Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Phase: NA
Conditions: Tricuspid Regurgitation
Sponsor: Edwards Lifesciences

Edwards PASCAL TrAnScatheter Valve RePair System in 
Tricuspid Regurgitation (CLASP TR) Early Feasibility Study 
Short Title: Edwards CLASP TR EFS 
Clinical Protocol 
(Clinical Investigational Plan) 
Study Number: 2018-10 
 
Effective Date: 12-APR-2019 
CONFIDENTIAL 
Study Sponsor: 
Edwards Lifesciences, LLC 
One Edwards Way 
Irvine, CA 92614 USA 
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. DOC-0077299 Rev: B – Clinical Investigation Plan Template; This form is required by DOC-
0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL Transcatheter Valve Repair System are trademarks of 
Edwards Lifesciences Corporation. 

Edwards CLASP TR EFS (#2018-10) 
 
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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 2 of 113 
TABLE OF CONTENTS 
PROTOCOL SYNOPSIS ............................................................................................................ 7 
1 
INTRODUCTION ............................................................................................................ 15 
1.1 
Clinical Background on Tricuspid Regurgitation ....................................................................... 15 
1.1.1 
Disease Process............................................................................................................ 15 
1.1.2 
Etiology ........................................................................................................................ 15 
1.1.3 
Anatomy and Pathophysiology of Tricuspid Regurgitation ......................................... 16 
1.1.4 
Prognosis of Tricuspid Regurgitation ........................................................................... 16 
1.1.5 
Diagnostic Assessments for Tricuspid Regurgitation ................................................... 17 
1.2 
Treatments and Therapies for Tricuspid Regurgitation ............................................................ 18 
1.2.1 
Medical Treatment ...................................................................................................... 18 
1.2.2 
Surgical Intervention of the Tricuspid Valve ................................................................ 18 
1.2.3 
Transcatheter Methods of Treatment ......................................................................... 20 
1.3 
Intended Use of Device ............................................................................................................. 23 
1.4 
Prior Testing .............................................................................................................................. 23 
1.5 
Prior Clinical Experience With the PASCAL System .................................................................. 23 
1.5.1 
Compassionate Use Experience of the PASCAL System in Treating Tricuspid 
Regurgitation ............................................................................................................... 23 
2 
STUDY DEVICE .............................................................................................................. 24 
2.1 
General Device Description and Components .......................................................................... 24 
2.2 
Implant System ......................................................................................................................... 24 
2.2.1 
PASCAL Implant ........................................................................................................... 25 
2.2.2 
Implant Catheter.......................................................................................................... 25 
2.2.3 
Steerable Catheter ....................................................................................................... 26 
2.3 
Guide Sheath ............................................................................................................................ 26 
2.4 
Stabilizer ................................................................................................................................... 26 
2.5 
Table ......................................................................................................................................... 27 
3 
RISKS AND BENEFITS ..................................................................................................... 27 
3.1 
Potential Risks ........................................................................................................................... 27 
3.2 
Minimization of Risks ................................................................................................................ 31 
3.3 
Potential Benefits ..................................................................................................................... 31 
3.4 
Justification For Clinical Study .................................................................................................. 32 
4 
STUDY OBJECTIVES ....................................................................................................... 33 
5 
FEASIBILITY ENDPOINTS ................................................................................................ 33 
5.1 
Safety Endpoint......................................................................................................................... 33 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
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 of 113 
5.2 
Performance Endpoints ............................................................................................................ 33 
5.2.1 
Device Success ............................................................................................................. 33 
5.2.2 
Procedural Success ...................................................................................................... 34 
5.2.3 
Clinical Success ............................................................................................................ 34 
5.3 
Echocardiographic, Clinical, and Functional Endpoints and Parameters ................................. 34 
5.3.1 
Echocardiographic Endpoints and Parameters............................................................ 34 
5.3.2 
Clinical and Functional Endpoints and Parameters ..................................................... 35 
5.3.3 
Additional Safety Assessments .................................................................................... 36 
6 
STUDY DESIGN .............................................................................................................. 36 
7 
PATIENT POPULATION .................................................................................................. 36 
7.1 
Demographic and Clinical Characterisitics................................................................................ 36 
7.2 
Inclusion Criteria ....................................................................................................................... 37 
7.3 
Exclusion Criteria ...................................................................................................................... 37 
7.4 
Study Exit Criteria and Procedures ........................................................................................... 40 
8 
PROCEDURES AND METHODS ....................................................................................... 41 
8.1 
Site Personnel Training ............................................................................................................. 41 
8.2 
Device and Procedure Training ................................................................................................. 42 
8.3 
Informed Consent ..................................................................................................................... 42 
8.4 
Patient Enrollment .................................................................................................................... 43 
8.5 
Imaging Assessments ................................................................................................................ 43 
8.6 
Screening/Baseline Assessments .............................................................................................. 43 
8.7 
Recommended Antiplatelet / Anticoagulation Therapy ........................................................... 45 
8.8 
Implantation Procedure ............................................................................................................ 45 
8.8.1 
Device Preparation ...................................................................................................... 47 
8.8.2 
Antibiotic Prophylaxis .................................................................................................. 47 
8.8.3 
Contrast Media ............................................................................................................ 47 
8.9 
Post-Procedure/Pre-Discharge (12-24 Hours) .......................................................................... 47 
8.10 Discharge .................................................................................................................................. 48 
8.11 Follow-up Evaluations ............................................................................................................... 49 
8.12 Unscheduled Follow-up ............................................................................................................ 50 
8.13 Description of Data to Be Collected.......................................................................................... 50 
8.14 Study Patient Completion ......................................................................................................... 50 
8.15 Study Termination and Close-Out ............................................................................................ 50 
8.16 Schedule of Assessments .......................................................................................................... 51 
9 
DEVICE MANAGEMENT ................................................................................................. 53 
9.1 
Device Shipment ....................................................................................................................... 53 
9.2 
Inventory and Accountability Records ...................................................................................... 53 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 4 of 113 
9.3 
Device Storage .......................................................................................................................... 53 
9.4 
Device Return ........................................................................................................................... 53 
10 DATA COLLECTION AND REPORTING ............................................................................. 54 
10.1 Data Management .................................................................................................................... 54 
10.2 Case Report Forms (CRFs) ......................................................................................................... 54 
10.3 Source Documentation Requirements ..................................................................................... 55 
10.4 Quality Control and Assurance Procedures .............................................................................. 55 
11 ADVERSE EVENT REPORTING AND ASSESSMENTS .......................................................... 55 
11.1 Definitions ................................................................................................................................. 56 
11.1.1 Adverse Event .............................................................................................................. 56 
11.1.2 Serious Adverse Event ................................................................................................. 56 
11.1.3 Anticipated Adverse Events ......................................................................................... 56 
11.1.4 Unanticipated Adverse Device Effect (UADE) .............................................................. 56 
11.2 AE Reporting Requirements ..................................................................................................... 56 
11.3 Findings That Do Not Require Reporting to the Sponsor ......................................................... 57 
11.4 Pre-Existing Conditions ............................................................................................................. 58 
11.5 Investigator AE Causality Assessment ...................................................................................... 58 
11.6 Patient Deaths .......................................................................................................................... 59 
11.7 Sponsor Assessment and Reporting ......................................................................................... 59 
11.8 Investigational Device Explants ................................................................................................ 60 
11.9 Investigational Device Observations and Deficiencies ............................................................. 60 
12 STATISTICAL ANALYSIS .................................................................................................. 60 
12.1 Sample Size ............................................................................................................................... 60 
12.2 Analysis Populations ................................................................................................................. 60 
12.2.1 Intention-to-Treat (ITT) Population ............................................................................. 60 
12.2.2 As-Treated (Implanted) Population ............................................................................. 61 
12.2.3 Per-protocol (PP) Population ....................................................................................... 61 
12.3 Statistical Analysis ..................................................................................................................... 61 
12.4 Safety and Performance Endpoint Analysis .............................................................................. 62 
12.4.1 Safety Endpoints .......................................................................................................... 62 
12.4.2 Performance Endpoints ............................................................................................... 62 
12.5 Analysis of Other Endpoints and Parameters ........................................................................... 62 
12.6 Additional Safety Analysis ......................................................................................................... 62 
12.7 Treatment of Missing or Spurious Data .................................................................................... 62 
12.8 Analysis Software ...................................................................................................................... 63 
13 MONITORING ............................................................................................................... 63 
13.1 Monitoring Methods ................................................................................................................ 63 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
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Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 5 of 113 
13.1.1 Monitoring Plan ........................................................................................................... 63 
13.2 Protocol Deviations and Medical Emergencies ........................................................................ 64 
13.3 Communication Procedures ..................................................................................................... 65 
14 CLINICAL STUDY BOARDS .............................................................................................. 65 
14.1 Data Safety Monitoring Board (DSMB) ..................................................................................... 65 
14.2 Clinical Events Committee (CEC)............................................................................................... 65 
14.3 Central Screening Committee ................................................................................................... 66 
14.4 Echocardiography Imaging Core Laboratory ............................................................................ 66 
15 ETHICAL AND REGULATORY CONSIDERATIONS .............................................................. 66 
15.1 Applicable Regulations and Guidelines .................................................................................... 66 
15.2 Data Protection and Patient Confidentiality ............................................................................ 67 
15.3 Institutional Review Board Approval ........................................................................................ 67 
15.4 Informed Consent ..................................................................................................................... 67 
15.5 Investigator Responsibilities ..................................................................................................... 68 
15.5.1 General Duties ............................................................................................................. 68 
15.5.2 Investigator Records .................................................................................................... 68 
15.5.3 Investigator Reports .................................................................................................... 69 
15.6 Sponsor Responsibilities ........................................................................................................... 69 
15.6.1 General Duties ............................................................................................................. 69 
15.6.2 Selection of Investigators ............................................................................................ 70 
15.6.3 Monitoring the Study................................................................................................... 70 
15.6.4 Sponsor Records .......................................................................................................... 70 
15.6.5 Sponsor Reports .......................................................................................................... 70 
15.7 Clinical Study Changes .............................................................................................................. 71 
15.8 Audits and Inspections .............................................................................................................. 71 
15.9 Publication Policy ...................................................................................................................... 71 
APPENDIX A: 
STUDY DEFINITIONS .................................................................................. 72 
APPENDIX B: 
REFERENCES ............................................................................................. 87 
APPENDIX C: 
ABBREVIATIONS AND ACRONYMS ............................................................. 90 
APPENDIX D: 
SAMPLE INFORMED CONSENT FORM ........................................................ 93 

Edwards CLASP TR EFS (#2018-10) 
 
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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 6 of 113 
LIST OF TABLES 
Table 1.  Grading the Severity of Chronic TR by Echocardiography (Zoghbi et al., JASE 2017) .................. 17 
Table 2.  Expanded 5-grade Scale for Determining Severity of TR (Hahn, Eu Heart J Cardiovasc Imag 2017)
 ................................................................................................................................................... 18 
Table 3.  PASCAL System Device and Model Number ................................................................................. 24 
Table 4.  Screening/Baseline ....................................................................................................................... 44 
Table 5.  Screening/Baseline Assessment Windows ................................................................................... 45 
Table 6.  Procedure Information ................................................................................................................. 46 
Table 7.  Post Procedure/Pre-Discharge ..................................................................................................... 47 
Table 8.  Discharge/7 Days Post-procedure ................................................................................................ 48 
Table 9.  Follow-Up Evaluations .................................................................................................................. 49 
Table 10.  Follow-up Visit Windows ............................................................................................................ 50 
Table 11.  Schedule of Assessments ........................................................................................................... 51 
Table 12.  Applicable Regulations and Guidelines ...................................................................................... 66 
 
 
LIST OF FIGURES 
Figure 1.  Dilation of the Tricuspid Annulus ................................................................................................ 16 
Figure 2.  Kaplan-Meier Survival Curves for All Patients with Severe Tricuspid Regurgitation (Nath et al., 
JACC 2004) ................................................................................................................................. 16 
Figure 3.  Indication for Surgery According to the 2014 AHA/ACC VHD Guidelines ................................... 19 
Figure 4.  Tricuspid Surgical Repair Techniques .......................................................................................... 20 
Figure 5.  Implant System, Guide Sheath, and Stabilizer ............................................................................ 24 
Figure 6.  PASCAL Implant ........................................................................................................................... 25 
Figure 7.  A) Implant System  B) Steerable Catheter and Implant Catheter ............................................... 25 
Figure 8.  Loader ......................................................................................................................................... 26 
Figure 9.  A) Guide Sheath  B) Introducer ................................................................................................... 26 
Figure 10.  Stabilizer .................................................................................................................................... 27 
Figure 11.  Table .......................................................................................................................................... 27 
 
 
 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 7 of 113 
PROTOCOL SYNOPSIS 
Study Number 
2018-10 
Study Version 
C 
Title 
Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid 
Regurgitation (CLASP TR) Early Feasibility Study 
Short Title 
Edwards CLASP TR EFS 
Sponsor 
Edwards Lifesciences, LLC 
One Edwards Way 
Irvine, CA 92614 
Sponsor Contact 
TMTT Clinical Affairs 
Edwards Lifesciences, LLC 
One Edwards Way, Irvine, CA 92614 USA 
Email:  TMTT_Clinical@edwards.com 
Device Name 
Edwards PASCAL Transcatheter Valve Repair System (hereinafter 
referred to as “the PASCAL System”) 
Intended Use 
The Edwards PASCAL Transcatheter Valve Repair System (the PASCAL 
System) is intended for patients with tricuspid regurgitation deemed to 
be potential candidates for transcatheter tricuspid valve repair with the 
PASCAL System by the local Heart Team. 
Study Objectives 
The objectives of this early feasibility study are to: 
x Evaluate the safety and performance of the PASCAL System 
x Provide guidance for future clinical study designs utilizing the 
PASCAL System 
x Provide guidance for future PASCAL System developments 
Study Design 
Prospective, single arm, multi-center, early feasibility study (EFS) to 
evaluate the safety and performance of the PASCAL System in the 
treatment of symptomatic severe tricuspid regurgitation (TR). 
Up to 65 patients (pending FDA approval) will be enrolled in this study at 
up to 30 investigational sites (pending 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, and 
annually for 5 years post implant procedure. 

Edwards CLASP TR EFS (#2018-10) 
 
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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 8 of 113 
Feasibility 
Endpoints 
Safety Endpoint: 
Safety will be analyzed as a composite endpoint of Major Adverse Events 
(MAEs) at 30 days which includes: 
x Cardiovascular mortality 
x Myocardial infarction (MI) 
x Stroke 
x Renal complications requiring unplanned dialysis or renal 
replacement therapy 
x Severe bleeding* 
x Unplanned or emergency re-intervention (either percutaneous or 
surgical) related to the device 
x Major access site and vascular complications requiring intervention 
Performance Endpoints: 
x Device success:  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. Per 
device analysis. 
x Procedural success:  device success with evidence of a reduction in 
TR grade by at least one gradei (scale: none/trace, mild, moderate, 
severe, massive, torrentialii) at end of procedure, and without the 
need for a surgical or percutaneous intervention prior to hospital 
discharge. Per patient analysis. 
x Clinical success:  procedural success without MAEs at 30 days.  Per 
patient analysis. 
*Severe bleeding includes fatal, life-threatening, extensive, or major bleeding, 
as defined by MVARCiii [see also Appendix A: Study Definitions] 
                                                     
 
i The TR grading scale used to determine procedural success is based on the scale proposed by Hahn and Zamorano 
(scale: none/trace, mild, moderate, severe, massive, torrential), while patient eligibility is based on the grading 
scale presented in the current ASE guidelines (Zoghbi et al., JASE 2017). 
ii Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J Cardiovasc 
Imaging. 2017;18(12):1342-1343. 
iii Stone GW, Adams DH, Abraham WT, et al. Clinical Trial Design Principles and Endpoint Definitions for 
Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From 
the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015;66(3):308-321. 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 9 of 113 
Echocardiographic, 
Clinical, and 
Functional 
Endpoints and 
Parameters 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Echocardiographic Endpoint and Parameters: 
A. Reduction in TR severity (assessed by TR grade and quantitative 
measures) as assessed by TEE pre- and post-implant in the procedure 
room. 
B. TTE parameters assessed at baseline, discharge, 30 days, 6 months, 1 
year, and annually until 5 years post procedure 
1. TR grade 
2. Vena Contracta (2D) 
3. EROA (PISA/2D or 3D/3D color Doppler) 
4. Regurgitant volume 
5. Tricuspid annular dimensions 
6. TV inflow gradient 
7. Cardiac output 
8. Right ventricle dimensions 
9. Right atrium volume 
10. Left ventricular Ejection Fraction 
11. Inferior Vena Cava dimensions/respiratory variations 
12. Hepatic vein flow reversal 
13. Pulmonary artery pressure (mean) 
14. Right ventricular function 
Clinical and Functional Endpoints: 
A. All-cause mortality 
B. Heart failure hospitalizations 
C. Unplanned or emergency re-intervention (either percutaneous or 
surgical) related to the device 
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. Quality of life and functional status assessed by: 
1. NYHA Classification 
2. 6-Minute Walk Test (6MWT) 
3. KCCQ 
4. Short Form Health Survey (SF-36) 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
Clinical Investigation Plan Template; This form is required by DOC-0089089; Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL 
Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 10 of 113 
Echocardiographic, 
Clinical, and 
Functional 
Endpoints and 
Parameters 
(cont.) 
Clinical and Functional Parameters: 
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 
D. Electronic Diary (eDiary)iv:  Administered via a handheld device as 
follows: 
1. Baseline:  Question(s) from PROMIS Mood questionnaire, Visual 
Analog Scale (VAS), and KCCQ-12 will be administered daily for a 
minimum of 2 weeks before the index procedure and then 
paused at time of admission for index procedure. 
2. Post discharge:  Starting post discharge, question(s) will be 
administered daily for 7 days, every other week, to the 12-
month follow-up visit. 
3. 12-month follow-up visit:  Starting at the 12-month follow-up 
visit, question(s) will be administered daily for a week, up to 7 
days. 
E. Activity Monitoringiv:  Administered via a wearable monitor as follows: 
1. Baseline:  Activity monitoring will occur for a minimum of 2 
weeks before the index procedure and then paused at time of 
admission for index procedure 
2. 30 days post discharge 
3. 2 weeks at 3 months, 6 months, 9 months, and 12 months post 
index procedure. 
F. General Clinical and Laboratory Parameters assessed by: 
1. Creatinine, BUN, uric acid, and eGFR 
2. Liver Panel (Albumin, Bilirubin, ALP, ALT, AST, GGT) 
G. Diuretic medications and doses (No change in current or new 
addition to diuretics are allowed for at least 3 months post 
procedure unless medically required, i.e. severe hypotension or signs 
and symptoms of hypervolemia.) 
                                                     
 
iv 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. 

Edwards CLASP TR EFS (#2018-10) 
 
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BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. DOC-0077299 Rev: B – 
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Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 11 of 113 
Enrollment 
Criteria 
(Inclusion) 
Patients enrolled must meet ALL of the following criteria: 
1. Age ш 18 years old 
2. Symptomatic despite optimal medical therapy per local Heart Team 
3. Functional or degenerative TR graded as severev as assessed by the 
echo core lab 
4. The local site Heart Team determines that the patient is appropriate 
for transcatheter tricuspid valve repair 
5. Patient is willing and able to comply with all specified study 
evaluations and provides written informed consent. 
Enrollment 
Criteria 
(Exclusion) 
 
 
 
 
 
 
 
 
 
 
 
 
Potential patients will be excluded if ANY of the following criteria apply: 
1. Echocardiographic parameters (any of the following): 
a. Tricuspid valve anatomy precluding proper device deployment 
and function, including: 
i. Evidence of severe calcification in the annulus or 
subvalvular apparatus 
ii. Evidence of moderate to severe calcification in the 
grasping area 
iii. Excessive chordae structure in the grasping area 
iv. Presence of perforation in the grasping area 
v. Leaflet length < 8 mm 
vi. Septo-lateral coaptation gap > 10 mm 
vii. Severe leaflet tethering or immobile leaflet 
b. LVEF < 30% 
c. 
Severe right ventricular dysfunction as assessed by the core lab 
2. Primary non-degenerative tricuspid disease (e.g. carcinoid, rheumatic, 
endocarditis, traumatic, pacemaker lead-induced, iatrogenic, 
tricuspid stenosis) 
                                                     
 
v The TR grading scale used to determine procedural success is based on the scale proposed by Hahn and 
Zamorano (scale: none/trace, mild, moderate, severe, massive, torrential), while patient eligibility is based on 
the current ASE guidelines; Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for Noninvasive 
Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography 
Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 
2017;30(4):303-371. 

Edwards CLASP TR EFS (#2018-10) 
 
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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. DOC-0077299 Rev: B – 
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Transcatheter Valve Repair System are trademarks of Edwards Lifesciences Corporation. 
 
Page 12 of 113 
Enrollment 
Criteria 
(Exclusion) 
(cont.) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Previous tricuspid valve repair or replacement that would interfere 
with placement of PASCAL 
4. Presence of trans-tricuspid pacemaker or defibrillator leads which: 
a. Would prevent proper TR reduction due to interaction of the 
lead with the leaflets 
b. Were implanted in the RV within the last 3 months 
5. Severe aortic, mitral and/or pulmonic valve stenosis and/or 
regurgitation 
6. Active endocarditis within 3 months of the scheduled implant 
7. Hemodynamically significant pericardial effusion 
8. Intra-cardiac mass, thrombus, or vegetation 
9. Untreated clinically significant coronary artery disease requiring 
revascularization 
10. MI or known unstable angina within 30 days prior to the index 
procedure 
11. Any invasive cardiac procedure within 30 days prior to the index 
procedure 
12. Any cardiac surgery within 3 months prior to procedure 
13. Suspicion of pericardial adhesions that may preclude leaflet 
approximation (e.g. post pericarditis, constrictive pericarditis, 
calcifications visible on imaging) 
14. Hemodynamic instability or on IV inotropes unless part of 
prehabilitation 
15. Severe uncontrolled hypertension (SBP ш 180 mmHg and/or DBP ш 
110 mmHg) 
16. Pulmonary systolic pressure > 60 mmHg as assessed by echo core lab 
17. Stroke or transient ischemic attack (TIA) within the past 30 days 
18. Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) 
ч 30 mL/min/1.73 m2 or patient is on chronic dialysis 
19. 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) 
20. Significant frailty (i.e. Katz Index of Independence in Activities of Daily 
Living (ADL) ч 2) within 3 months of scheduled implant 

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Enrollment 
Criteria 
(Exclusion) 
(cont.) 
21. Continuous home oxygen for primary severe COPD 
22. Chronic anemia (Hgb < 9 g/dL) not corrected by transfusion 
23. Thrombocytopenia (Platelet count < 100,000/mm3) or thrombocytosis 
(Platelet count > 750,000/mm3) 
24. Bleeding disorders or hypercoagulable state 
25. Active peptic ulcer or active gastrointestinal (GI) bleeding within 3 
months of the scheduled implant 
26. Contraindication to anticoagulants or antiplatelet agents 
27. Current, or history of IV drug use 
28. Pregnant or lactating; or female of childbearing potential with a 
positive pregnancy test 24 hours before any study-related radiation 
exposure 
29. Patients in whom transesophageal echocardiography is 
contraindicated. 
30. In the opinion of the investigator, access to the femoral vein with a 22 
FR guide is deemed not feasible (e.g. IVC filter, DVT, occluded femoral 
veins). 
31. Untreatable hypersensitivity or contraindication to any of the 
following: 
a. Aspirin and Clopidogrel and Ticlopidine 
b. Heparin and Bivalirudin, or Warfarin 
c. 
Nitinol Alloys (Nickel and Titanium) 
d. Contrast media 
32. Currently participating in another investigational biologic, drug or 
device study that has not completed the primary endpoint or that 
clinically interferes with the endpoints of this study. 
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 atrial septal defect, RV dysplasia, and arrhythmogenic RV. 
35. Co-morbid condition(s) that, in the opinion of the investigator, could 
limit the patient’s ability to participate in the study, including 
compliance with follow-up requirements, or that could impact the 
scientific integrity of the study. 
36. Patient is under guardianship. 

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Echo 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 protocol, which is provided to the sites. 
Data Safety 
Monitoring 
Board (DSMB) 
The DSMB is 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, 
procedures, and monitoring criteria will be defined in the DSMB Charter. 
Clinical Events 
Committee (CEC) 
The CEC is responsible for reviewing and adjudicating specified individual 
adverse events over the course of the study.  CEC activities, including 
roles and responsibilities, procedures, and definitions will be defined in 
the CEC Charter. 
 

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Version C 
Page 15 of 113 
1 INTRODUCTION 
1.1 
Clinical Background on Tricuspid Regurgitation 
1.1.1 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 as a result of 
right ventricular relaxation and descent of the base of the heart resulting in a gradient of pressure 
from the atrium to the right ventricle (RV), allowing blood to flow through the tricuspid valve, 
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 tricuspid valve is 
unable to form a tight seal in systole (when it should be closed), allowing blood to flow back into 
the right atrium. 
Although TR often accompanies mitral or aortic valve disease, it is initially asymptomatic, 
traditionally considered less clinically significant, and usually left untreated. Hence, 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.1  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.2  Patients with severe TR usually present with signs 
or symptoms of right heart failure (HF), including peripheral edema and ascites.3 
1.1.2 Etiology 
TR can have many underlying etiologies, but the majority of these can be divided into two major 
categories: primary TR and functional 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, functional (secondary 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 TR3 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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1.1.3 Anatomy and Pathophysiology of Tricuspid Regurgitation 
The TV orifice is semilunar and consists of three leaflets (anterior, posterior and septal) inserted 
into a fibrous annulus.  Each leaflet is 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 1.4 
 
Figure 1.  Dilation of the Tricuspid Annulus 
1.1.4 Prognosis of Tricuspid Regurgitation 
Tricuspid regurgitation is a common echocardiographic finding that is often considered benign 
unless associated with significant pulmonary hypertension or RV 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).2  Severe TR is associated with a 
poor prognosis, independent of age, biventricular systolic function, RV size, and inferior vena 
cava (IVC) dilation.2 
 
Figure 2.  Kaplan-Meier Survival Curves for All Patients with Severe Tricuspid Regurgitation (Nath et 
al., JACC 2004) 

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Figure 3.  Indication for Surgery According to the 2014 AHA/ACC VHD Guidelines 
Left-sided valve surgery and moderate functional TR in the presence of pulmonary hypertension 
(PHTN) was assigned as a class IIb indication in the AHA guidelines. 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.3,10 
Although the guidelines have expanded the indications for invasive TR treatment, surgical 
repair/replacement is uncommonly performed12 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.10,13 
There are four main surgical TV repair techniques14: Kay repair, De Vega technique, Clover repair 
(degenerative) and annuloplasty (Figure 4).  The Kay repair is a simple and validated solution in 
which a bicuspidation 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.15  
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.16  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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A. Annuloplasty, B. De-Vega technique, C. Clover repair, D. Kay repair 
Figure 4.  Tricuspid Surgical Repair Techniques 
1.2.3 Transcatheter Methods of Treatment 
Medical management is likely to provide only temporary symptom relief. The lack of sustained 
benefit from medical therapies and the low prevalence of surgery has prompted the search for 
alternative transcatheter repair and/or replacement therapies.17,18 
1.2.3.1 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 or limited retrospective clinical series, 
primarily for valve-in-valve patients19,20 or patients with rheumatic disease.21  In addition, the 
GATE Tricuspid Valved Stent (NaviGate Cardiac Structures, Lake Forest, CA) has been performed 
in patients under compassionate use and is under investigation.18 
1.2.3.2 Transcatheter Tricuspid Valve Repair (TTVr) 
In the past decade, transcatheter aortic valve replacement (TAVR) has been used successfully in 
increasing numbers and is considered a treatment option even in moderate risk patients.22  The 
success of TAVR stimulated attempts at transcatheter mitral valve replacement (TMVR) to 
facilitate percutaneous treatment of mitral regurgitation (MR).  TMVR has been proven to be far 
more complex than TAVR.  However, there are several transcatheter devices that are approved 
for transcatheter mitral valve repair (TMVr).  The MitraClip System (Abbott Vascular, Santa Clara, 
CA) is approved for use in the EU (2008) and the U.S. (2013).   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.23  TMVR devices are also being tested24 and the field of 
transcatheter repair and replacement of the mitral valve is expected to grow further in the 
following years.  It is clear, therefore, that the next important step in the field of percutaneous 
treatment of structural heart disease will focus on the "forgotten”, tricuspid valve. 

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Several transcatheter devices are being investigated for the treatment of TR.  The devices that 
have been developed can be divided according to the therapeutic target as follows:  
annuloplasty/annular reconstruction devices, coaptation devices, and caval valve implantation 
(CAVI), and leaflet devices.17,18 
Annulopasty/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), which received CE mark in April 2018.  Data from the TRI-REPAIR 
study showed that annular reduction provided significant reduction in EROA and was sustained 
at 6 months.  Clinically and statistically significant improvements in functional status (NYHA Class 
and peripheral edema), quality of life (KCCQ Score) and exercise capacity (6MWD) were observed 
at 6 months.25 
Other annuloplasty devices including 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 MIA annuloplasty implant are 
in the investigational stage. 
The Trialign System is a system that mimics the surgical Kay procedure, with the aim of reducing 
TR by bicuspidization obtained with the plication of the anterior and posterior annulus.  Published 
30-day follow-up results from the SCOUT trial (NCT02574650) showed that the Trialign device 
was safe, successfully reduced annular area and regurgitant orifice, and improved left ventricular 
forward stroke volume.26 
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).18 
The TRAIPTA device is an experimental epicardial Nitinol loop placed around the antrioventricular 
groove providing an external annuloplasty.27  Currently, a new TRAIPTA device for human testing 
is under development.18 
The Millipede IRIS Transcatheter Annuloplasty Ring is a complete simi-rigid annuloplasty ring that 
is placed in the supra-annular position. It has been used for mitral valve repair and is under 
investigation.18 

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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.18 
Coaptation Devices 
The FORMA Tricuspid Transcatheter Repair System (Edwards Lifesciences, Irvine, CA) includes a 
Spacer that is placed in the center of the TV orifice improving leaflet coaptation, thereby aiming 
to reduce the large regurgitant orifice and decrease TR.  One-year follow-up data on 18 patients 
treated 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.28  In addition, 
follow-up data at 24-36 months showed considerable and sustained TR reduction accompanied 
by significant functional improvement.29 In the FORMA Early Feasibility Study (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.30 
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.31,32 Similarly, the ongoing HOVER trial is assessing heterotopic 
implantation of the Edwards-Sapien XT valve in the inferior vena cava (NCT02339974).33 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), which has been approved for mitral 
repair has also been used in the tricuspid valve.  Edge-to-edge tricuspid valve repair with single 
or multiple clip(s) has been successfully used for the treatment of TR in selected high-risk patients 
with malcoaptation of the tricuspid valve.34-37 In a retrospective analysis of 42 cases treated at a 
single center in Germany, successful edge-to-edge repair was achieved in 83% (35/42) patients.36 
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.37  While several case reports and series 

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have been published on the use of the MitraClip System in the treatment of TR, it remains under 
investigation and is being evaluated in the TRILUMINATE study (NCT03227757). 
The Edwards PASCAL System 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.38,39 Evaluation of the PASCAL System in 
treating patients with TR is warranted and clinical cases have been performed under a 
compassionate use setting (summarized in section 1.5). 
1.3 
Intended Use of Device 
The Edwards PASCAL System is intended for patients with tricuspid regurgitation deemed to be 
potential candidates for transcatheter tricuspid valve repair with the PASCAL System by the local 
Heart Team. 
1.4 
Prior Testing 
A Report of Priors contained in the Clinical Investigator’s Brochure (CIB) has been prepared for 
the PASCAL System. This document provides the prior testing conducted on the system 
components for pre-clinical testing, in-vivo testing, and biocompatibility testing. 
1.5 
Prior Clinical Experience With the PASCAL System 
1.5.1 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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Anticipated or potential adverse events that may occur during the study are listed below. These 
events may be associated with the PASCAL System, transcatheter procedure, diagnostic cardiac 
tests (e.g. TEE, TTE, MSCT scan, exercise tolerance, etc.), ancillary procedures or may occur in the 
heart failure population over time. Complications associated with standard cardiac 
catheterization, the use of anesthesia and use of the PASCAL System could lead to the following 
outcomes: conversion to open heart surgery, emergent or non-emergent reoperation, explant, 
permanent disability, or death.  There may also be other risks that are unknown at this time. 
The following anticipated adverse events have been identified as possible complications of 
the PASCAL System and procedure: 
x Abnormal lab values 
x Allergic reaction to anesthetic, contrast, heparin, Nitinol 
x Anemia or decreased Hgb, may require transfusion 
x Aneurysm or pseudoaneurysm 
x Angina or chest pain 
x Anaphylactic shock 
x Arrhythmias – atrial (i.e. AF, SVT) 
x Arrhythmias – ventricular (i.e. VT, VF) 
x Arterio-venous fistula 
x Atrial septal injury requiring intervention 
x Bleeding 
x Cardiac arrest 
x Cardiac failure 
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 permanent pacemaker 
x Deep vein thrombosis (DVT) 
x Deterioration of native valve (e.g. leaflet tearing, retraction, thickening) 
x Dislodgement of previously deployed implant 
x Dyspnea 
x Edema 

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x Electrolyte imbalance 
x Emboli/embolization including air, particulate, calcific material, or thrombus 
x Endocarditis 
x Esophageal irritation 
x Esophageal perforation or stricture 
x Exercise intolerance or weakness 
x Fever 
x Failure to retrieve any PASCAL system components 
x Gastrointestinal bleeding or infarct 
x Heart failure 
x Hematoma 
x Hemodynamic compromise 
x Hemolysis 
x Hemorrhage requiring transfusion or intervention 
x Hypertension 
x Hypotension 
x Implant deterioration (wear, tear, fracture, or other) 
x Implant embolization 
x Implant malposition or failure to deliver to intended site 
x Implant migration 
x Implant thrombosis 
x Infection 
x Inflammation 
x LVOT obstruction 
x Mesenteric ischemia 
x Multi-system organ failure 
x Myocardial infarction 
x Nausea and/or vomiting 
x Nerve injury 
x Neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke 
x Non-neurological thromboembolic events 
x Pain 

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x Papillary muscle damage 
x Paralysis 
x PASCAL system component(s) embolization 
x Peripheral ischemia 
x Pleural effusion 
x Pulmonary edema 
x Pulmonary embolism 
x Reaction to anti-platelet or anticoagulation agents 
x Renal failure 
x Renal insufficiency 
x Respiratory compromise, respiratory failure, atelectasis, pneumonia - may require 
prolonged ventilation 
x Retroperitoneal bleed 
x Septal damage or perforation 
x Septicemia, sepsis 
x Skin burn, injury or tissue changes due to exposure to ionizing radiation 
x Single leaflet device attachment (SLDA) 
x Syncope 
x Stroke 
x Transient ischemic attack (TIA) 
x Tricuspid valve injury 
x Tricuspid valve stenosis 
x Urinary tract infection and/or bleeding 
x Vascular injury or trauma, including dissection or occlusion 
x Valvular regurgitation 
x Vessel spasm 
x Ventricular wall damage or perforation 
x Wound dehiscence, delayed or incomplete healing 
x Worsening of heart failure 
x Worsening tricuspid regurgitation / valvular insufficiency 

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There may be other risks that are unknown at this time. All safety events will be collected and 
reviewed throughout the entire 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. 
3.2 
Minimization of Risks 
All efforts will be made to minimize the identified risks by taking the following measures: 
x Selection of investigators in this study: Interventional Cardiologist – 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 
PASCAL 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). 
3.3 
Potential Benefits 
The potential benefits associated with the use of the PASCAL System are related to eliminating 
the need for open chest surgery and cardiopulmonary bypass associated with surgical mitral 
repair/replacement by using a percutaneous approach. The potential benefits to patients are 
expected to be similar to those of other leaflet repair transcatheter devices. The benefits may 
include but are not limited to, the following: 

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x Delay in time to first surgical tricuspid valve replacement/repair and cardiopulmonary 
bypass 
x Elimination of need for surgical tricuspid valve replacement/repair and cardiopulmonary 
bypass, thus reducing incidence of: 
i. 
Reoperation due to cardiac complications 
ii. 
Myocardial infarctions  
iii. 
Neurological complications (i.e. TIA, stroke) 
iv. 
Infections 
v. 
Pulmonary complications (i.e. pulmonary edema) and the need for mechanical 
ventilation support required after the procedure 
vi. 
Need for blood transfusions due to bleeding 
vii. 
Post-procedural arrhythmias 
viii. 
Pain and complications (i.e. deep wound infection) associated with sternotomy 
or thoracotomy 
ix. 
Overall recovery time, including a reduction in the time spent in the intensive 
care unit 
x The ability to reliably assess post-placement tricuspid regurgitation during the valve 
repair procedure (because the heart has not been arrested) 
x Clinical improvement (e.g. NYHA Class, 6 minute walk test) 
x Overall advancement of medical and scientific knowledge which may benefit future 
patients with similar conditions may be gained through this clinical study.  
x There may also be other benefits that are unknown at this time 
3.4 
Justification For Clinical Study 
This study, the first with the PASCAL System in the United States, is designed as a prospective, 
single arm, multi-center, early feasibility study. This study is designed to assess the safety and 
performance of the PASCAL System in the treatment of TR. 
Treatments currently available for this patient population include medical therapy, surgical 
replacement or repair of the tricuspid valve, and alternative investigational transcatheter 
tricuspid valve repair systems (e.g. Edwards FORMA or Cardioband, Abbott MitraClip). 

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4 STUDY OBJECTIVES 
The objectives of this early feasibility study are to: 
x Evaluate the safety and performance of the PASCAL System 
x Provide guidance for future clinical study designs utilizing the PASCAL System 
x Provide guidance for future PASCAL System developments 
Data collected in this clinical study will include safety and performance of the investigational 
system, as well as up to 5-year clinical outcomes. 
5 FEASIBILITY ENDPOINTS 
5.1 
Safety Endpoint 
Safety will be analyzed as a composite endpoint of Major Adverse Events (MAEs) at 30 days which 
includes: 
x Cardiovascular mortality 
x Myocardial infarction (MI) 
x Stroke 
x Renal complications requiring unplanned dialysis or renal replacement therapy 
x Severe bleeding* 
x Unplanned or emergency re-intervention (either percutaneous or surgical) related to 
the device 
x Major access site and vascular complications requiring intervention 
5.2 
Performance Endpoints 
5.2.1 Device Success 
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.  Per device analysis. 
                                                     
 
* Severe bleeding includes fatal, life-threatening, extensive, or major bleeding, as defined by MVARC 
[see also Appendix A: Study Definitions] 

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5.2.2 Procedural Success 
Device success with evidence of a reduction in TR grade by at least one grade (scale: none/trace, 
mild, moderate, severe, massive, torrential*9) at end of procedure, and without the need for a 
surgical or percutaneous intervention prior to hospital discharge.  Per patient analysis. 
5.2.3 Clinical Success 
Procedural success without MAEs at 30 days.  Per patient analysis. 
5.3 
Echocardiographic, Clinical, and Functional Endpoints and Parameters 
5.3.1 Echocardiographic Endpoints and Parameters 
A. Reduction in TR severity (assessed by TR grade and quantitative measures) as assessed by TEE 
pre- and post-implant in the procedure room. 
Additional echocardiographic parameters will be compared to baseline: 
B. TTE parameters assessed at baseline, discharge, 30 days, 6 months, 1 year and annually until 
5 years post procedure: 
1. TR grade 
2. Vena Contracta (2D) 
3. EROA (PISA/2D or 3D/3D color Doppler) 
4. Regurgitant volume 
5. Tricuspid annular dimensions  
6. TV inflow gradient 
7. Cardiac output 
8. Right ventricle dimensions 
9. Right atrium volume 
10. Left ventricular Ejection Fraction 
11. Inferior Vena Cava dimensions/respiratory variations 
12. Hepatic vein flow reversal 
13. Pulmonary artery pressure (mean) 
14. Right ventricular function 
                                                     
 
* The TR grading scale used to determine procedural success is based on the scale proposed by Hahn and 
Zamorano (scale: none/trace, mild, moderate, severe, massive, torrential), while patient eligibility is based on 
the grading scale presented in the current ASE guidelines (Zoghbi et al., JASE 2017). 

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5.3.2 Clinical and Functional Endpoints and Parameters 
Clinical and Functional Endpoints – assessed at baseline and at various time points, depending 
on the parameter (see Table 11) 
A. All-cause mortality 
B. Heart failure hospitalizations 
C. Unplanned or emergency re-intervention (either percutaneous or surgical) related to the 
device 
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. Quality of life and functional status assessed by: 
1. NYHA Classification 
2. 6-Minute Walk Test (6MWT) 
3. KCCQ 
4. Short Form Health Survey (SF-36) 
Clinical and Functional Parameters 
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 
D. Electronic Diary (eDiary)*:  Administered via a handheld device as follows: 
1. Baseline:  Question(s) from PROMIS Mood questionnaire, Visual Analog Scale (VAS), 
and KCCQ-12 will be administered daily for a minimum of 2 weeks before the index 
procedure and then paused at time of admission for index procedure. 
2. Post discharge:  Starting post discharge, question(s) will be administered daily for 7 
days, every other week, to the 12-month follow-up visit. 
3. 12-month follow-up visit:  Starting at the 12-month follow-up visit, question(s) will be 
administered daily for a week, up to 7 days. 
                                                     
 
* 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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E. Activity Monitoring*: Administered via a wearable monitor as follows: 
1. Baseline: Activity monitoring will occur for a minimum of 2 weeks before the index 
procedure and then paused at time of admission for index procedure 
2. 30 days post discharge 
3. 2 weeks at 3 months, 6 months, 9 months, and 12 months post index procedure. 
F. General Clinical and Laboratory Parameters assessed by: 
1. Creatinine, BUN, uric acid, and eGFR 
2. Liver Panel (Albumin, Bilirubin, ALP, ALT, AST, GGT) 
G. Diuretic medications and doses (No change in current or new addition to diuretics are 
allowed for at least 3 months post procedure unless medically required, i.e. severe 
hypotension, or signs and symptoms of hypervolemia.) 
5.3.3 Additional Safety Assessments 
In addition to the above endpoints and parameters, a listing of all the AEs and SAEs for the entire 
study population will be provided. 
6 STUDY DESIGN 
This is a prospective, single arm, multi-center, early feasibility study designed to evaluate the 
safety and performance of the PASCAL System in the treatment of symptomatic severe tricuspid 
regurgitation (TR). 
Up to 65 patients (pending FDA approval) will be enrolled in the study at up to 30 investigational 
sites (pending FDA approval) in the US. All enrolled study patients will be assessed for clinical 
follow-up at the following intervals: discharge, 30 days, 6 months, 1 year, and annually for 5 years 
post implant procedure. 
A description of each study visit and required study procedures are included in Section 8, 
Procedures and Methods. In addition, a summary of required procedures is listed in Table 11. 
7 PATIENT POPULATION 
7.1 
Demographic and Clinical Characterisitics 
This clinical study is for adult patients with symptomatic severe tricuspid regurgitation who are 
deemed to be appropriate potential candidates for transcatheter tricuspid repair with the 
PASCAL System as assessed by the Heart Team. 

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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 PASCAL device in the treatment of patients with 
severe TR was 78 ± 5 years, and we expect that this EFS will enroll patients with the same baseline 
characteristics.  Additionally, patients that received the Edwards Cardioband Tricuspid Valve 
Reconstruction System as part of the European TRI-REPAIR study were on average 75.6 ± 6 years 
of age.  Although those patients were not treated with the Edwards PASCAL System, we expect 
that this EFS will enroll patients with similar baseline characteristics as those studied under the 
TRI-REPAIR protocol, as well.  Therefore, we expect that participants will qualify for Medicare 
coverage through the age criteria and we anticipate that the results of this study will be 
generalizable to the Medicare population. 
All patients who meet the initial study eligibility requirements will be evaluated for study 
participation. 
Candidates for this study must meet all of the following inclusion criteria and none of the 
exclusion criteria. 
7.2 
Inclusion Criteria 
Patients enrolled must meet ALL of the following criteria: 
1. Age ш 18 years old 
2. Symptomatic despite optimal medical therapy per local Heart Team 
3. Functional or degenerative TR graded as severe* as assessed by the echo core lab 
4. The local site Heart Team determines that the patient is appropriate for transcatheter 
tricuspid valve repair 
5. Patient is willing and able to comply with all specified study evaluations and provides 
written informed consent. 
7.3 
Exclusion Criteria 
Potential patients will be excluded if ANY of the following criteria apply: 
1. Echocardiographic parameters (any of the following): 
a. Tricuspid valve anatomy precluding proper device deployment and function, including: 
                                                     
 
* The TR grading scale used to determine procedural success is based on the scale proposed by Hahn and 
Zamorano (scale: none/trace, mild, moderate, severe, massive, torrential), while patient eligibility is based on 
the grading scale presented in the current ASE guidelines (Zoghbi et al., JASE 2017). 

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i. Evidence of severe calcification in the annulus or subvalvular apparatus 
ii. Evidence of moderate to severe calcification in the grasping area 
iii. Excessive chordae structure in the grasping area 
iv. Presence of perforation in the grasping area 
v. Leaflet length < 8 mm 
vi. Septo-lateral coaptation gap > 10 mm 
vii. Severe leaflet tethering or immobile leaflet 
b. LVEF < 30% 
c. 
Severe right ventricular dysfunction as assessed by the core lab 
2. Primary non-degenerative tricuspid disease (e.g. carcinoid, rheumatic, endocarditis, 
traumatic, pacemaker lead-induced, iatrogenic, tricuspid stenosis) 
3. Previous tricuspid valve repair or replacement that would interfere with placement of 
PASCAL. 
4. Presence of trans-tricuspid pacemaker or defibrillator leads which: 
a. Would prevent proper TR reduction due to interaction of the lead with the leaflets 
b. Were implanted in the RV within the last 3 months 
5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation 
6. Active endocarditis within 3 months of the scheduled implant 
7. Hemodynamically significant pericardial effusion 
8. Intra-cardiac mass, thrombus, or vegetation 
9. Untreated clinically significant coronary artery disease requiring revascularization 
10. MI or known unstable angina within 30 days prior to the index procedure 
11. Any invasive cardiac procedure within 30 days prior to the index procedure 
12. Any cardiac surgery within 3 months prior to procedure 
13. Suspicion of pericardial adhesions that may preclude leaflet approximation (e.g. post 
pericarditis, constrictive pericarditis, calcifications visible on imaging) 
14. Hemodynamic instability or on IV inotropes unless part of prehabilitation 
15. Severe uncontrolled hypertension (SBP ш 180 mmHg and/or DBP ш 110 mmHg) 
16. Pulmonary systolic pressure > 60 mmHg as assessed by echo core lab 
17. Stroke or transient ischemic attack (TIA) within the past 30 days 
18. Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) ч 30 mL/min/1.73 m2 
or patient is on chronic dialysis 

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19. 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) 
20. Significant frailty (i.e. Katz Index of Independence in Activities of Daily Living (ADL) ч 2) 
within 3 months of scheduled implant 
21. Continuous home oxygen for primary severe COPD 
22. Chronic anemia (Hgb < 9 g/dL) not corrected by transfusion 
23. Thrombocytopenia (Platelet count < 100,000/mm3) or thrombocytosis (Platelet count > 
750,000/mm3) 
24. Bleeding disorders or hypercoagulable state 
25. Active peptic ulcer or active gastrointestinal (GI) bleeding within 3 months of the scheduled 
implant 
26. Contraindication to anticoagulants or antiplatelet agents 
27. Current, or history of, IV drug use 
28. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 
hours before any study-related radiation exposure 
29. Patients in whom transesophageal echocardiography is contraindicated. 
30. In the opinion of the investigator, access to the femoral vein with a 22 FR guide is deemed 
not feasible (e.g. IVC filter, DVT, occluded femoral veins). 
31. Untreatable hypersensitivity or contraindication to any of the following: 
a. Aspirin and Clopidogrel and Ticlopidine 
b. Heparin and Bivalirudin, or Warfarin 
c. 
Nitinol Alloys (Nickel and Titanium) 
d. Contrast media 
32. Currently participating in another investigational biologic, drug or device study that has not 
completed the primary endpoint or that clinically interferes with the endpoints of this 
study. 
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 atrial septal 
defect, RV dysplasia, and arrhythmogenic RV. 
35. Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient’s 
ability to participate in the study, including compliance with follow-up requirements, or that 
could impact the scientific integrity of the study. 
36. Patient is under guardianship. 

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7.4 
Study Exit Criteria and Procedures 
The reason for study exit will be documented on the appropriate case report forms and in the 
medical records for each patient who exits the study. 
Patients may exit the study for any of the following reasons: 
x Screen Failure 
x Study Device Attempted But Not Implanted 
o Enrolled patients for whom the implant procedure was prematurely aborted 
(e.g., entered procedure room and anesthesia induced, but study procedure not 
attempted (i.e. skin incision to introduce the PASCAL System) or TTVr procedure 
attempted but did not receive a study device, will be followed for 30 days for 
safety evaluations only or until resolution of any adverse events related to the 
implant procedure and then exited from the study. 
x Study Device Re-intervention/Explant 
o Patients who have a surgical re-intervention where the device is explanted will 
be followed for 30 days post-re-intervention for safety evaluations only or until 
resolution of any adverse events related to the re-intervention and then exited 
from the study.  Patients who have a percutaneous re-intervention where the 
study device remains in place will continue to be followed for the duration of 
the study. 
x Completion per Protocol 
x Withdrawal 
o Patient Withdrawal:  The 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:  The 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 Death 
x Lost to Follow-up 
o If a patient cannot be reached for a follow-up visit, the Investigator will 
document the contact efforts made to the patient and/or effort to obtain 
hospital records in the appropriate electronic case report form. If the patient 
cannot be reached in any way, or misses a visit, the patient will be considered 
“unable to contact” for that time interval. After three (3) documented 
unsuccessful attempts to make contact prove unsuccessful, a certified letter will 

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be sent to the patient’s residence. If there is no response after the certified 
letter is sent, the patient will be considered “lost to follow-up”. 
o For patients who are lost to follow-up or withdraw early, Sponsor may request 
the site to search the Social Security Death Index and/or other death registries 
and may request the site to obtain the death certificate, if applicable. 
x In all cases of withdrawal (as described above), withdrawn patients will not undergo 
further study follow-up procedures after the time of study exit. A study patient who has 
been withdrawn from the study will not be replaced. 
x All data collected up until the time of withdrawal, including imaging studies such as 
echocardiography scans, will be analyzed in encrypted form and will be kept in 
encrypted form for the entire duration of the study. 
8 PROCEDURES AND METHODS 
8.1 
Site Personnel Training 
To ensure proper device usage, uniform data collection and protocol compliance training is 
required for relevant study site personnel in accordance with the roles outlined in the Individual 
Delegation of Authority Log. 
At the beginning of the study, the Sponsor will provide training to site personnel.  Training will 
include the Instructions for Use (IFU) of the device, study protocol, case review process, 
identification of eligible patients, instructions on data collection, standardized data collection for 
core laboratory analysis, methods for soliciting data from alternative sources and regulatory 
requirements. 
Ongoing training may be provided in one of the following formats by the Sponsor or its designee: 
live training sessions, teleconference, WebEx, online or read and review.  Retraining may be 
performed for sites who have demonstrated protocol or implant procedure compliance issues. 
Documentation of site personnel qualifications and training should be maintained in the site’s 
clinical study files and copies collected and forwarded to the Sponsor. 

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8.2 
Device and Procedure Training 
Investigators performing the implant procedure will receive device training, prior to patient 
enrollment that includes: 
x Didactic session – presentations outlining the functionality of the device and all 
procedural steps with an in-depth discussion on the unique aspects of the system. 
x Hands on session – bench-top simulator deployments providing a simulated clinical 
experience. 
The Investigator formal training will be performed by the Study Sponsor prior to patient 
enrollment at the study site. 
Sponsor or affiliated personnel shall be available to assist with the technical aspects of the 
device/procedure.  Training will be documented. 
8.3 
Informed Consent 
The 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 by providing them 
an overview of the study including the background, risks, benefits and study procedures. If 
patients are interested in participating in the study, the patient will sign the Institutional Review 
Board (IRB) approved informed consent form (ICF) prior to any study-specific procedures being 
performed. 
The Sponsor must approve any modifications to the ICF prior to submission to the IRB, and/or 
FDA (as required).  A sample ICF is provided in Appendix D: Sample Informed Consent Form. 
Once the Investigator has determined the patient’s eligibility, the patient must sign the 
institution’s IRB-approved ICF prior to participation.  Failure to provide informed consent renders 
the patient ineligible for the study. 
The ICF will be written in the native language of the patient and administered only by the 
Investigator or IRB-approved personnel who speaks the native language of the patient.  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 
Patient Enrollment 
A Screening/Enrollment Log will be maintained to document the screening and enrollment of all 
patients assessed for study participation.  The screening of patients qualifying for this study 
should be such that all patients are offered the possibility of participating and are therefore 
evaluated according to the selection criteria defined in this protocol.  Patients who are consented 
to participate in the study, but do not fulfill enrollment criteria, will be considered “screen 
failures” and will not count towards the overall enrollment cap.  The reason for “screen failure” 
will be documented. 
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. 
Patients will be considered “provisionally enrolled” when they have signed the ICF agreeing to 
participate in the study and have been deemed eligible for study participation by meeting the 
study criteria (Sections 7.2 and 7.3). 
A patient will be considered “enrolled” at the time of skin incision to introduce the PASCAL 
System into the body. 
8.5 
Imaging Assessments 
Imaging assessments (TTE, TEE) shall be performed according to the current version of the core 
lab echocardiographic acquisition protocol. 
8.6 
Screening/Baseline Assessments 
The following procedures and measurements will be performed during this visit (Table 4; refer to 
Table 5 for assessment windows): 

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9 DEVICE MANAGEMENT 
9.1 
Device Shipment 
Devices will be transported to the study site when the Clinical Study Agreement is in place, the 
study site has obtained applicable regulatory (e.g. IRB, FDA) approvals, and a patient eligible for 
implant has been identified. 
Devices will be provided to the study site as needed 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 
participating study sites by Study Sponsor personnel and will be accompanied by delivery of 
investigational device documentation (e.g. IFU, packing lists, transfer of investigational product 
form, etc.).  The Investigator(s) or designee will take inventory of the product and complete the 
delivery documentation with receipt date and signature. Both the study site and the Study 
Sponsor will retain copies of these documents.  The Investigator or designee will maintain a 
Device Accountability Log (as provided by the Sponsor) of all investigational devices documenting 
their receipt, disposition and return during this clinical study.  The log will be kept with the 
documents for the clinical study and will be available for review during Study 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 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 designee. 
9.4 
Device Return 
The Investigator will receive instructions from the Sponsor on the return process (e.g. Sponsor 
request, study is terminated, or product expiration, etc.).  All investigational devices must be 
returned to Edwards Lifesciences and the date of return must be recorded on the log.  All unused 
devices in original package and/or those in opened packages as well as those removed from the 

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original package will be returned upon receipt of this notice.  The Investigator’s copy of the 
Device Accountability log must document any unused devices that have been returned. 
Used devices may be handled and disposed of in the same manner as hospital waste and bio-
hazardous materials in accordance with local regulations. There are no special risks related to the 
disposal of these devices.  All returns and dispositions of devices will be captured on the Device 
Accountability Log. 
10 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 Case Report Forms (CRFs) 
Electronic case report forms (eCRFs) will be used to collect patient data during the study.  The 
Investigator, or an individual 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 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. 
11 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 or withdrawal of consent). 

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11.1 Definitions 
11.1.1 Adverse Event 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in patients, users, or other 
persons, whether or not related to the investigational medical device. 
11.1.2 Serious Adverse Event 
A serious adverse event (SAE) is an adverse event that: 
x Results in death 
x Is life-threatening 
x Requires inpatient hospitalization or prolongation of existing hospitalization 
x Results in persistent or significant disability/incapacity, or 
x Is an important medical event which may jeopardize the patient, and may require 
medical or surgical intervention to prevent one of the above outcomes 
A planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigation plan (CIP), without a serious deterioration in health, is not considered a serious 
adverse event. 
11.1.3 Anticipated Adverse Events 
Anticipated adverse events are AEs that have been identified in the CIP, IFU, and informed 
consent as possible adverse events. 
11.1.4 Unanticipated Adverse Device Effect (UADE) 
Unanticipated adverse device effect (UADE) 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. 
11.2 AE Reporting Requirements 
The Investigator will report all adverse events to the Sponsor as soon as possible, but no later 
than 10 working days after the Investigator first learns of the event. 

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Each adverse event 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. 
At the time of initial notification, the following minimal information must be provided:  
x Study site number 
x Patient ID number 
x Site’s awareness date 
x AE description 
x Causal relationship to device and implant procedure, if known 
The site will provide the Sponsor copies of relevant supporting source documentation (e.g. 
admission H&P, implant procedure report, discharge summary, echocardiogram and laboratory 
results) for all adverse events requiring CEC adjudication (at a minimum, safety endpoints) and 
those events determined by the Sponsor to require additional investigation. 
Adverse events must be followed until resolution, the patient is lost to follow-up, the patient has 
withdrawn consent, or the adverse event is otherwise explained. 
The Investigator will inform their IRB and FDA of adverse events 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 requiring 
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 without signs or symptoms of 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 adverse 
event 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 reported prior to patient enrollment will not be 
recorded as an AE. In the event there is a worsening in the pre-existing medical condition or 
symptoms due to the device, implant procedure, or study-related procedures, 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 adverse event 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 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. 
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 

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were 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. 
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 study 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. 
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). 
11.7 Sponsor Assessment and Reporting 
The Sponsor is responsible for the classification and reporting of adverse events and ongoing 
safety evaluation of the clinical investigation in accordance with 21 CFR 812. 
All AEs will be reviewed by the Sponsor’s Clinical Safety department. Each AE will be assessed for 
seriousness, device and procedure relatedness, and whether it was anticipated or not anticipated 
(based on the list of potential risks provided in section 3.1). In case of disagreement between the 
Sponsor or CEC and the Investigator, the Sponsor will communicate both opinions to concerned 
parties, as necessary. 
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 unanticipated adverse device effect (UADE) to FDA as 
soon as possible, but no later than 10 working days after first receiving notice of the effect. 

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11.8 Investigational Device Explants 
An Edwards’ study device that is explanted at any time with an allegation of device malfunction 
or deficiency, should be returned to the Sponsor for evaluation. All other explants should be 
discarded. 
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. Patients will then be exited from the study once AE(s) resolved or 180 days post-
explant, whichever comes first. Return kits for explanted devices will be provided upon request 
by the clinical monitor or study team. 
11.9 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. 
12 STATISTICAL ANALYSIS 
12.1 Sample Size 
This clinical study will enroll up to 65 patients (pending FDA approval). 
 
 
 
12.2 Analysis Populations 
12.2.1 Intention-to-Treat (ITT) Population 
The intention-to-treat (ITT) population includes all patients who signed informed consent, met 
eligibility criteria, and in whom the study procedure has been attempted (i.e. skin incision to 
introduce the PASCAL System). 
The ITT population will be used for performance endpoints and safety analysis. 

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12.2.2 As-Treated (Implanted) Population 
The as-treated (implanted) population is a subset of the ITT population and includes all patients 
in whom the study device is implanted and remains in position at the time of the patient’s exit 
from the procedure room. 
The as-treated (implanted) population will be the primary analysis population for performance 
and additional safety assessment. 
12.2.3 Per-protocol (PP) Population 
The per-protocol (PP) population is a subset of as-treated (implanted) population in whom there 
are no major inclusion/exclusion criteria-related deviations. 
Additional analyses of performance and safety data using the PP population will be performed if 
there is a clinically meaningful difference from the as-treated population. 
12.3 Statistical Analysis 
Descriptive analyses will be performed for all study endpoints and parameters. 
For continuous variables, data will be summarized using the number of observations, mean, 
median, standard deviation, minimum, maximum, and 95% confidence intervals (based on 
normal distribution). Nonparametric techniques may be used if the data does not meet the 
assumptions of parametric tests. 
For categorical variables, data will be summarized using the number of observations, 
percentages, and 95% confidence intervals. 
For time-to-event variables, survival analysis will be used to analyze the data. Summary data 
including the number of patients at risk and number of patients with the event will be provided. 
Patients without events will be censored at their last known event-free time point. Time to first 
event curves will be constructed using Kaplan-Meier estimates. 
For selected variables, in addition to descriptive summary statistics at each follow-up 
assessment, change from baseline to subsequent time point will be summarized. Paired (i.e., 
patients with available data at both baseline and respective time point) and unpaired data will 
be presented separately for selected variables. In general, patients with missing baseline or 
following-up values will be excluded from the analysis unless otherwise specified. 

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12.4 Safety and Performance Endpoint Analysis 
12.4.1 Safety Endpoints 
The safety endpoint for this clinical study is a composite endpoint of Major Adverse Events 
(MAEs) at 30 days.  No hypothesis testing will be performed for this endpoint. MAE endpoint and 
its components will be summarized by counts, percentage and 95% Confidence Interval (CI) of 
the percentage. CEC-adjudicated data will be used in the analysis. 
12.4.2 Performance Endpoints 
All performance endpoints will be summarized by counts and percentages. 
The device success endpoint will be evaluated on a per device basis. 
The procedure and clinical endpoints will be evaluated on a per patient analysis. 
12.5 Analysis of Other Endpoints and Parameters 
Echocardiographic data will be evaluated by a core laboratory. The change from baseline for 
selected TTE and TEE parameters will be summarized for each of the pre-specified follow-up time 
points. 
All-cause mortality rates will be computed using binary proportion or Kaplan-Meier method. 
Heart failure re-hospitalization rates, unplanned or emergency re-intervention (either 
percutaneous or surgical) rates related to the device, and composite of MAEs at pre-specified 
follow-up periods will be summarized with counts and percentages. 
Change from baseline in NYHA Functional Classification and Edema assessment will be presented 
as shift from baseline for each of the pre-specified follow-up periods.  
For other continuous endpoints and parameters, change from baseline at pre-specified follow-
up time points will be summarized by mean and standard deviation. For other categorical 
endpoints and parameters, summary statistics including number of observations, percentage, 
and 95% confidence intervals will be provided. 
12.6 Additional Safety Analysis 
A listing of all the AEs and SAEs for the ITT population will be provided. 
12.7 Treatment of Missing or Spurious Data 
Unless otherwise specified, all analysis will be based on available data only. 

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12.8 Analysis Software 
Unless otherwise specified, all analyses will be performed using SAS®, version 9.4 or later. 
13 MONITORING 
The Sponsor, or its designee, will monitor and manage the data for the investigational study. 
The clinical contact on behalf of the Sponsor will be: 
 
 
 
 
 
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.  
A study monitor will be assigned to monitor the progress of the study by the Sponsor.  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 ICF 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. 
13.1.1 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 

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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 and applicable regulatory body approvals 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. 
Periodic monitoring visits will be made at the enrolling study site in accordance with site 
enrollment rates. The study site should be monitored a minimum of twice per year by the study 
monitor. 
Upon termination or conclusion of the study, the study monitor will perform a close-out visit. 
13.2 Protocol Deviations 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 

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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 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. 
13.3 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. 
14 CLINICAL STUDY BOARDS 
14.1 Data Safety Monitoring Board (DSMB) 
The Data Safety Monitoring Board is responsible for reviewing aggregate safety data reported 
during the study and assessing whether the overall safety of the study remains acceptable. DSMB 
activities, including roles and responsibilities, procedures, and monitoring criteria will be defined 
in the DSMB Charter. 
14.2 Clinical Events Committee (CEC) 
The Clinical Events Committee is responsible for reviewing and adjudicating specified individual 
adverse events over the course of the study.  CEC activities, including roles and responsibilities, 
procedures, and definitions will be defined in the CEC Charter. 

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15.2 Data Protection and Patient Confidentiality 
The Sponsor is dedicated to maintaining the confidentiality and privacy of patients who volunteer 
to participate in the study.  The Investigator is responsible for maintaining confidentiality 
throughout the clinical study. 
All data used in the analysis and reporting of this evaluation will be without identifiable reference 
to the patient (patient identifiers include, but are not limited to: patient’s name/initials, social 
security number or equivalent, and medical/hospital number).  Authorized personnel assigned 
by the Sponsor will have access to the confidential files and will have the right to inspect and 
copy 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 (for example, the General Data Protection 
Regulation 2016/679 (“GDPR”) for EU patients), including providing notice and obtaining patient 
consent regarding the processing of their personal data. 
15.3 Institutional Review Board Approval 
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. 

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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 
15.5.1 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. 
The Investigator is responsible for obtaining and maintaining IRB approval for the study at his/her 
study site.  If there is a change or addition of an Investigator, all required documents must be 
updated, accordingly. 
15.5.2 Investigator Records 
Records to be maintained by the Investigator include, but are not limited to, the following: 
x Clinical study protocol and all amendments 
x Signed Clinical Trial Agreement (CTA) and any amendments 
x IRB approval letters, including continuing reviews and all amendments/changes 
x IRB-approved informed consent documents 
x All correspondence with another Investigator, IRB, Sponsor, Monitor or FDA, including 
required reports 
x Records of receipt, use or disposition of a device 
The following records must be maintained for each patient enrolled in the study: 
x Signed ICF and documentation of informed consent process 
x All relevant source documentation for study visits and study-related procedures 
including Investigator assessment of clinically significant or non-clinically significant 
findings (e.g. abnormal ECG, out-of-range lab values, etc.) 
x Supporting documentation of any adverse events 

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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. 
Upon study completion, the study files must be maintained in a known location for a period in 
accordance with local regulatory requirements. 
15.5.3 Investigator Reports 
In addition to adverse event reporting requirements discussed in Section 11, the following 
reports are required: 
x Withdrawal of IRB approval.  Within five (5) business days, the Investigator will report a 
withdrawal of approval by the reviewing IRB of the Investigator’s part of an investigation 
to the Sponsor. 
x Informed Consent.  If an Investigator uses a device without obtaining informed consent, 
the Investigator shall report such use to Sponsor and the reviewing IRB within five (5) 
working business days after the use occurs. 
x Progress reports. The Investigator will submit progress reports on the investigation to 
Sponsor and the IRB at least yearly. 
x Final Report.  Upon completion or termination of this Study, the Investigator must 
submit a final written report to Sponsor and the IRB as required by the regulations.  The 
report must be submitted within three (3) 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. 
15.6 Sponsor Responsibilities 
15.6.1 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. 

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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. 
15.6.2 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. 
15.6.3 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. 
15.6.4 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. 
15.6.5 Sponsor Reports 
The Study Sponsor will prepare and submit the following accurate and complete reports to the 
IRB and the pertinent regulatory agencies in a timely manner: 
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. 

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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 the request was made and should 
include the reason for the device recall. 
x A final written report is to be completed and submitted to IRB and the pertinent 
regulatory agencies within six (6) 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. 
15.7 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. 
15.8 Audits and Inspections 
The study may be subject to a quality assurance audit by the Sponsor or a designee, as well as 
inspection by appropriate regulatory authorities.  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. 
15.9 Publication Policy 
Publication or presentation of the overall clinical study results and/or site-specific results requires 
prior written approval of Edwards.  If Edwards approves the publication or presentation of the 
overall clinical study results and/or site-specific results, then Institutions and Investigators will 
comply with the Publications and Public Disclosure Section of the Clinical Trial Agreement.  
Edwards may provide statistical support for the publication process. 
The study results will be made public within 24 months of the end of data collection and a full 
report of the outcomes. 

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APPENDIX A: STUDY DEFINITIONS 
Endpoints identified in the CEC Charter will be adjudicated by the independent CEC. A detailed 
CEC Charter will further define the endpoint definitions. In case of inconsistency between the 
protocol and the CEC Charter, the CEC Charter will be the final determining document. 
Access Site 
(Sponsor Definition) 
Site of insertion of study device components. 
Access Site and Vascular Complications  
(MVARC Definition) 
I. Vascular complications 
x. 
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 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 
xi. 
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 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) 

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II. Cardiac structural complications due to access-related issues 
i. 
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 
ii. 
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 
Access Site and Vascular Complications Requiring Intervention 
(Sponsor Definition) 
Complications (i.e. dissection, perforation, arteriovenous fistula, pseudoaneurysm formation, 
retroperitoneal hemorrhage, thromboembolism) requiring intervention (percutaneous or 
surgical). 
*refer to MVARC definition above for definition of access site and vascular complications 
Activity Monitoring 
The continuous tracking of physical activity through the use of a patient deployed wearable 
monitoring device 
Acute Kidney Injury (AKI) 
(MVARC) 
Defined per MVARC as maximal change in serum Creatinine (sCR) from baseline to 7 days 
post-procedure. 
Stage 1:  Increase in sCr to 150%–199% (1.50–ϭ͘ϵϵǆŝŶĐƌĞĂƐĞǀƐ͘ďĂƐĞůŝŶĞͿ͕ŝŶĐƌĞĂƐĞŽĨшϬ͘ϯ
ŵŐͬĚů;шϮϲ͘ϰŵŵŽůͬůͿǁŝƚŚŝŶϰϴŚ͕ŽƌƵƌŝŶĞŽƵƚƉƵƚфϬ͘ϱŵůͬŬŐͬŚĨŽƌшϲŚďƵƚфϭϮŚ 
Stage 2:  Increase in sCr to 200%–299% (2.00–2.99 x increase vs. baseline) 
or urine output фϬ͘ϱŵůͬŬŐͬŚĨŽƌшϭϮŚďƵƚфϮϰŚ 
Stage 3:  /ŶĐƌĞĂƐĞŝŶƐƌƚŽшϯϬϬй;хϯ͘ϬǆŝŶĐƌĞĂƐĞǀƐ͘ďĂƐĞůŝŶĞͿ͕ƐƌŽĨшϰ͘ϬŵŐͬĚů;шϯϱϰ
ŵŵŽůͬůͿǁŝƚŚĂŶĂĐƵƚĞŝŶĐƌĞĂƐĞŽĨшϬ͘ϱŵŐͬĚů;ϰϰŵŵŽůͬůͿ͕ƵƌŝŶĞŽƵƚƉƵƚфϬ͘ϯŵůͬŬŐͬŚĨŽƌшϮϰ
Ś͕ŽƌĂŶƵƌŝĂĨŽƌшϭϮŚ͖ƉĂƚŝĞŶƚƐƌĞĐĞŝǀŝng renal replacement therapy are considered stage 3 
irrespective of other criteria 

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Adverse Device Effect 
(ISO 14155:2011) 
Adverse event related to the use of an investigational medical device. 
NOTE 1- This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device. 
NOTE 2- This includes any event that is a result of a use error or intentional abnormal use of 
the investigational medical device 
Bleeding 
(MVARC Definition) 
I.  Minor 
Any overt†, actionable sign of hemorrhage (e.g., more bleeding than would be expected for a 
clinical circumstance, including bleeding found by imaging alone) that 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 bleeding 
KǀĞƌƚďůĞĞĚŝŶŐĞŝƚŚĞƌĂƐƐŽĐŝĂƚĞĚǁŝƚŚĂĚƌŽƉŝŶƚŚĞŚĞŵŽŐůŽďŝŶůĞǀĞůŽĨшϯ͘ϬŐͬĚůŽƌƌĞƋƵŝƌŝŶŐ
ƚƌĂŶƐĨƵƐŝŽŶŽĨшϯƵŶŝƚƐŽĨǁŚŽůĞďůŽŽĚŽƌƉĂĐŬĞĚZAND does not meet the criteria of life-
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  
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). 

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Examples of overt bleeding include: 
x Pseudoaneurysm 
x Retroperitoneal hematoma seen on CAT scan 
x Visible access site hematoma 
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. 
Cardiac Tamponade 
(Sponsor Definition) 
Pressure on the heart that occurs when blood or fluid builds up in the space between the 
heart muscle (myocardium) and the outer covering sac of the heart (pericardium). 
Causality Assessment 
Adverse events will be assessed by the Investigator for causality to the study device and 
index procedure as defined in MEDDEV 2.7/3 revision 3.  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;  

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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 explained by another cause, but additional information may be 
obtained. 
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);  
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;  

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Page 77 of 113 
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). 
Clinical Success 
Procedural success without MAEs at 30 days. Per patient analysis. 
Death 
(MVARC Definition) 
All events with an outcome of death will be classified to determine whether the death was 
related to cardiovascular (CV) or non-cardiovascular (non-CV) cause. 
Although categorizing the initiating or proximate cause of cardiovascular death may be 
difficult, major complications contributing to death should be identified. A diagnosis of non- 
cardiovascular death requires the primary cause to be clearly related to another condition 
(e.g., trauma, cancer, or suicide). For this study purpose, all deaths that are not unequivocally 
related to a non-cardiovascular condition are considered cardiovascular death. 
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) 

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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 
x Homicide 
x Suicide 
x Other noncardiovascular 
Device Deficiency 
(ISO 14155:2011 Definition) 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. This may include malfunctions, use error (outcome of device use was 
different than intended) and inadequacy in the information supplied by the manufacturer. 
Device Embolization 
(ISO 5840-3) 
Dislodgement from the intended and documented original position to an unintended and 
non-therapeutic location 
Device Malfunction 
(FDA 21 CFR 803.3) 
Failure of a device to meet its performance specifications or otherwise perform as intended. 
Performance specifications include all claims made in the labeling for the device. 
Device Migration 
(ISO 5840-3) 
Detectable movement or displacement of the device from its original position within the 
implant site, without embolization. 
Device Success 
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. Per device 
analysis. 

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Embolism 
Free flowing blood clot or lesion material that is located in the systemic or pulmonary 
circulation 
A peripheral embolic event is an operative, autopsy or clinically documented embolus that 
produces symptoms from complete or partial obstruction or a peripheral (noncerebral) 
artery. 
Endocarditis 
An inflammation of the inside lining of the heart chambers and heart valves (endocardium). 
Endocarditis can involve the heart muscle, heart valves, or lining of the heart. 
Enrollment 
Patient will be considered “provisionally enrolled” when they have signed the informed 
consent form agreeing to participate in the study and have been deemed eligible for study 
participation by meeting the study criteria (Sections 7.2-7.3). A patient will be considered 
“enrolled” at the time of skin incision to introduce the PASCAL System into the body. 
Electronic Diary (eDiary) 
The collection of patient reported outcomes (PRO) through a patient deployed computer 
or mobile/handheld/tablet device to administer questions/questionnaires to the patient. 
Explant 
Removal of the study device after completion of the implant procedure for any reason. 
Heart Failure 
A progressive condition that involves a supply-demand mismatch, usually due to loss of 
pumping ability by the heart (heart muscle weakens and gradually loses its ability to pump 
enough blood through the body), generally accompanied by fluid accumulation in body 
tissues, especially the lungs and lower limbs. 
Heart Failure Hospitalization – An unplanned hospitalization that results in at least one 
overnight stay (i.e., where the admission date and the discharge date are different) that 
includes increased signs and/or symptoms of worsening heart failure and requires the 
administration or augmentation of existing heart failure therapy. 
Severe Heart Failure – See NYHA Class IV 
Heart Team 
The ‘HEART Team', for the purpose of this study, must include a minimum of one 
Cardiologist, one Cardiac Surgeon, one Heart Failure specialist, and one Echocardiographer. 

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Hemolysis (Device Hemolysis) 
Rupturing of red blood cells (erythrocytes) and the release of their contents (cytoplasm) into 
surrounding fluids. 
Device hemolysis is defined as hemolysis in or near the investigational device that interferes 
with the function of the device. Device hemolysis related thrombus may be confirmed by 
operation, autopsy, or diagnostically by such methods as echocardiography, angiography, or 
magnetic resonance imaging 
Hospitalization/Re-hospitalization 
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: a hospital stay for ш 24 hours with 
signs and/or laboratory evidence of worsening heart failure AND administration of 
intravenous or mechanical heart failure therapies. An ER stay for ш 24 hours would 
qualify as a CHF 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 subclassified 
into: 
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 
Infection 
Known infection requiring intravenous antibiotics for other than prophylaxis, and/or 
extended hospitalization. 

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Kansas City Cardiomyopathy Questionnaire (KCCQ) 
A health-related quality-of-life measure for patients with congestive heart failure. 
KCCQ-12:  A 12 question abridged and validated version of the full KCCQ 
questionnaire 
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, MI, stroke, renal complications 
requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or 
emergency re-intervention (either percutaneous or surgical) related to the device and major 
access site and vascular complications requiring intervention. 
Modified Rankin Scale 
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 
Myocardial Infarction 
(MVARC Definition) 
Myocardial infarction (MI) classification and criteria for diagnosis is defined as follows: 
I. 
PeriprocĞĚƵƌĂůD/;чϰϴŚŽƵƌƐĂĨƚĞƌ index 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
laboratory ULN (Upper Limit of Normal) PLUS new ST-segment elevation or 
ĚĞƉƌĞƐƐŝŽŶŽĨшϭŵŵŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐ;ŵĞĂƐƵƌĞĚϴϬŵƐĂĨƚĞƌƚŚĞ:-point) 
x The peak CK-MB measured withiŶϰϴŚŽĨƚŚĞƉƌŽĐĞĚƵƌĞƌŝƐĞƐƚŽшϱǆh>EǁŝƚŚ
ŶĞǁƉĂƚŚŽůŽŐŝĐĂůYǁĂǀĞƐŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐŽƌŶĞǁƉĞƌƐŝƐƚĞŶƚ> 
x In the absence of CK-MB measurements and a normal baseline cTn, a cTn (I or 
dͿůĞǀĞůŵĞĂƐƵƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞW/ƌŝƐĞƐƚŽшϳϬǆƚŚĞůŽĐĂl laboratory ULN 
PLUS new ST-ƐĞŐŵĞŶƚĞůĞǀĂƚŝŽŶŽƌĚĞƉƌĞƐƐŝŽŶŽĨшϭŵŵŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐ
(measured 80 ms after the J-point) 

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x The peak CK-DŵĞĂƐƵƌĞĚǁŝƚŚŝŶϰϴŚŽĨƚŚĞƉƌŽĐĞĚƵƌĞƌŝƐĞƐƚŽшϯϱǆh>EǁŝƚŚ
ŶĞǁƉĂƚŚŽůŽŐŝĐĂůYǁĂǀĞƐŝŶшϮĐŽŶƚŝŐƵŽƵƐůĞĂĚƐŽƌŶew persistent LBBB. 
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 
ŶĞǁ>Ϳ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 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. 
‡Adapted with permission from Thygesen et al. 

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Page 83 of 113 
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 
A person with the disease (tricuspid regurgitation) being screened to participate or 
participating in this clinical study 
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 
Peripheral Thromboembolic Event 
See “Embolism” 
Pre-Existing Condition 
A pre-existing condition is one that was present prior to clinical study screening. 
Procedural Success 
Device success with evidence of a reduction in TR grade by at least one grade (scale: 
none/trace, mild, moderate, severe, massive, torrential10) at end of procedure, and without 
the need for a surgical or percutaneous intervention prior to hospital discharge. Per patient 
analysis. 
Prosthesis 
An artificial substitute 
Re-intervention 
(Sponsor Definition) 
Any intervention on the previously implanted study device (repair, alteration or replacement) 
                                                     
 
10 Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J Cardiovasc 
Imaging. 2017;18(12):1342-1343. 

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Page 84 of 113 
Renal Complication (Long-Term) 
Long-term Renal Complication is defined as onset of renal replacement therapy (i.e 
hemodialysis, renal transplant) 
New need for renal replacement therapy 
(Sponsor Definition) 
New need for renal replacement therapy (i.e hemodialysis, renal transplant) 
Screen Failure 
A patient who has signed the consent but, does not fulfill enrollment criteria: does not meet 
the inclusion criteria or who meets at least one of the exclusion criteria. 
Septicemia 
(Sponsor Definition) 
Systemic infection requiring hospitalization and treatment with antibiotics. 
Serious Adverse Event (SAE) 
(FDA 21 CFR 812.3) 
An adverse event that 
x Results in death 
x Is life-threatening 
x Requires inpatient hospitalization or prolongation of existing hospitalization 
x Results in persistent or significant disability/incapacity 
o Is an important medical event which may jeopardize the patient, and may require 
medical or surgical intervention to prevent one of the above outcomes  
Severe Bleeding 
(Sponsor Definition) 
Severe bleeding is a fatal, life-threatening, extensive, or major bleeding, as defined by 
MVARC. 
SF-36 
A survey with 36 questions that results in two scales of mental and physical functioning and 
overall health related quality of life. 
SF-12:  A 12 question abridged and validated version of the SF-36 

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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 
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 
II. TIA: duration of a focal or global neurological deficit ,24 h and neuroimaging does not 
demonstrate a new haemorrhage or infarct 
Confirmation of the diagnosis by at least one of the following:  
x Neurologist or neurosurgical specialist, or 
x Neuroimaging procedure (CT scan or brain MRI) 
x Non-neurologist physician (if neurologist is not available) 
x 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 
 

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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ϭŵZ^ĐĂƚĞŐŽƌǇĨƌŽŵĂŶŝŶĚŝǀŝĚƵĂů͛ƐƉƌĞ-stroke baseline 
 
II.  Non-disabling: mRS score of < 2 at 90 days (or the last available clinical visit with 
ĞǀĂůƵĂďůĞĚĂƚĂͿ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:  
 
1. 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 
2. 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 
3. 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.* 
 
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. 
 

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APPENDIX B: REFERENCES 
1. 
Rodes-Cabau J, Hahn RT, Latib A, et al. Transcatheter Therapies for Treating Tricuspid Regurgitation. 
J Am Coll Cardiol. 2016;67(15):1829-1845. 
2. 
Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll 
Cardiol. 2004;43(3):405-409. 
3. 
Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients 
with valvular heart disease: a report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57-185. 
4. 
Dreyfus GD, Corbi PJ, Chan KM, Bahrami T. Secondary tricuspid regurgitation or dilatation: which 
should be the criteria for surgical repair? The Annals of thoracic surgery. 2005;79(1):127-132. 
5. 
Arsalan M, Walther T, Smith RL, 2nd, Grayburn PA. Tricuspid regurgitation diagnosis and treatment. 
European heart journal. 2017;38(9):634-638. 
6. 
Badano LP, Agricola E, Perez de Isla L, Gianfagna P, Zamorano JL. Evaluation of the tricuspid valve 
morphology and function by transthoracic real-time three-dimensional echocardiography. Eur J 
Echocardiogr. 2009;10(4):477-484. 
7. 
Rodes-Cabau J, Taramasso M, O'Gara PT. Diagnosis and treatment of tricuspid valve disease: 
current and future perspectives. Lancet. 2016;388(10058):2431-2442. 
8. 
Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for Noninvasive Evaluation of Native 
Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in 
Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 
2017;30(4):303-371. 
9. 
Hahn RT, Zamorano JL. The need for a new tricuspid regurgitation grading scheme. Eur Heart J 
Cardiovasc Imaging. 2017;18(12):1342-1343. 
10. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular 
heart disease: The Task Force for the Management of Valvular Heart Disease of the European 
Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). 
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11. Benedetto U, Melina G, Angeloni E, et al. Prophylactic tricuspid annuloplasty in patients with dilated 
tricuspid annulus undergoing mitral valve surgery. The Journal of thoracic and cardiovascular 
surgery. 2012;143(3):632-638. 
12. O'Neill WW, O'Neill BP. Transcatheter tricuspid valve intervention: the next frontier. J Am Coll 
Cardiol. 2015;65(12):1196-1198. 
13. Chang BC, Lim SH, Yi G, et al. Long-term clinical results of tricuspid valve replacement. The Annals of 
thoracic surgery. 2006;81(4):1317-1323, discussion 1323-1314. 
14. Boyd JH, Edelman JJB, Scoville DH, Woo YJ. Tricuspid leaflet repair: innovative solutions. Ann 
Cardiothorac Surg. 2017;6(3):248-254. 
15. Kay JH, Maselli-Campagna G, Tsuji KK. Surgical Treatment of Tricuspid Insufficiency. Ann Surg. 
1965;162:53-58. 

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16. De Vega NG. [Selective, adjustable and permanent annuloplasty. An original technic for the 
treatment of tricuspid insufficiency]. Rev Esp Cardiol. 1972;25(6):555-556. 
17. Taramasso M, Maisano F. Transcatheter tricuspid valve intervention: state of the art. 
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional 
Cardiology of the European Society of Cardiology. 2017;13(Aa):Aa40-aa50. 
18. Grasso C, Popolo Rubbio A, Braun D, Hausleiter J, Nickenig G. Transcatheter treatment of tricuspid 
regurgitation (focusing on current technologies). EuroIntervention : journal of EuroPCR in 
collaboration with the Working Group on Interventional Cardiology of the European Society of 
Cardiology. 2018;14(AB):AB112-AB120. 
19. Godart F, Baruteau AE, Petit J, et al. Transcatheter tricuspid valve implantation: a multicentre 
French study. Arch Cardiovasc Dis. 2014;107(11):583-591. 
20. Kefer J, Sluysmans T, Vanoverschelde JL. Transcatheter Sapien valve implantation in a native 
tricuspid valve after failed surgical repair. Catheter Cardiovasc Interv. 2014;83(5):841-845. 
21. Ribichini F, Pesarini G, Feola M, et al. Transcatheter tricuspid valve implantation by femoral 
approach in trivalvular heart disease. The American journal of cardiology. 2013;112(7):1051-1053. 
22. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in 
Intermediate-Risk Patients. N Engl J Med. 2016;374(17):1609-1620. 
23. Maisano F, Taramasso M, Nickenig G, et al. Cardioband, a transcatheter surgical-like direct mitral 
valve annuloplasty system: early results of the feasibility trial. European heart journal. 
2016;37(10):817-825. 
24. Cheung A, Webb J, Verheye S, et al. Short-term results of transapical transcatheter mitral valve 
implantation for mitral regurgitation. J Am Coll Cardiol. 2014;64(17):1814-1819. 
25. Hausleiter J. Transcatheter tricuspid valve repair: six month follow-up from the multicenter trial. 
Transcatheter Cardiovascular Therapeutics; 2018; San Diego, CA. 
26. Hahn RT, Meduri CU, Davidson CJ, et al. Early Feasibility Study of a Transcatheter Tricuspid Valve 
Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017;69(14):1795-1806. 
27. Rogers T, Ratnayaka K, Sonmez M, et al. Transatrial intrapericardial tricuspid annuloplasty. JACC 
Cardiovasc Interv. 2015;8(3):483-491. 
28. Perlman G, Praz F, Puri R, et al. Transcatheter Tricuspid Valve Repair With a New Transcatheter 
Coaptation System for the Treatment of Severe Tricuspid Regurgitation: 1-Year Clinical and 
Echocardiographic Results. JACC Cardiovasc Interv. 2017;10(19):1994-2003. 
29. Asmarats L. TCT-76: Long-term outcomes following transcatheter tricuspid valve repair with the 
FORMA system. Transcatheter Cardiovascular Therapeutics; 2018; San Diego, CA. 
30. Perlman G. The FORMA Spacer: Technology and Clinical Updates. Transcatheter Cardiovascular 
Therapeutics; 2018; San Diego, CA. 
31. Lauten A, Ferrari M, Hekmat K, et al. Heterotopic transcatheter tricuspid valve implantation: first-in-
man application of a novel approach to tricuspid regurgitation. European heart journal. 
2011;32(10):1207-1213. 

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Page 89 of 113 
32. Lauten A, Figulla HR, Unbehaun A, et al. Interventional Treatment of Severe Tricuspid Regurgitation: 
Early Clinical Experience in a Multicenter, Observational, First-in-Man Study. Circ Cardiovasc Interv. 
2018;11(2):e006061. 
33. O'Neill BP, Wheatley G, Bashir R, et al. Study design and rationale of the heterotopic implantation 
of the Edwards-Sapien XT transcatheter valve in the inferior VEna cava for the treatment of severe 
tricuspid regurgitation (HOVER) trial. Catheter Cardiovasc Interv. 2016;88(2):287-293. 
34. 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. 
35. Braun D, Nabauer M, Orban M, et al. Transcatheter treatment of severe tricuspid regurgitation 
using the edge-to-edge repair technique. EuroIntervention : journal of EuroPCR in collaboration with 
the Working Group on Interventional Cardiology of the European Society of Cardiology. 
2017;12(15):e1837-e1844. 
36. 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 : 
journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the 
European Society of Cardiology. 2018;14(3):e290-e297. 
37. 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. 
38. 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. 
39. Webb J. Compassionate Use of the Edwards PASCAL Mitral Valve System: 6-Month Results. 
Transcatheter Cardiovascular Therapeutics; 2017; Denver, CO. 
40. Sorajja P, Mack M, Vemulapalli S, et al. Initial Experience With Commercial Transcatheter Mitral 
Valve Repair in the United States. J Am Coll Cardiol. 2016;67(10):1129-1140. 
41. Nickenig G, Estevez-Loureiro R, Franzen O, et al. Percutaneous mitral valve edge-to-edge repair: in-
hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel 
Registry. J Am Coll Cardiol. 2014;64(9):875-884. 
42. Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: 
early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-
approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013;62(12):1052-1061. 
43. Hausleiter J, Ruf T, Connelly KA, et al. Novel transcatheter repair system for the treatment of severe 
tricuspid regurgitation. European Society of Cardiology Congress 2018; 2018; Munich, Germany. 
44. 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. 
45. 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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APPENDIX D: SAMPLE INFORMED CONSENT FORM 
 
 

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