an alternative treatment for ASD closure is
recommended. Consideration should be given to the patient’s total
exposure to radiation if prolonged or multiple attempts are
required for placement of the occluder.
5. Removal of the occluder should be considered if:

Lock loop does not capture all three eyelets;

Occluder will not come to rest in a planar position apposing
the septal tissue;

Occluder allows excessive shunting; or

Impingement on adjacent cardiac structures is observed.
Expansion of an occluder disc may occur in the periprocedural time 
period. If there is uncertainty that an expanded device remains locked, 
fluoroscopic examination without contrast is recommended in order to 
identify if the Lock Loop captures all three eyelets.  
5.4.4.2 
Access Site Management 
Closure of the femoral venous puncture site should be performed per 
hospital standards. Access site hemostasis may be achieved by 
manual compression, or by utilizing alternative methods, such as a 
suture closure device. 
Pre-Discharge  
Prior to institutional discharge, pre-discharge evaluations will be 
performed following the schedule of events (section 5.2). Imaging 
required is either transesophageal or transthoracic echocardiography 
(TEE/TTE) or intracardiac echocardiography (ICE). 
Unsuccessful GORE® Septal Occluder Procedure 
Subjects with unsuccessful placement of a GORE® Septal Occluder (no 
study device implanted at conclusion of index procedure) will be 
followed through 30 days post index procedure.  Subjects will be 
contacted by phone at 30 days for follow-up; upon completion of the 
telephone follow-up Case Report Form (CRF) at the 30-day Unsuccessful 
Implant interval, subject is discontinued from the study. These subjects 
will be considered enrolled and a technical failure for purposes of study 
analysis. 

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Post-Procedure Care 
At the discretion of the Investigator, subjects will be encouraged to limit 
their physical activities for at least two weeks after occluder placement. 
In uncomplicated cases with satisfactory closure, subjects may be 
discharged from the hospital as soon as deemed appropriate by the 
study Investigator. 
Patients are required to be treated with antiplatelet therapy, such as 
aspirin and/or clopidogrel bisulfate, for 6 months post index procedure 
per the institutional standard of care or physician’s general practice. The 
decision to continue antiplatelet therapy beyond 6 months is at the 
discretion of the Investigator.  
Post-Procedure Evaluations and Testing 
Post-procedure evaluations will be performed according to the schedule 
of events. Follow-up information will be recorded in the Clinical Data 
Management System (CDMS) through the 36 month interval or at the 
time of subject withdrawal or discontinuation from the study. 
At post-procedure follow-up intervals (30 days, 6, 12, and 36 months) a 
TTE or TEE is required for all subjects with the GORE® Septal Occluder to 
evaluate defect closure status.  
Fluoroscopic examination without contrast (En face and lateral views) 
will be performed at the 6 and 36 month intervals in order to identify 
and assess wire frame fractures. Please refer to the requirements below 
to determine if fluoroscopic evaluation is required for subject, or only 
necessary if clinically indicated. 
Lack of device stability may be indicative of wire frame fractures. All 
device fractures are reported on the Subject Follow-up Evaluation CRF.  
Additionally, device fractures that result in device removal because of 
device instability or other clinical sequelae will be reported as adverse 
events. Chest x-ray is not suitable imaging to evaluate the occluder and 
defect closure. 
Fluoroscopy Requirements 

Subject IDs referenced with 100 and 200 numbers within the
study database must complete 6 and 36 month fluoroscopic
imaging. These are the first 150 subjects enrolled (50 Pivotal
and 100 Continued Access).

Subject IDs with 300 numbers, fluoroscopic images are
optional and only recommended in subjects where device
stability is questionable at any follow up interval. Subjects

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enrolled with 300 numbers begin with the 151st enrollment 
through the time of PMA approval. 
Institutional subject records or documents from a referring institution or 
physician (i.e., catheterization report, discharge summary, or 
echocardiographic transcription) should not be forwarded to the 
Sponsor. Necessary records should be available for scheduled 
monitoring by the Contract Research Organization (CRO) on the 
Sponsor’s behalf. Documentation for adverse events may be requested. 
All echocardiography and fluoroscopy images obtained at procedural 
and study follow up intervals must be recorded in DICOM format 
according to echocardiographic guidelines provided with this protocol 
and uploaded to the BioClinica WebSend secure web portal. Baseline 
and implant images will be reviewed by the Echo Core Lab to assist in 
evaluating closure progress at subsequent intervals.  
At the 24 month interval subjects should be contacted and a telephone 
questionnaire CRF completed. 
All planned and unplanned visits, regardless of etiology, will be 
documented in the CDMS system, including reporting of any adverse 
events. It is important that the Investigator encourage subjects to return 
for all required follow-up visits.  The clinical study objectives will not be 
realized if a significant number of subjects are lost to follow-up or 
discontinued from further study participation.  
Reinterventions 
Reinterventions to the study device (GORE® Septal Occluder) will be 
reported on the Intervention CRF.  If the GORE® Septal Occluder is 
removed as part of the reintervention, then the subject is discontinued 
from the study.  If the GORE® Septal Occluder remains implanted, then 
the subject will continue to be enrolled and will complete study follow-
up as prescribed. 
Follow-up Visit Windows 
The follow-up visits should be completed within an acceptable time 
frame and in accordance with the protocol defined visit windows.  The 
follow-up intervals are calculated as calendar days from index 
procedure.  The visit windows are calculated as +/- the number of 
calendar days. 
30 Days 
6 Months 
12 Months 
24 Months 
36 Months 
Day 30 
+/- 14 days 
Day 180 
+/- 14 days 
Day 365 
+/- 60 days 
Day 730 
+/- 60 days 
Day 1095 
+/- 60 days 

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If the visit is not able to be completed during these windows the visit 
should be completed as soon as possible; however, it will be considered 
a protocol deviation and should be reported per local Institutional 
Review Board (IRB) policy. Visits performed outside the prescribed 
window will be reported as an Unscheduled visit. 
Subject Withdrawal from the Clinical Study 
A subject may withdraw from the clinical study at any time and for any reason, 
and should notify the Investigator in this event.  Subjects are not obligated to 
reveal their reasons for withdrawal. The subject will be withdrawn if he/she 
relocates to another geographic area that requires a change of physician and 
such suitable physician cannot be identified. 
The Investigator may withdraw the subject from the clinical study at any time 
based on his/her medical judgment.  It is important that the Investigator 
encourage subjects to return for all required follow-up visits within the 
designated window.  The clinical study objectives may not be realized if a 
significant number of subjects are lost to follow-up.  A subject may withdraw, 
or be withdrawn by the Investigator, if he or she is unable to continue 
participation in the study due to any condition unrelated to the study.  
The Investigator or designee must complete the appropriate CRF (Study 
Completion/Discontinuation Form) documenting the subject’s withdrawal or 
discontinuation from the clinical study.  The subject will be considered 
withdrawn once the Sponsor receives the respective CRF.     
At any time other than the immediate index procedure during the study where 
complications prevent retention of the GORE® Septal Occluder (i.e., 
embolization or other event requiring device removal), the subject will be 
discontinued from further study follow-up.  All adverse events will be 
collected and reported in compliance with this protocol through the point of 
device removal. The Investigator or designee will complete the Study 
Completion/Discontinuation Form documenting the subject’s discontinuation 
from the clinical study.  
Subject Lost to Follow-Up 
A subject will be considered lost to follow-up and terminated from the study 
once they have missed at least one follow-up visit or at the discretion of the 
Investigator or Sponsor, and three documented attempts have been made by 
the Investigator or designee to contact the subject or legally authorized 
representative.  One of the three documented attempts must include a 
certified letter.  

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Subject Study Completion 
A subject has completed the study when the 36 month follow-up visit has 
been completed. Any subject who does not complete the 36 month follow-up 
visit due to voluntary withdrawal, physician withdrawal, death or any other 
reason will be considered a withdrawal. Subjects will not be provided with 
any medical care by the Sponsor after study completion or withdrawal. 
Explant Procedures 
The GORE® Septal Occluder may be explanted during a surgical procedure or 
as part of an autopsy. Investigative Centers are requested to return explanted 
device to W. L. Gore & Associates, Inc. for gross and histological evaluation. 
Prior to planned or potential device retrieval, contact the GORE® Septal 
Occluder Study Manager to communicate that a specimen is being retrieved 
from a study subject. A specimen shipping kit will be sent immediately to the 
Investigative Center. The specimen kit provides specific packaging and 
handling instructions for the specimen and contains a shipping container. 
Clinical Study Administration 
Training 
Participating Investigators are required to complete device didactic and 
protocol training prior to first implant. The first study implant is observed by a 
Gore representative and is considered a clinical training case. 
Device Accountability and Storage 
The GORE® Septal Occluder may be used only under the supervision of the 
Investigator and in strict accordance with this protocol and applicable laws 
and regulations. The occluder may be implanted only in subjects who meet 
the inclusion/exclusion criteria set forth in this protocol. The Investigator will 
maintain accurate, detailed records of all devices received from Sponsor. The 
Investigator will record and maintain records of each device used on the 
corresponding CRF, and will notify Sponsor immediately if any devices are 
damaged or unaccounted for. The devices must be accessible only to the 
personnel involved in the study and stored in a secure facility. 
Upon completion or termination of the clinical study or the Investigator’s 
participation in the clinical study, or at the Sponsor’s request, the Investigator 
will return any remaining supply of the device or dispose of the devices as 
directed by the Sponsor. 

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Core Laboratory  
All protocol prescribed imaging (screening/pre-procedure, procedure, pre-
discharge, 30 days, and 6, 12 and 36 months) must be recorded in DICOM 
format, subject information de-identified by turning off the system overlay 
feature and replaced with study ID, and images uploaded to BioClinica 
WebSend secure web portal. The Core Laboratory will access images through 
the BioClinica web portal and evaluate prescribed intervals. Results of core 
lab evaluations will be available on the subject EDC records. 
Study Monitoring  
Clinical Investigative Site monitoring for this study will be provided by 
Theorem Clinical Research. Monitoring oversight will be provided by the 
Sponsor. 
The Investigative Site monitors are qualified by training and experience to 
oversee the progress of the study at the site and will ensure that the 
Investigators and their staff understand and adhere to both the applicable 
regulatory requirements and the study protocol. In addition, they may assist 
in resolution of any problems that may arise during the study. 
Monitoring Procedures 
6.4.1.1 
Clinical Investigative Site Initiation Visit 
Site initiation will be performed to assure that each Investigator and 
his/her staff understands the protocol, applicable regulations, human 
subject protection requirements, and the Investigator’s obligations. 
This visit will ensure that required documentation with the appropriate 
approval is in place prior to subject enrollment. 
6.4.1.2 
Periodic Clinical Investigative Site Visits 
Periodic site visits will occur as necessary to ensure continuing 
adequacy of facilities and adherence to the clinical study protocol, the 
GCPs, and applicable regulations and laws that pertain to the conduct 
of the clinical study. During these visits, the monitor will also review 
the CRFs and source documentation, the timely submission of 
accurate records to the Sponsor, and the maintenance of proper 
records. A report will be written following each investigative site visit 
and a follow up letter will be provided to the site with a summary of 
findings. 
6.4.1.3 
Clinical Monitor Reports 
The Sponsor’s Clinical Monitor(s) will prepare a written report for the 
Sponsor following each investigative site visit.  Reports will include 

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specific information regarding observations made at the site visit, 
including staff members consulted, records reviewed, subject 
enrollment and general progress of the study, status of any problems 
identified, any correctional action recommended, and any other 
information deemed pertinent by the Sponsor’s Clinical Monitor. 
Protocol Deviations 
A protocol deviation is defined as any change, divergence, or departure from 
the study design or procedures of a research protocol that is under the 
Investigator’s control and that has not been approved by the IRB. The 
Investigator is responsible for reporting protocol deviations to their IRB per 
IRB policy and the Sponsor promptly. The Sponsor will determine the effect of 
the protocol deviation on the scientific soundness of the clinical study and 
subject safety and determine if additional reports or actions are required. 
Additional action may include site retraining, removal of devices from the 
site, and/or site termination. 
The Investigator will not implement any changes to the protocol without first 
obtaining written agreement from the Sponsor and documented approval 
from the IRB, except in the event of an immediate hazard(s) to a subject. 
Protocol Amendments 
The Investigator will maintain a copy of the original protocol and all 
amendments. The Investigator will obtain IRB approval on all amendments in 
a timely manner. The sponsor will ensure proper training of Investigator and 
site staff on all protocol amendments as necessary. 
Sponsor Representatives 
Sponsor representatives may be present during study procedures to support 
the Investigator. The representatives may provide guidance for use of the 
device. 
Source Documents and Access to Source Data 
The Investigator will keep all study records, source data and investigational 
devices available for inspection by the Sponsor, Sponsor’s monitors, and 
regulatory authorities. 
Source data is defined as all information in original records, certified copies 
of original records of clinical findings, observations, or other activities in a 
clinical investigation necessary for the reconstruction and evaluation of the 
clinical investigation. 

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Study Records Retention 
The Investigator will maintain complete, accurate and current study records 
as required by applicable regulatory requirements. Records will be 
maintained during the clinical study and for a minimum of two years after the 
latter of the date on which the study is terminated or completed, or the date 
the records are no longer required to support regulatory approval of the 
device. In any event, clinical study records will not be disposed of, nor 
custody of the records transferred, without prior written Sponsor approval. 
Investigator records will include, but are not limited to: 

All study-related correspondence with another Investigator, the
IRB, the Sponsor, a Monitor, regulatory authority, or a study
subject.

Accountability records of receipt, use and disposition of all
investigational devices including the type and quantity of the
devices, the dates of their receipt, and the lot numbers. In
addition, the names of all persons who received, used or
disposed of each device.

Subject records that include the subject’s case history (e.g.,
medical records, reports of procedures, diagnostic tests and
laboratory reports), the signed informed consent and process,
and exposure to the device. In addition, all relevant
observations, including records concerning adverse device
effects, information and data on the condition of each subject
upon entering and during the course of the investigation, and
previous medical history should be retained. Pertinent
information will be documented on standardized CRFs provided
by the Sponsor.

A copy of the study protocol and all amendments. Any
deviations from the protocol will be documented.

Reports and information pertaining to Unanticipated Adverse
Device Effects (UADEs).

All information pertaining to IRB review and approval of the
clinical study. This includes a copy of the IRB approval or any
subsequent renewal, the IRB-approved Informed Consent
Form(s), and a certification stating that the IRB is in compliance
with Food and Drug Administration (FDA) regulations.

An original signed Investigator Agreement or equivalent.
The Investigator will prepare and submit the following reports:  

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
IRB approval withdrawal: information pertaining to withdrawal
of IRB approval will be provided to the Sponsor within five
working days after the Investigator has been notified of the
withdrawal.
Progress reports: 

Progress reports documenting the procedure, AEs and follow-up
data concerning individual subjects will be submitted to the
Sponsor on standardized CRFs. The Investigator may also be
required to submit progress reports to the institutional IRB and
to the Sponsor summarizing the Investigator’s experience
during the study.
Other: 

Any other reports as reasonably requested by the Sponsor or
required by FDA.
Publication Plan 
The International Committee of Medical Journal Editors (ICMJE) member 
journals have adopted a trials-registration policy as a condition for 
publication.  This policy requires that all clinical trials be registered in a 
public trials registry.  The Sponsor will register the study and post results as 
required by this policy and applicable U.S. laws and regulations.  
It is the intent of the Sponsor that the multicenter results of this study will be 
submitted for publication (in a peer reviewed journal).  A publications 
committee will be established to review the multicenter results and develop 
publications at the completion of the study.  The timing of the multicenter 
publication may be dependent on regulatory submissions and approvals.  
Individual Sites should coordinate requests for publication through the 
publications committee or the Sponsor. 
Data Collection and Submission 
The Clinical Data Management System (CDMS) for this study will be provided 
by Medidata Solutions Worldwide, 79 Fifth Avenue, 8th Floor, New York, New 
York 10003.  
Data Collection Methods 
This study will report clinical data using the Medidata Rave® web-based 
application. The Rave® system will be the database of record for the protocol 

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and subject to regulatory inspections. All Rave® users will be trained to use 
the CDMS and will comply with study specific guidelines/instructions. 
Subject data will be collected using protocol-specific electronic case report 
forms (eCRF). eCRF Guidelines will be provided to sites at the time of 
database training. Site staff will enter data directly into the eCRF for review by 
the Sponsor and/or CRO.  
Data Clarification and Correction 
Once entered, data will be evaluated to ensure that it is complete, consistent 
and logically sound.  Data changes or query resolution within the CDMS will 
be addressed at the site level. All changes, reasons for changes, and persons 
making the changes will be captured in the system’s audit trail. 
 
CRF Completion Schedule 
All CRFs should be completed within 14 working days of each visit.  
Risk Assessment 
Possible benefits and risks associated with the study procedures and device 
placement are outlined in the IRB-approved informed consent form. 
Some risks are possible with transcatheter approaches, including: 

access site complications

incomplete closure of the defect

repeat procedure to the septal defect

air embolism

myocardial infarction

pericardial tamponade

cardiac arrest

renal failure

sepsis

significant pleural or pericardial effusion requiring drainage

significant bleeding

endocarditis

headache or migraine

Transient Ischemic Attack (TIA) or stroke

death

cardiac arrhythmias

thromboembolic events
Risks specific to the GORE® Septal Occluder device include, but are not 
limited to:  

unsuccessful device delivery

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
fracture of the wire frame resulting in device instability or other
clinical sequelae

occluder disc expansion resulting in clinical sequelae or
intervention

possible allergic reaction to nickel in wires

perforation of cardiac tissue by the device

enlargement of the defect during or after device deployment

embolization of the implant

surgical intervention to correct device failure

insufficient closure of the defect
 
Minimization of Risks 
Potential risks associated with the use of the GORE® Septal Occluder will be 
minimized by the following: 

W. L. Gore & Associates, Inc. has performed qualification
testing on the device and device components and appropriate
quality control measures have been implemented into
production.

Investigators will be selected who are knowledgeable and
experienced in transcatheter closure of ostium secundum atrial
septal defects.

Comprehensive site Investigator and staff training will be
conducted to share information regarding the design of the
occluder, its application, and preliminary clinical results from
any pre-clinical and clinical studies.

The site Investigator, Co- and/or Sub-Investigators, clinical
study coordinator(s) or designee at each participating site will
be trained to the protocol, reminded of the importance of
patient selection and specific anatomy criteria when using the
occluder, and subject follow-up requirements.

Protocol inclusion/exclusion criteria and follow-up schedule
were designed to select appropriate subjects and identify
potential complications early.

Subjects will be assessed post-procedure and subsequently on
a regular basis to collect information on the subject’s status
and any reportable adverse events.

Data completed by the clinical sites will be monitored. An
initiation site visit and interim site visit(s) will be conducted as
appropriate to evaluate protocol compliance and to evaluate
the data for accuracy and subject safety.

Safety and efficacy data obtained during the clinical study will
be shared with the site Investigators to aid understanding of
the device and potential complications associated with its use.

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
An evaluation will be completed by the Investigator for each
subject against the inclusion/exclusion criteria before study
entry to ensure the subject’s defect and anatomy is
appropriate. Procedural echocardiographic or other appropriate
imaging will be used to assess the subject defect suitability.

Antiplatelet therapy will be prescribed for 6 months post index
procedure to reduce the risk of thrombosis. Peri-procedural
antibiotics prophylaxis is recommended to reduce the risk of
infection.

All protocol defined echocardiographic images will be reviewed
by the Echocardiography Core Laboratory to evaluate the heart
and any residual shunting across the ASD.

Risk of device embolization has been minimized in two ways.
First, the device is designed with a retrieval function. The ability
to retrieve the device is maintained until the Investigator
ensures proper fit into the defect.  Additionally, the occluder
size selected for the defect is recommended to be
approximately 1.75:1 (device nominal diameter-to-defect
diameter) and defects not greater than 17mm will be treated in
this protocol. An occluder that pulls through the defect after left
or right atrial disc conformation may be too small and should
be removed and replaced with a larger size.
Summary of Expected Benefits  
The expected benefit to the patient from the use of the GORE® Septal 
Occluder in the treatment of ostium secundum atrial septal defects is to 
reduce or arrest the shunting between the atria, to arrest or reverse the 
associated right heart and pulmonary pathology, and to have a short hospital 
stay and return to normal activity within two weeks of the procedure.  
Adverse Events and Safety Monitoring 
An adverse event (AE) is defined as any untoward medical occurrence in a 
subject whether device related or not.   
Anticipated Adverse Events 
A list of benefits and risks associated with the procedure- and device-related 
complications that may be anticipated in subjects undergoing transcatheter 
ostium secundum ASD closure are identified in Section 8.0, Risk Assessment.  
These pre-defined complications are considered anticipated AEs. If a 
complication occurs that is not on the list of known, potential complications 
and the Investigator believes that the complication is a potential UADE (see 

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section below), the site should immediately contact the Sponsor to determine 
reporting requirements. 
The Investigator at each investigative site is ultimately responsible for 
reporting AEs to the Sponsor.  The Investigator or designee is required to 
complete the appropriate CRFs to report the occurrence of AEs.  
Unanticipated Adverse Device Effects  
An unanticipated adverse device effect (UADE) is defined as “any serious 
adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects” (21 CFR Part 
812.3). 
“An Investigator shall submit to the sponsor and to the reviewing IRB a report 
of any unanticipated adverse device effect occurring during an investigation 
as soon as possible, but in no event later than 10 working days after the 
Investigator first learns of the effect” (21 CFR Part 812.150).  All UADEs must 
be documented by the Investigator including the date of onset, a complete 
description of the event, possible reason(s) for the event, severity, duration, 
actions taken and outcome.  Copies of all supporting documents will be 
uploaded into the CDMS concurrently with the appropriate CRF.  A report from 
the Sponsor will be submitted to the FDA and to all reviewing IRBs and 
participating Investigators within 10 working days after the sponsor first 
receives notice of the effect. 
Adverse Event Relationship 
Each reported AE will be assessed by the Investigator for its suspected 
relationship to the occluder device, interventional procedure, and/or study 
medications.  Each relationship will be defined as either: definitely related, 
probably related, possibly related, unrelated, or unknown.  
Serious Adverse Events 
Each AE will be assessed by the Investigator for seriousness. Each AE is 
categorized as either Serious or Non-Serious. A Serious Adverse Event (SAE) 
is an adverse event that: 
1. led to a death;
2. led to a serious deterioration in health of a subject that:

results in a life threatening illness or injury;

results in a permanent impairment of a body structure or body
function;

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
requires inpatient hospitalization or prolongation of existing
hospitalization;

results in medical or surgical intervention to prevent permanent
impairment to body structure or a body function; or
3. led to fetal distress, fetal death or a congenital abnormality/birth defect.
Adverse Event Severity 
Each AE will be assessed by the Investigator for severity.  The severity 
describes the maximum intensity of the adverse event; for purposes of 
consistency, these intensity grades are defined as follows: 
Mild 
Does not interfere with subject’s usual function 
Moderate 
Interferes to some extent with subject’s usual function
Severe 
Interferes significantly with subject’s usual function 
Note the distinction between the severity and the seriousness of an adverse 
event. A severe event is not necessarily a serious event. For example, a 
headache may be severe (interferes significantly with subject’s usual 
function) but would not be classified as serious unless it met one of the 
criteria for seriousness, as described in section 9.4. 
Adverse Event Data Collection 
All study AEs will be collected, recorded on the appropriate CRF, maintained 
in the CDMS, and documented in the subject’s permanent medical record. 
Adverse event reporting requirements are as follows: 

Adverse Event Name

Adverse Event Onset Date

Severity (see Section 9.5)

Primary Relationship (see Section 9.3)

Seriousness (see Section 9.4)

Treatment

Action Taken

Outcome

Adverse Event Resolution Date

If applicable, was AE cause of death.
Adverse Event Submission Guidelines: 

Adverse event reporting begins once the patient is enrolled in
the trial.  All adverse events should be reported from
enrollment through study completion/discontinuation.

An adverse event that changes from non-serious to serious
should be reported as a new adverse event.

Adverse events with an outcome status of “Ongoing” should be
assessed at each follow-up evaluation to determine if the event

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has resolved.  Adverse events ongoing at study 
completion/discontinuation should be left as “Ongoing” on the 
AE case report form.  

Provide a diagnosis if possible. If unable to provide diagnosis,
report the symptoms as separate events. Adverse Events
should be reported without abbreviations or narratives.

If a subject dies while on study, the cause of death will be
reported as the adverse event and “death” reported as the
event outcome on the AE case report form.   If the subject has
other ongoing adverse events at the time of death, the outcome
status of those events should be reported as “death” on each
AE case report form.
Adverse Event Coding 
Adverse Events will be categorized using the Medical Dictionary for Regulatory 
Activities (MedDRA) coding guidelines. 
Independent Data Review  
The Sponsor will establish an Independent Data Reviewer (IDR). The IDR will 
provide external oversight and review for potential safety concerns. The IDR is 
a physician expert in interventional cardiac therapy who is not participating in 
the trial and has no other affiliation with W. L. Gore & Associates, Inc. 
During the course of the study, the IDR will review aggregate accumulating 
safety data to monitor for the incidence of serious adverse events and other 
trends that would warrant modification or termination of the study. 
The IDR will review the overall safety data at regular intervals. The IDR 
responsibilities and operating procedures will be outlined in the IDR charter. 
Any IDR recommendations for study modification or termination because of 
concerns over subject safety or issues relating to data monitoring or quality 
control will be submitted in writing to the Sponsor for consideration. 
However, if the IDR at any time determines that a potential serious risk exists 
to subjects in the study, the IDR will immediately notify the Sponsor. 
Statistical Analysis 
 Primary Study Hypotheses 
This study is designed to test the null hypothesis that the Clinical Success 
rate at 6 months when using the GORE® Septal Occluder is inferior to the 

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lost to follow-up rate of up to 10% before the 6-month endpoint, a minimum 
of 150 subjects will be enrolled in the study.   
 Study Enrollment 
Enrollment in the GORE® Septal Occluder study will occur in three phases: 
1. Pivotal cohort of 50 subjects from a maximum of 10 sites.
Enrollment in this phase will begin upon Investigational Device
Exemption (IDE) approval. Upon completion of 6 month follow up
for all 50 subjects, a submission will be made to FDA for Pre-
Market Approval (PMA).
2. Continued Access cohort of 100 – 350 subjects from 10 – 21 (up to
11 additional) sites.  Enrollment in this phase will begin after FDA
acceptance of 30-day safety analysis on the Pivotal cohort.
3. Post Approval cohort of subjects will be enrolled depending on the
number achieved in Continued Access upon PMA approval.
Enrollment in this phase will begin after FDA pre-market approval
for GORE® Septal Occluder. (Post Approval Study [PAS] subjects
will be enrolled pursuant to the approval of this protocol and PMA.)
Total enrollment for the GORE® Septal Occluder study will be 150 – 400 
subjects.  All subjects will be enrolled and followed under the same criteria 
through the 36 months post index procedure. 
Data Analysis 
Timing of Analyses  
There are three planned analyses for the GORE® Septal Occluder study: 
1. A safety analysis on the pivotal cohort of 50 subjects at completion
of 30 day Screening follow-up.  This analysis will support
expansion of enrollment into the continued access phase.  This will
be a descriptive analysis with no hypothesis testing.
2. A PMA submission analysis on the pivotal cohort of 50 subjects at
completion of 6-month follow-up.  This analysis will support pre-
market approval of the GORE® Septal Occluder.  This will be a
descriptive analysis with no hypothesis testing.
3. The final study analysis at completion of enrollment of all subjects
and completion of 36-month (3-year) follow-up.  This analysis will
evaluate the primary study hypothesis.
 Analysis Populations 
The analysis populations for the study are: 

Per-Protocol (primary analysis population) – this population
will include enrolled subjects who had no inclusion/exclusion

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violations and who complete evaluation through the 6-month 
follow-up.   

Intent-to-treat – this population will include all enrolled
subjects.
Statistical Analysis of Primary Endpoint
The primary endpoint analysis will be a comparison of the proportion of 
subjects who meet the composite Clinical Success requirements 
through the 6-month follow-up between the study population and the 
historical control population of GORE® HELEX Septal Occluder studies.  
The primary analysis population will be the per-protocol population.  The 
primary endpoint will be compared using a two-sample binomial 
proportions test with a non-inferiority margin of 10%.  In statistical 
terms: 
T
T
T
C
C
C
T
C
n
p
p
n
p
p
p
p
z
)
1(
)
1(







where: 
pC = observed Clinical Success proportion at 6 months in control group 
nC = number of subjects with primary endpoint evaluation in control 
group 
pT = observed Clinical Success proportion at 6 months in test group 
nT = number of subjects with primary endpoint evaluation in test group 
The test statistic z is assumed to have a standard Normal distribution.  
Based on the alpha ≤0.05 criterion, a result of z< -1.64 will result in 
rejection of the null hypothesis in favor of the alternative hypothesis and 
a conclusion that the GORE® Septal Occluder is not inferior to the current 
GORE® HELEX Septal Occluder. 
Statistical Analysis of Secondary Endpoints 
The study is not designed to evaluate statistical hypotheses for the 
secondary endpoints.  Therefore, no analyses are planned for the 
secondary endpoints.  Any analyses would be considered exploratory.  
Secondary endpoints will be presented as descriptive statistics. 
Evaluation of Poolability of Presence vs. Absence of Atrial 
Septal Aneurysm 
Although the fraction of subjects enrolled with an atrial septal aneurysm 
(ASA) is expected to be small (perhaps 1 in 10) it is an important 
characteristic of ASD, and thus as a regulatory requirement will be 

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assessed for poolability with data from subjects without ASA. The 
statistical plan for this assessment will consist of two stages: baseline 
homogeneity and primary outcome comparability. 
For baseline homogeneity, the two subgroups will be compared on the 
following three baseline demographic and predictor covariates: age, 
gender, and balloon-sized ASD diameter. These subgroup comparisons 
will use the two-sample t-test, chi-square test, or Fisher’s Exact test, 
depending on the distribution of the covariate. 
For primary outcome comparability, covariate-by-ASA interactions will be 
assessed using logistic regression models where main effects for ASA 
and the covariate and the covariate-by-ASA interaction term will be 
regressed on the 6-month Clinical Success endpoint; this will be 
performed individually for each of the three baseline covariates. 
Statistically significant interactions will be assessed graphically for the 
nature of the interaction (quantitative vs. qualitative). Qualitative 
interactions (difference in direction of ASA effect across levels of 
covariate) will suggest that the ASA subgroups are not poolable, leading 
to analyses performed separately for each ASA subgroup. 
Finally, ASA subgroup and any baseline covariates deemed to be 
different between ASA subgroups will be included as main effects in a 
logistic regression model on the primary endpoint. If the ASA subgroup 
term is statistically significant then the ASA subgroups will not be 
considered outcome comparable, leading to analyses performed 
separately for each ASA subgroup. 
A significance level of =0.15 will be used for these poolability tests, 
without correction for multiplicity. Since this evaluation plan calls for a 
minimum of 7 significance tests, the overall Type-I error rate for this 
analysis may exceed 1 − (1 − 0.15)7 = 0.67. 
Ethical and Regulatory Considerations 
Statement of Compliance 
The study will be conducted in compliance with this protocol, International 
Conference on Harmonization Good Clinical Practice E6 (ICH_GCP), and 
applicable regulatory requirements. 
21 CRF Part 11 
Electronic Records; Electronic Signatures 
21 CRF Part 50 
Protection of Human Subjects 
21 CRF Part 54 
Financial Disclosure by Clinical Investigators 
21 CRF Part 56 
Institutional Review Boards 
21 CRF Part 812 
Investigational Device Exemptions 

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ICH-GCP E6 
International Conference on Harmonisation 
Regulations Guideline for Good Clinical 
Practice 
Compliance Responsibilities  
The Sponsor will conduct the clinical study in accordance with all applicable 
regulations and laws. The Sponsor will be responsible for documenting that 
Investigators have the necessary skills, training and information to properly 
conduct the clinical study. The Sponsor will ensure proper monitoring of the 
clinical study and ensure the Clinical Investigative Site has obtained 
Institutional Review Board (IRB) approval prior to enrollment. The Sponsor 
will provide information to the Investigators, the IRB, and the FDA 
concerning the progress and any new materials information about the 
clinical study. 
The Investigator will conduct the clinical study in accordance with all 
applicable regulations and laws, any relevant agreements, the study 
protocol, and all approval conditions of the IRB and FDA. The Investigator 
will ensure IRB approval is obtained prior to enrollment, maintained 
throughout the course of the study, and that all Institutional Review Board 
reporting requirements are met. The Investigator is responsible for 
protecting the rights, safety, and welfare of the subjects under the 
Investigator’s care and for the control of devices under investigation. Also, 
the Investigator is responsible for ensuring that informed consent is 
properly obtained. 
Subject Informed Consent 
The Investigator shall ensure that all potential subjects for this study are 
provided with a consent form describing this study and sufficient 
information to make an informed decision about their participation. 
The formal consent of a subject, using the IRB-approved consent form, must 
be obtained by the Investigator or designee before that subject undergoes 
any study procedure. The consent form will be signed and personally dated 
by the subject or legally acceptable surrogate, and the person who 
conducted the informed consent discussion. The original signed informed 
consent form will be retained in the subject records. A copy of the informed 
consent document will be given to the subject for their records. Any 
significant, new information that emerges while the study is in progress that 
may influence a subject’s willingness to continue to take part in the study 
will be provided. 
The Investigator shall ensure that documentation of the acquisition of 
informed consent is recorded in each subject’s records in accordance with 
21 CRF 812.140. 

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Independent Ethical Review 
The Investigator shall not enroll any subjects prior to obtaining approval for 
the study from a properly constituted Institutional Review Board. 
The Investigator will submit the protocol, informed consent forms and other 
information to be provided to subjects, such as survey instruments or 
questionnaires, and any proposed advertising/recruitment materials for 
written approval prior to site initiation. 
Conflict of Interest 
All Investigators will follow their institution’s conflict of interest policies. 
Investigators will provide Sponsor with sufficient accurate financial 
disclosure information to allow Sponsor to submit a complete and accurate 
certification or disclosure statement as required under 21 CRF Part 54, 
Financial Disclosure by Clinical Investigators. Investigators will promptly 
update this information if any relevant changes occur during the course of 
the investigation and for one (1) year following completion of the study. 
Confidentiality 
All subject records will be kept confidential to the extent provided by 
applicable laws and regulations. The study monitors and other authorized 
representatives of the Sponsor may inspect all documents and records 
required to be maintained by the Investigator, including but not limited to 
medical records. 
Such records may also be reviewed by the site’s independent ethical review 
board and other regulatory bodies (e.g. FDA). 
The Investigator will inform the subjects that their records will be reviewed. 

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References 
1. Boutin C MD; Musewe NN MD; Smallhorn JF, MD; Dyck JD, MD; Kobayashi
T, MD; Benson LN, MD. Echocardiographic Follow-up of Atrial Septal
Defect After Catheter Closure by Double-Umbrella Device. Circulation Vol
88, No 2 August 1993, p 621-627.
2. Brassard M, MD, Fouron JC, MD, van Doesburg NH, MD, Mercier LA, MD,
and De Guise P, MD. Outcome of Children With Atrial Septal Defect
Considered Too Small for Surgical Closure. Am J Cardiol 1999;83:1552–
1555. 
3. Fagan T, MD, Dreher D, BS, Cutright W, DVM, Jacobson ,MS, and Latson L,
MD. Fracture of the GORE HELEX Septal Occluder: Associated Factors and
Clinical Outcomes. Catheterization and Cardiovascular Interventions 
(2009) 73:941–948.
4. Jones TK, MD, FACC, Latson LA, MD, FACC, Zahn E, MD, FACC, Fleishman
CE, MD, FACC, Jacobson J, MS, Vincent R, MD, FACC, Kanter K, MD, Results
of the U.S. Multicenter Pivotal Study of the HELEX Septal Occluder for
Percutaneous Closure of Secundum Atrial Septal Defects. Journal of the 
American College of Cardiology, Vol. 49, No. 22, 2007, p 2215-2221.
5. Latson LA, MD, Jones TK, MD, Jacobson , MS, Zahn E, MD, and Rhodes JF,
MD,  Analysis of factors related to successful transcatheter closure of
secundum atrial septal defects using the HELEX septal occluder. American 
Heart Journal, Volume 151, Number 5, p 1129.e7-1129.e11.
6. Smith BG, Wilson N, Richens T,., and Knight WB. Midterm Follow-Up of
Percutaneous Closure of Secundum Atrial Septal Defect with Helex Septal
Occluder. Journal of Interventional Cardiology, Vol. 21, No. 4, 2008, p 363-
368. 
7. Warnes CA, Williams RG, Bashore TM, Child JS, Connolly HM, Dearani JA,
del Nido P, Fasules JW, Graham TP, Jr, Hijazi ZM, Hunt SA, King ME,
Landzberg MJ, Miner PD, Radford MJ, Walsh EP, and Webb GD. Circulation 
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8. Zhong-Dong Du, MD, Ziyad M. Hijazi, MD, MPH, FACC, Charles S.
Kleinman, MD, FACC, Norman H. Silverman, MD, FACC, Kinley Larntz, PHD.
Comparison Between Transcatheter and Surgical Closure of Secundum
Atrial Septal Defect in Children and Adults: Results of a Multicenter
Nonrandomized Trial. Journal of the American College of Cardiology, Vol.
39, No. 11, 2002, p 1836-1844i.