Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Phase: NA
Conditions: Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
Sponsor: Edwards Lifesciences

PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST 
NOT BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. 
 
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE 
are trademarks of Edwards Lifesciences Corporation.  
 
 
 
 
 
Edwards EVOQUE Tricuspid valve Replacement: Investigation of Safety and 
Clinical Efficacy after replacemeNt of tricuspid valve with transcatheter Device  
 
Short Title: TRISCEND Study 
 
 
 
Clinical Protocol 
(Clinical Investigation Plan) 
 
Study Number: 2019-06 
Version: 
 
Effective Date: May 04, 2021 
 
 
CONFIDENTIAL 
 
 
 
 
 
Study Sponsor: 
Edwards Lifesciences LLC 
 
 

TRISCEND Study (#2019-06)
Edwards Lifesciences, LLC
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC.
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation. 
Page 2 of 103
TABLE OF CONTENTS 
PROTOCOL SYNOPSIS.........................................................................................................................7
INTRODUCTION ........................................................................................................................13
1.1. Clinical Background on Tricuspid Regurgitation.........................................................................................13
Disease Process............................................................................................................................13
Etiology.........................................................................................................................................13
Anatomy and Pathophysiology of Tricuspid Regurgitation..........................................................14
Prognosis of Tricuspid Regurgitation ...........................................................................................15
Diagnostic Assessments for Tricuspid Regurgitation ...................................................................15
1.2. Treatments and Therapies for Tricuspid Regurgitation .............................................................................17
Medical Treatment.......................................................................................................................17
Surgical Intervention of the Tricuspid Valve ................................................................................17
Transcatheter Treatment Methods..............................................................................................20
1.2.3.1
Transcatheter Tricuspid Valve Repair (TTVr) ................................................................20
1.2.3.2
Transcatheter Tricuspid Valve Replacement (TTVR).....................................................23
1.3. Intended Use of the Device........................................................................................................................24
1.4. Prior Testing ...............................................................................................................................................24
Bench Testing...............................................................................................................................24
Biocompatibility Testing...............................................................................................................24
Sterilization Validation .................................................................................................................24
Acute Cadaver Testing..................................................................................................................24
Chronic Study Results...................................................................................................................24
Existing Clinical Data ....................................................................................................................25
STUDY DEVICE ..........................................................................................................................25
2.1. General System Description and Components ..........................................................................................25
Edwards EVOQUE Valve ...............................................................................................................26
Edwards EVOQUE Tricuspid Delivery System...............................................................................27
Edwards EVOQUE Dilator Kit........................................................................................................27
Edwards EVOQUE Loading System...............................................................................................28
Edwards EVOQUE Accessories (Stabilizer, Base, Plate)................................................................29
2.2. Method of Operation for the EVOQUE System..........................................................................................30
RISKS AND BENEFITS.................................................................................................................30
3.1. Summary ....................................................................................................................................................30
3.2. Potential Benefits.......................................................................................................................................31
3.3. Potential Risks............................................................................................................................................31
3.4. Minimization of Risk...................................................................................................................................33
3.5. Justification for Clinical Study ....................................................................................................................33
STUDY OBJECTIVES ...................................................................................................................34
ENDPOINTS ..............................................................................................................................34
5.1. Safety Endpoint..........................................................................................................................................34
5.2. Performance Endpoints..............................................................................................................................34
Device Success..............................................................................................................................34
Procedural Success.......................................................................................................................34

TRISCEND Study (#2019-06)
Edwards Lifesciences, LLC
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC.
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation. 
Page 3 of 103
Clinical Success.............................................................................................................................35
5.3. Echocardiographic Endpoint and Parameters............................................................................................35
Echocardiographic Endpoint ........................................................................................................35
Echocardiographic Parameters ....................................................................................................35
5.4. Clinical and Functional Endpoints and Parameters....................................................................................35
Clinical and Functional Endpoints ................................................................................................35
Clinical and Functional Parameters..............................................................................................36
5.5. Additional Safety Listings ...........................................................................................................................36
5.6. Exploratory Computed Tomography (CT) Parameters...............................................................................36
5.7. Electronic Diary and Activity Monitoring Sub-study ..................................................................................36
STUDY DESIGN..........................................................................................................................37
6.1. Number of Planned Patients......................................................................................................................37
6.2. Number of Planned Clinical Study Sites .....................................................................................................37
6.3. Expected Duration of Patient Participation ...............................................................................................37
PATIENT POPULATION ..............................................................................................................37
7.1. Demographic and Clinical Characteristics..................................................................................................37
7.2. Inclusion Criteria ........................................................................................................................................38
7.3. Exclusion Criteria........................................................................................................................................38
PROCEDURES AND METHODS....................................................................................................40
8.1. Site Personnel Training ..............................................................................................................................40
8.2. Device and Procedure Training ..................................................................................................................41
8.3. Informed Consent Procedure.....................................................................................................................41
8.4. Case Review ...............................................................................................................................................43
8.5. Patient Enrollment .....................................................................................................................................43
Screened Failures .........................................................................................................................43
Provisionally Enrolled...................................................................................................................43
Enrolled Patients ..........................................................................................................................43
8.6. Study Exit Criteria and Procedures.............................................................................................................43
8.7. Imaging Assessments ................................................................................................................................. 44
8.8. Screening/Baseline Examinations and Windows .......................................................................................45
8.9. Prior to Index Procedure............................................................................................................................47
Pre-Procedure Therapy ................................................................................................................47
8.10. Procedure...................................................................................................................................................47
Contrast Media.............................................................................................................................47
Implantation Procedure ...............................................................................................................47
8.11. Recommended Pre- and Post-Procedure Antiplatelet/Anticoagulation Therapy......................................48
Known Thrombosis and Bleeding Risk Factors.............................................................................48
Pre-Procedure Therapy ................................................................................................................49
Intraprocedural Therapy ..............................................................................................................49
Post-Procedure Therapy...............................................................................................................49
8.11.4.1
Post-Implant Up to 6 Months .....................................................................................49
8.11.4.2
Beyond 6 Months Post-Implant..................................................................................49
8.12. Recommended Post-Procedure Diuretic Therapy......................................................................................50
8.13. Post-Procedure Cardiac Rhythm Monitoring.............................................................................................51
8.14. Post-Procedure/Pre-Discharge...................................................................................................................51
Post-Procedure Study Procedures/Data Collection .....................................................................51

TRISCEND Study (#2019-06)
Edwards Lifesciences, LLC
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC.
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation. 
Page 4 of 103
8.15. Discharge Evaluation/Data Collection........................................................................................................52
8.16. Follow-up Visit Evaluations/Data Collection and Windows .......................................................................53
8.17. Unscheduled Follow-Up.............................................................................................................................54
8.18. Description of Data to Be Collected...........................................................................................................54
8.19. Study Patient Completion ..........................................................................................................................54
8.20. Study Termination and Close-Out..............................................................................................................54
8.21. Schedule of Assessments ...........................................................................................................................55
DEVICE MANAGEMENT .............................................................................................................57
9.1. Device Shipment ........................................................................................................................................57
9.2. Inventory and Accountability Records .......................................................................................................57
9.3. Device Storage ...........................................................................................................................................57
9.4. Device Return.............................................................................................................................................58
9.5. Patient Implant Card ..................................................................................................................................58
DATA COLLECTION AND REPORTING .........................................................................................58
10.1. Data Management .....................................................................................................................................58
10.2. Electronic Case Report Forms (eCRFs) .......................................................................................................58
10.3. Source Documentation Requirements.......................................................................................................59
10.4. Quality Control and Quality Assurance Procedures...................................................................................59
ADVERSE EVENT REPORTING AND ASSESSMENTS ......................................................................59
11.1. Definitions..................................................................................................................................................59
Adverse Event ..............................................................................................................................59
Serious Adverse Event..................................................................................................................60
Anticipated Adverse Events .........................................................................................................60
Unanticipated Adverse Device Effect...........................................................................................60
Device Deficiency .........................................................................................................................60
Device Malfunction ......................................................................................................................60
11.2. General Adverse Event Reporting Requirements ......................................................................................61
11.3. Findings That Do Not Require Reporting to the Sponsor...........................................................................61
11.4. Pre-Existing Conditions ..............................................................................................................................62
11.5. Investigator AE Causality Assessment........................................................................................................62
11.6. Patient Deaths............................................................................................................................................63
11.7. Sponsor Assessment and Reporting...........................................................................................................63
11.8. Investigational Device Observations and Deficiencies...............................................................................63
11.9. Investigational Device Explants..................................................................................................................63
STATISTICAL ANALYSIS..............................................................................................................64
12.1. Sample Size ................................................................................................................................................64
12.2. Analysis Populations ..................................................................................................................................64
12.3. General Approach ......................................................................................................................................65
12.4. Safety Endpoint Analysis............................................................................................................................65
12.5. Additional Safety Analysis..........................................................................................................................65
12.6. Performance, Functional and Other Endpoint Analysis.............................................................................66
12.7. Exploratory Computed Tomography (CT) Analysis ....................................................................................66
12.8. Missing Data...............................................................................................................................................66
12.9. Analysis Software.......................................................................................................................................66

TRISCEND Study (#2019-06)
Edwards Lifesciences, LLC
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC.
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation. 
Page 5 of 103
MONITORING ...........................................................................................................................67
13.1. Monitoring Methods..................................................................................................................................67
13.2. Monitoring Plan .........................................................................................................................................67
13.3. Protocol Deviation and Medical Emergencies ...........................................................................................68
13.4. Communication Procedures.......................................................................................................................68
CLINICAL STUDY BOARDS..........................................................................................................69
14.1. Data Safety Monitoring Board ...................................................................................................................69
14.2. Clinical Events Committee..........................................................................................................................69
14.3. Central Screening Committee ....................................................................................................................69
14.4. Echocardiography Imaging Core Laboratory..............................................................................................69
ETHICAL AND REGULATORY CONSIDERATIONS ..........................................................................69
15.1. Applicable Regulations and Guidelines......................................................................................................69
15.2. Data Protection and Patient Confidentiality ..............................................................................................70
15.3. Institutional Review Board.........................................................................................................................71
15.4. Informed Consent ......................................................................................................................................71
15.5. Investigator Responsibilities ......................................................................................................................71
General Duties..............................................................................................................................71
Investigator Records ....................................................................................................................72
Investigator Reports.....................................................................................................................72
Investigator Record Retention .....................................................................................................73
Investigator’s and Sponsor’s Annual and Final Reports...............................................................73
15.6. Sponsor Responsibilities ............................................................................................................................73
General Duties..............................................................................................................................73
15.7. Selection of Investigators...........................................................................................................................73
Monitoring the Study...................................................................................................................74
Sponsor Records...........................................................................................................................74
Sponsor Reports and Notifications...............................................................................................74
15.8. Clinical Study Changes................................................................................................................................75
15.9. Clinical Study Site Termination ..................................................................................................................75
15.10.
Audits and Inspections...........................................................................................................................75
15.11.
Publication Policy...................................................................................................................................75
REFERENCES .............................................................................................................................76
APPENDIX A: STUDY DEFINITIONS ....................................................................................................80
APPENDIX B: PATIENT PREFERENCE SURVEY TEMPLATE ....................................................................91
APPENDIX C: KATZ INDEX OF INDEPENDENCE IN ACTIVITIES OF DAILY LIVING....................................95
APPENDIX D: INSTRUCTIONS FOR 6-MINUTE WALK TEST...................................................................96
APPENDIX E: CHILD-PUGH SCORE .....................................................................................................97
APPENDIX F: PATIENT EDEMA QUESTIONNAIRE TEMPLATE...............................................................98
APPENDIX G: ABBREVIATIONS........................................................................................................100

TRISCEND Study (#2019-06) 
 
Edwards Lifesciences, LLC 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. 
 
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation.  
 
Page 6 of 103 
 
LIST OF TABLES 
Table 1: Grading the Severity of Chronic TR by Echocardiography (Zoghbi et al., JASE 201715) ................................. 16 
Table 2: Expanded 5-grade Scale for Determining Severity of TR16 ............................................................................. 17 
Table 3: EVOQUE System Components – Name and Model Number ......................................................................... 26 
Table 4: Anticipated or Potential Adverse Events ....................................................................................................... 31 
Table 5: Inclusion Criteria ............................................................................................................................................ 38 
Table 6: Exclusion Criteria............................................................................................................................................ 38 
Table 7: Screening and Baseline Procedures ............................................................................................................... 45 
Table 8: Screening/Baseline Assessment Windows ..................................................................................................... 46 
Table 9: Procedural Information .................................................................................................................................. 48 
Table 10: Post-Procedure and Pre-Discharge .............................................................................................................. 51 
Table 11: Discharge / 7 Days Post-Procedure .............................................................................................................. 52 
Table 12: Follow-up Evaluations .................................................................................................................................. 53 
Table 13: Follow-up Visit Windows ............................................................................................................................. 54 
Table 14: Schedule of Assessments ............................................................................................................................. 55 
Table 15:  Applicable Regulations and Guidelines ....................................................................................................... 70 
 
LIST OF FIGURES 
Figure 1: Dilatation of the Tricuspid Annulus .............................................................................................................. 14 
Figure 2: Kaplan-Meier Survival Curves for All Patients with Severe TR (Nath et al., JACC 2004) ............................... 15 
Figure 3: Indication for Surgery According to the 2020 ACC/AHA VHD Guidelines ..................................................... 18 
Figure 4: Recommendations for surgery in tricuspid regurgitation 2017 ESC/EACTS Guidelines ............................... 19 
Figure 5. Tricuspid Surgical Repair Techniques ........................................................................................................... 20 
Figure 6: The Edwards EVOQUE Valve ......................................................................................................................... 26 
Figure 7: The EVOQUE Tricuspid Delivery System ....................................................................................................... 27 
Figure 8: Edwards EVOQUE Dilator Kit ........................................................................................................................ 27 
Figure 9: Edwards EVOQUE Loading System Components .......................................................................................... 28 
Figure 10: Edwards EVOQUE Stabilizer, Base, and Plate ............................................................................................. 29 
Figure 11: Anticoagulant/Antiplatelet Therapy and Surveillance Recommendations ................................................ 50 
 
 
 
 
 

TRISCEND Study (#2019-06) 
 
Edwards Lifesciences, LLC 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. 
 
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation.  
 
Page 7 of 103 
Protocol Synopsis  
Study Number 
2019-06 
Study Version 
 
Title 
Edwards EVOQUE Tricuspid valve Replacement: Investigation of Safety and Clinical Efficacy 
after replacemeNt of tricuspid valve with transcatheter Device 
Short Title 
TRISCEND Study 
Device Name 
Edwards EVOQUE tricuspid valve replacement system (hereinafter referred to as the 
EVOQUE system).  
Intended Use 
The EVOQUE system is intended for the treatment of patients with at least moderate 
tricuspid regurgitation (TR) or prior heart failure hospitalization for TR. 
Study Objectives 
The objectives of this study are to: 
x 
Evaluate the safety and performance of the EVOQUE system 
x 
Provide guidance for future clinical study designs utilizing the EVOQUE system 
x 
Provide guidance for future EVOQUE system development efforts 
Study Design 
Prospective, single-arm, multi-center study to evaluate the safety and performance of the 
EVOQUE system in the treatment of patients with at least moderate TR, signs of TR, 
symptoms from TR, or prior heart failure hospitalizations for TR. 
 
Up to 200 patients (upon FDA approval) will be enrolled in this study at up to 30 
investigational sites (upon FDA approval) in the US. 
 
All enrolled study patients will be assessed at the following intervals: Screening/baseline, 
Procedure, Discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years 
post-procedure. 
Enrollment 
Criteria 
(Inclusion) 
Patients enrolled must meet ALL of the following criteria: 
1. ŐĞшϭϴǇĞĂƌƐŽůĚ 
2. Despite medical therapy (OMT) per the Local Heart Team, patient has signs of TR 
(peripheral edema or ascites), symptoms from TR, or prior heart failure hospitalization 
from TR  
x 
Note: Medical therapy is at investigator discretion and includes diuretic 
medications in stable doses, unless patient has documented history of 
intolerance. With the exception of prehabilitation, it is recommended no 
new diuretics be introduced and current diuretic doses be stable (i.e. no 
decrease of more than ½ or increase of 2x) unless medically required (e.g., 
severe hypotension or signs and symptoms of hypervolemia) for 30 days 
prior to the procedure. 
3. Functional and/or degenerative TR graded as at least moderate on a transthoracic 
echocardiogram (assessed by the echo core lab using a 5-grade classification)a 
4. The Local Heart Team determines that the patient is appropriate for transcatheter 
tricuspid valve replacement 
5. Patient is willing and able to comply with all specified study evaluations and provides 
written informed consent. 
 
a The TR grading scale used to determine patient eligibility is based on the scale proposed by Hahn and Zamorano (scale: 
none/trace, mild, moderate, severe, massive, torrential). 

TRISCEND Study (#2019-06) 
 
Edwards Lifesciences, LLC 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. D
 
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation.  
 
Page 8 of 103 
Enrollment 
Criteria 
(Exclusion) 
Potential patients will be excluded if ANY of the following criteria apply: 
1. Tricuspid valve anatomy precluding proper device deployment and function, 
evaluated by echo core lab and by CT  
2. Echocardiographic parameters (any of the following, assessed by echo core lab): 
a. LVEF < 25%   
b. Echocardiographic evidence of severe right ventricular dysfunction  
c. 
Pulmonary arterial systolic pressure (PASP) > 70 mmHg by echo Doppler or R 
heart catheterization OR PASP > 2/3 systemic BP with PVR > 5 Wood units 
after vasodilator challenge, in the absence of symptomatic hypotension or 
systolic BP < 90 mmHg  
3. Previous tricuspid intervention that could interfere with placement of the EVOQUE 
System 
4. Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following: 
a. Implanted in the RV within the last 3 months  
b. Patient is pacemaker dependent1 on trans-tricuspid lead without alternative 
pacing option 
c. 
Which has delivered appropriate ICD therapy 
5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation  
x 
Note: patients with concomitant mitral or aortic or pulmonic and tricuspid 
valve disease will have the option of getting their respective valve treated, 
and wait 60 days post-transcatheter or 90 days after surgical treatment prior 
to being reassessed for the study 
6. Active endocarditis within 3 months or infection requiring antibiotic therapy (oral or 
intravenous) within 2 weeks of the scheduled implant 
7. Hemodynamically significant pericardial effusion 
8. Intra-cardiac mass, thrombus, or vegetation. Chronic scarred LV apical or LAA thrombi 
can be considered. 
9. Clinically significant, untreated coronary artery disease requiring revascularization, 
evidence of acute coronary syndrome, recent myocardial infarction2 within 30 days 
prior to the index procedure 
10. Any percutaneous coronary, intracardiac (e.g., left atrial appendage occlusion, ASD 
closure, atrial fibrillation [AF] ablation, etc.), carotid, endovascular intervention, 
carotid surgery, within 30 days or cardiac surgery within 90 days prior to the index 
procedure 
11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery 
within the next 12 months 
12. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without 
afterload reduction, cardiogenic shock or the need for inotropic support or intra-
aortic balloon pump or other hemodynamic support device within 30 days of index 
procedure 
13. Resting systolic blood pressure < 90 or > 160 mmHg after repeated measurements 
14. Patient with refractory heart failure requiring advanced intervention (i.e. left 
ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure) 
15. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) or DVT/PE in the 
past 6 months prior to index procedure 
16. Presence of an occluded or thrombosed IVC filter that would interfere with the 
delivery catheter 
17. Stroke within 90 days prior to the index procedure 
18. DŽĚŝĨŝĞĚZĂŶŬŝŶ^ĐĂůĞшϰĚŝƐĂďŝůŝƚǇ 

TRISCEND Study (#2019-06) 
 
Edwards Lifesciences, LLC 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. 
 
Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation.  
 
Page 9 of 103 
19. ^ĞǀĞƌĞƌĞŶĂůŝŶƐƵĨĨŝĐŝĞŶĐǇǁŝƚŚĞƐƚŝŵĂƚĞĚŐůŽŵĞƌƵůĂƌĨŝůƚƌĂƚŝŽŶƌĂƚĞ;Ğ'&ZͿчϮϱ
mL/min/1.73m2 or requiring chronic renal replacement therapy at the time of 
screening committee approval 
20. Patients with hepatic insufficiency or cirrhosis with Child-Pugh score Class Cb 
21. Any physical impairment which limits the patient’s capacity to complete functional 
testing due to other medical conditions independent of their TR (e.g., orthopedic 
condition) 
22. Continuous home oxygen for primary severe COPD 
23. Chronic anemia with transfusion dependency or Hgb < 9 g/dL not corrected by 
transfusion at time of screening committee approval  
24. Thrombocytopenia (Platelet count < 75,000/mm3) or thrombocytosis (Platelet count > 
750,000/mm3) at the time of screening committee approval 
25. Known bleeding or clotting disorders or patient refuses blood transfusion 
26. Active gastrointestinal (GI) bleeding within 3 months of the scheduled implant 
27. Current or history of illicit drug use 
28. Pregnant or lactating; or female of childbearing potential with a positive pregnancy 
test within 14 days prior to intervention 
29. Patients in whom transesophageal echocardiography is contraindicated or cannot be 
completed. 
30. In the opinion of the investigator, access to the femoral vein with a guide sheath is 
deemed not feasible (e.g., occluded IVC filter, active DVT, occluded femoral veins). 
31. Untreatable hypersensitivity or contraindication to any of the following: all 
antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, 
glutaraldehyde, or contrast media. 
x 
Note: Patient must be able to tolerate at least one antiplatelet medication 
AND one anticoagulant medication 
32. Currently participating in another investigational biologic, drug or device study in 
which the patient has not reached a primary endpoint. 
33. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to 
< 12 months. 
34. Presence of significant congenital heart disease including but not limited to 
hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic 
RV.   
35. Presence of significant iatrogenic interatrial shunt (Qp/Qs > 1.5), or 
persistent/pancyclic (or respirophasic) right-to-left shunt, or right-to-left shunt with 
resting desaturation (SpO2 < 90%).  
36. Any condition, in the opinion of the investigator, making it unlikely the patient will be 
able to complete all protocol procedures and follow-ups 
37. Other medical, social, or psychological conditions that preclude appropriate consent 
and follow-up, including patients under guardianship 
38. Any patient considered to be part of a vulnerable population 
Safety Endpoint 
Safety will be analyzed as a composite endpoint of Major Adverse Events (MAEs) at 30 
days post-enrollment which includes: 
x 
Cardiovascular mortality 
x 
Myocardial infarction (MI) 
x 
Stroke 
x 
Renal complications requiring unplanned dialysis or renal replacement therapy 
x 
Severe bleeding (includes fatal, life-threatening, extensive, or major bleeding, as 
defined by MVARC3) 
 
b See Appendix E for Child-Pugh scoring system 

TRISCEND Study (#2019-06) 
 
Edwards Lifesciences, LLC 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. 
 
 Edwards Lifesciences, Edwards, the stylized E logo, and EVOQUE are 
trademarks of Edwards Lifesciences Corporation.  
 
Page 10 of 103 
x 
Non-elective tricuspid valve re-intervention, percutaneous or surgical  
x 
Major access site and vascular complications  
x 
Major cardiac structural complications 
x 
Device-related pulmonary embolism 
Performance 
Endpoints 
Device Success at exit from OR/Cath Lab 
x 
Device is deployed as intended and the delivery system is successfully retrieved as 
intended at the time of the patient’s exit from the cardiac catheterization laboratory.  
Procedural Success at Discharge 
x 
Device success without clinically significant paravalvular leak (PVL)4-6 on a 
transthoracic echocardiogram (assessed by the echo core lab).  
Clinical Success at 30 days 
x 
Procedural success without MAEs at 30 days.  
Echocardiographic 
Endpoint 
Reduction in TR grade: screening/baseline TTE compared to discharge TTE (assessed by 
the echo core lab using a 5-grade classification) 
Echocardiographic 
Parameters 
TTE parameters assessed at screening/baseline, discharge, all 30 days, 6 months, 1 year, 
and annually until 5 years post-procedure (by the echo core lab) 
1. TR grade 
2. Paravalvular leak severity 
3. Regurgitant volume 
4. TV inflow gradient 
5. Cardiac output 
6. Right atrium volume 
7. Left Ventricular Ejection Fraction 
8. Inferior Vena Cava dimensions/respiratory variations 
9. Hepatic vein flow reversal 
10. Pulmonary artery pressure (mean) 
11. Right ventricular function  
Clinical and 
Functional 
Endpoints 
The following endpoints assessed at 12 months and annually until 5 years post-procedure: 
A. All-cause mortality 
B. Heart failure hospitalizations 
C. Non-elective tricuspid valve re-intervention, percutaneous or surgical 
The following endpoints assessed at baseline, 30 days, 6 months, 12 months, and annually 
until 5 years post-procedure: 
D. Volume overload assessed by serial measurements of: 
1. Body weight 
2. Edema assessment (1+ to 4+) 
3. Ankle circumference measurement 
4. Patient edema questionnaire 
E. Functional Class, functional status, and Quality of Life assessed by: 
1. NYHA Classification  
2. 6-Minute Walk Test (6MWT)7 
3. Kansas City Cardiomyopathy Questionnaire (KCCQ) 
4. Short Form Health Survey (SF-36), version 2 
Clinical and 
Functional 
Parameters 
The following parameters assessed at baseline: 
A. Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale  
B. Katz Index of Independence in Activities of Daily Living (Katz ADL)  
C. Patient Preference Survey  

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Page 11 of 103 
The following assessed at discharge, 30 days, 6 months, 12 months, and annually until 5 
years post-procedure 
D. General Clinical and Laboratory Parameters: 
1. Complete Blood Count (CBC; including platelet count) 
2. Comprehensive Metabolic Panel (CMP; including Albumin, Bilirubin, ALP, 
ALT, AST, creatinine, BUN) 
3. Coagulation Panel (PT or PTT; INR for patients on vitamin K antagonist 
[VKA]) 
4. BNP or NT-proBNP  
5. GGT 
6. Uric acid and eGFR 
Exploratory 
Computed 
Tomography (CT) 
Parameters 
The following parameters will be assessed at 30 days and 12 months (where data is 
available): 
A. Cardiac remodeling (e.g., RV dimensions and volume) 
B. EVOQUE frame dimensions  
C. EVOQUE leaflet assessment 
D. EVOQUE positioning 
Electronic Diary 
and Activity 
Monitoring Sub-
study  
(up to 10 sites, 45 
patients, upon 
FDA approval) 
At up to 10 sites and up to 45 patients (upon FDA approval) with data through 12 months. 
A. Electronic Diary (eDiary)c: To measure quality of life improvement in greater detail, 
electronic patient reported outcomes will be collected via a handheld device. 
The following assessments will be used to measure quality of life throughout the sub-
study period: 
1. KCCQ 
2. EQ-5D-5L 
3. SF-12 
4. Mood questionnaire 
5. Symptom burden  
A daily assessment will be administered from baseline (for a minimum of 14 days 
before the index procedure) and then from post discharge through the 12-month 
follow-up visit. 
B. Activity Monitoring: To measure the improvement in functional status, an activity 
monitor (wristwatch) will be worn by patients. The monitor is worn from baseline (for 
a minimum of 14 days before index procedure), paused at time of admission for index 
procedure, and resumed post-discharge and worn through the 12-month follow-up 
visit. 
Sponsor 
 
 
 
Sponsor Contact 
 
 
 
     
 
c eDiary and Activity Monitoring to be implemented at system launch. Patients enrolled prior to system launch will not be 
required to participate in these assessments. 

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Page 12 of 103 
Data Safety 
Monitoring Board 
(DSMB) 
The Data Safety Monitoring Board (DSMB) will be comprised of independent, non-
investigator physicians, who will be responsible for reviewing aggregate safety data 
reported during the study and assessing whether the overall safety of the trial remains 
acceptable. DSMB activities, including roles and responsibilities, operating procedures, 
and monitoring criteria will be defined in the DSMB Charter.   
Clinical Events 
Committee (CEC) 
The Clinical Events Committee (CEC) will be comprised of independent, non-investigator 
physicians, and will be responsible for reviewing and adjudicating specified individual 
adverse events (AEs) over the course of the study.  
CEC activities, including roles and responsibilities, operating procedures, specific events to 
be adjudicated and definitions to be used by the CEC during adjudication will be defined in 
the CEC Charter.  
Cardiac Imaging 
Core Lab 
An independent echocardiographic imaging core laboratory will be utilized for assessment 
of echocardiograms.  Echocardiogram image acquisition shall be performed in accordance 
with the core laboratory’s recommended manual, which is provided to the sites. 
 
  
  
 
 
 

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Introduction
1.1.
Clinical Background on Tricuspid Regurgitation
Disease Process
Tricuspid Regurgitation (TR), tricuspid insufficiency or tricuspid incompetence describe a condition in 
which blood flow through the tricuspid valve (TV) flows in the incorrect direction during part of the 
cardiac cycle. Normally, during diastole, the tricuspid valve opens due to right ventricular relaxation 
and the base of the heart descending; this results in a gradient of pressure from the right atrium (RA) 
to the right ventricle (RV), allowing blood to flow through the tricuspid valve and into the RV. Diastole 
ends with atrial contraction. During early systole, the tricuspid valve closes thereby preventing a 
reversal of blood flow. However, in patients with TR, the closed tricuspid valve is unable to form a tight 
seal in systole and allows blood to flow back into the right atrium.
While TR often accompanies mitral or aortic valve disease, it is initially asymptomatic, traditionally 
considered less clinically significant, and usually left untreated. The tricuspid valve is commonly 
referred to as the “forgotten” valve. Moderate to severe TR affects up to 1.6 million patients in the 
U.S, of whom only 8,000 annually undergo tricuspid surgery.8 While trace to mild levels of TR are 
commonly found in a large number of patients without clinical consequence, moderate and severe 
levels can have detrimental effects on a patient’s quality of life and is associated with higher mortality.9
Patients with severe TR usually present with signs or symptoms of right heart failure (HF), including 
peripheral edema and ascites.10
Etiology
TR can have many underlying etiologies, but the majority of these can be divided into two major 
categories: primary TR and secondary TR. 
Primary (degenerative, organic or structural) TR refers to regurgitation resulting from disease 
processes affecting the integrity of the tricuspid valve leaflets and/or valve apparatus, such as in 
rheumatic heart disease, tricuspid valve prolapse, or endocarditis. 
In contrast, secondary (functional or non-structural) TR refers to regurgitation occurring in the absence 
of significant structural disease of the tricuspid valve and/or apparatus. Functional TR is present in 
approximately 80% of cases of significant TR10 and results from annular dilation and/or right ventricular 
enlargement that are often secondary to left heart failure from myocardial or valvular causes, right 
ventricular volume and pressure overload, and dilation of cardiac chambers. Significant TR may be 
clinically silent for a prolonged period, during which time progressive RV dilatation and dysfunction 
may develop, similar to changes that can occur with asymptomatic mitral regurgitation (MR) and its 
effect on left ventricle (LV) function.

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Anatomy and Pathophysiology of Tricuspid Regurgitation
The tricuspid valve orifice is semilunar and consists of three leaflets (anterior, posterior and septal) 
inserted into a fibrous annulus. Each leaflet is typically connected to one papillary muscle (as opposed 
to the redundancy found in the mitral valve apparatus). Being the largest valve orifice in the heart, the 
normal diameter is typically 30-35 mm. Annular dilatation is limited to the free wall due to fixation of 
the annulus at the septal portion and occurs from the antero-septal junction as shown in Figure 1.11
Figure 1: Dilatation of the Tricuspid Annulus

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Prognosis of Tricuspid Regurgitation
Tricuspid regurgitation is a common echocardiographic finding that is often considered benign unless 
associated with significant pulmonary hypertension, RV dysfunction, or LV dysfunction. It has been 
shown that increasing TR severity is associated with worse survival regardless of left ventricular 
ejection fraction (LVEF) or pulmonary artery pressure (Figure 2).9 Severe TR is associated with a poor 
prognosis and is independent of age, biventricular systolic function, RV size, and inferior vena cava 
(IVC) dilation. 9
Figure 2: Kaplan-Meier Survival Curves for All Patients with Severe TR (Nath et al., JACC 2004)
Diagnostic Assessments for Tricuspid Regurgitation
Tricuspid regurgitation can present without symptoms and may be a chance finding during 
echocardiography. The holosystolic murmur typical of TR increases during inspiration and can be 
auscultated on the lower left sternal border.12 When TR is severe it is typically associated with right 
heart failure and symptoms usually include neck palpitations, lower limb edema, ascites, fatigue, and 
dyspnea.
Transthoracic echocardiography (TTE) is currently the gold standard for diagnosis of TR and for 
assessing its severity.10 Transesophageal echocardiography (TEE) can be considered when TTE images 
are suboptimal or in specific cases such as endocarditis or presence of pacemaker leads.10 Better valve 
assessment and quantification may be achieved by real-time 3D echocardiography.13 Cardiovascular 
magnetic resonance (CMR) imaging, although not widely available, can provide more accurate 
regurgitation assessment and RV function measurements. Computed tomography (CT) is useful for 

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Figure 3: Indication for Surgery According to the 2020 ACC/AHA VHD Guidelines
Surgical treatment of moderate TR at the time of left-sided valve surgery in the presence tricuspid 
annular dilation (tricuspid annulus end diastolic diameter >4.0 cm) or prior signs and symptoms of 
right-sided heart failure was assigned as a class IIa indication in the 2020 ACC/AHA guidelines.19 The 
2017 ESC/EACTS Guidelines for the management of valvular heart disease provide a class I (level of 
evidence: C) recommendation for tricuspid valve surgery in patients with severe functional TR 
undergoing left-sided valve surgery. The ESC guidelines also include as class IIa patients with severe 
functional TR not undergoing left sided surgery who have symptoms or progressive RV 
dilation/dysfunction.10,17
The timing of surgical intervention remains controversial, mostly due to the limited data available and 
their heterogeneous nature (see indications for tricuspid valve surgery in Figure 4). Surgery should be 
carried out sufficiently early to avoid irreversible RV dysfunction.

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Figure 4: Recommendations for surgery in tricuspid regurgitation 2017 ESC/EACTS Guidelines
Although the guidelines have expanded the indications for invasive TR treatment, surgical 
repair/replacement is uncommonly performed probably due to high morbidity and mortality related 
to TV surgery, especially in patients who already had previous cardiac surgery. Most surgeons prefer 
to repair the TV rather than replace it, especially in functional TR.17,20
There are four main surgical TV repair techniques21: Kay repair, De Vega technique, Clover repair 
(degenerative) and annuloplasty with a tissue-based or synthetic ring (Figure 5). 
x
The Kay repair is a simple and validated solution in which a bicuspidization of the TV is 
accomplished by placating the annulus along the posterior leaflet. The sutures are tied, 
obliterating the posterior leaflet and thus creating a bicuspid valve. 22
x
The De Vega technique used to be one of the most common procedures for TV repair, where 
a single “purse-ring” suture is placed around the tricuspid annulus, avoiding the area of the 
atrioventricular node. The suture is tied, completing the annuloplasty.23  
x
The ‘Clover’ repair is a technique in which the central part of the free edges of the 
tricuspid leaflets are stitched together, producing a ‘clover’-shaped valve. This 
technique is reserved mainly for degenerative TR with valve prolapse.

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Page 20 of 103
A. Annuloplasty Ring, B. De-Vega technique, C. Clover repair, D. Kay repair
Figure 5. Tricuspid Surgical Repair Techniques
Transcatheter Treatment Methods
Medical management for the treatment of tricuspid regurgitation is likely to provide only temporary 
symptom relief for most patients. This lack of sustained benefit from medical therapies and the low 
prevalence of surgery has prompted the search for and development of alternative transcatheter 
repair and replacement therapies.24,25
1.2.3.1
Transcatheter Tricuspid Valve Repair (TTVr)
In the past decade, transcatheter aortic valve replacement (TAVR) has been used successfully in 
increasing numbers in patients suffering from severe aortic stenosis and is considered a treatment 
option even for moderate risk patients.26 The success of TAVR led to attempts at transcatheter mitral 
valve repair (TMVr) for percutaneous treatment of mitral regurgitation (MR). While the technology has 
been proven to be far more complex than TAVR, there are several approved TMVr devices: The 
MitraClip System (Abbott Vascular, Santa Clara, CA) is approved for use in the EU (2008) and the U.S. 
(2013) for the treatment of mitral regurgitation; the PASCAL System (Edwards Lifesciences) was 
recently approved in EU (2019) for treatment of mitral regurgitation; the Cardioband Mitral System 
(Edwards Lifesciences (formerly Valtech Cardio LTD, Or Yehuda, Israel) was also approved in the EU
(2015).27 There are additional transcatheter mitral valve replacement and repair devices under 
development; the field of percutaneous intervention for the mitral valve is expected to continue to 
grow in the coming years. 
It is a clear expectation that the next step in percutaneous structural heart disease treatments will 
focus on the “forgotten” tricuspid valve. Several transcatheter repair devices are being investigated 
for the treatment of TR and can be classified according to their therapeutic approaches.24,25  
x
annuloplasty/annular reconstruction devices
x
coaptation devices
x
caval valve implantation (CAVI)
x
leaflet devices

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Page 21 of 103 
Annuloplasty/Annular Reconstruction Devices 
The first commercially available transcatheter therapy for the treatment of TR was the Cardioband 
Tricuspid Valve Reconstruction System (Edwards Lifesciences, formerly Valtech Cardio LTD, Or Yehuda, 
Israel); it received CE mark in April 2018. Data from the TRI-REPAIR study showed that annular 
reduction from the Cardioband system provided significant reduction in EROA and this result was 
sustained 6 months post-procedure. The study also observed clinically and statistically significant 
improvements in functional status (NYHA Class and peripheral edema), quality of life (KCCQ Score), 
and exercise capacity (6MWD) at 6 months after the Cardioband implant procedure.28 
Other tricuspid valve annuloplasty devices under investigation include: the Trialign System (Mitralign, 
Tewksbury, MA), the TriCinch System (4Tech Cardio Ltd., Galway, Ireland), TRAIPTA device (NIH, 
Bethesda, MD), Millipede IRIS Transcatheter Annuloplasty Ring (Millipede, Santa Rosa, CA), and the 
MIA annuloplasty implant: 
x 
The Trialign System mimics the surgical Kay procedure and reduces TR by plicating the annulus, 
resulting in bicuspidization. Published 30-day follow-up results from the SCOUT trial 
(NCT02574650) showed the Trialign device was safe, successfully reduced annular area and 
regurgitant orifice, and improved left ventricular forward stroke volume.29 
x 
The TriCinch device is comprised of a corkscrew anchor that is anchored in the anteroposterior 
annulus and then retracted into the inferior vena cava by a Dacron band that connects the 
anchor to a self-expanding Nitinol stent. Data from the PREVENT trial (NCT02098200) showed 
an implant success rate of 75% (18/24) and four (17%) late anchor detachments during the 12-
month follow-up period. A new generation of the device has been developed and is under 
evaluation in the PROTECT feasibility study (NCT03294200).24 
x 
The TRAIPTA device is an experimental epicardial Nitinol loop placed around the 
atrioventricular groove providing an external annuloplasty.30 Currently, a new TRAIPTA device 
for human testing is under development.24 
x 
The Millipede IRIS Transcatheter Annuloplasty Ring is a complete semi-rigid annuloplasty ring 
that is placed in the supra-annular position. It has been used for mitral valve repair and is under 
investigation.24 
x 
The MIA is a device comprised of ultra-low mass proprietary compliant PolyCor™ anchors and 
MyoLast™ implantable elastomer that allow bicuspidization of the tricuspid valve. It is 
currently under investigation.24 
Coaptation Devices 
The FORMA Tricuspid Transcatheter Repair System (Edwards Lifesciences, Irvine, CA) involves a spacer 
placed in the center of the valve orifice for the purposes of improving leaflet coaptation and reducing 
TR. One-year follow-up data of patients in Canada and Switzerland under special 
access/compassionate use setting showed that use of the FORMA System was feasible and safe in high-
risk patients with severe TR.24,31 In addition, follow-up data at 24-36 months showed considerable and 

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Page 22 of 103 
sustained TR reduction accompanied by significant functional improvement.32 In the FORMA Early 
Feasibility Study (EFS; NCT02471807), significant TR reduction was observed and sustained at one year. 
Clinically significant and sustained improvements in NYHA functional class, 6MWD, and KCCQ scores 
at one year were observed, as well. 33  The US EFS and outside the United States (OUS) CE Mark studies 
have since been stopped, with visits of all enrolled patients continuing through the 3-year follow-up. 
Caval Valve Implantation 
Implantation of a prosthesis in the caval space has been performed as a last-resort approach for 
treatment with TR with refractory right HF as it aims to reduce the negative effects of venous 
congestion leading to reduced symptoms of right HF. While this does not directly correct the TR, it 
prevents back flow beyond the right atrium with the goal of reducing symptoms, normalizing liver 
function, and improving physical capacity. Lauten et al. reported the successful implantation of a self-
expandable valve tailored to the dimensions of the inferior vena cava with significant reductions in IVC 
pressures.34,35 Similarly, the ongoing HOVER trial is assessing heterotopic implantation of the Edwards-
SAPIEN XT valve in the inferior vena cava (NCT02339974).36 Of note, such an intervention may lead to 
ventricularization of the RV and cause severe deterioration in patients with severe RV heart failure. 
Leaflet Devices 
The MitraClip System (Abbott Vascular, Santa Clara, CA) is approved for use in the EU (2008) and the 
U.S. (2013) for the treatment of mitral regurgitation and the TriClip System (Abbott Vascular, Santa 
Clara, CA) is approved for the treatment of tricuspid regurgitation in the EU (2020). Edge-to-edge 
tricuspid valve repair with single or multiple MitraClip System (Abbott Vascular, Santa Clara, CA) 
devices has been successfully used for the treatment of TR in selected high-risk patients with 
malcoaptation of the tricuspid valve.37-40 In retrospective analysis of 42 cases treated at a single center 
in Germany, successful edge-to-edge repair was achieved in 83% (35/42) patients.38 In another report 
of 50 patients with right-sided HF and severe TR treated at 2 centers in Germany, persistent reduction 
of at least one TR grade was achieved in 90% of patients at 6 months and the NYHA class improved in 
79% of patients.40 Several case reports and series have been published on the use of the MitraClip 
System in the treatment of TR. The TriClip device is being evaluated in the TRILUMINATE study 
(NCT03227757) and the TRILUMINATE Pivotal Trial (NCT03904147). 
The Edwards PASCAL System, recently approved in EU for treatment of mitral (2019) and tricuspid 
(2020) regurgitation, percutaneously delivers a leaflet reconstruction device, which brings the leaflets 
together around an intravalvular spacer using independently actuating clasps. Use of the PASCAL 
System in treating patients with mitral regurgitation has been shown to be safe and feasible with a 
high rate of technical success.41,42 Evaluation of the PASCAL System in treating patients with TR is 
warranted and clinical cases have been performed under a compassionate use setting. Additionally, a 
multi-center, prospective, single-arm early feasibility trial assessing the PASCAL system for TR is 
enrolling and more studies are planned. 

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Page 23 of 103 
1.2.3.2 Transcatheter Tricuspid Valve Replacement (TTVR) 
Transcatheter valve replacement with the Edwards SAPIEN or Medtronic Melody valve has been 
described in the published literature on single case studies and limited retrospective clinical series, 
primarily for valve-in-valve patients43-45 and patients with rheumatic heart disease.46 The distinctive 
anatomy of the tricuspid valve has precluded expanded use of these devices for TTVR in native valves.47 
Several companies have developed TTVR specific systems and are in varying stages of development: 
the GATE Tricuspid Valved Stent (NaviGate Cardiac Structures, Lake Forest, CA), the LUX-Valve 
(Jenscare Biotechnology, Ningbo, China), TriSol (Trisol Medical Ltd., Inc., Yokneam, Israel), the TRiCares 
system (TRiCares GmbH, München, Germany).  
With the exception of NaviGate Cardiac Structures, the TTVR systems described below have yet to 
publish clinical trial data, though limited pre-clinical data, clinical data, and device descriptions have 
been published for some: 
x 
The NaviGate Cardiac Structures GATE Tricuspid Valved Stent is a self-expanding, conical-
shaped, nitinol device with three pericardial leaflets derived from equine pericardial tissue. 
The device has been implanted into patients either via the transatrial or transjugular approach 
under compassionate use and is currently under investigation.24  
Of 27 reported successful first-in-human GATE implantations in patients with severe/torrential 
TR, 78% (21/27) patients had none/trivial TR post-procedure and 100% patients (27/27) had 
TR чϮн ƉŽƐƚ-procedure.48 Similar findings were observed in single-site compassionate use 
experience: 5 patients with symptomatic massive or torrential TR were observed to have 
significant reductions of their TR of ч2+ post-implant. In 3-to-6 month post-procedure follow-
up visits by 4 of the 5 subjects, evidence of RV remodeling, increased cardiac output, and 
reduction in NYHA functional class was observed.49  
x 
The INTREPIDTM system is a self-expanding, tri-leaflet bovine pericardial prosthesis housed 
within a nitinol frame.50  A First-in-Man Case Experience was recently presented on the use of 
the INTREPID valve for severe TR.51 
x 
The LUX-Valve is a self-expanding nitinol device with bovine pericardial leaflets and a skirt 
designed to minimize paravalvular leak; it is intended to be deployed transatrially via 
thoracotomy.47  
x 
The TriSol valve is a self-expanding device comprised of an elastic nitinol frame with a porcine 
pericardial ventricular skirt, atrial polyester skirt, and bileaflet valve made from bovine 
pericardial tissue. The outside skirt is designed to seal the valve and prevent paravalvular 
leak.48 
x 
The TriCares valve is a self-expanding device comprised of bovine pericardial tissue on a nitinol 
stent.48 
 
 

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Page 24 of 103
1.3.
Intended Use of the Device
The EVOQUE system is intended for treatment of patients with at least moderate TR or prior heart 
failure hospitalizations for TR.
1.4.
Prior Testing
Bench Testing
Biocompatibility Testing
Sterilization Validation
Acute Cadaver Testing
Chronic Study Results

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Page 25 of 103
Existing Clinical Data
Between May 2019 and June 2020, 27 patients were treated for symptomatic TR with the EVOQUE 
system. Due to the nature of compassionate use cases, limited follow-up data is available.52  
Study Device
2.1.
General System Description and Components
The EVOQUE system is intended for the treatment of patients with at least moderate TR, signs of TR, 
symptoms from TR, or prior heart failure hospitalization for TR. 

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Page 27 of 103
Edwards EVOQUE Tricuspid Delivery System
Figure 7: The EVOQUE Tricuspid Delivery System
Edwards EVOQUE Dilator Kit
Figure 8: Edwards EVOQUE Dilator Kit

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Page 28 of 103
Edwards EVOQUE Loading System
Figure 9: Edwards EVOQUE Loading System Components

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Page 29 of 103
Edwards EVOQUE Accessories (Stabilizer, Base, Plate)
Figure 10: Edwards EVOQUE Stabilizer, Base, and Plate

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2.2.
Method of Operation for the EVOQUE System 
Risks and Benefits
3.1.
Summary
A risk management process has been implemented that is compliant with EN/ISO 14971:2019; in 
addition, a risk management plan was developed, and a risk analysis conducted.  
The risk analysis confirmed that the residual risks associated with the transcatheter tricuspid valve 
replacement (TTVR) System are similar to the clinical risks associated with any catheter-based 
(transcatheter) valve replacement system and have been mitigated to an acceptable level. The 
anticipated clinical risks to patients participating in the clinical investigation of the Edwards EVOQUE 
Tricuspid Valve Replacement System are identified in Section 3.3. 
The risks of participation are offset by the significant potential in clinical and functional benefits to 
patients with TR that comes through improving tricuspid valve function.

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Page 31 of 103 
3.2. Potential Benefits 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
3.3. Potential Risks 
Adverse events (AEs) that are anticipated in this clinical study are believed to be consistent with those 
associated with other minimally invasive surgical and catheter-based interventional cardiac/ structural 
heart procedures (Table 4). Complications may occur at any time during the procedure, post-
procedure or follow-up period. 
These events may be associated with the EVOQUE System, transcatheter procedure, diagnostic cardiac 
tests (e.g., TEE, TTE, MSCT scan, etc.), use of anesthesia, ancillary procedures or may occur in the heart 
failure population over time.  
Table 4: Anticipated or Potential Adverse Events 
x 
Abnormal Lab Values 
x 
Allergic reaction to anesthesia, contrast media, 
anti-coagulation medication or device materials 
x 
Anaphylactic Shock 
x 
Anemia or decreased Hgb, may require 
transfusion 
x 
Aneurysm or Pseudoaneurysm 
x 
Angina or Chest pain 
x 
Injury to the tricuspid apparatus including 
chordal damage, rupture, papillary muscle 
damage  
x 
Leaflet Tearing 
x 
Local and Systemic Infection 
x 
Mesenteric Ischemia or Bowel Infarction  
x 
Multi-System Organ Failure 
x 
Myocardial Infarction 

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Page 32 of 103 
x 
Arrhythmia – atrial (i.e. AF, SVT) 
x 
Arrhythmias – ventricular (i.e. VT, VF) 
x 
Arterio-venous Fistula  
x 
Bleeding  
x 
Cardiac (heart) Failure 
x 
Cardiac Arrest 
x 
Cardiac injury, including perforation 
x 
Cardiac tamponade / Pericardial effusion  
x 
Cardiogenic Shock  
x 
Chordal entanglement or rupture that may 
require intervention 
x 
Coagulopathy, coagulation disorder, bleeding 
diathesis 
x 
Conduction System Injury, which may require 
implantation of a pacemaker (temporary or 
permanent) 
x 
Conversion to open heart surgery  
x 
Coronary artery occlusion  
x 
Damage to or interference with function of 
pacemaker or implantable cardioverter 
defibrillator (ICD) 
x 
Death 
x 
Edema  
x 
Electrolyte Imbalance 
x 
Embolization including air, particulate, calcific 
material, or thrombus 
x 
Emergent Cardiac Surgery  
x 
Endocarditis 
x 
Esophageal Irritation 
x 
Esophageal Perforation or Stricture  
x 
EVOQUE system component(s) embolization 
x 
Failure to retrieve any EVOQUE system 
components 
x 
Fever 
x 
Frame Strut Fracture 
x 
Gastrointestinal Bleeding  
x 
Hematoma 
x 
Hemodynamic Compromise  
x 
Hemolysis / Hemolytic Anemia 
x 
Hemorrhage requiring transfusion/surgery 
x 
Hypertension 
x 
Hypotension 
x 
Inflammation 
x 
Nausea and/or vomiting  
x 
Nerve Injury  
x 
Neurological symptoms, including dyskinesia, 
without diagnosis of TIA or stroke 
x 
Non-emergent reoperation 
x 
Pain 
x 
Pannus Formation 
x 
Paralysis  
x 
Percutaneous Valve Intervention 
x 
Peripheral Ischemia 
x 
Permanent Disability 
x 
Pleural Effusion 
x 
Pneumonia 
x 
Pulmonary Edema 
x 
Pulmonary Embolism  
x 
Reaction to anti-platelet or anticoagulation 
agents 
x 
Rehospitalization  
x 
Renal Failure, 
x 
Respiratory failure, atelectasis – may require 
prolonged intubation  
x 
Retroperitoneal Bleed 
x 
RVOT Obstruction 
x 
Septicemia, sepsis 
x 
Skin burn, injury or tissue changes due to 
exposure to ionizing radiation    
x 
Stroke 
x 
Structural Deterioration 
x 
Thromboembolism 
x 
Transient ischemic attack (TIA) 
x 
Valve Dislodgement/Embolization 
x 
Valve Endocarditis 
x 
Valve Explant  
x 
Valve Leaflet Entrapment 
x 
Valve Malposition  
x 
Valve Migration 
x 
Valve Paravalvular Leak (PVL) 
x 
Valve Regurgitation (new or worsening 
tricuspid, aortic, mitral, pulmonary)  
x 
Valve Stenosis  
x 
Valve Thrombosis 
x 
Vessel Spasm 
x 
Wound Dehiscence, delayed or incomplete 
healing 
 
There may also be other risks that are unknown at this time. Adverse events will be collected and 
reviewed throughout the duration of the study and follow-up period. The Investigators will be notified 
of any additional risks identified that could affect the health, safety or welfare of the study patients. 

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Page 33 of 103 
3.4. Minimization of Risk 
All efforts will be made to minimize the identified risks by taking the following measures: 
x 
Selection of investigators in this study: Interventional Cardiologist or Cardiothoracic Surgeon   
must be board certified (or equivalent), experienced with performing transcatheter heart valve 
repair and replacement, and skilled in percutaneous coronary interventions and structural 
heart interventions as well as access site management. 
x 
Investigators will be trained in proper procedure performance and device operation prior to 
patient treatments. Training will include didactic and hands-on training with the EVOQUE 
System. 
x 
Well-defined clinical study protocol, including specific inclusion/exclusion criteria to enroll 
appropriate patients in the study. 
x 
A Screening Committee ensures final eligibility of patients for participation in the study. 
x 
There will be strong interdepartmental collaboration between interventional cardiology and 
cardiovascular surgery operators and a designated team of nurses, technicians and colleagues 
from supporting medical disciplines (e.g., anesthesiologist, heart failure specialist, echo-
cardiographer, radiologist). 
x 
The procedural location is to be an operating room, catheterization lab or hybrid operating 
room with fluoroscopic and echocardiographic imaging capabilities. 
x 
Close patient monitoring during the implant procedure and follow-up period. 
x 
Ongoing monitoring of study data and results, including the use of independent Clinical Events 
Committee (CEC) and Data Safety Monitoring Board (DSMB). 
 
3.5. Justification for Clinical Study 
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the 
EVOQUE system in the treatment of patients with at least moderate TR, signs of TR, symptoms from 
TR, or prior heart failure hospitalizations for TR. 
The currently available treatments for this patient population are palliative medical therapy and high-
risk surgical replacement or repair of the tricuspid valve. Treatment with the EVOQUE system may 
enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a 
minimally invasive approach. 
The Sponsor and clinical Investigators believe the potential benefits outweigh the potential risks. 
 
 
 

TRISCEND Study (#2019-06)
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Page 34 of 103
Study Objectives 
The objectives of this feasibility study are to:
x
Evaluate the safety and performance of the EVOQUE system
x
Provide guidance for future clinical study designs utilizing the EVOQUE system
x
Provide guidance for future EVOQUE system development efforts
Data collected in this clinical study will include safety and performance of the investigational system, 
as well as up to 5-year clinical outcomes. Analyses of the primary and secondary endpoints are 
discussed in more detail in Section 12. 
Endpoints
5.1.
Safety Endpoint
Safety will be analyzed as a composite endpoint of Major Adverse Events (MAEs) at 30 days post-
enrollment which includes:
x
Cardiovascular mortality
x
Myocardial infarction (MI)
x
Stroke
x
Renal complications requiring unplanned dialysis or renal replacement therapy
x
Severe bleeding (includes fatal, life-threatening, extensive, or major bleeding, as defined by 
MVARC)3
x
Non-elective tricuspid valve re-intervention, percutaneous or surgical 
x
Major access site and vascular complications 
x
Major cardiac structural complications
x
Device-related pulmonary embolism
5.2.
Performance Endpoints
Device Success
Device success is achieved if the study device is deployed as intended and the delivery system is 
successfully retrieved as intended at the time of the patient’s exit from the cardiac catheterization 
laboratory. This endpoint will have a per device analysis performed.
Procedural Success
Procedural success is “device success” without clinically significant paravalvular leak (PVL)4-6 on a 
transthoracic echocardiogram (assessed by the echo core lab) at time of discharge. This endpoint will 
have a per patient analysis performed.

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Page 35 of 103
Clinical Success
Clinical success is “procedural success” without any MAEs at 30 days. This endpoint will have a per 
patient analysis performed. 
5.3.
Echocardiographic Endpoint and Parameters
Echocardiographic Endpoint
The echocardiographic endpoint is reduction in TR grade, measured by comparing the 
screening/baseline TTE to the discharge TTE. This endpoint will be assessed by the echo core lab using 
a 5-grade classification system (Table 2). 
Echocardiographic Parameters
TTE parameters assessed at screening/baseline, discharge, 30 days, 6 months, 1 year, and annually 
until 5 years post-procedure (assessed by the echo core lab)
1.
TR grade
2.
Paravalvular leak severity
3.
Regurgitant volume
4.
TV inflow gradient
5.
Cardiac output
6.
Right atrium volume
7.
Left Ventricular Ejection Fraction
8.
Inferior Vena Cava dimensions/respiratory variations
9.
Hepatic vein flow reversal
10.
Pulmonary artery pressure (mean)
11.
Right ventricular function 
5.4.
Clinical and Functional Endpoints and Parameters
Clinical and Functional Endpoints
The following endpoints will be assessed at 12 months and annually until 5 years post-procedure:
A.
All-cause mortality
B.
Heart failure hospitalizations
C.
Non-elective tricuspid valve re-intervention, percutaneous or surgical
The following endpoints assessed at baseline, 30 days, 6 months, 12 months, and annually until 5 years 
post-procedure:
D. Volume overload assessed by serial measurements of:
1.
Body weight
2.
Edema assessment (1+ to 4+)
3.
Ankle circumference measurement
4.
Patient edema questionnaire

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Page 36 of 103
E.
Functional class, functional status and Quality of life assessed by:
1.
NYHA Classification  
2.
6-Minute Walk Test (6MWT)
3.
KCCQ
4.
Short Form Health Survey (SF-36v2)  
Clinical and Functional Parameters
The following parameters will be assessed at baseline:
A.
Baseline Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale
B.
Baseline Katz Index of Independence in Activities of Daily Living (Katz ADL)
C.
Baseline Patient Preference Survey (see Appendix B)
The following general Clinical and Laboratory Parameters assessed at discharge, 30 days, 6 months, 12 
months, and annually until 5 years post-procedure: 
A.
Complete Blood Count (CBC)
B.
Comprehensive Metabolic Panel (CMP)
C.
Coagulation Panel (PT or PTT; INR for patients on vitamin K antagonist
D. BNP or NT-proBNP
E.
GGT 
F.
Uric acid and eGFR
5.5.
Additional Safety Listings
A listing of all AEs and SAEs for the entire study population will be provided.
5.6.
Exploratory Computed Tomography (CT) Parameters 
The following parameters will be assessed at 30 days and 12 months (where data is available):
A.
Cardiac remodeling (e.g., RV dimensions and volume)
B.
EVOQUE frame dimensions  
C.
EVOQUE leaflet assessment
D. EVOQUE positioning 
5.7.
Electronic Diary and Activity Monitoring Sub-study
A sub study of up to 10 sites and up to 45 patients (upon FDA approval) with data through 12 months
will be conducted as follows:  
A.
Electronic Diary (eDiary): To measure quality of life improvement in greater detail, electronic 
patient reported outcomes will be collected via a handheld device. The following assessments 
will be used to measure quality of life throughout the sub-study period:
1.
KCCQ
2.
EQ-5D-5L
3.
SF-12
4.
Mood questionnaire
5.
Symptom burden 

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A daily assessment will be administered from baseline (for a minimum of 14 days before the 
index procedure) and then from post discharge through the 12-month follow-up visit.
B.
Activity Monitoring: To measure the improvement in functional status, an activity monitor 
(wristwatch) will be worn by patients. The monitor is worn from baseline (for a minimum of 
14 days before index procedure), paused at time of admission for index procedure, and 
resumed post discharge and worn through the 12-month follow-up visit.
Study Design 
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the 
EVOQUE system in the treatment of patients with at least moderate TR and signs of, symptoms from, 
or prior heart failure hospitalizations for TR.
6.1.
Number of Planned Patients
Up to 200 patients (upon FDA approval) are planned to be enrolled in this study. 
6.2.
Number of Planned Clinical Study Sites
Up to 200 patients (upon FDA approval) will be enrolled in this study at up to 30 investigational sites 
(upon FDA approval) in the US.
6.3.
Expected Duration of Patient Participation
All implanted study patients will be assessed for clinical follow-up at the following intervals: discharge, 
30 days, 6 months, 12 months and annually thereafter for 5 years post-procedure.
Study enrollment is expected to last approximately 18-24 months followed by 5 years of follow-up.
Patient Population
7.1.
Demographic and Clinical Characteristics
This clinical study is for adult patients with at least moderate TR and signs of TR, symptoms from TR, 
or prior heart failure hospitalizations for TR.  
Patients who appear to the Local Heart Team (which may include one Cardiologist, one Cardiac 
Surgeon, one Heart Failure specialist, and one Echocardiographer) to meet the initial study eligibility 
requirements will be evaluated for study participation by the Clinical Screening Committee. Candidates 
for this study must meet all of the following inclusion criteria and none of the exclusion criteria.
This study is expected to enroll patients with similar baseline characteristics to previously studied 
populations of percutaneous TR interventions. The mean age of the first-in-human compassionate use 
experience with the Edwards EVOQUE device in the treatment of patients with severe TR was 78 years, 
and we expect that this trial will enroll patients with similar baseline characteristics. Therefore, we 

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Page 42 of 103 
The general process for obtaining informed consent is as follows: 
x 
Study investigator(s) and/or delegated study personnel will approach patients with TR who 
meet general requirements to assess their interest in participating in the study   
x 
Ensure that the principal investigator or his/her authorized designee conducts the informed 
consent process; 
x 
Include all aspects of the clinical study that are relevant to the patient’s decision to participate 
throughout the clinical study; 
x 
Avoid any coercion or undue improper influence on, or inducement of, the patient to 
participate; 
x 
Not waive or appear to waive the patient’s legal rights; 
x 
Use native non-technical language that is understandable to the patient; 
x 
Provide ample time for the patient to read and understand the informed consent form and to 
consider participation in the clinical study; 
x 
Include personally dated signatures of the patient and the principal investigator, or an 
authorized designee responsible for conducting the informed consent process; 
x 
Provide the patient with a copy of the informed consent form and any other written 
information; and, 
x 
Ensure important new information is provided to new and existing patients throughout the 
clinical study. 
For the purpose of the study, and based on the local requirements at the site, the patients can initially 
agree to the transfer of their images to the Sponsor for their evaluation. Upon full review and 
confirmation of suitability of the patient for both the EVOQUE Tricuspid valve replacement   procedure 
and the study eligibility, the full ICF can then be signed. This process is providing that no study specific 
exams are being carried out as part of the screening process 
The Sponsor must approve any modifications to the ICF prior to submission to the IRB and/or FDA (as 
required).   
Once the Investigator has determined the patient’s eligibility, the patient must sign the institution’s 
IRB-approved ICF prior to any study-specific procedures being performed.  Failure to provide informed 
consent renders the patient ineligible for the study. 
The ICF will be written in a language understandable to the patient (or authorized representative) and 
administered only by the Investigator or IRB-approved personnel who speaks a language 
understandable to the patient (or authorized representative).  The Investigator or delegated person 
administering the consent must sign and date the ICF to indicate that the purpose, risks and benefits 
of the study were explained to the patient and that their signature was witnessed. 
The signed ICF must be retained by the study site for verification during on-site monitoring visits. The 
Investigator will retain the original consent form, a copy will be filed in the patient’s medical record, 
and a copy will be provided to the patient. 

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8.4.
Case Review
Patients who are considered for participation will be reviewed by the Cardiac Imaging Core Lab and 
Clinical Screening Committee (CSC). Before a case is submitted for review, the site Principal 
Investigator and Heart Team will screen the patient for fundamental enrollment criteria. Once fully 
screened and deemed an appropriate candidate, the site will submit the case for review and 
approval consideration by the CSC.
8.5.
Patient Enrollment
A Screening/Enrollment Log will be maintained to document the screening and enrollment of all 
patients assessed for study participation.  All patients who consent to the study will be entered into 
the Electronic Data Capture (EDC) system, including screen failures.
Screened Failures
Screening is conducted as follows: all patients considered to qualify for the study are offered the 
possibility of participating and are thereafter evaluated according to the selection criteria defined in 
this protocol. 
Patients who consent to participate in the study but do not fulfill enrollment criteria will be classified 
as “screen failures” and will not count towards the overall enrollment.  The screen failure reason(s)
will be documented.
Provisionally Enrolled
Patients are considered “provisionally enrolled” when they have signed the ICF agreeing to 
participate in the study and have been deemed eligible for study.
Enrolled Patients
A patient will be considered “enrolled” at the time of skin incision to introduce the EVOQUE System 
into the body. Enrolled patients will be assigned a unique identification number by the study Sponsor.  
The patient ID number together with the patient initials shall be used to identify the patient on all 
study-related documents.
A study procedure should be scheduled within 90 days of a patient signing an informed consent. 
8.6.
Study Exit Criteria and Procedures
All patients that sign an informed consent document for this study will have the study exit reason 
documented in the medical record and on the appropriate eCRF.  Patients may exit the study for any 
of the following reasons:
x
Screen Failure: Patients who are consented to participate in the study, but do not fulfill 
enrollment criteria. 

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Page 44 of 103 
x 
Study Device Attempted but Not Implanted: Enrolled patient for whom the implant 
procedure was prematurely aborted will be followed either for 30 days (for only safety 
evaluations) OR until resolution, stabilization, or is adequate explanation of any implant-
related AEs and then exited from the study. Examples include: 
o Procedure attempted (i.e. skin incision to introduce the EVOQUE System) but patient 
did not receive a study device 
x 
Study Device Re-intervention/Explant: Patient who has a surgical re-intervention for study 
device explant will be followed for 30 days after the re-intervention for safety evaluations only 
or until resolution of any AEs related to the re-intervention and then exited from the study.  
Note: a patient who has a percutaneous re-intervention where the study device remains in 
place will continue to be followed for the duration of the study. 
x 
Withdrawal 
o Patient Withdrawal:  A patient may voluntarily withdraw from the clinical study at any 
time, without penalty or loss of benefits to which they are otherwise entitled. 
o Physician Withdrawal:  An Investigator also has the right to withdraw a patient if s/he 
feels it is in the best interest of the patient to do so. 
x 
Patient death 
x 
Lost to Follow-up 
o If a patient cannot be reached for a follow-up visit, the Investigator will document contact 
efforts and/or efforts to obtain hospital records in the appropriate eCRF. If a patient 
cannot be reached in any way, or misses a visit, the patient will be considered “unable to 
contact” for that time interval.  
o After 3 documented unsuccessful attempts to make contact, a certified letter will be sent 
to the patient’s residence. If there is no response after a certified letter is sent, the patient 
will be classified as “lost to follow-up”. 
x 
Completion Per Protocol 
Withdrawn patients will not have any study follow-up visits or procedures after the time of study exit. 
All data collected up until the time of withdrawal, including imaging studies such as echocardiography 
scans, will be analyzed. 
For patients lost to follow-up or withdrawn early, the Sponsor may request the site to search the Social 
Security Death Index and/or other death registries and, if applicable, request the site to obtain a death 
certificate. 
Withdrawn or lost to follow-up patients will not be replaced. 
8.7. Imaging Assessments 
Imaging assessments (TTE, TEE, and CT) shall be performed according to the current version of the 
acquisition manual/guide. For screening and baseline examinations, pre-existing TTE and TEE 
examinations obtained through standard of care treatment and within trial specified windows (Table 
8, “Screening/baseline assessment windows”) may be used if they provide the required images/views 
to qualify anatomical inclusion/exclusion criteria and TR grade. For chest CT scan, a standard of care 
assessment of adequate quality capturing required anatomy for assessment can be used as the 
screening/baseline assessment, provided it is within 1 year prior to consent.  

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Page 49 of 103
preoperatively in the left atrium or left atrial appendage or post-implant in the left atrium or left 
ventricle; low ejection fraction or stroke volume, arrhythmia (e.g., AF), large left atrium, infection or 
inflammation, INR post-valve implantation below the target range of 2.5-3.5.
Known baseline bleeding risk factors include: history of uncontrolled hypertension (> 160 mmHg 
systolic); renal disease (dialysis, transplant, Cr > 2.6 mg/dL or > 200 μmol/L); liver disease (cirrhosis or 
bilirubin > 2x normal or AST/ALT/AP > 3x normal); stroke history; prior major bleeding or predisposition 
to bleeding; labile INR (unstable/high INR, time in therapeutic range < 60%); age > 65; medication usage 
predisposing to bleeding (antiplatelet agents, NSAIDS), alcohol or drug use history (> 8 drinks/week).
Pre-Procedure Therapy
Patients on warfarin or DOACs at baseline may be asked to discontinue use prior to implant procedure 
as deemed appropriate by the treating physician.
Intraprocedural Therapy
Heparin will be administered at procedure start. 
During the procedure, ACTs will be monitored and recorded on source documentation. Heparin will be 
ĂĚŵŝŶŝƐƚĞƌĞĚĚƵƌŝŶŐƚŚĞƉƌŽĐĞĚƵƌĞĂƐŶĞĞĚĞĚƚŽŵĂŝŶƚĂŝŶƚŚĞƉĂƚŝĞŶƚ͛ƐdĂƚш 250 seconds. The 
sheaths may be removed using closure devices and/or figure-of-eight sutures, or when ACT level is 
appropriate (e.g., reaches < 200 seconds) after implantation of the study devices.  
Use of protamine to reverse heparin therapy may be used at the investigator’s discretion with due 
consideration given to the relative risk of thrombosis formation.
Post-Procedure Therapy
8.11.4.1 Post-Implant Up to 6 Months
Recommendation for all patients: warfarin (target INR range 2.5-3.5) or other appropriate 
anticoagulant + acetylsalicylic acid (ASA, 75-100 mg) for up to the 6-month follow-up visit. 
Post-implant for patients on warfarin therapy, the use of heparin as a bridging agent to warfarin 
therapy may be used until the INR stabilizes at 2.5 or greater.  The use of home INR monitoring devices 
in addition to frequent assessment of INR by the treating physicians is recommended.
8.11.4.2 Beyond 6 Months Post-Implant
While long-term anticoagulation regimen is recommended, the anticoagulant and antiplatelet regimen 
past the 6-month follow up visit will be determined at the Investigator’s discretion. However, it is 
recommended that before and after warfarin (or other appropriate anticoagulant) discontinuation, 
patients should be assessed by transthoracic echocardiography to ensure an absence of valve 
thrombosis (Figure 11). 

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Page 50 of 103 
 
Figure 11: Anticoagulant/Antiplatelet Therapy and Surveillance Recommendations 
 
Following the 6-month visit, alternative anticoagulation/antiplatelet regimens may be considered 
according to the needs of individual patients or a hospital’s standard practice.  
In the absence of underlying indication for oral anticoagulation, the following is recommended: 
x 
Single antiplatelet therapy (aspirin 75-100 mg or clopidogrel 75 mg once daily). 
x 
Aspirin and clopidogrel should be prescribed for an overall duration of 6-12 months in case of 
coronary stenting in the setting of TTVR. 
In the presence of underlying indication for oral anticoagulation, the following is recommended: 
x 
Warfarin or other appropriate oral anticoagulation (OAC) alone without concomitant 
antiplatelet treatment. 
x 
For patients on warfarin or other appropriate OAC who also have an indication for anti-platelet 
therapy, an OAC and a single anti-platelet (either ASA or P2Y12 inhibitor) may be used.  
x 
In case of high bleeding risk, P2Y12 inhibitor may be prescribed. 
The precise long-term antithrombotic regimen should be dictated by patient-specific comorbidities 
relating to both thromboembolic and bleeding risk. However, there is a growing body of literature55 
suggesting better safety profiles of direct oral anticoagulants (DOACs) in head-to-head trials against 
warfarin for non-valvular atrial fibrillation. DOACs could be considered, based on investigators 
assessment. 
8.12. Recommended Post-Procedure Diuretic Therapy 
While post procedure OMT is per investigator discretion, it is recommended that patients be 
maintained on their pre-procedure diuretic regimen for 3 months post-implant. 

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L.
See Appendix F for Patient Edema Questionnaire Template
M. See Appendix B for Patient Preference Survey Template
N. Blood samples will be analyzed by local institution and any remaining blood sample will be discarded according to institutions 
regulations
O. To be conducted within 14 days prior to intervention for females of childbearing potential. Repeated peri-procedurally per local 
institutional standard of care as needed. 
P. eDiary collection via a handheld device:  A daily assessment will be administered for a minimum of 14 days before the index 
procedure and then from post discharge through the 12-month follow-up visit. 
Q. Activity monitoring (via a wearable monitor):  An activity monitor is worn for a minimum of 14 days before index procedure, 
then paused at time of admission for index procedure, resumed post discharge and worn through the 12-month follow-up visit. 
Device Management
9.1.
Device Shipment
Devices will be transported to a study site after a Clinical Study Agreement is in place, applicable 
regulatory (e.g., IRB, FDA) approvals are obtained, and an eligible patient has been identified.
Devices will be provided to study sites on an as needed basis for scheduled implant procedures. 
All investigational devices used in this study for investigational purposes will be labeled “Caution: 
Investigational Device, Limited by Federal (USA) law to investigational use.” 
9.2.
Inventory and Accountability Records
All device shipments will have inventory and shipment records.  Devices may be hand carried to study 
sites by Study Sponsor personnel; will have delivery of investigational device documentation (e.g., 
packing lists, transfer of investigational product form, etc.).  
The Investigator(s) or designee will take inventory of the product and complete delivery 
documentation with receipt date and signature. Both the study site and Sponsor will retain copies of 
these documents.  The Investigator or designee will maintain a Device Accountability Log (as provided 
by the Sponsor) for all investigational devices that document their receipt, disposition, and return.  The 
log will be kept with the documents for the clinical study and will be available for review during Sponsor 
monitoring visits.  Only investigators trained and identified in the Delegation of Authority form on file 
at Edwards Lifesciences may use the investigational devices.
Use of the investigational devices and accessories provided for use in this study is prohibited outside 
of this study protocol.
9.3.
Device Storage
The device inventory will be stored in a locked, controlled, cool and dry area as described in the IFU 
and/or presented on the device labeling.  This secured area will only be accessible to the Investigators 
or approved designees.

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9.4.
Device Return
All device returns and dispositions must be captured on the Device Accountability Log.
The Investigator will receive instructions from the Sponsor on the return process, when applicable 
(e.g., Sponsor request, study is terminated, or product expiration, etc.).  
All unused investigational devices (in original packaging, in opened packages, or removed from the 
original packaging) will be returned to the Sponsor, upon request.  
Study devices suspected to have a device malfunction or deficiency should be returned to the Sponsor 
(see Section 11.8 and 11.9 for more details). 
9.5.
Patient Implant Card
An implant card will be supplied to each patient implanted with the EVOQUE valve.
Data Collection and Reporting
The Sponsor will provide the study site with the clinical protocol, electronic case report forms, sample 
ICF(s), and all other necessary study-related documents.  The Sponsor’s Clinical Affairs Department, or 
designee, will conduct quality control and assurance of the study site, including but not limited to, data 
reviewing, data monitoring, and form collection. Every reasonable effort should be made to complete 
data entry in a timely manner.
10.1. Data Management
Sponsor will provide data management through a secure, password protected Electronic Data Capture 
(EDC) system accessible via the internet.
10.2. Electronic Case Report Forms (eCRFs) 
Electronic case report forms (eCRFs) will be used to collect patient data during the study.  The 
Investigator, or individual(s) designated by the Investigator, is responsible for entering all data from 
the study onto the eCRFs hosted on a dedicated website.  Electronic CRFs must be fully completed for 
each patient and signed electronically by the investigator and/or designee. The eCRFs should be 
completed at the first earliest opportunity.
Data entered into the eCRFs may be subject to system validation checks (e.g., format range checks).  
System checks are automatic (i.e. generated at the time of data entry) and ensure the validity of 
submitted data. A query will be generated when a discrepancy requiring review has been identified. 
Discrepancies will remain open until a resolution is reached.
The site Investigator or designee must ensure the accuracy and completeness of the recorded data 
and then provide an electronic signature on the appropriate eCRFs. Changes to data previously 
submitted to the Sponsor will require a new electronic signature to acknowledge/approve the changes.
The Sponsor will conduct ongoing reviews of eCRF data. Sites that do not complete all data entry tasks 
in a timely manner may be prohibited from enrollment until data submission is current.

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10.3. Source Documentation Requirements
All data that is entered in the eCRFs must have source documentation available in the patient medical 
records. Data to be collected for the study purposes must not be entered directly onto eCRFs. The data 
must be recorded from original source documents and available for review by the study monitor. 
Regulations require that Investigators maintain information in the study patient’s medical records that 
corroborate data collected on the eCRFs. The source documentation may consist of but is not limited 
to: operative or procedure reports, progress notes, discharge summaries, laboratory reports, 
radiographic reports, medication logs, and worksheets. Source documents may be in electronic form 
and/or hard (paper) copies. Data recorded directly on CRFs such as patient-reported questionnaires or 
other data are deemed acceptable for collection outside of the EDC.
Protocol deviation information can be recorded directly on the protocol deviation eCRF.
10.4. Quality Control and Quality Assurance Procedures
Because of the potential for errors and inaccuracies in entering data into eCRFs, originals or 
photocopies of all relevant procedural records and reports, post-procedural examinations, laboratory 
and other test results may be kept on file in the Investigator’s patient study files.  Access to eCRFs and 
copies of test results must be available at all times for inspection by the study monitor.
All clinical sites will be audited periodically by a study monitor employed or contracted by the Sponsor 
for protocol adherence, accuracy of eCRFs, and compliance to applicable regulations.  Evident patterns 
of non-compliance with respect to these standards will be cause for the site to be put on probation for 
a period of one month.  If corrective actions are not subsequently undertaken, the clinical site will be 
asked to withdraw.
The Sponsor will provide data management through a secure, password protected EDC system 
accessible via the Internet. Passwords will be issued to appropriate data management personnel to 
ensure confidentiality and protection of the data by allowing variable levels of access to the computer 
system. 
Adverse Event Reporting and Assessments 
Adverse events will be captured for all study patients from the time of enrollment until the patient’s 
participation has ended (i.e., completion of study, lost to follow-up, withdrawal of consent, or patient 
has died). 
11.1. Definitions
Adverse Event
An Adverse Event (AE; MDR 2017) is any untoward medical occurrence, unintended disease or injury 
or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other 
persons, in the context of a clinical investigation, whether or not related to the investigational 
device.

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Serious Adverse Event 
A serious adverse event (SAE; MDR 2017) is any AE that led to any of the following: 
a)
death,
b)
serious deterioration in health of the patient, that resulted in any of the following: 
- life-threatening illness or injury,
- permanent impairment of a body structure or a body function,
- hospitalization or prolongation of patient hospitalization,
- medical or surgical intervention to prevent life threatening illness, 
- injury or permanent impairment to a body structure or a body function, 
- chronic disease
c)
foetal distress, foetal death or a congenital physical or mental impairment or birth defect.
Note: A planned hospitalization for pre-existing condition, or a procedure required by the Clinical 
Investigation Plan, without a serious deterioration in health, is not considered a SAE. 
Anticipated Adverse Events
Anticipated adverse events are AEs that have been identified in the CIP, IFU, and informed consent as 
possible adverse events.
Unanticipated Adverse Device Effect
Unanticipated adverse device effect (UADE, 21 CFR Part 812) is 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 patients.
Device Deficiency
A device deficiency (DD, MDR 2017) is any inadequacy in the identity, quality, durability, reliability, 
safety or performance of an investigational device, including malfunction, use errors or inadequacy in 
information supplied by the manufacturer.
Device Malfunction
A device malfunction (ISO 14155) is a failure of an investigational medical device to perform in 
accordance with its intended purpose when used in accordance with the IFU

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11.2. General Adverse Event Reporting Requirements 
The Investigator or designee or designee will report all AEs and DDs to the Sponsor as soon as possible, 
but no later than 10 calendar days after the Investigator or designee or designee first learns of the 
event. 
Each AE must be reported on a separate AE CRF. In the event that the EDC system is not in service or 
otherwise not accessible, the Sponsor must be notified by email 
. The 
AE CRF should be completed as soon as possible thereafter. 
Completion of the AE form should not be delayed due to missing information. At the time of initial 
notification, the following minimal information should be provided:  
x 
Study site number 
x 
Patient ID number 
x 
Date of event 
x 
Site’s awareness date  
x 
AE description  
x 
Seriousness 
x 
Causal relationship to device and implant procedure 
The site will provide the Sponsor copies of relevant supporting source documentation requested (e.g., 
Implant procedure report, discharge summary, medication administration record (MAR), 
echocardiogram and laboratory results) for any of the following reasons: AEs requiring CEC 
adjudication (at a minimum, safety endpoints), events determined by the Sponsor to require additional 
investigation, and to determine patient care.  
Adverse events must be followed until resolution, the patient is lost to follow-up, the patient has 
withdrawn consent, or the AE is otherwise explained. 
The Investigator will inform the respective entities (IRB or FDA) of AEs in accordance with the relevant 
local and regional regulatory requirements. 
11.3. Findings That Do Not Require Reporting to the Sponsor 
For purposes of this study, the following findings are not considered adverse events, because of their 
nature, do not require reporting to the Sponsor. These findings are normally expected to occur in 
association with treatment of tricuspid regurgitation, and/or are associated with customary, standard 
care of patients undergoing transcatheter, cardiovascular procedures. 
x 
Post-procedure pain (within 48 hour of procedure) not requiring treatment or treated with 
non-opioids 
x 
Abnormal or out of range lab values (e.g., electrolyte imbalance) that are not clinically 
significant and do not require correction or treatment 
Note: Abnormal lab values that roll up to a diagnosis should not be reported as separate AEs 
(e.g., elevated BNP in patient with heart failure; increased K+ in patient with renal 
insufficiency; elevated white blood count in a patient with a diagnosed infection). 

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x 
Low grade temperature increase without signs and symptoms of infection 
x 
Minor, localized tenderness, swelling, induration, oozing, etc. at access site(s) 
x 
Sinus bradycardia or tachycardia that does not require treatment or intervention 
x 
Systolic or diastolic blood pressure changes that do not require treatment or intervention 
x 
The need for insulin in a diabetic patient in the post-op period 
 
This list of findings is intended to provide guidance to the study sites for the purpose of AE reporting. 
The Investigator should utilize his/her own clinical judgment in evaluating adverse experiences and 
may decide that the above findings should be reported as adverse events. 
11.4. Pre-Existing Conditions 
Pre-existing medical conditions or symptoms should not be reported as an AE. In the event there is a 
clinically significant worsening in the pre-existing medical condition or symptoms, then an AE must be 
recorded. 
11.5. Investigator AE Causality Assessment 
Adverse events will be assessed by the Investigator for causality to the study device and index 
procedure. The relationship between the use of the study device and study/implant procedure and the 
occurrence of each AE will be assessed and categorized. 
During causality assessment, clinical judgement shall be used and the relevant study documents (i.e. 
CIP, ICF, IFU and/or CIB) shall be consulted for the listing of foreseeable AEs/potential risks. The 
presence of confounding factors, such as concomitant medication/treatment, the natural history of 
the underlying disease, other concurrent illnesses or risk factors shall also be considered. 
x 
Not related: There is no relationship between the event and the device or implant 
procedure. 
x 
Unlikely: The relationship with the use of the device seems not relevant and/or the event 
can be reasonably explained by another cause, but additional information may be obtained. 
x 
Possible: The relationship with the use of the device is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g., an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment). Cases where 
relatedness cannot be assessed, or no information has been obtained should also be 
classified as possible. 
x 
Probable: The relationship with the use of the device seems relevant and/or the event 
cannot reasonably explained by another cause, but additional information may be obtained. 
x 
Related (Causal relationship): The event is related to the device and/or procedure beyond a 
reasonable doubt. 
*Reference Appendix A Study Definitions for the full causality definitions. 

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An AE can be related to both the study procedure and the study device. Complications of procedures 
are considered not related if the said procedures would have been applied to the patients in the 
absence of study device use/application. 
In certain cases, the event may not be able to be adequately assessed because information is 
insufficient or contradictory and/or the data cannot be verified or supplemented. The Sponsor and the 
Investigators will make the maximum effort to define and categorize the event and avoid these 
situations. 
11.6. Patient Deaths 
Every effort should be made to provide a copy of the death summary, and autopsy report as applicable, 
to the Sponsor. The Sponsor may also request additional information to support the cause of death 
(e.g., last available medical consult, echo report). All source documents should be de-identified. 
11.7. Sponsor Assessment and Reporting 
The Sponsor is responsible for the classification, assessment, and reporting of AEs and device 
deficiencies and ongoing safety evaluation of the clinical investigation in accordance with 21 CFR 812. 
A summary of adverse events will be reported to the FDA annually in the Annual Progress Report (APR). 
The Sponsor will also report any confirmed UADEs to the investigators, FDA, and IRBs as soon as 
possible, but no later than 10 working days after first receiving notice of the effect or in compliance 
with local regulatory requirements. 
11.8. Investigational Device Observations and Deficiencies 
All suspected device observations and deficiencies (i.e. malfunctions, use errors resulting in device 
malfunction, inadequate labelling) will be documented on an individual device observation and 
deficiency form or equivalent. 
In the event of a suspected deficiency or other device issue, the device shall be returned to the 
Sponsor, to the extent possible, for analysis. Instructions for returning the investigational device will 
be provided by the Sponsor. 
11.9. Investigational Device Explants 
An Edwards’ study device that is explanted at any time during the study should be returned to the 
Sponsor for evaluation. 
Once the study device is explanted, the patient is followed for 30 days after the explant, unless there 
is an ongoing related adverse event and its outcome is not deemed resolved by the Investigator.   
Return kits for explanted devices will be provided upon request by the clinical monitor or study team.  
 
 
 

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Statistical Analysis
12.1. Sample Size 
This is a multi-center, prospective, and single-arm study. Up to 200 patients (upon FDA approval) will 
be enrolled in this study at up to 30 investigational sites (upon FDA approval) in the US.  This sample 
size is adequate to evaluate the safety and performance of the EVOQUE System. 
12.2. Analysis Populations 
Analysis will be performed for the Enrolled, As-Treated (AT), Per-Protocol (PP) populations defined 
below:
x
Enrolled Population: all patients enrolled in the study, defined as patients who sign informed 
consent and have had the study procedure attempted (attempted defined as skin incision for 
study device). Enrolled population will be used for the safety analyses.
x
As-Treated Population: is a subset of the enrolled population who have had the study device 
implanted at the exit of procedure room. The AT population will be the analysis population for 
performance and functional endpoint analysis.
x
Per-Protocol Population: is a subset of the AT population who had no protocol deviations 
relating to inclusion and exclusion criteria for the trial.
Additional analyses of performance and safety data using the PP population will be performed if there 
is/are a clinically meaningful difference(s) from the enrolled and the as-treated populations.
The safety analysis will be performed for enrolled population with due consideration given to the 
respective required follow-up intervals and the performance analysis including device success, 
procedural success and clinical success will be performed for implanted population.
The echocardiographic and functional analyses will be a summarization of measures of hemodynamic 
performance including reduction of tricuspid regurgitation, NYHA Functional Class, 6-minute walk test, 
and Quality of Life based on the implanted population. Patients that undergo any type of repair or 
replacement procedure for the tricuspid valve will be excluded from the echocardiographic analysis at 
the time of the reintervention and summarized in a table. 
Clinical endpoints including all-cause mortality, heart failure hospitalizations, and non-elective re-
intervention related to the device will be analyzed based on implanted population.
For patients participating in the sub-study, a separate data analysis plan will be developed to analyze 
the actigraphy data collected from the activity monitor and electronic patient reported outcome data 
collected from the eDiary.

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12.3. General Approach 
For continuous variables, results will be summarized with the number of observations, mean, standard 
deviation, median, minimum, maximum, and 90% confidence interval (CI) by normal approximation.  
For categorical variables, results will be summarized with patient count, percentage, and 90% CI by 
normal approximation, where appropriate.  
Survival analysis techniques will be used to analyze time-to-event variables. Patients without events 
will be censored at their participation date in the study. For patients who did not have an event but 
remain in the study, they will be censored at the database extract date. Time to first event curves will 
be constructed using Kaplan-Meier estimates. 
Descriptive statistics will be presented at each assessment, including change from baseline to 
subsequent time point for selected endpoints. For the determination of event rates, the number of all 
patients in the patient population will be used as the denominator. For variables ascertained at follow-
up visit, the denominator will be based on number of evaluable patients. Unless otherwise noted, 
patients with missing data will be excluded from the denominator. 
When the sample size is small (e.g., <10 patients), analysis may be performed in the form of listings 
only. 
12.4. Safety Endpoint Analysis 
The safety endpoint of major adverse events (MAEs) at 30 days shall be analyzed via the Kaplan-Meier 
(KM) method for implanted population. In addition, the event rates of individual adverse event of 
MAEs will also be calculated at 30 days, 6 months, and annually by the Kaplan-Meier method: 
x 
Cardiovascular mortality 
x 
Myocardial infarction (MI) 
x 
Stroke 
x 
Renal complications requiring unplanned dialysis or renal replacement therapy 
x 
Severe bleeding (includes fatal, life-threatening, extensive, or major bleeding, as defined by 
MVARC) 
x 
Non-elective tricuspid valve re-intervention, percutaneous or surgical  
x 
Major access site and vascular complications  
x 
Major cardiac structural complications 
x 
Device-related pulmonary embolism 
12.5. Additional Safety Analysis 
A summary of the percentage of patientƐǁŚŽĞǆƉĞƌŝĞŶĐĞĂŶĞĂƌůǇĂĚǀĞƌƐĞĞǀĞŶƚ;ч30-day post-
procedure) and late adverse event (> 30 days post-procedure) will be reported for all adverse events.  
The count and percentage of patients who experience newly identified ECG changes, as identified by 
ambulatory cardiac monitoring, resulting in PPM, ICD, or CRT device implantation will be reported. 
Two-sided 90% confidence intervals will be constructed around the percentage of patients who 
experience newly identified ECG changes resulting in PPM, ICD, or CRT device implantation. This 

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Page 66 of 103 
analysis will only include patients who undergo ambulatory cardiac monitoring. The reported 
confidence intervals will be compared to the range as reported in the literature data.  
The count and percentage of patients who have a change in therapy (either new pacemaker for 
bradycardia or new ICD/new pharmacotherapy for tachycardias) as a result of ECG changes identified 
by ambulatory cardiac monitoring will be reported.  This analysis will only include patients who 
undergo ambulatory cardiac monitoring. 
12.6. Performance, Functional and Other Endpoint Analysis 
The device success, procedural success, and clinical success will be summarized by counts and 
percentages for the implanted population. NYHA performance will be assessed at baseline, 1 month, 
6 months, and annually up to 5 years. The distribution (numbers of patients and percentages) in the 
various NYHA classes will be tabulated at baseline, 1 month, 6 months, and annually up to 5 years. 
Echocardiographic performance data will be obtained at the following time points: baseline, 1 month, 
6 months, and annually up to 5 years. Descriptive statistics such as mean, standard deviation and range 
will be calculated for the continuous echo variables as well as the change from baseline for each 
variable. 
Change in overall (general) quality of life will be measured through the use of health status 
questionnaires (e.g., KCCQ) and a six-minute walk test. QoL metrics will be assessed at 1 month, 6 
months, and annually for 5 years from the implant procedure. 
The average overall (general) quality of life changes at baseline, 1 month, 6 months, and annually for 
5 years and the changes from baseline to follow up will be summarized by mean and standard deviation 
for the implanted cohort.  Patients that are missing a baseline or follow up values will be excluded from 
the analysis. 
12.7. Exploratory Computed Tomography (CT) Analysis  
The following data will be assessed and summarized descriptively as described Section 12.3 at 30 
days and 12 months 
x 
Cardiac remodeling (e.g., RV dimensions and volume) 
x 
EVOQUE frame dimensions  
x 
EVOQUE leaflet assessment 
x 
EVOQUE positioning  
12.8. Missing Data 
All statistical analyses will be performed using only those patients with available data required for 
endpoint analysis.  
12.9. Analysis Software 
Unless otherwise specified, the exact form of each algorithm will be the default of SAS®, using the 
latest release generally available at the time of analysis.  This will be version 9.4 or later. 

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PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST 
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Monitoring
The Sponsor, or its designee, will monitor and manage the data for the investigational study.
  
13.1. Monitoring Methods
All clinical sites will be monitored periodically by the Sponsor or designee to ensure compliance with 
the protocol and the Investigator’s Agreement and that all study patients have been properly 
consented. The monitor will ensure that the completed eCRFs match the source documents and work 
with the site to resolve differences through electronically generated queries or formal action items.
The study monitor will remain in close contact with the study site throughout the duration of the study 
to provide any needed materials, (i.e., study forms, etc.) answer any questions and ensure that proper 
staffing levels are being maintained by the Investigator. The study monitor will be responsible for 
verifying that patients have signed the Informed Consent Form as required by regulations, reviewing 
the data recorded on the eCRFs and visiting the study site periodically to observe study progress and 
compliance with the study protocol and regulations applicable to this clinical study.
13.2. Monitoring Plan
Monitoring visits will be scheduled throughout the duration of the clinical study between the monitor 
and the Investigator at a mutually convenient and available time. These visits will assure that the 
facilities are still acceptable, the study protocol is being followed, the IRB and FDA have been notified 
of approved protocol changes as required, complete records are being maintained, appropriate timely 
reports have been made to the Sponsor and the IRB, device and device inventory are controlled and 
the Investigator is carrying out all agreed activities. Any personnel changes must be reported to the 
study monitor immediately and a training program scheduled and documented.
Prior to activating a site for patient screening and enrollment, the Sponsor will ensure the following:
1.
An initiation visit has been conducted,
2.
IRB approval have been obtained and documented,
3.
The Investigator(s) and study personnel are appropriately trained and clearly understand the 
study,
4.
The Investigator(s) and study personnel accept the obligations incurred in undertaking this 
clinical study,
5.
The Delegation of Authority form has been completed properly
Upon termination or conclusion of the study, the study monitor will perform a close-out visit.

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PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST 
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13.3. Protocol Deviation and Medical Emergencies 
A protocol deviation is defined as an event where the Investigator or study personnel did not conduct 
the study according to the clinical protocol. Investigators shall be required to obtain approval from the 
Sponsor before initiating deviations from the study protocol, except where necessary to protect the 
life or physical well-being of a patient in an emergency. If an Investigator or designee contacts the 
Sponsor to obtain prior approval for a change to the clinical study requirements, the approval or 
disapproval will be documented in writing. A copy of the approval or disapproval will be forwarded to 
the Investigator and a copy will be maintained in the study files. Prior approval is generally not 
expected in situations where unforeseen circumstances are beyond the Investigator’s control, (e.g., 
patient did not attend scheduled follow-up visit, etc.) however the event is still considered a deviation. 
Deviations shall be reported to the Sponsor regardless of whether medically justifiable, pre-approved 
by the Sponsor, or taken to protect the patient in an emergency. Patient-specific and non-patient 
specific deviations (e.g., unauthorized use of an investigational device outside the study, unauthorized 
use of an investigational device by a physician who is not listed in the Delegation of Authority Log, etc.) 
will be reported to the Sponsor. Patient-specific deviation information must be recorded directly on 
the Protocol Deviation eCRF and non-patient specific deviations will be documented. Investigators will 
also adhere to procedures for reporting study deviations to their IRB in accordance with their specific 
reporting policies and procedures.  
A major protocol deviation or noncompliance is one that may have a significant impact on patient 
safety, well-being, the patient’s willingness to participate in the study, or that may compromise the 
integrity of the study data and analysis, including: 
A. Patients implanted/treated with study device not having met eligibility criteria at the time of 
implant/treatment 
B. Informed Consent not signed or signed after the initiation of non-standard of care, research 
related assessments 
C. UADE/USADE not reported to IRB/Sponsor within the required timeframe 
D. Unauthorized use/implant of an investigational device 
 
A minor protocol deviation or noncompliance is unlikely to have a significant impact on patient safety, 
wellbeing, or is unlikely to compromise the integrity of the study data and analysis. All protocol 
deviations or noncompliance will be reported to the IRB, as required. 
13.4. Communication Procedures 
During the course of the study, all study-relevant correspondence (letters, telephone call, emails and 
faxes) regarding the study must be maintained in the study binder provided by the Sponsor. This binder 
must be made available during monitoring visits and audits. 
 

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Page 69 of 103
Clinical Study Boards
14.1. Data Safety Monitoring Board
The Data Safety Monitoring Board (DSMB) will be comprised of independent, non-investigator 
physicians, who will be responsible for reviewing aggregate trial data reported during the study and 
assessing whether the overall safety of the trial remains acceptable. DSMB activities, including roles 
and responsibilities, operating procedures, and monitoring criteria will be defined in the DSMB 
Charter.
14.2. Clinical Events Committee 
The Clinical Events Committee (CEC) will be comprised of independent, non-investigator physicians, 
and will be responsible for reviewing and adjudicating specified individual adverse events over the 
course of the study. CEC activities, including roles and responsibilities, operating procedures, specific 
events to be adjudicated, and definitions to be used by the CEC during adjudication will be defined in 
the CEC Charter.  
14.3. Central Screening Committee
A Central Screening Committee (CSC) is comprised of members who are participating in the study. The 
role of the CSC is to review submitted cases to determine if the patient is an appropriate candidate for 
the study, with a focus on confirming suitability for enrollment.
14.4. Echocardiography Imaging Core Laboratory
An independent echocardiographic imaging core laboratory will be utilized for assessment of 
echocardiograms. Echocardiogram image acquisition shall be performed in accordance with the core 
laboratory’s manual, which is provided to the sites.
Ethical and Regulatory Considerations
15.1. Applicable Regulations and Guidelines
The regulations listed in Table 15 must be observed to comply with the Sponsor policy for conduct of 
clinical studies; they also represent sound research practice. It is the responsibilities of the 
Investigator(s) to comply with the requirements set forth in their country-specific regulations.

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Page 71 of 103
capacities, will have direct access to original/source data and will have the right to inspect all records 
pertinent to this study.
With respect to data protection and patient confidentiality, Sponsor, Institution and all Study 
Personnel will comply with applicable requirements, including providing Notice and obtaining patient 
Consent regarding the processing of their personal data.
15.3. Institutional Review Board
This protocol, the proposed ICF, other written patient information and any proposed advertising 
material must be submitted to the IRB for written approval. A copy of the written IRB approval of the 
protocol and ICF must be received by the Sponsor before recruitment of patients into the study and 
shipment of investigational product.
The Investigator must submit and, where necessary, obtain approval from the IRB for all subsequent 
protocol amendments and changes to the ICF.
The Investigator is responsible for obtaining annual IRB approval and renewal throughout the duration 
of the study. Copies of the Investigator’s reports and the IRB continuance of approval must be sent to 
the Sponsor.
15.4. Informed Consent
Sponsor will provide a sample ICF to the Investigator to prepare for use at his/her site.  The site-specific 
ICF, and any subsequent modifications, must be in agreement with current regulations and guidelines 
and must be approved by Sponsor prior to submission to the IRB.  The reviewing IRB must approve the 
ICF before use at the site.
Before participating in the clinical study, each patient must give written informed consent after the 
context of the study has been fully explained in a language that is easily understood by the patient.  
The patient must also be given the opportunity to ask questions and have those questions answered 
to his/her satisfaction.
A copy of each patient’s signed and dated ICF must be maintained by each Investigator in a designated 
clinical study administrative file.  A signed copy of the consent form must be given to each patient.  The 
consent process must be documented in the patient’s medical chart; the documentation should 
include minimally that consent was obtained prior to participation in the research study, date consent 
was obtained, and confirmation that a copy of the consent was given to the patient.
15.5. Investigator Responsibilities
General Duties
The Investigator shall ensure that all work and services described herein, or incidental to those 
described herein, shall be conducted in accordance with the highest standards of medical and clinical 
research practice and the applicable regulations. The Investigator shall be responsible for the day to 
day conduct of the clinical study and for the safety and well-being of patients enrolled. The Investigator 
will provide copies of the current study protocol to all staff responsible for study conduct.

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The Investigator is responsible for obtaining and maintaining IRB approval for the study at his/her study 
center.
If there is a change or addition of an Investigator, an amended Clinical Study Agreement must be 
completed promptly.
Investigator Records
The Principal Investigator (or designee) must maintain the following records for each patient enrolled 
in the study:
x
Signed patient consent form(s)
x
Copy of final completed eCRFs 
x
All lab and testing results
x
Record of any complications, adverse events, device deficiencies and/or malfunctions, with 
supporting documentation
x
Procedure reports, progress notes, physician and/or nursing notes, and patient office files
x
Records pertaining to patient deaths throughout the course of the study (including death 
records, death certificate and autopsy report, if performed)
x
Any other records that FDA/regulatory authority or ISO 14155 requires to be maintained by 
regulation or by specific requirement for a category of investigations or a particular 
investigation.
Investigator Reports
The Investigator will prepare and submit the following accurate and complete reports to the Study 
Sponsor and IRB in a timely manner:
x
Anticipated and unanticipated serious adverse device effects occurring during the study will 
be reported as described in Section 11, Adverse Event Reporting and Assessments.
x
Withdrawal of IRB approval will be reported to the Sponsor within 5 business days.
x
Annual progress reports will be submitted to the IRB.
x
Deviation from the clinical study protocol. Deviations to protect the patient’s life or physical 
well-being in an emergency will be reported to the Study Sponsor within 5 business days and 
to the IRB according to their reporting policy.
x
Use of the study device without informed consent will be reported within 5 business days after 
the use occurs.
x
A final written report within twelve (12) months of completion or termination of the study.
Upon request by a reviewing IRB or the pertinent regulatory agencies, the Investigator will provide 
current information about any aspect of the investigation.

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Investigator Record Retention
Investigator files containing all records and reports of the investigation should be retained for a 
minimum of two years after the completion/ termination of the investigational study, or as required 
by applicable regulations. They may be discarded upon written notification by the Sponsor. To avoid 
error, the Principal Investigator should contact Sponsor, before the destruction of any records and 
reports pertaining to the study to ensure they no longer need to be retained.
In addition, in accordance with the Clinical Study Agreement, the Sponsor should be contacted if the 
Principal Investigator plans to leave the study site so that appropriate arrangements for file 
custodianship can be made.
Investigator’s and Sponsor’s Annual and Final Reports
Each year an annual summary report shall be prepared by the Investigator which provides a summary 
of the number of patients treated to date as well as other pertinent clinical information associated 
with the investigational procedure. The annual report is required to be provided to the IRB and the 
Sponsor or their authorized agent.
The Sponsor or their designee will be responsible for preparing a compilation of all of the participating 
site results for submittal as an annual progress report to the FDA/regulatory authority.
Upon completion and/or termination of the study a final report shall be prepared. This report will 
contain a critical evaluation of all data collected during the course of the investigation at each 
institution. The Sponsor or its designee is responsible for preparing this compilation to Investigators 
for submittal as a final report to their reviewing IRB. The Sponsor or its designee will also provide this 
final report to FDA/regulatory authority.
15.6. Sponsor Responsibilities
General Duties
As the Study Sponsor of this clinical study, Edwards Lifesciences has the overall responsibility for the 
conduct of the study, including assurance that the study meets the regulatory requirements of the 
pertinent regulatory agencies.
In addition, the Sponsor declares that no employee/affiliate of the Sponsor or Investigator will be 
included or encouraged to participate in this investigational study.
The Study Sponsor will inform the Investigator of any new information about the study that may affect 
the health, safety or welfare of the patients or which may influence the patient’s decision to continue 
participating in the study.
15.7. Selection of Investigators
The Study Sponsor will select qualified Investigators and will provide investigational devices to 
participating study sites only.  The Study Sponsor will obtain signed CTAs and provide the Investigators 
with the information and supplies necessary to conduct the clinical study.

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Monitoring the Study
The Study Sponsor will ensure compliance with the signed clinical agreement, the protocol 
(investigational plan), the requirements of applicable regulations and guidelines (see Section 15.1) and 
any conditions of study approval by the IRB and regulatory bodies. The Sponsor will conduct an 
immediate investigation of any unanticipated adverse device effects (UADE) and if an event is found 
to present an unreasonable risk to study patients, the Study Sponsor will inform Investigators, IRBs, 
and regulatory bodies as required.
Sponsor Records
The Study Sponsor will maintain accurate, complete, and current records relating to this clinical study.  
Study records include CRFs, signed CTA, signed financial disclosure, protocols and protocol 
amendments, informed consent, device use, IRB approval letters, submissions, correspondence, 
including required reports, and other documents.  The Study Sponsor will maintain study 
documentation during the study and for a period in accordance with local regulatory requirements 
after the study is terminated or completed, or the study records are no longer required to support a 
regulatory submission.  Storage of the study records may be designated to a third party.
Sponsor Reports and Notifications
The Study Sponsor will prepare and submit the following accurate and complete reports to the IRB and 
the pertinent regulatory agencies as follows: 
x
Unanticipated adverse device effects reported by the study site will be evaluated and the 
participating Investigators, IRBs, and pertinent regulatory agencies will be informed of the 
results of the evaluation no later than 10 business days after the Sponsor first learns of the 
event.
x
Withdrawal of IRB approval will be reported to all participating IRBs and regulatory agencies 
within five (5) business days of receipt of withdrawal of approval.
x
Withdrawal of the pertinent regulatory agencies’ approval will be reported to investigational 
sites and IRB within five (5) business days after receiving the notice of approval of withdrawal.
x
Progress reports to the IRB at least annually and to the pertinent regulatory agencies as 
required.
x
Instances of return, repair, or disposition of any units of a device will be sent to IRB and the 
pertinent regulatory agencies within 30 days after a field safety corrective action is made and 
should include the reason for the request. 
x
A final written report is to be completed and submitted to IRB and the pertinent regulatory 
agencies within twelve (12) months after completion or termination of the study.
x
Use of the study device without informed consent will be reported to IRB and pertinent 
regulatory authorities within five (5) business days after notification of device use.
x
Upon request by a reviewing IRB or the pertinent regulatory agencies, the Sponsor will provide 
current information about any aspect of the investigation.
x
Temporary or any termination (planned or unplanned) of the clinical investigation will be 
reported to IRB and pertinent regulatory agencies within 15 days. If the study has been 
temporarily halted or terminated on safety grounds, notice will be given to pertinent 
regulatory agencies within 24 hours. 

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15.8. Clinical Study Changes 
Changes in the protocol may be made only by written amendment agreed upon by the Study Sponsor, 
the regulatory agency and IRB. As appropriate, the Study Sponsor will submit protocol amendments to 
the pertinent regulatory agencies and Investigators to obtain IRB approval prior to implementation. 
15.9. Clinical Study Site Termination 
The Sponsor reserves the right to terminate a study site from the study for any of the following reasons 
including, but not limited to: 
x 
Failure to obtain Informed Consent 
x 
Failure to report Serious Adverse Events in a timely manner  
x 
Repeated protocol violations 
x 
Repeated failure to complete Case Report Forms 
x 
Failure to enroll an adequate number of patients 
 
All study patients enrolled up to the point of site termination will continue to be followed per 
protocol requirements. 
15.10. Audits and Inspections 
The study may be subject to a quality assurance audit by the Sponsor or a designee, as well as 
inspection/audit by appropriate regulatory authorities or IRBs acting in their official capacities.  The 
Investigator must provide the auditor with all clinical investigation documents including the medical 
records for all enrolled patients. It is important that the Investigator and relevant study personnel are 
available during any audits and that sufficient time is devoted to the process.  In the event of an audit 
by regulatory authorities, the Investigator should contact the Sponsor as soon as possible. 
15.11. Publication Policy 
 
 
 
 
 
 
 
 
 

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2012;143(3):632-638.

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Perlman G, Praz F, Puri R, et al. Transcatheter Tricuspid Valve Repair With a New 
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ranscatheter Cardiovascular Therapeutics2018; San Diego, CA. 
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Lauten A, Ferrari M, Hekmat K, et al. Heterotopic transcatheter tricuspid valve implantation: 
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Lauten A, Figulla HR, Unbehaun A, et al. Interventional Treatment of Severe Tricuspid 
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O'Neill BP, Wheatley G, Bashir R, et al. Study design and rationale of the heterotopic 
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interventions : official journal of the Society for Cardiac Angiography & Interventions. 
2016;88(2):287-293. 

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Page 78 of 103 
37. 
Braun D, Nabauer M, Orban M, et al. Transcatheter treatment of severe tricuspid 
regurgitation using the edge-to-edge repair technique. EuroIntervention. 2017;12(15):e1837-
e1844. 
38. 
Lurz P, Besler C, Noack T, et al. Transcatheter treatment of tricuspid regurgitation using edge-
to-edge repair: procedural results, clinical implications and predictors of success. 
EuroIntervention. 2018;14(3):e290-e297. 
39. 
Nickenig G, Kowalski M, Hausleiter J, et al. Transcatheter Treatment of Severe Tricuspid 
Regurgitation With the Edge-to-Edge MitraClip Technique. Circulation. 2017;135(19):1802-
1814. 
40. 
Orban M, Besler C, Braun D, et al. Six-month outcome after transcatheter edge-to-edge 
repair of severe tricuspid regurgitation in patients with heart failure. Eur J Heart Fail. 
2018;20(6):1055-1062. 
41. 
Praz F, Spargias K, Chrissoheris M, et al. Compassionate use of the PASCAL transcatheter 
mitral valve repair system for patients with severe mitral regurgitation: a multicentre, 
prospective, observational, first-in-man study. The Lancet. 2017;390(10096):773-780. 
42. 
Webb J. Compassionate Use of the Edwards PASCAL Mitral Valve System: 6-Month Results. 
Paper presented at: Transcatheter Cardiovascular Therapeutics2017; Denver, CO. 
43. 
Calvert PA, Himbert D, Brochet E, et al. Transfemoral implantation of an Edwards SAPIEN 
valve in a tricuspid bioprosthesis without fluoroscopic landmarks. EuroIntervention. 
2012;7(11):1336-1339. 
44. 
Godart F, Baruteau AE, Petit J, et al. Transcatheter tricuspid valve implantation: a multicentre 
French study. Arch Cardiovasc Dis. 2014;107(11):583-591. 
45. 
Kefer J, Sluysmans T, Vanoverschelde JL. Transcatheter Sapien valve implantation in a native 
tricuspid valve after failed surgical repair. Catheterization and cardiovascular interventions : 
official journal of the Society for Cardiac Angiography & Interventions. 2014;83(5):841-845. 
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Ribichini F, Pesarini G, Feola M, et al. Transcatheter tricuspid valve implantation by femoral 
approach in trivalvular heart disease. Am J Cardiol. 2013;112(7):1051-1053. 
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Asmarats L, Puri R, Latib A, Navia JL, Rodes-Cabau J. Transcatheter Tricuspid Valve 
Interventions: Landscape, Challenges, and Future Directions. J Am Coll Cardiol. 
2018;71(25):2935-2956. 
48. 
Demir OM, Regazzoli D, Mangieri A, et al. Transcatheter Tricuspid Valve Replacement: 
Principles and Design. Front Cardiovasc Med. 2018;5:129. 
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Hahn RT, George I, Kodali SK, et al. Early Single-Site Experience With Transcatheter Tricuspid 
Valve Replacement. JACC Cardiovasc Imaging. 2019;12(3):416-429. 
50. 
Sorajja P, Bapat V. Early experience with the Intrepid system for transcatheter mitral valve 
replacement. Ann Cardiothorac Surg. 2018;7(6):792-798. 
51. 
Bapat VN. The INTREPID Valve for Severe Tricuspid Regurgitation: First-in-Man Case 
Experience. Paper presented at: CRT2020; February 23, 2020; National Harbor, MD. 
52. 
Fam N. Transfemoral TTVR with EVOQUE for severe TR. Paper presented at: PCR e-
Course2020; Online. 
53. 
Dennis M, Mead G, Doubal F, Graham C. Determining the modified Rankin score after stroke 
by postal and telephone questionnaires. Stroke. 2012;43(3):851-853. 
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Savio K, Pietra GL, Oddone E, Reggiani M, Leone MA. Reliability of the modified Rankin Scale 
applied by telephone. Neurol Int. 2013;5(1):e2. 
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Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus Warfarin in Patients with Atrial 
Fibrillation. New England Journal of Medicine. 2009;361(12):1139-1151. 

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Page 79 of 103 
56. 
Moussa ID, Klein LW, Shah B, et al. Consideration of a new definition of clinically relevant 
myocardial infarction after coronary revascularization: an expert consensus document from 
the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 
2013;62(17):1563-1570. 
57. 
Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. 
Circulation. 2012;126(16):2020-2035. 
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oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60(8):646-649. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Page 80 of 103 
 
Appendix A: Study Definitions 
Access Site  
(VARC-1 Definition) 
Any location (arterial or venous) traversed by a guidewire, catheter or sheath. 
Access Site and Vascular Complications  
(MVARC 2015 Definition) 
I. 
Vascular complications 
A. Major access site vascular complications, including: 
i. 
Aortic dissection or aortic rupture, or 
ii. 
Access site-related† arterial or venous injury (dissection, stenosis, ischemia, arterial, or 
venous thrombosis including pulmonary emboli, perforation, rupture, arteriovenous 
fistula, pseudoaneurysm, hematoma, retroperitoneal hematoma, atrial septal defect‡), 
irreversible nerve injury, or compartment syndrome resulting in death; hemodynamic 
compromise; life-threatening, extensive, or major bleeding (MVARC primary bleeding 
scale); visceral ischemia; or neurological impairment, or 
iii. 
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting 
in amputation or irreversible end-organ damage, or 
iv. 
Unplanned endovascular or surgical interventions resulting in death; life-threatening, 
extensive, or major bleeding (MVARC bleeding scale); visceral ischemia; or neurological 
impairment 
B. Minor access site vascular complications, including: 
i. 
Access site arterial or venous injury (dissection, stenosis, arterial, or venous thrombosis 
including pulmonary emboli, ischemia, perforation, rupture, arteriovenous fistula, 
pseudoaneurysm, hematoma, retroperitoneal hematoma, atrial septal defect‡) not 
resulting in death; life-threatening, extensive, or major bleeding (MVARC primary 
bleeding scale); visceral ischemia; or neurological impairment, or 
ii. 
Distal embolization treated with embolectomy and/or thrombectomy not resulting in 
amputation or irreversible end-organ damage, or 
iii. 
Any unplanned endovascular stenting or unplanned surgical intervention not meeting 
the criteria for a major vascular complication, or 
iv. 
Vascular repair (via surgery, ultrasound-guided compression, transcatheter 
embolization, or stent-graft) 
II. 
Cardiac structural complications due to access-related issues 
A. Major cardiac structural complications, including: 
i. 
Cardiac perforation* or pseudoaneurysm resulting in death, life-threatening bleeding, 
hemodynamic compromise, or tamponade, or requiring unplanned surgical or 
percutaneous intervention 
B. Minor cardiac structural complications, including: 
i. 
Cardiac perforation* or pseudoaneurysm not meeting major criteria 
*Including the left ventricle, left atrium, coronary sinus, right atrium, and right ventricle 
†May arise from the access procedure per se or complications from vascular closure devices 
‡Meeting pre-specified criteria for a hemodynamically significant shunt, or requiring unplanned 
percutaneous or surgical closure 

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Page 81 of 103 
Activity Monitoring 
The continuous tracking of physical activity through the use of a patient deployed wearable 
actigraphy device 
Bleeding 
(MVARC 2015 Definition) 
 
I. 
Minor 
Any overt†, actionable sign of hemorrhage (e.g., more bleeding than would be expected for a 
ĐůŝŶŝĐĂůĐŝƌĐƵŵƐƚĂŶĐĞ͕ŝŶĐůƵĚŝŶŐďůĞĞĚŝŶŐĨŽƵŶĚďǇŝŵĂŐŝŶŐĂůŽŶĞͿƚŚĂƚŵĞĞƚƐшϭŽĨƚŚĞ
following:  requiring nonsurgical medical intervention by a health care professional; leading to 
hospitalization or increased level of care; prompting evaluation; or requires 1 or 2 units of whole 
blood or packed red blood cell (RBC) transfusion and otherwise does not meet criteria for major, 
extensive, or life threatening. 
II. 
Major  
Overt bleeding either associated ǁŝƚŚĂĚƌŽƉŝŶƚŚĞŚĞŵŽŐůŽďŝŶůĞǀĞůŽĨшϯ͘ϬŐͬĚůŽƌƌĞƋƵŝƌŝŶŐ
ƚƌĂŶƐĨƵƐŝŽŶŽĨшϯƵŶŝƚƐŽĨǁŚŽůĞďůŽŽĚŽƌƉĂĐŬĞĚZEĚŽĞƐŶŽƚŵĞĞƚƚŚĞĐƌŝƚĞƌŝĂŽĨůŝĨĞ-
threatening or extensive bleeding. 
III. 
Extensive 
KǀĞƌƚƐŽƵƌĐĞŽĨďůĞĞĚŝŶŐǁŝƚŚĚƌŽƉŝŶŚĞŵŽŐůŽďŝŶŽĨшϰŐͬĚůŽƌǁŚŽůĞďůŽŽĚŽƌƉĂĐŬĞĚZ
transfusion шϰhǁŝƚŚŝŶĂŶǇϮϰ-ŚƉĞƌŝŽĚ͕ŽƌďůĞĞĚŝŶŐǁŝƚŚĚƌŽƉŝŶŚĞŵŽŐůŽďŝŶŽĨшϲŐͬĚůŽƌ
ǁŚŽůĞďůŽŽĚŽƌƉĂĐŬĞĚZƚƌĂŶƐĨƵƐŝŽŶшϰh;ZƚǇƉĞϯďͿǁŝƚŚŝŶ30 days of the procedure. 
IV. 
Life-threatening 
Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial 
necessitating surgery or intervention, or intramuscular with compartment syndrome OR 
bleeding causing hypovolemic shock or hypotension (systolic blood pressure < 90 mm Hg lasting 
> 30 min and not responding to volume resuscitation) or requiring significant doses of 
vasopressors or surgery. 
V. 
Fatal bleeding 
Bleeding adjudicated as being a proximate cause of death. Severe bleeding adjudicated as being 
a major contributing cause of a subsequent fatal complication, such as MI or cardiac arrest, is 
also considered fatal bleeding. 
 
†“Overt” bleeding is defined as clinically obvious (visible bleeding and bleeding identified by imaging 
only). Examples of overt bleeding include: 
x 
Pseudoaneurysm 
x 
Retroperitoneal hematoma seen on CAT scan 
x 
Visible access site hematoma 
x 
Gross hematuria, hematemesis and hematochezia  
 
Procedural bleeding has to be an overt bleeding from vascular system either at or remote from the 
access/surgical site. Thresholds for reporting procedural bleeding for study index procedure >100 ml 
total EBL (Estimated Blood Loss) from access site. 
All post-procedural overt bleeding events must be reported including hematuria, melena, 
hematemesis, occult gastrointestinal bleeds or drop in Hgb with overt source of bleeding detected 
requiring transfusions etc. If the reason for Hgb drop was other than due to the overt bleeding i.e. due 
to hemodilution, chronic iron deficiency anemia etc., it will not be considered as a bleeding event. 

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Page 82 of 103 
Causality Assessment 
Adverse events will be assessed by the Investigator for causality to the study device and index 
procedure. The relationship between the use of the study device and study/implant procedure and 
the occurrence of each adverse event shall be assessed and categorized. During causality assessment, 
clinical judgement shall be used and the relevant study documents (i.e. Clinical Protocol, ICF, IFU 
and/or IB) shall be consulted for the listing of foreseeable adverse events/potential risks. The 
presence of confounding factors, such as concomitant medication/treatment, the natural history of 
the underlying disease, other concurrent illnesses or risk factors shall also be considered. 
Not related: relationship to the device or procedures can be excluded when: 
x 
the event is not a known side effect of the product category the device belongs to or of 
similar devices and procedures; 
x 
the event has no temporal relationship with the use of the investigational device or the 
procedures; 
x 
the serious event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
x 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious event; 
x 
the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
x 
the serious event can be attributed to another cause (e.g., an underlying or concurrent 
illness/ clinical condition, an effect of another device, drug, treatment or other risk factors); 
x 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
x 
harms to the patient are not clearly due to use error; 
In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious event. 
Unlikely:  the relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but additional information may be obtained.  
Possible:  the relationship with the use of the investigational device is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g., an underlying or concurrent illness/clinical 
condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
Probable:  The relationship with the use of the investigational device seems relevant and/or the event 
cannot reasonably [be] explained by another cause, but additional information may be obtained. 
Causal Relationship (Related):  the serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
x 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
x 
the event has a temporal relationship with investigational device use/application or 
procedures;  
x 
the event involves a body-site or organ that  
o the investigational device or procedures are applied to;  
o the investigational device or procedures have an effect on;  
x 
the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known);  

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Page 83 of 103 
x 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible);  
x 
other possible causes (e.g., an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
x 
harm to the patient is due to error in use;  
x 
the event depends on a false result given by the investigational device used for diagnosis, 
when applicable;  
 
In order to establish relatedness, not all criteria listed above must be met at the same time, 
depending on the type of device, procedure and the serious event. 
An adverse event can be related both to the study procedure and the study device. Complications of 
procedures are considered not related if the said procedures would have been applied to the patients 
also in the absence of investigational device use/application. 
 
In some particular cases the event may not be able to be not adequately assessed because 
information is insufficient or contradictory and/or the data cannot be verified or supplemented. The 
sponsor and the Investigators will make the maximum effort to define and categorize the event and 
avoid these situations. 
Clinical Frailty Scale© 
A 9 point single question administered to measure frailty. Developed by the Canadian Study of Health 
and Aging (CSHA). 
Death 
(MVARC 2015 Definition) 
A. Cardiovascular Death 
Cardiovascular death is defined as any of the following contributing conditions:  
x 
Heart failure (sub-classified into left ventricular vs. right ventricular dysfunction) 
x 
Myocardial infarction 
x 
Major bleeding 
x 
Thromboembolism 
x 
Stroke 
x 
Arrhythmia and conduction system disturbance 
x 
Cardiovascular infection and sepsis (e.g., mediastinitis and endocarditis) 
x 
Tamponade 
x 
Sudden, unexpected death 
x 
Other cardiovascular 
x 
Device failure 
x 
Death of unknown cause (adjudicated as cardiovascular) 
B. Non-cardiovascular Death 
Any death in which the primary cause of death is clearly related to another condition: 
x 
Non-cardiovascular infection and sepsis (e.g., pneumonia) 
x 
Renal failure 
x 
Liver failure 
x 
Cancer 
x 
Trauma 

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Page 84 of 103 
x 
Other non-cardiovascular 
Device Deficiency 
(MDR 2017 definition)  
A device deficiency (MDR 2017) is any inadequacy in the identity, quality, durability, reliability, safety 
or performance of an investigational device, including malfunction, use errors or inadequacy in 
information supplied by the manufacturer. 
 
Device Embolization 
(MVARC 2015 Definition) 
Device movement during or after deployment such that it loses contact with its initial position, 
includes detachment leading to device embolization. 
Device Malfunction 
(ISO 14155 Defintion) 
Failure of an investigational medical device to perform in accordance with its intended purpose when 
used in accordance with the IFU. 
Electronic Diary (eDiary) 
The collection of electronic patient- reported outcomes (PRO) through a patient-deployed 
handheld device to administer quality of life assessments to the patient. 
EQ-5D-5L 
A survey comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression) that measures health-related quality of life. 
Explant 
Removal of the study device after completion of the implant procedure for any reason. 
Hemolysis 
(MVARC 2015 / Sponsor Definition) 
The presence of a paravalvular leak on transesophageal or transthoracic echocardiography plus 
anemia requiring transfusion plus decreased haptoglobin and/or increased LDH levels 

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Page 85 of 103 
Hospitalization/Re-hospitalization  
(MVARC 2015 Definition) 
Hospitalization is defined as any unplanned admission to the hospital (including an emergency 
department visit) for either a diagnostic or therapeutic purpose following discharge from the index 
hospitalization. 
 
All hospitalizations will be classified to determine whether the hospitalization was related to: 
x 
CHF (Congestive Heart Failure) hospitalization: ĂŚŽƐƉŝƚĂůƐƚĂǇĨŽƌшϮϰŚŽƵƌƐǁŝƚŚƐŝŐŶƐ
and/or laboratory evidence of worsening heart failure AND administration of intravenous or 
ŵĞĐŚĂŶŝĐĂůŚĞĂƌƚĨĂŝůƵƌĞƚŚĞƌĂƉŝĞƐ͘ŶZƐƚĂǇĨŽƌшϮϰŚŽƵƌƐǁŽƵůĚƋƵĂůŝĨǇĂƐĂ,&
hospitalization endpoint, even absent formal hospital admission, as such a prolonged stay 
represents a severe episode of heart failure. 
x 
Other CV hospitalization: hospitalization due for coronary artery disease, acute myocardial 
infarction, hypertension, cardiac arrhythmias, cardiomegaly, pericardial effusion, 
atherosclerosis, stroke, or peripheral vascular disease without qualifying heart failure. 
x 
Non-CV hospitalization: hospitalization that is not due to heart failure or other cardiovascular 
causes, as defined above 
 
Patients hospitalized with heart failure meeting these criteria should further be sub-classified as: 
x 
Primary (cardiac-related) heart failure: this may be due to any cardiac cause, including 
primary LV dysfunction with or without medication or dietary noncompliance, acute MI, 
arrhythmias, and worsening valve dysfunction. 
x 
Secondary (non-cardiac related) heart failure: when a non-cardiac primary condition is 
present such as pneumonia, urinary tract infection, or renal failure, which results in fluid 
overload or myocardial failure. 
 
Note: only primary heart failure should be considered a valid criterion for heart failure hospitalization 
Local Heart Team 
The ‘Local Heart Team', for the purpose of this study, may include one Cardiologist, one Cardiac 
Surgeon, one Heart Failure specialist, and one Echocardiographer. 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
A health-related quality-of-life measure for patients with congestive heart failure. 
Katz Index of Independence in Activities of Daily Living (Katz ADL) 
Completed by the site, the Katz ADL is a 6-question assessment of functional status as a measurement 
of the patient’s ability to perform activities of daily living 
Major Adverse Event (MAE) 
In this study, MAEs are defined as Cardiovascular mortality, Myocardial infarction (MI), Stroke, Renal 
complications requiring unplanned dialysis or renal replacement therapy, Severe bleeding (includes 
fatal, life-threatening, extensive, or major bleeding, as defined by MVARC3), Non-elective tricuspid 
valve re-intervention, percutaneous or surgical, Major access site and vascular complications, Major 
cardiac structural complications, and Device-Related Pulmonary Embolism. 
 
 

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Page 86 of 103 
Modified Rankin Scale (mRS) 
0: No symptoms at all 
1: No significant disability despite symptoms; able to carry out all usual duties and activities 
2: Slight disability; unable to carry out all previous activities, but able to look after own affairs 
without assistance 
3: Moderate disability; requiring some help, but able to walk without assistance 
4: Moderately severe disability; unable to walk without assistance and unable to attend to own 
bodily needs without assistance 
5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention 
6: Dead 
Mood Questionnaire 
A combined anxiety and depression assessment, developed by the National Institute of Health, to be 
administered on the eDiary for patients participating in the sub-study.  
Myocardial Infarction 
(MVARC Definition) 
Myocardial infarction (MI) classification and criteria for diagnosis is defined as follows: 
I. 
WĞƌŝƉƌŽĐĞĚƵƌĂůD/;чϰϴŚŽƵƌƐĂĨƚĞƌŝŶĚĞǆprocedure)*†: 
A. In patients with normal baseline CK-MB (or cTn): 
x 
The peak CK-DŵĞĂƐƵƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞƉƌŽĐĞĚƵƌĞƌŝƐĞƐƚŽшϭϬǆƚŚĞůŽĐĂůůĂďŽƌĂƚŽƌǇ
ULN (Upper Limit of Normal) PLUS new ST-ƐĞŐŵĞŶƚĞůĞǀĂƚŝŽŶŽƌĚĞƉƌĞƐƐŝŽŶŽĨшϭŵŵŝŶ
шϮcontiguous leads (measured 80 ms after the J-point) 
x 
The peak CK-DŵĞĂƐƵƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞƉƌŽĐĞĚƵƌĞƌŝƐĞƐƚŽшϱǆh>EǁŝƚŚŶĞǁ
ƉĂƚŚŽůŽŐŝĐĂůYǁĂǀĞƐŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐŽƌŶĞǁƉĞƌƐŝƐƚĞŶƚ;ůĞĨƚďƵŶĚůĞďƌĂŶĐŚďůŽĐŬͿ
LBBB 
x 
In the absence of CK-MB measurements and a normal baseline cTn, a cTn (I or T) level 
ŵĞĂƐƵƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞW/ƌŝƐĞƐƚŽшϳϬǆƚŚĞůŽĐĂůůĂďŽƌĂƚŽƌǇh>EW>h^ŶĞǁ^d-
ƐĞŐŵĞŶƚĞůĞǀĂƚŝŽŶŽƌĚĞƉƌĞƐƐŝŽŶŽĨшϭŵŵŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐ;ŵĞĂƐƵƌĞĚϴϬŵƐĂĨƚĞƌ
the J-point) 
x 
The peak CK-MB measuƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞƉƌŽĐĞĚƵƌĞƌŝƐĞƐƚŽшϯϱǆh>EǁŝƚŚŶĞǁ
ƉĂƚŚŽůŽŐŝĐĂůYǁĂǀĞƐŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐŽƌŶĞǁƉĞƌƐŝƐƚĞŶƚ>͘ 
B. In patients with elevated baseline CK-MB (or cTn):  
x 
The CK-MB (or cTn) rises by an absolute increment equal to those levels recommended 
above from the most recent pre-procedure level plus, new ECG changes as described. 
II. 
Spontaneous MI (>48 hours after index procedure): 
Detection of rise and/or fall of cardiac biomarkers (preferably cTn) with at least 1 value above 
the 99th percentile URL (or ULN in the absence of URL) together with at least 1 of the 
following: 
A. Symptoms of ischemia 
B. ECG changes indicative of new ischemia (new ST-segment or T-wave changes or new LBBB) 
ŽƌŶĞǁƉĂƚŚŽůŽŐŝĐĂůYǁĂǀĞƐŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐ 
C. Imaging evidence of a new loss of viable myocardium or new wall motion abnormality 
III. 
MI associated with sudden, unexpected cardiac death‡:  
Sudden cardiac death or cardiac arrest, often with symptoms suggestive of myocardial 
ischemia, and accompanied by presumably new ST-segment elevation or new LBBB and/or 
evidence of fresh thrombus by coronary angiography and/or at autopsy, but death occurs 

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Page 87 of 103 
before blood samples could be obtained or at a time before the appearance of cardiac 
biomarkers in the blood 
IV. 
Pathological findings of an acute myocardial infarction‡ 
 
Note: The use of high sensitivity (hs)-troponins is recommended for diagnosis of Type II (spontaneous) 
MI, but has not been studied for assessment of periprocedural MI. Standard troponin assays are 
therefore recommended for evaluation of Type I MI 
Situations where MI is suspected must be carefully evaluated by taking into consideration past 
medical history, procedural specifics, renal function etc. It is known that cardiac procedures are 
associated with multiple confounding factors that contribute to myocardial damage 
*Periprocedural biomarker elevation >ULN not meeting the criteria for MI should be categorized as 
“myonecrosis not meeting MI criteria.”  
†Adapted from Moussa et al.56 
‡Adapted with permission from Thygesen et al.57 
New York Heart Association Classification (NYHA Class) 
Class I:  Patients with cardiac disease but without resulting limitations of physical activity. 
Class II:  Patients with cardiac disease resulting in slight limitation of physical activity. Patients are 
comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. 
Class III:  Patients with cardiac disease resulting in marked limitation of physical activity. Patients are 
comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal 
pain. 
Class IV:  Patients with cardiac disease resulting in inability to carry on any physical activity without 
discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at 
rest. If any physical activity is undertaken, discomfort is increased 
Patient Preference Survey 
A survey that includes but is not limited to a patient’s preference for an intervention, clinical 
outcome/result, or functional change 
Pre-Existing Condition 
A pre-existing condition is one that was present prior to clinical study screening. 
Pulmonary Embolism 
(Sponsor Definition) 
 
Pulmonary embolic event is an operative, autopsy or clinically documented embolus that produces 
symptoms from complete or partial obstruction of a pulmonary or bronchial artery. Confirmation of 
pulmonary embolism is done through diagnostic testing such as TTE/TEE, ventilation/perfusion lung 
(VQ) scan, angiogram, MRI or CT.  

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Page 88 of 103 
Re-intervention 
(Sponsor Definition) 
Any surgical or percutaneous intervention that repairs, alters or adjusts, or replaces the previously 
implanted study device or native valve after the patient leaves the procedure room from the index 
procedure. 
NOTE: The endpoint is “Non-elective tricuspid valve re-intervention (percutaneous or surgical)”. 
Elective: The procedure could be deferred without increased risk of compromised cardiac outcome. 
Non-Elective: The procedure could not be deferred without increased risk of compromised cardiac 
outcome; includes Urgent and Emergent: 
x 
Urgent – Procedure required during same hospitalization in order to minimize chance of 
further clinical deterioration. 
x 
Emergent – An emergency operation is one in which there should be no delay in providing 
operative intervention. 
Renal Complications 
(Sponsor Definition) 
Renal Complication is defined as new need for replacement therapy, including hemodialysis, renal 
transplant, continuous renal replacement therapy, peritonal dialysis, etc. 
Severe Bleeding 
(Sponsor Definition) 
Severe bleeding is a fatal, life-threatening, extensive, or major bleeding, as defined by MVARC. 
SF-36v2 
A survey with 36 questions that results in two scales of mental and physical functioning and overall 
health related quality of life. 
SF-12v2:  A 12 question abridged and validated version of the SF-36v2 
Stroke/TIA (Transient Ischemic Attack) 
(MVARC 2015 Definition) 
 
Stroke Diagnostic Criteria: 
I. 
Acute episode of a focal or global neurological deficit with at least one of the following:  
A. Change in level of consciousness 
B. Hemiplegia, hemiparesis, numbness, sensory loss affecting one side of the body 
C. Dysphasia or aphasia, hemianopia, amaurosis fugax, other neurological signs or symptoms 
consistent with stroke 
II. 
No other readily identifiable non-stroke cause for the clinical presentation (e.g., brain tumor, 
trauma, infection, hypoglycemia, peripheral lesion, pharmacological influences) to be 
determined by or in conjunction with a neurologist.* 
 
The neurological event type classification 
I. 
Stroke: 
Duration of symptoms: 
x 
ĨŽĐĂůŽƌŐůŽďĂůŶĞƵƌŽůŽŐŝĐĂůĚĞĨŝĐŝƚшϮϰŚŽƵƌƐŽƌ 
x 
A focal or global neurological deficit < 24 hours if available neuroimaging indicates a new 
intracranial or subarachnoid hemorrhage (hemorrhagic stroke) or central nervous system 
infarction (ischemic stroke) or 
x 
The neurological deficit results in death 

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Page 89 of 103 
II. 
TIA: duration of a focal or global neurological deficit < 24 hours and neuroimaging does not 
demonstrate a new hemorrhage or infarct 
 
Confirmation of the diagnosis by at least one of the following:  
I. 
Neurologist or neurosurgical specialist, or 
II. 
Neuroimaging procedure (CT scan or brain MRI) 
III. 
Non-neurologist physician (if neurologist is not available) 
IV. 
Clinical presentation alone*** 
 
Stroke types will be adjudicated as: 
I. 
Ischemic: an acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused 
by an infarction of the central nervous system tissue  
II. 
Hemorrhagic: an acute episode of focal or global cerebral or spinal dysfunction caused by 
intraparenchymal, intraventricular, or subarachnoid hemorrhage 
III. 
Undetermined: if there is insufficient information to allow categorization as ischemic or 
hemorrhagic 
 
Stroke severity 
It is recognized that an assessment of stroke is incomplete without an appropriate measurement of 
the disability resulting from the stroke, hence, mRS closest to 90 days post event** will be used to 
assess clinical disability. 
I. 
Disabling: ŵZ^ƐĐŽƌĞŽĨшϮĂƚϵϬĚĂǇƐ;ŽƌƚŚĞůĂƐƚĂǀĂŝůĂďůĞĐůŝŶŝĐĂůǀŝƐŝƚǁŝƚŚĞǀĂůƵĂďůĞĚĂƚĂͿ
EĂŶŝŶĐƌĞĂƐĞŝŶш 1 mRS category from an individual’s pre-stroke baseline 
II. 
Non-disabling: mRS score of < 2 at 90 days (or the last available clinical visit with evaluable data) 
ŽƌĚŽĞƐŶ͛ƚƌĞƐƵůƚŝŶĂŶŝŶĐƌĞĂƐĞŝŶшϭŵZ^ĐĂƚĞŐŽƌǇĨƌŽŵƉƌĞ-stroke baseline  
 
TIA 
Acute episode of a focal or global neurological deficit fulfilling the following criteria:  
I. 
Resulting in at least one of the following 
x 
Change in level of consciousness 
x 
Hemiplegia 
x 
Hemiparesis 
x 
Numbness 
x 
Sensory loss affecting one side of the body 
x 
Dysphasia or aphasia 
x 
Hemianopia 
x 
Amaurosis fugax 
x 
Other neurological signs or symptoms consistent with stroke 
II. 
Duration of deficit could be one of the following: 
x 
A focal or global neurological deficit < 24 hours  
x 
Any available neuroimaging does not demonstrate a new hemorrhage or infarct 
III. 
No other readily identifiable non-stroke cause for the clinical presentation (e.g., brain tumor, 
trauma, infection, hypoglycemia, peripheral lesion, pharmacological influences) to be 
determined by or in conjunction with a neurologist.* 
 

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Page 90 of 103 
Notes:  
*Patients with non-focal global encephalopathy will not be reported as a stroke without unequivocal 
evidence based upon neuroimaging studies. 
**Evaluation of stroke between 30 and 90 days is acceptable if 90-day follow-up not available 
***If a stroke is reported without evidence of confirmation of the diagnosis by one of these methods, 
the event may still be considered a stroke on the basis of the clinical presentation alone. 
6-Minute Walk Test (6MWT) 
A submaximal exercise test used to assess aerobic capacity and endurance that entails measurement 
of distance walked over a span of 6 minutes.  
 
 
 

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Page 96 of 103 
Appendix D: Instructions for 6-Minute Walk Test 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Page 97 of 103 
Appendix E: Child-Pugh Score