PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Phase: NA
Conditions: Persistent Atrial Fibrillation
Sponsor: Boston Scientific Corporation

 
 
 
 
 
 
 
PersAFOne:  
Feasibility Study of the  
FARAPULSE™ Endocardial Multi Ablation System in the Treatment 
of 
Persistent Atrial Fibrillation  
 
 
 
CLINICAL INVESTIGATION PLAN (CIP) NUMBER: CS0607 REVISION E 
 
 
 
SPONSOR: 
FARAPULSE, INC. 
3715 HAVEN AVE.  SUITE 110 
MENLO PARK, CA 94025 
USA 
 
 
 
 
 
ISSUE DATE: 29 JANUARY 2020 
 
 
This document contains confidential and proprietary information and may not be copied or reproduced in 
whole or in part without the express written permission of FARAPULSE, INC., MENLO PARK, CA. 
 
 

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PROTOCOL NO.  CS0607, REVISION E  
 
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CONFIDENTIAL 
 
Revision History 
 
Revision 
Change Description 
A 
Initial Release 
B 
Updated to Reflect Change of System Name 
C 
Correction of typographical errors throughout document 
D 
Skipped for administrative purposes 
E 
• Added use of amiodarone after day of index ablation procedure 
as an additional exclusion criterion (exclusion criteria #14) 
•  Updated clinical experience data for prior clinical 
investigations 
• Added total fluoroscopy dose as an assessment in addition to 
exposure time  
• 
For women of childbearing potential, a pregnanacy test added 
to 6 and 12 mo follow-up visits, in the event that fluoroscopic 
examination of diaphragm is required 
• 
Added revision history table 
• 
Updates to syntax throughout document for clarity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONFIDENTIAL 
 
 
 
TABLE OF CONTENTS 
 
PRIMARY STUDY CONTACTS ...............................................................................................7 
EXECUTIVE SUMMARY ........................................................................................................8 
ABBREVIATIONS AND ACRONYMS .....................................................................................15 
1. 
INTRODUCTION.........................................................................................................17 
1.1 
BACKGROUND AND RATIONALE ......................................................... 17 
1.2 
IRREVERSIBLE ELECTROPORATION (IRE) ........................................... 17 
1.3 
SUMMARY OF FARAPULSE CLINICAL STUDIES ................................. 18 
1.3.1 ENDOCARDIAL ABLATION STUDIES – THE IMPULSE STUDY ..............18 
1.3.2 ENDOCARDIAL ABLATION STUDIES – THE PEFCAT STUDY .................18 
1.4 
RATIONALE FOR CONDUCTING THIS FEASIBILITY STUDY ...................... 19 
2. 
INVESTIGATIONAL DEVICES ....................................................................................21 
2.1 
NAMES OF INVESTIGATIONAL DEVICES ............................................... 21 
2.2 
INTENDED USE ................................................................................ 21 
2.3 
CLASSIFICATION .............................................................................. 21 
2.4 
FARAPULSE ENDOCARDIAL MULTI ABLATION SYSTEM ..................... 21 
2.4.1 FARAWAVE ENDOCARDIAL ABLATION CATHETER SYSTEM .............23 
2.4.2 FARAFLEX ENDOCARDIAL ABLATION CATHETER .............................24 
2.4.3 FARASTAR ENDOCARDIAL GENERATOR SYSTEM ..............................25 
2.4.4 FARADRIVE DEFLECTABLE SHEATH .................................................26 
2.5 
DEVICE ACCOUNTABILITY ................................................................. 26 
2.6 
RETURN OF DEVICES ....................................................................... 27 
3. 
STUDY DESIGN .........................................................................................................28 
3.1 
STUDY OBJECTIVE ........................................................................... 28 
3.2 
STUDY OVERVIEW ........................................................................... 28 
3.3 
SUBJECT CONFIDENTIALITY .............................................................. 28 
3.4 
WRITTEN INFORMED CONSENT ......................................................... 28 
3.5 
STUDY ENTRY CRITERIA .................................................................. 29 
3.5.1 INCLUSION CRITERIA ............................................................................29 
3.5.2 EXCLUSION CRITERIA ...........................................................................29 
3.6 
ENROLLMENT .................................................................................. 31 
3.7 
SAMPLE SIZE .................................................................................. 31 
3.8 
INVESTIGATIONAL  SITES .................................................................. 31 
3.9 
DURATION OF SUBJECT PARTICIPATION ............................................. 31 
3.10 
SUBJECT COMPLETION OR WITHDRAWAL ........................................... 32 
3.10.1 STUDY COMPLETION .............................................................................32 
3.10.2 VOLUNTARY WITHDRAWAL .................................................................32 
3.10.3 INVESTIGATOR INITIATED WITHDRAWAL ..............................................32 
3.10.4 DOCUMENTATION .................................................................................32 
3.10.5 CONTINUING MEDICAL CARE ...............................................................32 
3.10.6 LOST TO FOLLOW-UP ............................................................................32 

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3.11 
PROCEDURES ................................................................................. 33 
3.11.1 INDEX PROCEDURE ...............................................................................33 
3.11.2 75-DAY REMAP PROCEDURE ................................................................34 
3.11.3 BLANKING PERIOD ................................................................................34 
3.11.4 ARRHYTHMIA CORE LAB ......................................................................34 
3.12 
SCHEDULE OF EVENTS AND ASSESSMENTS........................................ 35 
3.12.1 BASELINE ..............................................................................................35 
3.12.2 INDEX PROCEDURE ...............................................................................35 
3.12.3 PRE-DISCHARGE ...................................................................................35 
3.12.4 30-DAY VISIT .......................................................................................36 
3.12.5 75-DAY VISIT AND REMAPPING PROCEDURE ........................................36 
3.12.6 6-MONTH VISIT ....................................................................................37 
3.12.7 12-MONTH VISIT ..................................................................................37 
3.12.8 UNSCHEDULED VISITS ..........................................................................38 
3.13 
SCHEDULE OF STUDY ASSESSMENTS ................................................ 39 
4. 
BENEFIT RISK ASSESSMENT ....................................................................................40 
4.1 
POTENTIAL ADVERSE EVENTS .......................................................... 40 
4.2 
POTENTIAL RISKS ............................................................................ 41 
4.3 
POTENTIAL BENEFITS ....................................................................... 42 
5. 
STATISTICAL ANALYSIS AND REPORTING ...............................................................43 
5.1 
GENERAL STATISTICAL CONSIDERATIONS .......................................... 43 
5.2 
CONTROL OF SYSTEMATIC ERROR AND BIAS ...................................... 43 
5.3 
SAMPLE SIZE JUSTIFICATION ............................................................ 43 
5.4 
SUBJECT DISPOSITION ..................................................................... 44 
5.5 
IMPUTATION FOR MISSING DATA ....................................................... 44 
5.6 
POPULATIONS FOR ANALYSIS ........................................................... 44 
5.7 
FINAL CLINICAL REPORT .................................................................. 44 
6. 
OUTCOME MEASURES ..............................................................................................45 
6.1 
PRIMARY SAFETY ENDPOINT ............................................................ 45 
6.2 
SECONDARY SAFETY ENDPOINTS ..................................................... 46 
6.3 
PRIMARY FEASIBILITY ENDPOINT ....................................................... 46 
6.4 
SECONDARY FEASIBILITY ENDPOINTS ................................................ 46 
6.5 
ADDITIONAL ASSESSMENTS .............................................................. 47 
6.6 
PROCEDURAL ASSESSMENTS ........................................................... 47 
7. 
ADVERSE EVENTS, DEVICE EFFECTS, MALFUNCTIONS AND DEFICIENCIES ..........48 
7.1 
ADVERSE EVENTS ........................................................................... 48 
7.2 
SERIOUS ADVERSE EVENTS ............................................................. 48 
7.3 
DEVICE EFFECTS ............................................................................. 48 
7.3.1 ADVERSE DEVICE EFFECTS ...................................................................48 
7.3.2 SERIOUS ADVERSE DEVICE EFFECTS ....................................................49 
7.3.3 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS .........................49 
7.4 
DEVICE DEFICIENCIES ...................................................................... 49 
7.5 
USE ERRORS .................................................................................. 49 
7.6 
MALFUNCTIONS ............................................................................... 49 
7.7 
CAUSALITY RELATIONSHIP ................................................................ 49 
7.8 
REPORTING ..................................................................................... 51 

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CONFIDENTIAL 
8. 
MONITORING ............................................................................................................53 
9. 
STUDY MANAGEMENT .............................................................................................55 
9.1 
KEY CONTRIBUTORS ........................................................................ 55 
9.1.1 STUDY SPONSOR ...................................................................................55 
9.1.2 CRO .....................................................................................................55 
9.1.3 ARRHYTHMIA CORE LAB ......................................................................55 
9.2 
ETHICAL CONSIDERATIONS ............................................................... 55 
9.2.1 STUDY CONDUCT ..................................................................................56 
9.2.2 ETHICS REVIEW ....................................................................................56 
9.2.3 INFORMED CONSENT .............................................................................56 
9.2.4 COVERAGE OF EXPENSES ......................................................................56 
9.2.5 CONFIDENTIALITY ................................................................................56 
9.3 
INSURANCE ..................................................................................... 57 
9.4 
AUDITS AND INSPECTIONS ................................................................ 57 
9.5 
SPONSOR RESPONSIBILITIES ............................................................ 57 
9.6 
MONITOR RESPONSIBILITIES ............................................................. 58 
9.7 
INVESTIGATOR RESPONSIBILITIES ..................................................... 59 
9.8 
INVESTIGATOR TRAINING .................................................................. 60 
9.9 
SITE TRAINING ................................................................................ 60 
9.10 
CLINICAL EVENTS AND DATA MONITORING COMMITTEE ...................... 61 
9.11 
DATA MANAGEMENT ........................................................................ 61 
9.12 
STUDY SUSPENSION OR EARLY TERMINATION .................................... 61 
9.13 
CRITERIA FOR SUSPENDING/ TERMINATING A STUDY CENTER ............. 62 
9.14 
DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN ....................... 62 
10. 
REGULATORY CONSIDERATIONS .............................................................................63 
10.1 
MAINTAINING RECORDS ................................................................... 63 
10.2 
DATA HANDLING AND RECORD KEEPING ............................................ 63 
10.2.1 SOURCE DOCUMENTS ...........................................................................63 
10.2.2 DATA COLLECTION ...............................................................................63 
10.3 
ETHICS COMMITTEE AND COMPETENT AUTHORITY APPROVAL ............. 64 
10.4 
PROCEDURE FOR AMENDING THE CIP ............................................... 64 
THE PROCESS OF AMENDING THE CIP AND/OR RELATED DOCUMENTS IS THE 
RESPONSIBILITY OF THE SPONSOR.  THE PROCEDURE FOR AMENDING THE 
CIP SHALL BE AS FOLLOWS: .............................................................. 64 
10.5 
DEVICE ACCOUNTABILITY ................................................................. 65 
11. 
PUBLICATION POLICY ..............................................................................................66 
12. 
BIBLIOGRAPHY .........................................................................................................67 
 
 
 

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CONFIDENTIAL 
 
LIST OF TABLES 
 
Table 1 
FARAPULSE Endocardial Multi Ablation System – Components ..................... 22 
Table 2 
CE Marked Devices Utilized in Conjunction with FARAPULSE System........... 22 
Table 3 
Summary of Study Assessments ........................................................................... 39 
Table 4 
Composite Safety Endpoint Definitions ............................................................... 45 
 
 
 
 
LIST OF FIGURES 
 
Figure 1 
FARAPULSE Endocardial Multi Ablation System Components .........................23 
Figure 2 
FARAWAVE Endocardial Ablation Catheter .......................................................24 
Figure 3 
FARAFLEX Endocardial Ablation Catheter .........................................................25 
Figure 4 
FARADRIVE Deflectable Sheath and Dilator ......................................................26 
 
 
 
 
 

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CONFIDENTIAL 
Primary Study Contacts 
 
SPONSOR 
FARAPULSE, Inc. 
3715 Haven Ave.  Suite 110 
Menlo Park, CA 94025, USA 
Tel: +1 650  422 3633 
 
PRINCIPAL INVESTIGATOR 
 
 
 
Pr. Petr Neuzil 
Nemocnice Na Homolce 
Roentgenova 2 
Prague 150 30 
Czech Republic 
Tel: +420 257 272 211 
 
CLINICAL RESEARCH 
ORGANIZATION 
MedPass International SAS 
95b Boulevard Pereire 
75017 Paris,  
France 
Tel: +33 (0)1 42 12 83 30 
 
LEGAL REPRESENTATIVE 
MPLR SAS 
95bis Boulevard Pereire 
75017 Paris 
France 
Tel: +33 (0)1 42 12 83 30 
 
ECG CORE LAB 
MDT – Medical Data Transfer, s.r.o. 
Zabrdovicka 2, 615 00 Brno 
Czech Republic 
Contact: Veronika Bolkova 
Tel: +420 725 069 195 
iowa@mdtekg.cz  
 
 
 
 

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CONFIDENTIAL 
Executive Summary 
SPONSOR NAME: 
FARAPULSE, Inc. 
FULL TITLE OF STUDY: 
Feasibility Study of the FARAPULSE™ Endocardial Multi Ablation 
System in the Treatment of Persistent Atrial Fibrillation 
SHORT TITLE OF 
STUDY: 
PersAFOne  
(pronounced per-'se-fa-nē) 
PROTOCOL NUMBER:  
CS0607, Revision E 
OBJECTIVE: 
The objective of this safety and feasibility study is to assess 
whether the endocardial creation of electrically nonconductive 
lesions via PEF catheter ablation applied using the FARAPULSE 
Endocardial Multi Ablation System is a feasible and safe treatment 
for PersAF and associated AFL 
CLINICAL HYPOTHESIS: Endocardial creation of electrically nonconductive lesions in 
cardiac tissue via PEF catheter ablation using the FARAPULSE 
Endocardial Multi Ablation System is a feasible and safe treatment 
for PersAF. 
NAME OF 
INVESTIGATIONAL 
DEVICES: 
FARAPULSE Endocardial Multi Ablation System  
• 
FARAWAVE™ Endocardial Ablation Catheters  
• 
FARAFLEX™ Endocardial Ablation Catheter  
• 
FARASTAR™ Endocardial Generator System  
• FARADRIVE™ Deflectable Sheath  
STUDY OVERVIEW: 
This is a prospective, multi-center safety and feasibility study in 
subjects with persistent AF. Subjects will undergo percutaneous 
PEF ablation for pulmonary vein isolation as well as cavotricuspid 
isthmus interruption and other left atrial ablations at the 
investigator’s discretion. Subjects will then be followed at 30 
days, 75 ± 15 days, 6 months and 12 months for adverse events, 
recurrence of arrhythmia after a 90 day blanking period and other 
relevant outcome measures. 
STUDY POPULATION 
Subjects with documented symptomatic persistent AF (AF 
duration 7 – 365 days) and a 24-hour Holter monitor showing 
continuous AF within 90 days prior to the enrollment date; who 
are refractory or intolerant to at least one Class I/III antiarrhythmic 
agent. 
PLANNED 
ENROLLMENT: 
Up to 40 subjects 
CLINICAL SITES: 
Up to 4 clinical sites in Europe 

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CONFIDENTIAL 
DURATION OF 
PARTICIPATION: 
Subjects will be followed at 30 days, 75 days, 6 months and 12 
months with a 90-day Blanking Period for recurrent atrial 
fibrillation, atrial flutter or atrial tachycardia following the Index 
Procedure.  
Reablation with the study device(s) during the Blanking Period is 
permitted but does not extend either the Blanking Period or the total 
follow-up interval. 
The enrollment period is estimated to take 9 months and subjects 
will be followed for up to 12 months. The total study duration will 
be approximately 21 months. 
PLANNED PROCEDURE: 
Index Procedure: 
• Subjects will undergo an attempt to isolate all pulmonary 
veins or their anatomic equivalent.  
• Subjects with a past history of atrial flutter, who are at risk 
of atrial flutter, who present with atrial flutter during the 
Index Procedure or who have inducible cavotricuspid 
isthmus-mediated (typical) flutter may undergo ablation of 
the cavo-tricuspid isthmus at the discretion of the 
investigator.  
• Additional left atrial lesions may be made at the discretion 
of the investigator including focal sites, electrical gaps and 
lines of isolation. 
 
75-Day Remap Procedure: 
• Subjects will undergo a remapping procedure at 75 ± 15 
days to assess the durability of the ablation lesions 
performed during the Index Procedure. 
• During this procedure, additional ablations may be made at 
the discretion of the investigator to optimize patient 
outcomes. 

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CONFIDENTIAL 
PRIMARY SAFETY 
ENDPOINT: 
The primary safety endpoint for this study is the Composite Safety 
Endpoint (CSE) defined as the incidence of the following early-
onset and late-onset serious adverse events (SAEs) which are 
device- or procedure-related, as adjudicated by the CEDMC. (See 
Table 4. Composite Safety Endpoint Definitions in Section 
6.1).   
Early onset (within 30 days of an Index or Remap Procedure) 
• Death  
• Myocardial infarction (MI)  
• Persistent diaphragmatic paralysis  
• Stroke or transient ischemic attack (TIA)  
• Peripheral or organ thromboembolism  
• Pericarditis 
• Cardiac tamponade / perforation  
• Vascular access complications requiring intervention 
• Heart block  
Late onset (any time during follow-up through 12 months) 
• Pulmonary vein (PV) stenosis (> 70% diameter reduction 
from baseline)  
• Atrio-esophageal fistula  
SECONDARY SAFETY 
ENDPOINTS: 
1. The Primary Safety Endpoint assessed at 7 days  
2. The proportion of subjects with a device- or procedure-
related SAE 
3. The proportion of subjects with stroke or TIA 
4. The proportion of subjects requiring cardioversion 
5. The proportion of subjects requiring an arrhythmia-related 
(AF, AFL or AT) hospitalization 
PRIMARY FEASIBILITY 
ENDPOINT: 
The proportion of subjects that achieve Acute Procedural Success 
(APS) defined as the percutaneous endocardial creation of a 
complete, electrically isolating set of lesions around the ostia of 
the pulmonary veins (PVI) using the FARAPULSE Endocardial 
Multi Ablation System during the Index Procedure, as clinically 
assessed by entrance and/or exit block performed ≥ 20 minutes 
after the last PVI lesion is made. 

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SECONDARY 
FEASIBILITY 
ENDPOINTS: 
 
 
 
1. The proportion of subjects who undergo the protocol-
specified 75-Day Remapping Procedure and achieve Chronic 
Procedural Success (CPS) defined as persistent electrical 
isolation of all initially ablated pulmonary veins. Chronic 
Procedural Success will be subdivided by Index Procedure 
only CPS and Reablated CPS subjects.  
2. The proportion of attempted subjects that achieve Acute CTI 
Success, defined as the creation of bi-directional electrical 
block across the cavotricuspid isthmus using the 
investigational devices using the FARAPULSE Endocardial 
Multi Ablation System during the Index Procedure. 
3. Durability of the CTI and/or other extra-PV lesion set(s), 
when applicable.  Durability is defined as unaltered integrity 
of each such lesion assessed at the Remapping Procedure. 
4. The proportion of subjects that achieve Therapeutic Success, 
defined as freedom from: 
a. Post Blanking Period through assessment: occurrence of 
AF, AFL or AT or ablation for AF/AFL/AT using the 
study device 
b. At any time: ablation for AF/AFL/AT with a nonstudy 
device 
Therapeutic Success will be assessed from the end of the 90-
day Blanking Period through Months 6 and 12 and will be 
subdivided by on / off AFDs (Atrial Fibrillation Drugs) post-
Blanking Period. 
ADDITIONAL 
ASSESSMENTS: 
 
1. Proportion of subjects with early recurrence of atrial 
fibrillation (ERAF) by 90 days after the Index Procedure. 
2. Time to Therapeutic Failure. 
3. Proportion of all ablated pulmonary veins that are isolated at 
the Index Procedure using the study device. 
4. Proportion of all ablated pulmonary veins isolated using the 
study device during the Index Procedure that remain isolated 
at the 75-day remapping procedure. 
5. The proportion of attempted subjects that achieve Chronic 
CTI Success, defined as persistent bi-directional electrical 
block across the CTI assessed at the 75-day  Remapping 
Procedure. 
6. The proportion of attempted subjects that achieve Chronic 
Focal Success, defined as persistent electrical 
nonconductivity of all extra-PV tissue targeted for ablation in 
the Index Procedure, excluding the CTI.  

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PROCEDURAL 
ASSESSMENTS: 
 
1. Assessments of duration for procedure components 
a. Procedure time (initiation of venous access to 
venous access closure) 
b. Dwell time (sum of catheter entry-to-exit 
durations for each cardiac chamber) 
c. Total ablation time (first ablation to last ablation) 
d. Fluoroscopy time and dose (total duration and 
dose of exposure) 
2. Characterization of lesion sets 
a. PVI ablations 
b. Extra-PV ablations, excluding CTI ablations 
c. CTI ablations 
d. Anomalous PV ablations 
INCLUSION CRITERIA 
Study subjects are required to meet all the following inclusion 
criteria to participate in this study: 
1. Patients with documented drug-resistant symptomatic 
persistent AF meeting all three of the following criteria: 
a. Patient is refractory or intolerant to at least one Class 
I/III antiarrhythmic agent. 
b. ECG-documented first episode of persistent AF, lasting 
longer than 7 days but not longer than 365 days 
c. Holter within 90 days prior to the Enrollment Date 
demonstrating 24 hours of continuous AF 
2. Patients who are ≥ 18 and ≤ 75 years of age on the day of 
enrollment. 
3. Patient participation requirements: 
a. Lives locally 
b. Is willing and capable of providing Informed Consent 
to undergo study procedures 
c. Is willing to participate in all examinations and follow-
up visits and tests associated with this clinical study. 

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EXCLUSION CRITERIA 
Subjects will be excluded from participating in this study if they 
meet any one of the following exclusion criteria: 
1. AF that is: 
a. Paroxysmal (longest AF episode < 7days) 
b. Longstanding (has persisted > 12 months or that does 
not respond to cardioversion if < 12 months) 
c. Secondary to electrolyte imbalance, thyroid disease, 
alcohol abuse or other reversible / non-cardiac causes 
2. Left atrial anteroposterior diameter ≥ 5.5 cm as documented by 
transthoracic echocardiography (TTE) or computed tomography 
(CT) 
3. Any of the following cardiac procedures, implants or 
conditions: 
a. Clinically significant arrhythmias other than AF, AFL or 
AT 
b. Hemodynamically significant valvular disease 
c. Prosthetic heart valve  
d. NYHA Class III or IV CHF 
e. Previous endocardial or epicardial ablation or surgery 
for AF 
f. Atrial or ventricular septal defect closure 
g. Atrial myxoma 
h. Left atrial appendage device or occlusion 
i. Pacemaker, implantable cardioverter defibrillator or 
cardiac resynchronization therapy devices 
j. Significant or symptomatic hypotension 
k. Bradycardia or chronotropic incompetence 
l. History of pericarditis 
m. History of rheumatic fever 
n. History of congenital heart disease with any residual 
anatomic or conduction abnormality 
4. Any of the following within 3 months prior to enrollment: 
a. Myocardial infarction 
b. Unstable angina 
c. Percutaneous coronary intervention 
d. Heart surgery (e.g. coronary artery bypass grafting, 
ventriculotomy, atriotomy) 
e. Heart failure hospitalization 
f. Stroke or TIA 
g. Clinically significant bleeding 
h. Pericarditis or pericardial effusion 
i. Left atrial thrombus  
5. History of blood clotting or bleeding abnormalities. 

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CONFIDENTIAL 
EXCLUSION CRITERIA 
(CONTINUED) 
6. Contraindication to, or unwillingness to use, systemic 
anticoagulation  
7. Contraindications to CT or MRI 
8. Sensitivity to contrast media not controlled by premedication 
9. Women of childbearing potential who are pregnant, lactating 
or not using birth control 
10. Medical conditions that would prevent participation in the 
study, interfere with assessment or therapy, significantly 
raise the risk of study participation, or confound data or its 
interpretation, including but not limited to 
a. Body mass index (BMI) > 40 
b. Solid organ or hematologic transplant, or currently being 
evaluated for an organ transplant 
c. Severe lung disease, pulmonary hypertension, or any 
lung disease involving abnormal blood gases or 
significant dyspnea 
d. Renal insufficiency with an estimated creatinine 
clearance < 30 mL/min/1.73 m2, or any history of renal 
dialysis or renal transplant  
e. Active malignancy or history of treated cancer within 24 
months of enrollment 
f. Clinically significant gastrointestinal problems 
involving the esophagus, stomach and/or untreated acid 
reflux 
g. Clinically significant infection 
h. Predicted life expectancy less than one year 
11. Clinically significant psychological condition that in the 
investigator’s opinion would prohibit the subject's ability to 
meet the protocol requirements 
12. Current or anticipated enrollment in any other clinical study 
13. Employment by FARAPULSE or the same hospital 
department or office of any investigator, or a family member 
of any of the preceding groups.  
14. Use of amiodarone after day of index ablation procedure.  
Patients will cease use of amiodarone on or before the date of 
the index ablation procedure. 
 
 

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CONFIDENTIAL 
Abbreviations and Acronyms 
ACT 
Activated clotting time 
ADE 
Adverse device effect 
AE 
Adverse Event 
AF 
Atrial fibrillation 
AFD 
Atrial Fibrillation Drug 
AFL 
Atrial flutter 
APS 
Acute Procedural Success 
AT 
Atrial tachycardia 
BMI 
Body Mass Index 
CA 
Competent Authority 
CBC 
Complete blood count 
CEDMC Clinical Events and Data Monitoring Committee 
CHA2DS2-VASc     Termed “CHADS-VASC” a clinical prediction rule for stroke 
CHF 
Congestive heart failure 
CIP 
Clinical Investigation Plan 
CPS 
Chronic Procedural Success 
CRF 
Includes CRF (case report form) and eCRF (electronic case report form) 
CRO 
Clinical research organization 
CSE 
Composite Safety Endpoint 
CT 
Computed tomography 
CTI 
Cavotricuspid isthmus 
DCCV 
Direct current cardioversion 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
ERAF 
Early recurrence of atrial fibrillation 
ICF 
Informed Consent Form 
INR 
International normalized ratio 
IVC 
Inferior vena cava 
LA 
Left atrium or left atrial 
MI 
Myocardial infarction 
MRI 
Magnetic resonance imaging 
NIHSS 
National Institutes of Health Stroke Scale 
NYHA 
New York Heart Association 
PAF 
Paroxysmal atrial fibrillation 
PersAF 
Persistent atrial fibrillation 
PEF 
Pulsed electric field 
PT 
Prothrombin time 
PTT 
Partial thromboplastin time 
PV 
Pulmonary vein 
PVI  
Pulmonary vein isolation 
PVS 
Pulmonary vein stenosis 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event  
TEE 
Transesophageal echocardiography 
TIA 
Transient ischemic attack 

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CONFIDENTIAL 
TTE 
Transthoracic echocardiography 
TTM 
Transtelephonic monitor 
UADE 
Unanticipated adverse device effect 
USADE Unanticipated serious adverse device effect 
 
 
 
 

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CONFIDENTIAL 
1. Introduction 
1.1 
Background and Rationale 
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting 
approximately 2.2 million people in the United States and 4.5 million in the European 
Union.1, 2.  The incidence increases with advancing age, affecting 6% of the population 
over age 60 and 10% of the population over age 803, 4.  Age-adjusted population 
trending projects 16 million people in the United States will have AF by 20505.  Atrial 
fibrillation remains a significant cause of morbidity and mortality in industrialized 
societies.  The annual risk of AF related stroke is 5% per year and one of every six 
strokes diagnosed occurs in the presence of AF.6 Therefore, patients with AF require 
long-term anticoagulation to prevent embolic events.  Failure to manage AF may also 
lead to anatomic and electrical remodeling of the left atrium, tachycardia-induced 
cardiomyopathy, and reduced left ventricular function (heart failure).  AF remains an 
extremely costly public health burden, with annual per patient cost of care approaching 
€3000 (approximately U.S.  $3200).7  
The Heart Rhythm Society (HRS) 2017 Consensus Statement on Catheter and Surgical 
Ablation of Atrial Fibrillation8 defines several different stages of atrial fibrillation. 
• Paroxysmal AF (PAF): AF that terminates spontaneously or with intervention 
within 7 days of onset.   
• Persistent AF (PersAF): continuous AF that is sustained beyond 7 days. 
o Long-standing persistent AF: continuous AF of greater than 12 months’ 
duration. 
o Permanent AF: the presence of [persistent] AF that is accepted by the 
patient and physician, and for which no further attempts to restore or 
maintain sinus rhythm will be undertaken. 
Catheter ablation for the treatment of PAF is increasingly being performed as first line 
therapy for PAF and clinical evidence is accruing that this may well become an 
accepted first line treatment. 
Catheter ablation for the treatment of PersAF is complicated by the heterogeneity of the 
underlying pathophysiologic mechanisms and the generally reduced efficacy of 
ablation for continuous AF states. A small study of catheter ablation vs. antiarrhythmic 
drug treatment of PersAF found a significant advantage of ablation over AFDs. 9 While 
no catheter system has received FDA or CE Mark labeling to date, several single arm 
clinical investigations seeking device approvals for this indication are under way. 
1.2 
Irreversible Electroporation (IRE)  
Al-Sakere 200710 described irreversible electroporation as a non-thermal tissue ablation 
technique in which intense short duration electrical fields are used to permanently open 
pores in cell membranes, thus producing non-thermal tissue ablation.  Their study, 
using a mouse model, showed complete regression in 92% of treated tumors.  IRE 
ablation has a tissue specific mechanism of ablation.  The tissue injury from IRE 
ablation occurs at the cellular level with loss of homeostasis leading to necrosis or 

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apoptosis.11 12 13 14 IRE ablation typically spares the extracellular matrix, which 
facilitates rapid wound healing.15, 16, 17, 18, 19 
Thomson 201120 reported a case-series study (N=38) assessing the safety of IRE for 
treating liver, kidney or lung cancers in humans.  The first four patients showed signs 
of transient ventricular arrhythmia, so subsequent patients were all treated using 
electrocardiogram (ECG)-synchronized deliver of electroporation pulses.  There were 
two further arrhythmias, and two cases of inadvertent damage to neighboring organs.  
68% of tumors were completely ablated.  The authors concluded that IRE is safe for 
clinical use, provided ECG-synchronized delivery is used.   
A research group led by FHM Wittkampf in Utrecht has been investigating the 
potential effectiveness and safety of epicardial electroporation in AF ablation 
procedures using porcine models.  Wittkampf 201121 (N=10) used a circular ablation 
catheter and showed that PVI was achieved in all animals, with no sign of stenosis at 3-
week follow up.  Van Driel 201422 (N=6) confirmed this result out to 3-month follow 
up.  Neven 201423 (N=5) showed that electroporation lesion depth depended on the 
level of electrical energy applied, reaching 8 mm at 300 joules. 
Van Driel 2015 (N=20) showed that electroporation could create deep lesions close to 
the phrenic nerve without damage to the nerve.  Neven 2014 similarly showed that 
neighboring coronary arteries were undamaged by electroporation (N= 5).  These 
animal studies suggest that irreversible electroporation can safely create deep lesions in 
heart tissue when applied epicardially without harming adjacent tissues. 
1.3 
Summary of FARAPULSE Clinical Studies 
1.3.1 
Endocardial Ablation Studies – The IMPULSE Study 
FARAPULSE, Inc. initiated a safety and feasibility study at Na Homolce Hospital in 
Prague, Czech Republic and Hopital Cardiologique du Haut-Leveque in Pessac, 
France under the “IMPULSE” Protocol, CS0188.  This study is being conducted 
using the FARAPULSE Endocardial Ablation System.  Forty (40) patients were 
enrolled between January and December of 2018.  Thirty (30) patients were enrolled 
in Prague and ten (10) were enrolled in Bordeaux.  All patients were discharged in 
good condition.  One patient was treated for tamponade at the conclusion of the Index 
Procedure and the event was resolved.  Three patients were re-hospitalized for atrial 
arrhythmia and all of these events were resolved.  One patient experienced a 
prolonged index hospitalization due to an arteriovenous groin fistula which was 
resolved.  At the conclusion of the index Procedure, all (100%) pulmonary veins 
(PVs) were isolated using the FARAPULSE Endocardial Ablation System.  Thirty-
five (35) patients have returned for the protocol-defined 3-month remapping 
procedure to assess durable PV isolation.  In these patients, 70% of PVs remained 
isolated.  All PVs in fourteen (14) patients remained isolated.  These results support 
the safety and performance of the system. 
1.3.2 
Endocardial Ablation Studies – The PEFCAT Study 
FARAPULSE, Inc. has also initiated a safety and feasibility study at Na Homolce 
Hospital in Prague, Czech Republic and Hopital Cardiologique du Haut-Leveque in 

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Pessac, France under the “PEFCAT” Protocol, CS0267. This study is being 
conducted using the FARAPULSE Endocardial Ablation System.  Sixty (60) patients 
have been enrolled between October 2018 and June 2019.  Fifty (50) patients were 
enrolled in Prague and ten (10) were enrolled in Bordeaux.  All patients were 
discharged in good condition.  One patient was treated for an air embolism during the 
index Procedure and the event was resolved.  Three patients were re-hospitalized for 
atrial arrhythmia and all of these events were resolved.  One patient was hospitalized 
for back pain and the event was resolved.  One patient experienced a prolonged index 
hospitalization due to an arteriovenous groin fistula which was resolved.  At the 
conclusion of the index Procedure, all pulmonary veins (PVs) in all patients were 
isolated using the FARAPULSE Endocardial Ablation System.  Fourty-nine (49) 
patients have returned for the protocol-defined 75-day remapping procedure to assess 
durable PV isolation.  In these patients, 96% of PVs remained isolated.  All PVs in 
thirty-nine (39) patients undergoing reassessment remained isolated.  These results 
support the safety and performance of the system. 
1.4 
Rationale for Conducting This Feasibility Study 
Catheter ablation for PAF with a variety of energy sources and catheter configurations 
has been demonstrated to be a safe and effective procedure. The  FARAPULSE 
Endocardial Multi Ablation System has undergone preclinical and clinical testing to 
demonstrate that it can isolate pulmonary veins quickly and with minimal 
complications, using a standard catheter-based endocardial procedure. Ongoing clinical 
follow-up demonstrates durable lesions at 75 day remapping procedures.  
This study expands the use of the the FARAPULSE Endocardial Multi Ablation 
System to the treatment of patients with PersAF. The availability of both the 
FARAWAVE Ablation Catheter and the FARAFLEX Ablation Catheter allow the 
delivery of PEF ablation in the same locations as existing treatment such as RF 
ablation, and thus permit treatment of PersAF. 
Potential Risks: Based on the growing experience with the similar FARAPULSE 
Endocardial Multi Ablation System, the risks associated with this small feasibility 
study are not expected to differ from those products that are approved and available on 
the market for catheter-based or surgical ablation procedures. In addition, verification 
and validation testing of the FARAPULSE Endocardial Multi Ablation System will 
ensure device safety and performance during the clinical investigation as well as 
compliance with the applicable parts of the Medical Device Directive 93/42/EEC. 
FARAPULSE will ensure through its Risk Management processes that the residual 
risks have been reduced to a level that is as low as possible.   
 
Potential Benefits: A study of up to 40 patients for assessment in this protocol will have 
the following potential benefits: 
• To provide treatment to subjects with PersAF using an investigational device 
which has demonstrated the ability to isolate pulmonary veins and reduce the 
subsequent occurrence of symptomatic atrial fibrillation in a small number of 
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• To generate additional data demonstrating that the endocardial creation of 
electrically isolating lesions via Pulsed Electric Field (PEF) catheter ablation 
applied using the FARAPULSE Endocardial Multi Ablation System is a safe 
and potentially effective treatment for drug-resistant, recurrent, symptomatic 
persistent atrial fibrillation (PersAF); 
• To assess the feasibility and safety of the FARAFLEX Ablation Catheter for 
focal ablation in accordance with its proposed indication for use; 
• To assess the protocol elements and design for subsequent use in an expanded 
multi-center European CE Mark Trial. 
Please see Section 4.0, Benefit Risk Assessment, for additional details regarding the 
assessment of benefits and risks associated with this study. 

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2. Investigational Devices 
2.1 
Names of Investigational Devices 
The FARAPULSE Endocardial Multi Ablation System is comprised of the following 
devices: 
• FARAWAVE Endocardial Ablation Catheter 
• FARAFLEX Endocardial Ablation Catheter 
• FARASTAR Endocardial Generator System 
• FARADRIVE Deflectable Sheath. 
2.2 
Intended Use 
The FARAPULSE Endocardial Multi Ablation System is indicated for the treatment of 
drug refractory, recurrent, symptomatic persistent atrial fibrillation. 
The FARAFLEX Endocardial Ablation Catheter is used as an adjunctive device in the 
endocardial treatment of persistent atrial fibrillation with the following intended uses:  
• Gap ablation to complete electrical isolation of the pulmonary veins,  
• Focal ablation of cardiac arrhythmias, and  
• Creation of ablation line between the inferior vena cava and the tricuspid valve. 
2.3 
Classification 
The FARAWAVE Endocardial Ablation Catheter and FARAFLEX Endocardial 
Ablation Catheter are classified as Class III medical devices.  Per  MDD 93/42/EEC 
Annex IX Rule 6 applies to the ablation catheters, which defines the catheters as  
surgically invasive devices intended for transient use (<60 min) that specifically 
controls, diagnoses, monitors or corrects a defect of the heart or of the central 
circulatory system through direct contact with these parts of the body. 
The FARASTAR Endocardial Generator System is classified as a Class IIb medical 
device.   Per MDD 93/42/EEC Annex IX Rule 9 applies to the generator system, which 
defines it as an active therapeutic device that is intended to administer or exchange 
energy to and from the human body in a potentially hazardous way, taking account of 
the nature, the density and the site of application of the energy.   
The FARADRIVE Deflectable Sheath is classified as a Class III medical device.  Per 
MDD 93/42/EEC Annex IX Rule 6 applies to the Deflectable Sheath System, which 
defines it as a surgically invasive device intended for transient use (<60 min) that 
specifically controls, diagnoses, monitors or corrects a defect of the heart or of the 
central circulatory system through direct contact with these parts of the body. 
2.4 
FARAPULSE Endocardial Multi Ablation System 
The FARAPULSE Endocardial Multi Ablation System used in the proposed clinical 
investigation consists of the FARAWAVE Endocardial Ablation Catheter, the 
FARAFLEX Endocardial Ablation Catheter, the FARASTAR Endocardial Generator 
System, and the FARADRIVE Deflectable Sheath. These components, sub-components 
and model numbers are listed in Table 1. 
 

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Table 1. 
FARAPULSE Endocardial Multi Ablation System – Components 
 
Component 
Sub Components 
Model Numbers 
FARAWAVE Endocardial 
Ablation Catheter  
 
 
1.  Ablation Catheter (31 mm or 35 mm 
fully deployed diameter) 
2.  Extension Cable 
 
40T401 (31 mm) and 
40T404 (35 mm) 
 
40T407 (extension 
cable) 
FARAFLEX Endocardial 
Ablation Catheter  
(adjunctive device) 
1. Ablation Catheter (17 mm fully 
deployed 
     diameter) 
2.  Extension Cable 
 
40T405 (catheter) 
40T406 (extension 
cable) 
FARASTAR Endocardial 
Generator System 
 
 
 
 
1. Pulsed Electric Field Generator 
(PEFG) 
2. Two Coaxial Cables 
3. Pace Filter Box 
4. Two Catheter Switch Boxes 
 
60T401 
FARADRIVE Deflectable 
Sheath  
 
(or commercially available CE 
Marked Deflectable Sheath 
System such as the CE Marked 
Oscor Destino™ Twist 
UniDirectional Deflectable 
Guiding Sheath)* 
1.  Sheath 
2.  Dilator 
20T401 
 
During the course of the investigation certain CE Marked medical devices may be 
used in conjunction with the FARAPULSE Endocardial Multi Ablation System. 
These are listed in Table 2. 
 
Table 2. 
CE Marked Devices Utilized in Conjunction with FARAPULSE System 
 
CE Marked Devices That May be Used in Conjunction with  
FARAPULSE Endocardial Multi Ablation System 
*Oscor Destino™ Twist UniDirectional Deflectable Guiding Sheath 
St. Jude BRK 98cm Transseptal Needle 
MicroPace StimCor Cardiac Stimulator 
 
A schematic of the FARAPULSE Endocardial Multi Ablation System is depicted in 
Figure 1 following. 
 
 

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Note: Blue dotted box shows the sterile, single-use components of the system 
Figure 1. 
FARAPULSE Endocardial Multi Ablation System Components 
 
2.4.1 
FARAWAVE Endocardial Ablation Catheter System 
The FARAWAVE Endocardial Ablation Catheter System consists of two (2) 
components: Ablation Catheter and Extension Cable, which are used together.  Both 
components are sterile and single use only.  
The ablation catheter is offered in two different sizes: 31 mm (REF 40T401) and 
35mm (REF 40T404) deployed diameters, to accommodate varying pulmonary vein 
anatomy. Selection of either catheter will be at the investigator’s discretion.  
The Ablation Catheter is a multi-electrode catheter that connects electrically to the 
Endocardial Generator System.  It consists of a multi-electrode  ablation catheter with 
electrodes arranged on splines.  The Ablation Catheter consists of a distal section with 
five splines that deploy into a basket-shaped configuration or flower-shaped 
configuration with five petals, a shaft section, and a proximal handle with a manually 
operated deployment control (Figure 2), which depicts a fully deployed distal flower-
shapedconfiguration.   

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Figure 2. 
FARAWAVE Endocardial Ablation Catheter  
Each spline has a single electrode that is separately wired to facilitate connection to a 
mapping or recording system (this is an optional feature offered to the user). The 
handle includes a flush port for saline infusion, a deployment control knob with a 
guidewire lumen hub that can be connected to a hemostasis valve, and a cable with 
connectors.  The catheter connectors connect to an Extension cable (part of the 
Endocardial Ablation Catheter System) with numbered connectors on each of its 
ends.  These connect to the multi-channel FARASTAR Endocardial Generator. The 
Pulsed Electric Field energy is delivered via the FARASTAR Endocardial Generator 
over the set of ablation catheter electrodes. The Extension Cable is a single-use sterile 
cable that provides additional cable length to connect to the FARASTAR Endocardial 
Generator.   
Additional details are provided in the IFU LBL0195 for the specific use and 
procedural steps of the FARAWAVE Endocardial Ablation Catheter. 
2.4.2 FARAFLEX Endocardial Ablation Catheter 
The FARAFLEX Endocardial Ablation Catheter is a multi-electrode unidirectional, 
deflectable percutaneous catheter that connects to the FARASTAR Endocardial 
Generator and is designed to deliver PEF energy from the Endocardial Generator for 
cardiac tissue ablation.  The FARAFLEX Endocardial Ablation Catheter is an 
adjunctive catheter designed to create smaller focal-type lesions for the following 
indications for use: 
• Gap ablation to complete electrical isolation of the pulmonary veins,  
• Focal ablation of cardiac arrhythmias, and  
• Creation of ablation line between the inferior vena cava and the tricuspid valve. 
 

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The catheter consists of the following major sections: 1) distal section with electrodes 
arranged on four (4) splines, 2) catheter shaft, and 3) proximal handle with manually 
operated deflection and deployment controls, flush port, and connector. Figure 3 
depicts a deployed FARAFLEX Endocardial Ablation Catheter. 
 
 
 
Figure 3. 
FARAFLEX Endocardial Ablation Catheter 
 
The catheter can be deployed into basket-shaped configurations to accommodate 
various anatomical locations. The ablation catheter is visible under fluoroscopy due to 
the presence of marker bands at the distal tip and proximal end of the splines, as well 
as electrodes on each of four (4) splines.  
2.4.3 FARASTAR Endocardial Generator System  
The FARASTAR Endocardial Generator System consists of the following 
components – Pulsed Electric Field Generator (PEFG), BNC Coaxial Cable (2 units), 
Pace Filter Box (1-2 units), and Switch Box (2 units).  The Endocardial Generator 
System is designed to deliver PEF energy to endocardial sites in the heart via the 
FARAWAVE and FARAFLEX Endocardial Ablation Catheters and other compatible 
devices (refer to IFU LBL0195 and IFU LBL0565 for the specific use and procedural 
steps of the Endocardial Ablation Catheters, respectively; LBL0193 for the 
FARADRIVE Deflectable Sheath and LBL0198 for the FARASTAR Endocardial 
Generator System).   
The FARASTAR Endocardial Generator is a 16-channel output unit that generates a 
pulsed voltage waveform that can be delivered to the ablation catheter electrodes. The 
FARASTAR Generator, while capable of operating between 1400V and 2100V, 
currently allows ablation energy in discrete user-selectable voltage settings between 
1400V and 2000V. 
As an input, a compatible cardiac stimulator unit for cardiac pacing is applied to the 
cardiac chambers via pacing catheters and to the FARASTAR Endocardial Generator 
with a coaxial cable to synchronize the application of therapeutic PEF energy to the 
actively paced heart.  The physician confirms proper synchronization by actuating a 

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button on the FARASTAR Endocardial Generator user interface. The BNC Coaxial 
Cable is used to connect the generator to a commercially available compatible cardiac 
stimulator/pacing device.   
Details regarding the generator are provided in the FARASTAR Endocardial 
Generator System User Manual LBL0198. 
2.4.4 FARADRIVE Deflectable Sheath  
The FARAWAVE Endocardial Ablation Catheter and FARAFLEX Endocardial 
Ablation Catheter are used with the FARADRIVE Deflectable Sheath or a compatible 
CE Marked Deflectable Sheath System (13F) such as the CE Marked Oscor 
Destino™ Twist UniDirectional Deflectable Guiding Sheath. 
The FARADRIVE Deflectable Sheath consists of two (2) primary components: 
Deflectable Sheath and Dilator, which are used together.  Both components are sterile 
and single use only. 
The FARADRIVE Deflectable Sheath is comprised of a distal deflectable section and 
a shaft section which connect to the handle.  The handle includes a knob to control 
the deflection of the distal tip and a flush port for infusion of saline or contrast.  The 
Dilator is intended for insertion through the sheath lumen and includes a shaped tip 
for dilation for vascular or chamber access ( Figure 4). 
 
 
Figure 4. 
FARADRIVE Deflectable Sheath and Dilator 
 
2.5 
Device Accountability 
The FARAPULSE Endocardial Multi Ablation System will be stored in a secure 
location and access will be controlled.  Records will be maintained to document the 
physical location of inventory from shipment and removal from Sponsor or Contract 
Manufacture facility through use and / or return or disposal. 
The site will be responsible for maintaining a Device Accountability Log provided by 
the Sponsor or its designated representative. At a minimum the following will be 
recorded: Date of receipt, FARAPULSE Endocardial Multi Ablation System 

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components identification number (Generator, Ablation Catheter and Deflectable 
Sheath lot and / or serial number), expiration date, date of use, subject unique 
identification code and date of disposal or return of the device. 
If there is a product Device Deficiency / Malfunction or other need to return the system 
or system components to the Sponsor or Contract Manufacture, the Sponsor or designee 
should be contacted for safe product disposal and/ or return details.  Appropriate CRF 
will be completed in the event of a Device Deficiency / Malfunction. 
The Investigator is responsible for ensuring that the investigational devices are used 
only under the Investigator’s supervision and are only used according to this protocol 
and any approved amendments.  The Investigator will not supply an investigational 
device to any person not authorized to participate in the study.  The Investigator shall 
document on the Case Report Forms (CRFs) the lot numbers and / or serial numbers of 
the devices used during each case. 
2.6 
Return of Devices 
All unused investigational devices will be returned to the Study Sponsor or designee 
upon completion of the clinical study.  Any investigational device that does not meet 
performance specifications will also be returned to the Study Sponsor or designee for 
analysis per company procedures.  The Investigator or his/ her designated 
representative is responsible for device accountability and disposition of all used and 
unused devices.  The Study Sponsor or its designated representative will conduct 
device reconciliation at the completion of subject enrollment or at the conclusion of the 
study. 
 

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3. Study Design 
3.1 
Study Objective 
The objective of this safety and feasibility study is to assess whether the endocardial 
creation of electrically nonconductive lesions via PEF catheter ablation applied using 
the FARAPULSE Endocardial Multi Ablation System is a feasible and safe treatment 
for PersAF and associated AFL.  
3.2 
Study Overview 
This is a prospective, multi-center, unblinded single arm safety and feasibility study.  
Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at 
the clinical discretion of the investigator receive PEF ablation of additional 
arrhythmogenic locations.  Subjects will be followed at 30 days, 75 days, 6 months and 
12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period 
and other relevant outcome measures.  
3.3 
Subject Confidentiality 
Enrolled subjects will be assigned a unique, pseudo-anonymous identifier that will be 
used to maintain confidentiality of each subject’s medical information.  Subject names 
and other protected health information will not be captured on the CRFs.  In addition, 
all patient identifiers except the unique pseudo-anonymous identifier should be 
redacted from any images or other data submitted from the participating site to the 
Sponsor or the Sponsor’s designated reviewers for analysis. All information concerning 
subjects or their participation in this study will be considered confidential.  Only the 
authorized Sponsor, designated representative personnel, designated consultants and 
regulatory agencies will have access to these confidential files.   
3.4 
Written Informed Consent 
All subjects must provide written Informed Consent using the EC-approved ICF before 
undergoing any study related procedures.   
Routine clinical evaluations that would be performed as part of the normal clinical care 
of patients may be performed prior to such consent and used as part of the screening 
assessment.  If the subject is subsequently consented and enrolled in the study, the 
results of such evaluations may be used as study data. 
Subjects cannot be asked to sign the ICF until the study has been fully approved by the 
institution’s EC and by the CA, if applicable, and the Sponsor or their CRO 
representative has received and reviewed the EC-approved ICF.  Subjects who meet the 
general entry criteria will be asked to sign an ICF as approved by the relevant 
regulatory authorities before any study-specific tests or procedures are performed.   
The Investigator or a designated member of his / her staff should approach the subject 
to obtain written informed consent.  As far as possible, non-technical language shall be 
used that is understandable to the subject.  The background of the proposed study and 
the benefits and risks of the procedures and study should be explained.  The subject 
should be provided with ample time to read the ICF and discuss it with their family and 
physician.  The subject shall be informed that his / her participation in the clinical 

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investigation is confidential.  The ICF must be read and understood by the subject and 
the subject’s questions answered.  The ICF must be signed and dated by both the 
subject and Investigator conducting informed consent prior to subject enrollment and 
before the subject undergoes any study-related procedures.  All subjects are to receive 
copies of their signed and dated ICF.  A copy of the approved ICF along with a copy of 
each patient’s signed ICF will be maintained by the Investigator in a designated clinical 
study administrative file.  Subjects may not be consented after receiving any 
medication that might alter their ability to comprehend the consent form (e.g.  
sedatives, narcotics, etc.).  Study personnel should explain that even if a subject agrees 
to participate in the study and signs the ICF, the subject may not be eligible to 
participate if he / she fails to meet the screening criteria. 
Written informed consent must be obtained prior to performing any protocol driven 
tests or any procedures that are not standard of care for a percutaneous ablation 
procedure that the subject is scheduled to undergo. 
Once written consent has been obtained, the subject will be entered on a Screening Log, 
which will be maintained at each site.  All subjects who provide written informed 
consent will be entered on the screening log regardless of whether or not they are 
enrolled in the study. 
 
3.5 
Study Entry Criteria 
3.5.1 
Inclusion Criteria 
Study subjects are required to meet all the following inclusion criteria to participate in 
this study: 
 
1. Patients with documented drug-resistant symptomatic persistent AF meeting all 
three of the following criteria: 
a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic 
agent. 
b. ECG-documented first episode of persistent AF, lasting longer than 7 
days but not longer than 365 days 
c. Holter within 90 days prior to the Enrollment Date demonstrating 24 
hours of continuous AF 
2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment. 
3. Patient participation requirements: 
a. Lives locally. 
b. Is willing and capable of providing Informed Consent to undergo study 
procedures. 
c. Is willing to participate in all examinations and follow-up visits and tests 
associated with this clinical study. 
3.5.2 Exclusion Criteria 
Subjects will be excluded from participating in this study if they meet any one of the 
following exclusion criteria: 

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1. Atrial fibrillation that is any of the following: 
a. Paroxysmal (longest AF episode < 7days) 
b. Longstanding (has persisted > 12 months or that does not respond to 
cardioversion if < 12 months) 
c. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or 
other reversible / non-cardiac causes 
2. Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic 
echocardiography (TTE) or computed tomography (CT) 
3. Any of the following cardiac procedures, implants or conditions: 
a. Clinically significant arrhythmias other than AF, AFL or AT 
b. Hemodynamically significant valvular disease 
c. Prosthetic heart valve  
d. NYHA Class III or IV CHF 
e. Previous endocardial or epicardial ablation or surgery for AF 
f. Atrial or ventricular septal defect closure 
g. Atrial myxoma 
h. Left atrial appendage device or occlusion 
i. Pacemaker, implantable cardioverter defibrillator or cardiac 
resynchronization therapy devices  
j. Significant or symptomatic hypotension 
k. Bradycardia or chronotropic incompetence 
l. History of pericarditis 
m. History of rheumatic fever 
n. History of congenital heart disease with any residual anatomic or 
conduction abnormality 
4. Any of the following within 3 months prior to enrollment: 
a. Myocardial infarction 
b. Unstable angina 
c. Percutaneous coronary intervention 
d. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, 
atriotomy) 
e. Heart failure hospitalization 
f. Stroke or TIA 
g. Clinically significant bleeding 
h. Pericarditis or pericardial effusion 
i. Left atrial thrombus  
5. History of blood clotting or bleeding abnormalities. 
6. Contraindication to, or unwillingness to use, systemic anticoagulation.  
7. Contraindications to CT or MRI. 
8. Sensitivity to contrast media not controlled by premedication. 
9. Women of childbearing potential who are pregnant, lactating or not using birth 
control. 
10. Medical conditions that would prevent participation in the study, interfere with 
assessment or therapy, significantly raise the risk of study participation, or 
confound data or its interpretation, including but not limited to: 

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a. Body mass index (BMI) > 40 
b. Solid organ or hematologic transplant, or currently being evaluated for an 
organ transplant 
c. Severe lung disease, pulmonary hypertension, or any lung disease 
involving abnormal blood gases or significant dyspnea 
d. Renal insufficiency with an estimated creatinine clearance < 30 
mL/min/1.73 m2, or any history of renal dialysis or renal transplant  
e. Active malignancy or history of treated cancer within 24 months of 
enrollment 
f. Clinically significant gastrointestinal problems involving the esophagus, 
stomach and/or untreated acid reflux 
g. Clinically significant infection 
h. Predicted life expectancy less than one year 
11. Clinically significant psychological condition that in the investigator’s opinion 
would prohibit the subject's ability to meet the protocol requirements. 
12. Current or anticipated enrollment in any other clinical study. 
13. Employment by FARAPULSE or the same hospital department or office of any 
investigator, or a family member of any of the preceding groups.  
14. Use of amiodarone after day of index ablation procedure.  Patients will cease 
use of amiodarone on or before the date of the index ablation procedure. 
3.6 
Enrollment 
Subjects that meet all of the eligibility criteria and are deemed suitable by the 
investigator will be invited to participate in the study.   
Subjects will be considered enrolled at the time of signing the ICF. 
Each subject will be assigned a unique study identification code to protect each 
subject’s confidential health information.  The unique study identification code will not 
include date of birth or subject’s first and last initials and will be used to link study data 
and other study information to the subject in lieu of the subject name.  The Subject 
Name Log will be used to link the unique study identity code to the subject and will be 
maintained at the site.  This log will remain confidential and will not be provided to the 
Sponsor, but only used for reference when monitoring at the study site. 
3.7 
Sample Size 
Up to 40 subjects in total will be enrolled at up to four sites in this clinical safety and 
feasibility study. Approved sites will enroll at least 5 and not more than 20 subjects. 
3.8 
Investigational  Sites 
The clinical study will be conducted at up to four investigational sites. 
3.9 Duration of Subject Participation 
Subjects will be followed at 30 days, 75 days, 6 months and 12 months with a 90-day 
Blanking Period for recurrent atrial fibrillation, atrial flutter or atrial tachycardia 
following the Index  Procedure. 

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Reablation with the study device(s) during the Blanking Period is permitted but does not 
extend either the Blanking Period or the total follow-up interval. 
The enrollment period is estimated to take 9 months and subjects will be followed for up 
to 12 months for a total duration of approximately 21 months. 
3.10 Subject Completion or Withdrawal 
3.10.1 Study Completion 
Once the subject has completed the final 12 month follow-up visit they are to be 
exited from the study. 
3.10.2 Voluntary Withdrawal 
Subjects may voluntarily withdraw from the study at any time for any reason.  
3.10.3 Investigator Initiated withdrawal 
The investigator may withdraw the subject due to any of the following situations: 
• adverse event (AE); or 
• study investigator may withdraw a patient from the study without the patient’s 
consent if the investigator has a concern for the patient’s rights, safety or 
welfare 
3.10.4 Documentation 
At the time of study withdrawal or completion for any reason, the study exit CRF will 
be completed, including the reason for exit. 
3.10.5 Continuing Medical Care 
Subjects leaving the study at any time will continue to receive appropriate medical 
care without prejudice. 
3.10.6 Lost to Follow-Up 
If the investigator has attempted to contact a subject at least three times within 60 
days and received no response, the subject may be considered lost to follow-up.  The 
investigator will document that a minimum of three attempts were made to contact 
the subject, including sending a certified letter if current address is known, prior to 
exiting the subject from the study. 
At the time of confirmed lost to follow-up status, the study exit CRF will be 
completed. 

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3.11 Procedures 
3.11.1 Index Procedure 
The investigator will confirm that the following have been achieved: 
• For women of childbearing potential – a negative pregnancy test 
• Baseline NIHSS score 
• The patient is not on amiodarone 
FARAPULSE Endocardial Ablation procedure patients will undergo anesthesia 
according to institutional protocol.  They will then be prepared in conventional sterile 
fashion for a cardiac catheterization procedure.  Femoral vein access will be obtained 
via Seldinger technique.  Transseptal access to the left atrium will then be obtained 
using either a FARADRIVE Deflectable sheath or a commercially approved sheath 
and Brockenbrough needle.  The transseptal sheath will then be withdrawn, leaving 
guidewire access to the left atrium.  The FARADRIVE Deflectable Sheath, or a 
commercial equivalent as described above in Table 2, will then be prepared and 
advanced via guidewire to the left atrium.  Commercially approved multielectrode 
pacing catheters will then be placed via conventional technique at the investigator’s 
discretion.  A baseline electrophysiological assessment of pulmonary vein connection 
to the left atrium will be made and documented via FARAWAVE or a commercially 
approved diagnostic catheter placed in each addressable pulmonary vein.  A baseline 
3D electroanatomical map may also be made at the investigator’s discretion.  The 
diagnostic catheter will then be removed from the FARADRIVE Deflectable Sheath 
or commercial equivalent. 
The FARAWAVE Ablation Catheter will then be prepared and advanced over the 
guidewire to the left atrium through the sheath.  The guidewire will be advanced into 
a target pulmonary vein, the catheter splines will be deployed to suit target anatomy 
by retracting the deployment knob, and the deployed catheter will be advanced to the 
ostium of the target pulmonary vein.  At the investigator’s discretion, contrast 
venography may be performed to verify placement of the catheter at the ostium.  
Cardiac pacing capture from the external cardiac stimulator will be obtained via 
connection to a diagnostic catheter.  Once pacing capture is confirmed, ablation will 
be performed.  Ablation dose will be selected at the investigator’s discretion in 
accordance with LBL0198, FARASTAR Generator User Manual.   
Ablation with the FARAWAVE Ablation Catheter may be repeated at the same site 
or at another target site at the physician’s discretion using deployment configurations 
to suit target anatomy. Each addressable pulmonary vein will be ablated in turn 
beginning with placement of the guidewire, deployment of the ablation catheter, 
confirmation of pacing capture, and ablation.  The effect of the ablation(s) may be 
checked post-procedure by pacing maneuvers, ECG recordings, 3D electroanatomic 
mapping, or by using the mapping electrodes on the ablation catheter splines. 
Ablation using the FARAFLEX Ablation Catheter may be performed to close gaps in 
electrical isolation of pulmonary veins, focally ablate cardiac arrhythmias, or create a 
line of ablation at the cavo-tricuspid isthmus (CTI).  
 

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For a detailed description of procedure workflow refer to LBL0193 (FARADRIVE 
Deflectable Sheath), LBL0195 (FARAWAVE Endocardial AblationCatheter ), 
LBL0565 (FARAFLEX Endocardial Ablation Catheter and LBL0198 (FARASTAR 
Endocardial Generator System).   
3.11.2 75-Day Remap Procedure 
The 75-Day Remap Procedure will follow the steps contained in Section 3.11.1, 
Index Procedure, as determined by investigator discretion to achieve protocol-
required mapping and any required reablation. 
3.11.3 Blanking Period 
The Blanking Period consists of Day 0 (the date of Index Procedure) through and 
including Day 90.  
During the Blanking Period, any recurrence of AF will be documented; however, 
recurrences of AF, AFL or AT during this time will not be considered Therapeutic 
Failures.   
Subjects may undergo one repeat ablation during the Blanking Period without 
creating a Therapeutic Failure, following the procedure detailed in the preceding 
sections. This may occur during the Remap Procedure or at another procedure as 
clinically indicated.  
If a second repeat ablation procedure is performed during this time, or any nonstudy 
device is used for cardiac ablation, the subjects will be considered a Therapeutic 
Failure but will remain in the study. 
Towards the end of the Blanking Period, any AFD treatment will be discontinued 
unless the Investigator deems the withdrawal of AFD treatment not to be in the best 
interests of the patient. 
3.11.4 Arrhythmia Core Lab 
An Arrhythmia Core Lab will oversee the provision, collection and analysis of data 
from the Event Monitors and Holter Monitors specified in this protocol. 
• An Event Monitor will be provided at the 75-Day Remap to be used through the 
remainder of the 12-month follow-up interval for weekly scheduled and ad hoc 
symptomatic monitoring.  Investigational sites will be provided with the Event 
Monitor and instructions for its use by the Arrhythmia Core Lab.  The 
investigational sites will then provide the device and instructions for use to the 
subject.  The Event Monitor will be returned to the Arrhythmia Core Lab at the 
time of the subject’s exit from the study. ECG data from the Event Monitor will 
be analyzed by the Arrhythmia Core Lab.   
• A 24-hour continuous ECG monitor will be provided at the 6 and 12-Month 
Visits.  Investigational sites will be provided with the continuous ECG monitor 
device and instructions for its use by the Arrhythmia Core Lab.  The 
investigational sites will then provide the device and instructions for use to the 
subject.  The device will be worn by the subject for a single 24-hour period and 

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then returned to the Core Lab with shipping materials provided by the core lab. 
ECG data from this monitor will be analyzed by the Core Lab.   
3.12 Schedule of Events and Assessments 
Subjects will complete the following visits and assessments as indicated below and as 
summarized in Section 3.12 Table 3 Summary of Study Assessments.   
3.12.1 Baseline 
The following baseline data will be collected: 
• Medical history 
• AFD and anticoagulation medication history 
• Pregnancy test (all women of child-bearing potential) 
• 12-lead ECG 
• Cardiac CT or MRI adequate to characterize left atrial and pulmonary vein 
dimensions 
• TEE or other imaging modality for exclusion of left atrial thrombus 
• NYHA Classification 
• NIHSS score 
• CHA2DS2-VASc score 
3.12.2 Index Procedure 
The Index Procedure will be performed according to Section 3.11.1, Index 
Procedure. The following procedural data will be collected: 
• Pregnancy test (all women of childbearing potential if baseline pregnancy test 
obtained more than 14 days prior to procedure) 
• Post-ablation 3D electroanatomical maps 
• Post-ablation fluoroscopic examination of diaphragm motion to assess phrenic 
nerve response 
• Adverse Events 
• Procedural times  
• Lesion set data  
• Device deficiencies and malfunctions  
3.12.3 Pre-Discharge 
Prior to hospital discharge the following data will be collected: 
• Adverse Events 
• Data regarding the use, changes in or discontinuation of anticoagulation, rate 
control and/or antiarrhythmic medications. 
• Cardiac rhythm as determined by a 12-lead ECG 
• Occurrence, date, indication and outcome of any cardioversion(s) 
• At the investigator’s discretion: a post-procedural mediastinal gadolinium-
enhanced MRI 
• Stroke/TIA assessments 

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o NIHSS score 
o A neurologic examination will be performed and recorded if: 
 If the NIHSS score has increased by 2 or more points  
 If there is a clinical suspicion of stroke or TIA 
3.12.4 30-Day Visit 
Discharged subjects will return for an office visit 30 days (± 7 days) post-ablation 
treatment.  (Any subject who continues to be hospitalized 30 days post-ablation will 
have their 30-Day Visit assessment performed in-hospital).  The following data will be 
collected at the 30-Day Visit: 
• Adverse Events 
• Symptoms of recurrent arrhythmia  
• Data regarding the use, changes in or discontinuation of anticoagulation, rate 
control and/or antiarrhythmic medications. 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the visit 
• Cardioversions, ablations or hospital admissions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
3.12.5 75-Day Visit and Remapping Procedure 
Patients undergoing protocol-specified remapping: 
Subjects will undergo the protocol-stipulated remapping procedure at 75 ± 15 days 
post-Index Procedure as defined in Section 3.11.2, 75-Day Remap Procedure.  
• A 3D electroanatomical remapping procedure will be performed to assess 
electrical isolation of the pulmonary veins. Any electrical gaps may be closed at 
the investigator’s discretion using study devices, or if necessary, a commercially 
approved ablation device (which constitutes a Therapeutic Failure). 
• For patients who received extra-PV ablation at index, including those receiving 
ablation of the CTI, the persistence of nonconductivity in targeted tissue will be 
evaluated with either pacing maneuvers or electroanatomical mapping. 
 
Procedure-specific data will be collected as follows: 
• Procedural times  
• Lesion set data  
• Device deficiencies and malfunctions  
 
All subjects whether undergoing remapping or not: 
• Event Monitor: An Event Monitor and training will be provided to the subject, 
to be used for weekly scheduled and ad hoc symptomatic monitoring through 
the remainder of study follow-up. (See Section 3.11.4, Arrhythmia Core Lab). 
If necessary patients will be provided with an Event Monitor by mail, telephonic 
training and successful transmission of a monitoring record. 
• AFD Management: For patients who do not require reablation during the 75-
Day remap visit AFD may be stopped at the investigator’s discretion. 

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The following data will be collected from all subjects at 75 ± 15 days: 
• Adverse Events 
• Symptoms of recurrent arrhythmia  
• Fluoroscopic examination of diaphragm motion is required if: 
o Patient underwent remapping to assess phrenic nerve response 
o The patient declined a remap procedure but the post Index Procedure 
fluoroscopic examination indicated diminished phrenic nerve response 
• Data regarding the use, changes in or discontinuation of anticoagulation, rate 
control and/or antiarrhythmic medications. 
• Pregnancy test (all women of child-bearing potential) prior to remap 
• Cardiac rhythm as determined by a 12-lead ECG 
• Cardiac CT or MRI scan to assess the patency of the pulmonary veins 
• Cardioversions, ablations or hospital admissions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
3.12.6 6-Month Visit 
Subjects will return for an office visit 6 months (180 days ± 30 days) following the 
Index Procedure.  The following data will be collected at the 6-Month Visit: 
• Adverse Events 
• Symptoms of recurrent arrhythmia 
• If either the post-Index Procedure or post-75-Day Remap Procedure 
fluoroscopies indicated diminished phrenic nerve response, and resolution has 
not been previously demonstrated, a repeat fluoroscopic examination.  Females 
of childbearing potential undergoing this examination will also receive a 
pregnancy test prior. 
• Data regarding the use, changes in or discontinuation of anticoagulation, rate 
control and/or antiarrhythmic medications 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the visit 
• Arrythmia assessment (See Section 3.11.4, Arrhythmia Core Lab). 
o A 24-hour continuous ECG monitor and training will be provided to the 
subject 
o Event Monitor compliance will be reviewed for weekly scheduled and ad 
hoc symptomatic monitoring and retraining of the subject provided as 
needed 
• Cardioversions, ablations or hospital admissions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
3.12.7 12-Month Visit 
Subjects will return for an office visit 12 months (365 days ± 30 days) following the 
Index Procedure.  At a minimum, the following data will be collected at the 12-Month 
Visit: 
• Adverse Events 

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• Symptoms of recurrent arrhythmia 
• If either the post-Index Procedure or post-75-Day Remap Procedure 
fluoroscopies indicated diminished phrenic nerve response, and resolution has 
not been previously demonstrated, a repeat fluoroscopic examination.  Females 
of childbearing potential undergoing this examination will also receive a 
pregnancy test prior. 
• Data regarding the use, changes in or discontinuation of anticoagulation, rate 
control and/or antiarrhythmic medications. 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the visit 
• Arrythmia assessment (See Section 3.11.4, Arrhythmia Core Lab). 
o A 24-hour continuous ECG monitor will be provided to the subject. 
o Instructions for returning the Event Monitor will be provided 
• Cardioversions, ablations or hospital admissions since last visit  
• Heart failure status as assessed by NYHA classification at the time of visit 
3.12.8 Unscheduled Visits 
Any unscheduled follow-up visits that occur throughout the study, other than routine 
follow-up visits per the institution’s or investigator’s normal standard of care, shall be 
documented.  At the minimum, the following data will be collected: 
• Adverse Events 
• Symptoms of recurrent arrhythmia 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the visit 
• Event Monitor compliance will be reviewed for weekly scheduled and ad hoc 
symptomatic monitoring and retraining of the subject provided as needed. 
• Cardioversions, ablations or hospital admissions since last visit  
• Heart failure status as assessed by NYHA classification at the time of visit 
 
 

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3.13 Schedule of Study Assessments 
Table 3. Summary of Study Assessments 
Assessment 
Baseline 
Procedure 
Pre-Discharge 
30-Days Post-
Procedure (± 7 
days) 
75-Days (± 15 days) 
6-Month 
(180 ± 30 
days) 
12-Month 
(365 ± 30 
days) 
Unscheduled 
Medical History, CHA2DS2-VASc 
X 
 
 
 
 
 
 
 
AFD and Anticoagulant Medications  
X 
 
X 
X 
X 
X 
X 
X 
Symptoms of recurrent arrhythmia 
 
 
 
X 
X 
X 
X 
X 
History of cardioversions, ablations, 
hospital admissions since last visit 
 
 
X 
X 
X 
X 
X 
X 
Pregnancy test (for females of 
childbearing potential) 
X 
X 
 
 
X 
X4 
X4 
 
12-lead ECG 
X 
 
X 
X 
X 
X 
X 
X 
24-Hour Continuous ECG Monitor 
(e.g., Holter) 
 
 
 
 
 
X 
X 
 
Cardiac CT/MRI for LA and PV 
dimensions 
X 
 
 
 
X 
 
 
 
Mediastinal MRI 
 
 
X1 
 
 
 
 
 
TEE or other imaging modality (to 
exclude left atrial thrombus) 
X 
 
 
 
 
 
 
 
Electroanatomical Mapping 
 
X 
 
 
X 
 
 
 
Event Monitor readiness/compliance 
 
 
 
 
X 
X 
X 
X 
NIHSS 
X 
 
X 
 
 
 
 
 
Neurologic exam 
 
 
X2 
 
 
 
 
 
NYHA Classification 
X 
 
X 
X 
X 
X 
X 
X 
Fluoroscopic Examination of 
Diaphragm 
 
X 
 
 
X if remapped, 
X3 if not 
X3 
X3 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
1   At investigator’s discretion 
2   If NIHSS score has increased by 2 or more points or if clinical suspicion of stroke/TIA 
3   If the Index Procedure or Remap Procedure study indicated decreased phrenic nerve function and resolution has not yet been demonstrated. 
4  As required for females of childbearing potential undergoing fluoroscopic examination of the diaphragm 
 

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4. Benefit Risk Assessment 
The Sponsor has conducted an analysis of the benefits and risks of the 
FARAPULSE Endocardial Multi Ablation System and ablation procedure as 
described below.  The conclusion of this review is that the subject investigation is 
justified because the overall potential benefit to the population outweighs the risks. 
4.1 
Potential Adverse Events 
The following anticipated adverse events have been identified as possible 
complications of percutaneous atrial fibrillation ablation procedures in general as 
well as with the FARAPULSE Endocardial Multi Ablation System: 
• Access site complications (e.g., hematoma, pseudo-aneurysm, laceration, 
bleeding) potentially requiring surgical intervention 
• Air embolism 
• Allergic reaction or fever resulting from contact with catheters 
• Anemia 
• Arrhythmia, potentially requiring cardioversion, defibrillation, or rhythm 
management device 
• Arteriovenous fistulae 
• Back pain 
• Bed sores 
• Bleeding, hematoma, hemorrhage or aneurysm at vascular access sites 
• Blood pressure changes including hypotension or hypertension 
• Coronary artery or vein injury 
• Cardiac tamponade or perforation 
• Cardiac arrest or cardiac failure  
• Catheter entrapment 
• Cardiogenic shock 
• Conduction system injury resulting in sinus arrest or heart block, either 
transient or permanent, potentially requiring pacemaker insertion 
• Congestive heart failure  
• Death 
• Drug allergic reaction or side effects (e.g., from contrast, steroids, analgesics, 
anesthetics, anticoagulants, sedatives, etc.) 
 
• Embolism due to presence of thrombus or introduction of air 
• Esophageal injury, ulcer or fistula 
• Hemorrhage 
• Hemodynamic compromise 
• Hemopericardium 
• Hemoperitoneum 
• Hemothorax 
• Local infection, systemic infection, and/or sepsis 
• Muscle contractions due to electric stimulation 
• Myocardial infarction / transient ischemia 

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• Nerve damage 
• Organ failure 
• Pain 
• Perforation (e.g., of diaphragm, liver, lung, and/or vessels). 
• Pericardial irritation 
• Pericardial effusion 
• Pericarditis 
• Peritonitis 
• Phrenic nerve injury with paralysis of the diaphragm and breathing 
impairment 
• Pneumomediastinum 
• Pneumopericardium 
• Pneumoperitoneum 
• Pneumothorax 
• Pulmonary vein injury or stenosis 
• Risk of cancer or birth defect/harm to fetus from x-ray exposure 
• Skin burns/irritation from x-ray exposure  
• Stroke/transient ischemic attack 
• Surgical procedure to remove retained catheter 
• Thrombosis 
• Vessel damage, dissection, or occlusion. 
4.2 
Potential Risks 
As detailed in Section 1.4, Summary of FARAPULSE Clinical Studies, the risk 
profile associated with the FARAPULSE Endocardial Multi Ablation System and 
the ablation procedure is expected to be consistent with similar devices currently in 
clinical use for percutaneous cardiac ablation for treatment of persistent atrial 
fibrillation.   
The FARAPULSE Endocardial Multi Ablation System is a Pulsed Electric Field 
(PEF) ablation system that produces continuous transmural cardiac lesions to treat 
atrial fibrillation using an ablation procedure that is similar to other commercially 
available percutaneous ablation catheters.  More specifically: 
• The device system is used during percutaneous endocardial ablation procedures 
like other commercially approved catheter systems.   
• The device system is composed of similar biocompatible materials. 
• The device system is a non-thermal ablation technology with targeted cardiac 
tissue specific mechanism of ablation. 
• The device uses the standard percutaneous techniques for ablation procedures. 
• The device utilizes a standard irreversible electroporation generator to deliver 
energy in the form of ablation dose.   
 
A fundamental difference between the FARAPULSE Endocardial Multi Ablation 
System and other commercially approved atrial fibrillation ablation systems is that 
the Pulsed Electric Field or irreversible electroporation energy is delivered through 

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electrodes embedded in the endocardial ablation catheter for delivery of such 
energy in the pulmonary veins. 
As such, the potential risks are roughly equivalent to those associated with 
commercially released systems being used for percutaneous cardiac ablation 
procedures.  Currently, the complication rates for commercially available catheters 
are low and have declined as physicians have continued to learn more about cardiac 
ablation techniques.  Furthermore, FARAPULSE, Inc. has conducted bench and in-
vivo testing to ensure safe use of the device during clinical investigation and is in 
compliance with the applicable requirements of the Medical Device Directive 
93/42/EEC.   
4.3 
Potential Benefits 
There are no guaranteed benefits from participation in this study.  Information 
gained from the conduct of this study may also be of benefit to other persons with 
the same medical condition. 
A study of up to 40 patients for assessment in this protocol will have the following 
potential benefits: 
• To provide treatment to subjects with PersAF using an investigational 
device which has demonstrated the ability to isolate pulmonary veins and 
reduce the subsequent occurrence of symptomatic atrial fibrillation in a 
small number of patients treated for PAF (see Section 1.4, Summary of 
FARAPULSE Clinical Studies); 
• To generate additional data demonstrating that the endocardial creation of 
electrically isolating lesions via Pulsed Electric Field (PEF) catheter ablation 
applied using the FARAPULSE Endocardial Multi Ablation System is a 
safe and potentially effective treatment for drug-resistant, recurrent, 
symptomatic persistent atrial fibrillation (PersAF); 
• To assess the feasibility and safety of the FARAFLEX Ablation Catheter for 
focal ablation in accordance with its proposed indication for use; 
• To assess the protocol elements and design for subsequent use in an 
expanded multi-center European CE Mark Trial. 
 

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5. Statistical Analysis and Reporting 
A Statistical Analysis Plan (SAP) will be prepared that governs the collection, 
analysis and reporting of the data from this investigation. This section summarizes 
the essential elements of that plan. 
5.1 
General Statistical Considerations 
All statistical analyses will be performed using validated statistical software.  
Continuous variables will be summarized using standard quantitative statistics: 
number of available observations, mean, standard deviation, median, quartiles and 
range (minimum and maximum observed values). The number of missing 
observations will also be specified. 
Categorical variables will be summarized using classical frequency statistics: 
number of available observations and percentages by categories. Percentages will 
be calculated on the number of available observations. The number of missing 
observations will also be specified. 
When applicable, bilateral asymptotic or exact confidence intervals for binomial 
distributions will be calculated at the 95% level. 
A full data listing will be prepared. Data will be pooled from all study sites.   
All related and resulting reports, documents and data will be produced and 
maintained in such a way as to ensure their control and the protection of subject 
privacy as far as is reasonably practicable.  Data files and analytic reports will be 
archived according to requisite regulatory standards. 
5.2 
Control of Systematic Error and Bias 
Subjects are not randomized in this single arm study and therefore masking is not 
achievable.  Error and bias are being controlled by several means, including a 
comprehensive set of study procedures as defined in the protocol to ensure 
consistent management and outcome measure assessment.  Follow-up Holter 
monitoring and event monitoring data, and all MRI/CT dimensions of PVs, will be 
assessed objectively by third parties according to standard clinical protocols.  
Primary effectiveness and safety outcomes will be reviewed by an independent 
Clinical Events – Data Monitoring Committee (CEDMC).  A complete Study 
Report will allow scientific and clinical reviewers to independently assess potential 
error and bias. 
Study outcomes will be reviewed and adjudicated by an independent Clinical 
Events and Data Monitoring Committee (CEDMC) more fully described in Section 
9.10, Clinical Events and Data Monitoring Committee. 
5.3 
Sample Size Justification  
This investigation is the next phase of ongoing feasibility studies to allow the 
controlled introduction of a new cardiac ablation catheter (FARAFLEX 
Endocardial Ablation Catheter). This is a feasibility study with no formal 
hypothesis testing and therefore no required sample size.  Study results will be 

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presented using descriptive statistics.  Results from this study will be used to inform 
and design additional clinical studies. 
Forty (40) subjects at up to four sites will allow the assessment of the modified 
devices and the initial experience and training of investigators and study staff at a 
new investigational site. 
5.4 
Subject Disposition 
The disposition of all subjects enrolled in the study will be described in tables and 
diagrams, including numbers screened, treated and assessed at each scheduled 
follow-up interval.  Subjects who do not complete the study will be enumerated and 
the reason(s) for their discontinuation will be described. 
5.5 
Imputation for Missing Data 
Imputations for missing data in (e.g., withdrawn subjects, loss to follow-up, missing 
data) will not be performed.  Analyses will be performed with all available data 
only. 
5.6 
Populations for Analysis 
Enrolled Population: all subjects who provided their informed consent. 
Safety Subjects/Intent to Treat Subjects: all enrolled subjects except those who 
terminate their participation prior to the beginning of the Index Procedure. 
Per Protocol Subjects: Intent-to-treat subjects for whom the Index Procedure is 
finished without interfering investigational device deficiency or malfunction. 
Reasons for exclusion from the populations will be given, and a summary of 
adverse events for these subjects, if any, will be provided. 
5.7 
Final Clinical Report 
A final clinical report including these analyses will be prepared at the conclusion of 
the study or at such time as the study may be prematurely terminated.  Copies of the 
final report will be provided to the investigator and their EC and to the CA as 
applicable. 
 
 

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6. Outcome Measures 
6.1 
Primary Safety Endpoint 
The primary safety endpoint for this study is the Composite Safety Endpoint (CSE) 
defined as the incidence of the following early-onset and late-onset serious adverse 
events (SAEs) which are device- or procedure-related, as adjudicated by the 
CEDMC and defined below in Table 4. Composite Safety Endpoint Definitions. 
Early onset (within 30 days of an Index or Remap Procedure) 
• Death  
• Myocardial infarction (MI)  
• Persistent diaphragmatic paralysis  
• Stroke or transient ischemic attack (TIA)  
• Peripheral or organ thromboembolism  
• Pericarditis 
• Cardiac tamponade / perforation  
• Vascular access complications requiring intervention 
• Heart block  
Late onset (any time during follow-up through 12 months) 
• Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)  
• Atrio-esophageal fistula  
 
Table 4. 
Composite Safety Endpoint Definitions 
 
Adverse Event 
Description/Criteria 
Death 
Death 
Myocardial infarction (MI) 
Myocardial infarction will be demonstrated by any one of the 
following:  
1) detection of ECG changes indicative of new ischemia (new 
ST-T wave changes or new LBB) that persist for more than 1 
hour. 
2) development of new pathological Q waves on an ECG 
3) imaging evidence of new loss of viable myocardium or new 
regional wall motion abnormality 
Persistent diaphragmatic 
paralysis 
Diaphragmatic paralysis: Change from baseline diaphragmatic 
function as demonstrated radiographically by elevation of the 
diaphragm above the normal range but not due to a pulmonary 
process such as atelectasis. 
Permanent: not resolved by completion of study follow-up  
Stroke or transient ischemic 
attack (TIA) 
Stroke is an acute symptomatic episode of neurological 
dysfunction attributed to a vascular cause (ischemia or 
hemorrhage) in which symptoms last more than 24 hours, or if 
symptoms last less than 24 hours, a brain imaging study 
demonstrates infarction.   
Transient ischemic attack is a new focal neurological deficit 
with rapid symptom resolution always within 24 hours. 

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Adverse Event 
Description/Criteria 
Peripheral or organ 
thromboembolism 
Formation in a blood vessel of a clot (thrombus) that results 
from the breaking loose of all or part of an existing thrombus, 
which is then carried by the blood to lodge in/occlude a more 
distal vascular site. 
Pericarditis 
Inflammation of the pericardial space that results in an effusion 
that leads to hemodynamic compromise or required 
pericardiocentesis, prolongs hospitalization by more than 48 
hours, requires hospitalization, or persists for more than 30 days 
following the ablation procedure. 
Cardiac 
tamponade/perforation 
The development of a significant pericardial effusion during or 
within 30 days of undergoing the index AF ablation procedure.  
A significant pericardial effusion is one which results in 
hemodynamic compromised (<80mmHg systolic bp), requires 
elective or urgent pericardiocentesis, or results in a 1cm or more 
pericardial effusion as documented by echocardiography.   
Vascular access 
complications requiring 
intervention 
Vascular access complication (e.g. groin hematoma, AV fistula, 
pseudoaneurysm) requiring intervention (e.g. surgical repair, 
blood transfusion). 
Heart block  
Impairment of AV conduction requiring permanent pacing 
intervention, if resulting from inappropriate ablation application. 
Pulmonary vein (PV) 
stenosis  
>70% diameter reduction of pulmonary vein from baseline 
CT/MRA scan. 
Atrio-esophageal fistula 
Connection between the atrium and the lumen of the esophagus 
as evidenced by documentation of esophageal erosion combined 
with evidence of a fistulous connection to the atrium. 
 
6.2 
Secondary Safety Endpoints 
1. The Primary Safety Endpoint assessed at 7 rather than 30 days  
2. The proportion of subjects with a device- or procedure-related SAE 
3. The proportion of subjects with stroke or TIA 
4. The proportion of subjects requiring cardioversion 
5. The proportion of subjects requiring an arrhythmia-related hospitalization 
6.3 
Primary Feasibility Endpoint 
The proportion of subjects that achieve Acute Procedural Success (APS) defined as 
the percutaneous endocardial creation of a complete, electrically isolating set of 
lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE 
Endocardial Multi Ablation System during the Index Procedure, as clinically 
assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI 
lesion is made. 
6.4 
Secondary Feasibility Endpoints 
1. The proportion of subjects who undergo the protocol-specified 75-Day 
Remapping Procedure and achieve Chronic Procedural Success (CPS) defined 
as persistent electrical isolation of all initially ablated pulmonary veins. 
Chronic Procedural Success will be subdivided by Index Procedure only CPS 
and Reablated CPS subjects.  

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2. The proportion of attempted subjects that achieve Acute CTI Success, defined 
as the creation of bi-directional electrical block across the CTI using the 
investigational devices. 
3. Durability of the CTI and/or other extra-PV lesion set(s), when applicable.  
Durability is defined as unaltered integrity of each such lesion assessed at the 
Remapping Procedure. 
4. The proportion of subjects that achieve Therapeutic Success, defined as 
freedom from: 
a. Post-Blanking Period through assessment: occurrence of AF, AFL or AT, 
or ablation for AF/AFL/AT using the study device 
b. At any time: ablation for AF/AFL/AT with a nonstudy device 
Therapeutic Success will be assessed from the end of the 90 Day Blanking 
Period through  Months 6 and 12 and will be subdivided by on / off AFDs 
(Atrial Fibrillation Drugs) post-Blanking Period. 
6.5 
Additional Assessments 
1. Proportion of subjects with early recurrence of atrial fibrillation (ERAF) by 90 
days after the initial study ablation. 
2. Time to Therapeutic Failure 
3. Proportion of all ablated pulmonary veins that are isolated at the Index 
Procedure using the study device. 
4. Proportion of all ablated pulmonary veins isolated using the study device 
during the Index Procedure that remain isolated at the 75-day Remapping 
Procedure. 
5. The proportion of attempted subjects that achieve Chronic CTI Success, 
defined as persistent bi-directional electrical block across the CTI as assessed 
at the 75-day remapping procedure. 
6. The proportion of attempted subjects that achieve Chronic Focal Success, 
defined as persistent electrical nonconductivity of extra-PV tissue targeted for 
ablation in the Index Procedure, excluding the CTI  
6.6 
Procedural Assessments 
1) Assessments of duration for procedure components: 
a. Procedure time (initiation of venous access to venous access closure) 
b. Dwell time (sum of catheter entry-to-exit durations for each cardiac 
chamber) 
c. Total ablation time (first ablation to last ablation) 
d. Fluoroscopy time and dose (total duration and dose of exposure) 
2) Characterization of lesion sets: 
a. PVI ablations 
b. Extra-PV ablations, excluding CTI ablations 
c. CTI ablations 
d. Anomalous PV ablations 

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7. Adverse Events, Device Effects, Malfunctions and Deficiencies 
 
7.1 
Adverse Events 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the investigational 
medical device. 
NOTE 1: 
This definition includes events related to the investigational medical device 
or the comparator. 
NOTE 2:   This definition includes events related to the procedures involved. 
NOTE 3:   For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
NOTE 4: 
This definition excludes medical conditions, findings or abnormalities 
present at the time of enrollment, which are defined as pre-existing 
conditions. Pre-existing conditions will not be included in the adverse 
event dataset. However, a worsening of a pre-existing condition during the 
study does constitute an adverse event. 
7.2 
Serious Adverse Events 
A Serious Adverse Event (SAE) is an adverse event that led to: 
• Death, 
• 
Serious deterioration in the health of the subject, that either resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function. 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE 1: 
Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not 
considered a serious adverse event.  
7.3 
Device Effects 
7.3.1 
Adverse Device Effects 
An Adverse Device Effect (ADE) is an adverse event related to the use of an 
investigational medical device 
NOTE 1:  This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2: 
This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
NOTE 3: 
“Related to the uses of an investigational medical device” shall be defined 
for this protocol as a determination that the effects was probably or 
definitely related to an investigational device. 

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7.3.2 Serious Adverse Device Effects 
A Serious Adverse Device Effect (SADE) is an adverse device effect (ADE) that 
has resulted in any of the consequences characteristic of a Serious Adverse Event. 
(SAE). 
7.3.3 
Unanticipated Serious Adverse Device Effects 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious adverse 
device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report as embodied in Section 
4.1 of this CIP. 
NOTE 1: 
Anticipated serious adverse device effect (ASADE) is an effect which by 
its nature, incidence, severity or outcome has been identified in the risk 
analysis report. 
NOTE 2: 
 If an SAE is determined to be probably or definitely related to the device 
and has not been previously anticipated, the clinical finding would be 
classified as an unanticipated serious adverse device effect (USADE). 
7.4 
Device Deficiencies 
A Device Deficiency is an inadequacy of an investigational medical device related 
to its identity, quality, durability, reliability, safety or performance. This may 
include malfunctions, use error, or inadequacy in the information supplied by the 
manufacturer. 
7.5 
Use Errors 
An Use Error is an act or omission of an act that results in a different medical 
device response than intended by the manufacturer or expected by the user 
NOTE 1: 
Use error includes slips, lapses, and mistakes. 
NOTE 2: 
An unexpected physiological response of the subject does not in itself 
constitute a use error. 
7.6 
Malfunctions 
A Malfunction is a failure of an investigational medical device to perform in 
accordance with its design specifications and intended purpose when used in 
accordance with the instructions for use or the subject CIP. 
7.7 
Causality Relationship 
The investigator will assess the causality of all adverse events in relation to the 
investigational device or any other study-related procedures according to five 
different levels of causality: 
1) Not related: relationship to the device or procedures can be excluded when: 
• 
the event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
• 
the event has no temporal relationship with the use of the investigational 
device or the procedures; 

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• 
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; 
• 
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; 
• 
the event involves a body-site or an organ not expected to be affected by the 
device or procedure; 
• 
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); 
• 
harms to the subject 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. 
2) 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. 
3) 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. 
4) Probable: the relationship with the use of the investigational device seems 
relevant and/or the event cannot reasonably have explained by another cause, but 
additional information may be obtained. 
5) Causal relationship: the serious event is associated with the investigational 
device or with procedures beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the device belongs 
to or of similar devices and procedures; 
• 
the event has a temporal relationship with investigational device 
use/application or procedures; 
• 
the event involves a body-site or organ that 
• 
the investigational device or procedures are applied to; 
• 
the investigational device or procedures have an effect on; 
• 
the serious event follows a known response pattern to the medical device (if 
the response pattern is previously known); 
• 
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); 

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• 
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; 
• 
harm to the subject is due to error in use; 
• 
In order to establish the 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. 
7.8 
Reporting 
AEs and SAEs: 
All AEs, including all SAEs, will be monitored from the time of enrollment through 
discharge for this study.  All AEs must be documented in the patient chart and 
recorded in the appropriate CRF.  A description of the event, including the start 
date, resolution date, action taken and the outcome shall be provided along with the 
Investigator’s assessment of the seriousness of the event and the relationship 
between the AE and the study devices and/or procedures. 
All AEs should be followed until the event is resolved, judged to be chronically 
stable or 12 month study follow-up has been completed.  The investigational site 
will provide relevant follow-up information to the Sponsor or designee upon 
request. 
The investigator shall also report to the Sponsor or its designee any Device 
Deficiencies or Malfunctions that did not but might have led to a SAE if such an 
event were to recur. 
The investigator shall notify the Sponsor and the designated CRO immediately and 
not later than 24 hours after the Investigator has become aware of a SAE or Device 
Deficiency / Malfunction that might have led to a SAE.  
The Investigator shall report the  SAE or Device Deficiency / Malfunction on the 
appropriate CRF  
Should mail correspondence be necessary, documents can be sent to the following:  
CRO: 
 
MedPass International SAS  
Fax:  
  
+33 (0)1 40 53 81 11 
Sponsor: 
FARAPULSE, Inc. 
Email: 
 
clinical@farapulse.com  
 
 
 
Contact:  
Mr.  Christopher Schneider 
Return of Subject Device: 
In all cases, and whenever possible the device involved in the AE, SAE, Device 
Deficiency / Malfunction as described above is to be returned to the Sponsor or 
Sponsor’s designee for analysis and investigation, as appropriate. The Study 
Coordinator shall contact the Sponsor for instructions on returning the device. 

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Device Deficiencies and Malfunctions: 
All Device Deficiencies / Malfunctions that did not contribute and would not likely 
contribute to a SAE, shall be documented on the Device Deficiency / Malfunction 
CRF and submitted to the Sponsor within 7 days after the observed Device 
Deficiency / Malfunction.  The Sponsor’s Quality Assurance function shall ensure an 
assessment is completed for each reported Device Deficiency / Malfunction. Such 
information shall be provided in the final clinical report. 
Depending on the local requirements or following agreement between both parties, 
the Sponsor, its designated representative (CRO) or the Principal Investigator will 
be responsible for performing safety reporting to the Ethics Committee according to 
the relevant local regulatory requirements.  
The Sponsor or designated representative (CRO) will be responsible for reporting to 
the National Competent Authority according to national requirements in accordance 
with MEDDEV 2.7/3.  
 

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8. Monitoring 
Clinical monitors, qualified by training and experience, will be responsible for 
monitoring and overseeing the conduct of the study in accordance with the Study 
Monitoring Plan.   
The clinical monitors will evaluate compliance with the protocol, any specific 
recommendations made by the site’s EC and the signed Investigator Agreement.  
Phone contacts and site visits will be conducted to ensure that the protocol is being 
followed and that any protocol deviations are properly documented.  Clinical 
monitoring will include a verification that the ICFwas properly obtained for all 
enrolled study participants, a review of clinical records for accuracy and 
completeness, resolution of missing or inconsistent results and a review of source 
documents.  The clinical monitor will verify that the CRFs are in agreement with 
the source documentation and other records.  The Investigator will make available 
to the clinical monitor for review all ICFs, all completed CRFs, source 
documentation and other relevant records for all enrolled subjects at the site.   
If a deficiency is noted during an on-site monitoring visit or at any other time 
during the course of the study, the clinical monitor is required to discuss the 
situation with the Investigator and the Sponsor to ensure compliance. 
The Sponsor or its designated representative, qualified by training and experience, 
will be responsible for monitoring and overseeing the conduct of the study.  The 
accuracy of all collected data will be verified for: 
• Eligibility criteria 
• Baseline characteristics 
• Primary safety and feasibility endpoints 
• Secondary endpoints 
• Adverse events (including SAEs) and Device Deficiencies / Malfunction 
Reporting 
Verification will utilize source documents including, but not limited to, medical 
records, office/ clinic notes, procedure reports, laboratory results, physician and 
nursing progress notes.  Verification and quality of data, monitoring of clinical 
study progress and Investigator compliance with the approved protocol will be 
conducted by the Sponsor or its designated representative. 
The Sponsor or its designated representative must be allowed to visit the clinical 
site and have direct access to all study records throughout the duration of the study.  
The monitor will review all source data and compare them to the data documented 
in the CRFs, in addition to performing a review of the Regulatory Site Binder, and 
assessing device accountability.  The Investigator and / or institution will provide 
direct access to source data/ documents for study-related monitoring, audits, and 
regulatory review and inspection. 
It is important that the Investigator and other relevant site personnel, including the 
research study coordinator, are available for consultation with the clinical monitors 

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during the monitoring visits and that sufficient time is devoted at the site for the 
monitoring process.   
Additionally, telephone, email contact, and onsite visits will be conducted on a 
regular basis with the Investigator and the site staff to ensure that the protocol is 
being followed and to address any issues that may occur during the study. 
If a deficiency is noted during the course of the study, the clinical monitor is 
required to discuss the situation with the site and the Sponsor (if required) to secure 
compliance.  A Monitoring Site Visit Report will be issued to the Investigator and 
Sponsor.  

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9. Study Management 
The Sponsor has overall responsibility for the conduct of the study according to 
Good Clinical Practice Guidelines (ICH E6 Consolidated Guidance to Good 
Clinical Practice) as well as any conditions imposed by local and national 
regulatory authorities. 
For the subject investigation, the Sponsor will have direct responsibilities and will 
delegate other responsibilities to appropriate and qualified consultants, contractors 
and/ or CROs.  Together, the Sponsor, consultants and CRO will ensure that the 
study is conducted according to the approved CIP, EC-approved ICF and all 
applicable governing regulations.  All personnel to participate in the conduct of this 
clinical study will be qualified by education and/or experience to perform their 
tasks. 
9.1 
  Key Contributors 
9.1.1 
Study Sponsor 
FARAPULSE, Inc. 
3715 Haven Ave.  Suite 110 
Menlo Park, CA 94025, USA 
Phone: 617-686-7661 
Email: kschneider@farapulse.com 
9.1.2 
CRO 
MedPass International SAS 
95b Boulevard Pereire 
75017 Paris, France 
Tel No: +33 1.42.12.83.30 
9.1.3 
Arrhythmia Core Lab 
MDT – Medical Data Transfer, s.r.o. 
Zabrdovicka 2, 615 00 Brno 
Czech Republic 
Contact: Veronika Bolkova 
Tel: +420 725 069 195 
iowa@mdtekg.cz 
  
9.2 
Ethical Considerations 
It is expected that all parties will share in the responsibility for ethical conduct in 
accordance with their respective roles in the investigation.  The Sponsor and the 
Investigator shall avoid improper influence or inducement of the subject, monitor, 
other clinical investigator or other parties participating in or contributing to the 
clinical investigation. 

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9.2.1 
Study Conduct 
The study will be performed in accordance with the relevant parts of the Code of 
Federal Regulations, ICH Guidelines for Good Clinical Practices, the European 
Standard ISO 14155, the Declaration of Helsinki, and any regional and/or national 
regulations.  The clinical investigation shall not begin until the required approval 
has been obtained from the National CA and the local EC.  Any additional 
requirements imposed by the regulatory authority or EC shall be followed.  These 
principles shall prevail over interests of science and society and shall be 
understood, observed and applied at every step in this clinical investigation. 
9.2.2 Ethics Review 
Before any subject can be enrolled in this study, the local or national EC and the 
CA must review and approve the CIP and the ICF to be used.  A subject cannot be 
asked to sign the ICF until the study has been fully approved by the institution’s 
EC and by the CA, if applicable.  The Sponsor or their designated CRO will 
require a copy of any EC correspondence, as well as the final EC approval letter 
and the final EC-approved ICF, and approvals for the CIP and ICF revisions on 
amendments from the EC. The Sponsor or their designated CRO will keep all of 
the CA correspondence, as well as the CA approval letter. 
9.2.3 Informed Consent 
Subjects will not sign the ICF until the study has been fully approved by the 
institution’s Ethics Committee and the Sponsor or their designated CRO has 
received and reviewed the specific EC-approved ICF.  When the Investigator has 
determined the eligibility of a specific subject to enter the study, the ICF must be 
completed.  The ICF must be read and understood by the subject, the subject’s 
questions answered, and the form signed by the subject before any study-related 
procedures can be performed.  All subjects are to receive copies of their signed 
ICF. 
9.2.4 Coverage of Expenses 
Study participants will be reimbursed for travel costs related to study hospital 
visits. 
9.2.5 Confidentiality 
Confidentiality of subjects will be maintained throughout the study.  A unique 
identification code will be assigned to each subject participating in this study.  
Any data that may be published in abstracts, scientific journals, or presented at 
medical meetings will reference a unique subject code and will not reveal the 
subject’s identity.  The Sponsor, CRO, Investigators and Site personnel will make 
every reasonable effort to protect the confidentiality of all subjects participating in 
the study. 

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9.3 
Insurance 
The Sponsor will maintain the appropriate and necessary insurance coverage for the 
duration of the study. 
9.4 
Audits and Inspections 
The Principal Investigator will also allow representatives of the governing EC, CA, 
U.S. Food and Drug Administration, and other applicable regulatory agencies to 
inspect all study records, CRFs, and corresponding portions of the subject’s office 
and/or hospital medical records at regular intervals throughout the study.  These 
inspections are for the purpose of verifying adherence to the CIP, completeness and 
exactness of the data being entered onto the CRFs and compliance with regulatory 
agency regulations. 
The Principal Investigator will inform the Sponsor or the Sponsor’s designee should 
they be audited or inspected by any regulatory agencies.  The Sponsor or the 
Sponsor’s designee will also inform the site if they are made aware of a pending 
audit or inspection by a regulatory agency. 
9.5 
Sponsor Responsibilities 
Sponsor has the overall responsibility for  the study and will: 
• Select qualified Investigators, clinical investigators and study sites. 
• Select qualified monitors. 
• Provide the CIP and any subsequent amendments. 
• Provide appropriate information and Investigational system training to the 
Investigator and study site staff. 
• Ensure that all deviations from the CIP are reviewed with the appropriate 
Investigator(s) and reported on the CRFs and the final clinical report and that 
any necessary preventative or corrective action is taken. 
• Ensure that all AEs and all ADEs are reported and reviewed with the 
Investigator(s), and where appropriate, that all SAEs and all SADEs are 
appropriately reported. 
• Ensure that all Device Deficiencies / Malfunctions are reviewed by the 
Sponsor, and properly assessed and investigated, as appropriate. 
• Promptly inform the Investigator and where applicable, any regulatory 
authorities, if the study is prematurely terminated or suspended and the reason 
for the termination or suspension. 
• Ensure proper device usage, uniform data collection and protocol compliance. 
• Provide site initiation training to include review of the FARAPULSE 
Endocardial Multi Ablation System Instructions for Use, the Clinical 
Investigation Plan, CRF instructions, CRFs, AE/SAE/Device Deficiency 
reporting and requirements for obtaining informed consent. 
• Provide the FARAPULSE Endocardial Multi Ablation System to the 
participating study site, in quantities to support study activities. 
• Coordinate ongoing communication with CROs, consultants and study site to 
resolve any problems concerning the protocol or data collection 

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• Every effort will be made to ensure compliance with the protocol. 
• Retain ownership of all clinical data generated in this study and control the 
use of the data for purposes of regulatory submissions to CAs. 
• Protect subject confidentiality. 
• Provide Regulatory Site Binder to site. 
9.6 
Monitor Responsibilities 
Clinical monitors, qualified by training and experience, will be responsible for 
monitoring and overseeing the conduct of the study. 
Site Initiation Visit: Sponsor personnel and / or clinical monitors will conduct site 
initiation visits at the investigational site to ensure that the Principal Investigator 
and other investigational site personnel involved in the conduct of this investigation 
have received and understood the requirements and contents of this Clinical 
Investigation Plan, the Investigator’s Brochure, the patient ICF, the CRFs, CRF 
Instructions, AE/SAE/Device Deficiency reporting requirements, and the 
Instructions for Use and the Institution and/ or Investigator Agreement. 
Site Monitoring: The clinical monitors will conduct routine on-site monitoring 
visits and phone calls in accordance with a Study Monitoring Plan to evaluate 
compliance with the CIP, any specific recommendations made by the site’s EC and 
the signed Institution and/or Investigator Agreement and to ensure that the CIP is 
being followed and that any protocol deviations are properly documented on the 
respective CRF.  Clinical monitoring will include a verification that informed 
consent was properly obtained and documented for all enrolled study participants, a 
review of clinical records and CRFs for accuracy and completeness, resolution of 
missing or inconsistent results and a review of source documents. 
Clinical monitoring will include a review of all adverse events, SAEs and Device 
Deficiencies / Malfunctions to ensure that all information has been reported to the 
Sponsor, EC and regulatory authorities as required by the Clinical Investigational 
Plan and applicable standards and laws. 
The clinical monitor will verify that the CRFs are complete and in agreement with 
the source documentation and other records.  The clinical monitor will ensure that 
all CRFs have been signed and dated by the Investigator. 
The Investigator will make available to the clinical monitor for review all ICFs, all 
CRFs, source documentation and other relevant records for all enrolled subjects at 
the site.  It is important that the Investigator and other relevant site personnel are 
available for consultation with the clinical monitors during the monitoring visits 
and that sufficient time is devoted at the site for the monitoring process. 
If a deficiency is noted during an on-site visit or at any other time during the course 
of the study, the clinical monitor is required to discuss the situation with the 
Investigator and the Sponsor, and to subsequently monitor the implementation of 
corrective actions that are required to address the situation. 
All monitoring activities will be documented by the clinical monitor in a 
Monitoring Report and will include, at a minimum, the date, investigational site 

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visited, names of all personnel involved in the visit, a listing of all documents 
reviewed and a summary of all findings, facts, deviations, conclusions and 
recommended actions to be taken.  Key findings will be reviewed with the clinical 
investigator.  
Upon completion of the study, a study close out visit will be conducted to ensure 
that all data collection and study requirements are complete. 
9.7 
Investigator Responsibilities 
At a minimum, the following documents will be provided by the investigational site 
to the Sponsor prior to study start (consent of the first subject): 
• Signed Clinical Trial Agreements 
• Signed Financial Disclosure Form 
• Signed Clinical Investigation Plan Signature Page 
• Investigator and Co-Investigator’s current Curriculum Vitae 
• Any other additional documents as required by the Sponsor 
The Investigator is responsible for ensuring that the investigation is conducted 
according to all signed agreements, the CIP, governing regulations, data protection 
regulations, medical device laws, the Declaration of Helsinki and any other 
conditions imposed by the relevant regulatory authorities.  The Investigator is 
responsible for maintaining medical and study records for every subject 
participating in the clinical study (including information maintained electronically 
such as digital imaging).  The Investigator will also maintain original source 
documents from which study-related data are derived. 
The Investigator(s) shall be responsible for the day to day conduct of the 
investigation as well as for the safety and well-being of the human subjects 
involved in the clinical investigation. 
The Investigator(s) shall: 
• Have the qualified and trained resources to conduct the investigation properly. 
• Obtain from the Sponsor the information which the Investigator(s) judges 
essential about the device and be familiar with this information. 
• Be well acquainted with the CIP before signing the signature page. 
• Support the monitor, auditor, if applicable, in their activities to verify 
compliance with the CIP, to perform source data verification and to correct the 
CRF where inconsistencies or missing values are identified. 
• Discuss with the Sponsor management any question of modification of the CIP. 
• Make sure that the CIP is followed by all responsible for the conduct of the 
study at his/ her institution.  Any deviation shall be documented and reported to 
the study Sponsor and CRO. 
• Make the necessary arrangements to ensure the proper conduct and completion 
of the investigation. 
• Make the necessary arrangements for emergency treatment, as needed, to 
protect the health and welfare of the subject. 

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• Ensure that appropriate EC and CA approval is obtained prior to the start of the 
investigation. 
• Inform Sponsor about adverse events and Device Deficiencies / Malfunctions in 
a timely manner; document on applicable CRFs. 
• Endeavor to ensure an adequate recruitment of subjects. 
• Ensure that the subject has adequate information and time to provide informed 
consent. 
• Ensure that informed consent is obtained and documented on the EC-approved 
ICF. 
• Ensure that clinical records are clearly marked to indicate that the subject is 
enrolled in this study. 
• Provide subjects with well-defined procedures for any emergency situation and 
safeguard the subject’s interest.  Under these circumstances, deviations from the 
CIP shall not require the prior approval of the Sponsor or the national and local 
regulatory authorities.  Such deviations shall not be considered as a breach of 
agreement but shall be documented and reported to Sponsor. 
• Ensure that information which becomes available as a result of the clinical 
investigation which may be of importance to the health of a subject and the 
continuation of the investigation shall be made known to the Sponsor and, if 
pertinent to the safety or well-being of the subject, and the private clinician. 
• Inform the subject and/ or the subject’s physician about any premature 
termination or suspension of the investigation with a rationale for study 
termination. 
• Have primary responsibility for the accuracy, legibility and security of all 
investigation data, documents and subject records both during and after the 
investigation. 
• Sign each subject’s CRF, as applicable. 
• Be responsible for the supervision and assignment of duties at his/ her clinical 
center. 
• 
Ensure that all investigational devices are kept in a secure location and that all 
Systems are accounted for on the Device Accountability Form (number of 
devices used, discarded and returned to Sponsor). 
• 
Investigator shall assign responsibility of Regulatory Site Binder and its 
maintenance to the Research Study Coordinator. 
9.8 
Investigator Training 
The participating investigator will be trained in the use of the FARAPULSE 
Endocardial Multi Ablation System prior to participating in the study.  Device 
training will be conducted by the Sponsor or its representatives.  All device training 
will be documented in a training log that will be maintained in the Regulatory Site 
Binder. 
9.9 
Site Training 
To ensure accurate, complete and reliable data, the Sponsor or its representatives 
will provide instructional material to the site, as appropriate; instruct the 

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investigator and study personnel on the CIP, the completion of the CRFs including 
CRF Instructions, and study procedures; communicate regularly with site personnel 
via mail, email, telephone, and/or fax; and make periodic monitoring visits to the 
site.  During those visits, the Sponsor or its representatives will monitor the subject 
data recorded in the CRFs against the source documents at the site for all enrolled 
subjects. 
9.10 Clinical Events and Data Monitoring Committee 
The Sponsor has established an external group of expert physicians who are not 
investigators to serve as the Clinical Events and Data Monitoring Committee 
(CEDMC).  This group will consist of a panel of 3 experienced, independent 
physicians who are not investigators and who will be supported by the Medical 
Monitor and Study Statistician. A combined CEDMC procedure is an appropriate 
structure for a 40 subject feasibility study. 
The CEDMC will review and approve a Charter. The CEDMC will convene during 
the study to screen, classify and adjudicate all adverse events reported in the subject 
investigation as well as major study outcomes. The CEDMC will be provided with 
case summaries, relevant source documents and any other information required to 
evaluate and adjudicate the adverse events and study outcomes. 
The CEDMC will also convene to review safety data and trends during the conduct 
of the study.  This formal assessment will occur at a minimum after the enrollment 
of 20 and then 40 subjects.  The CEDMC will recommend to the Sponsor whether a 
study pause or termination is required if it identifies a trend that indicates a danger 
to patient safety.  
9.11  Data Management 
Data management procedures will be included in the Study Management Plan. 
CRFs will be made available to the participating site.  Investigators are responsible 
for the accurate completion of patient CRFs during the study. The Investigator will 
ensure that complete, accurate and timely data on CRFs are completed, that 
protocol requirements are followed and that complications, adverse events and 
adverse device effects are correctly reported and investigated, as appropriate.   The 
Investigator is expected to maintain all source documents as required by the CIP, 
including laboratory results, supporting medical records, and signed ICFs.  The 
source documents will be used during the regular monitoring visits to verify 
information from the database against data contained on the completed CRFs. 
After CRF Monitoring has been complete and deficiencies / discrepancies resolved, 
CRFs will be provided to the Sponsor or CRO, and data from the study will be 
entered from the CRFs into a central database.  CRF data will be reviewed to 
identify any inconsistent or missing data and any adverse events.  Any data issues 
are to be promptly addressed with the Investigator by the CRO. 
9.12  Study Suspension or Early Termination 
The study can be discontinued at any site at the discretion of the Investigator or 
study Sponsor for reasons including, but not limited to, the following: 

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• Occurrence of adverse events unknown to date in respect to their nature, severity, 
or duration, or the unexpected incidence of known adverse events. 
• Obtaining new scientific knowledge that shows that the study is no longer valid 
or necessary. 
• Data demonstrates a benefit to subjects who undergo percutaneous ablation with 
the FARAPULSE Endocardial Multi Ablation System making treatment without 
the FARAPULSE Endocardial Multi Ablation System unethical. 
• Insufficient recruitment of subjects. 
• Unanticipated adverse device effect (UADE) presenting an unreasonable risk to 
subjects (Sponsor may terminate the study immediately) 
• Persistent non-compliance with the Clinical Investigation Plan. 
• Persistent non-compliance with regulatory requirements. 
If the study is discontinued or suspended prematurely, the Sponsor shall promptly 
inform the clinical investigator/ investigational center of the termination or 
suspension and the reason(s) for discontinuation / suspension.  The national and 
local regulatory authorities shall also be informed promptly and provided with the 
reason(s) for the termination or suspension by the Sponsor, CRO or by the clinical 
investigator/ investigation center. Further, if the study is discontinued or suspended 
prematurely, patients enrolled to that point will continue to be followed for safety 
through the 12-month timepoint.   
9.13  Criteria for Suspending/ Terminating a Study Center 
Sponsor reserves the right to stop the screening of subjects at the study center at any 
time after the study initiation visit if no subjects have been enrolled or if the center 
has multiple or severe protocol violations without justification or fails to follow 
remedial actions.  
Possible reasons for suspending/ terminating the study center include, but are not 
limited to: 
• Repeated failure to complete CRFs prior to scheduled monitoring visits; 
• Failure to obtain written informed consent using the EC-approved ICF; 
• Failure to report SAEs/ USADEs to Sponsor within 24 hours of knowledge; 
• Loss of (or unaccounted for) investigational product inventory or repeated failure 
of device accountability. 
9.14 Deviations from the Clinical Investigation Plan 
The Investigator is not allowed to deviate from the approved CIP except in 
emergency circumstances. 
The Investigator must notify the Sponsor and the CRO of any deviation from the 
CIP and document the reason for the deviation. 
The Investigator shall notify the Sponsor and the reviewing EC of any deviation 
from the CIP, as per national requirements, to protect the life or physical well-being 
of a subject in an emergency.  Such notice shall be given as soon as possible, but in 
no event later than five (5) working days after the emergency occurred.  

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10. Regulatory Considerations 
10.1 Maintaining Records 
The Sponsor and CRO will maintain copies of critical correspondence, regulatory 
approvals, Trial Master Files, clinical data, shipment of devices, adverse events, 
serious adverse events, serious adverse device effects and other records related to 
the clinical study.  
Trial records will be maintained for a minimum of 3 years following the completion 
of research activities and closure of the study with Ethics Committees, whichever is 
longer. 
10.2  Data Handling and Record Keeping 
10.2.1 Source Documents 
The Investigator must maintain detailed source documents on all subjects who are 
enrolled or who undergo screening in the study.  Source documents include but 
are not limited to, subject medical records, hospital charts, clinic charts, 
investigator subject study files, as well as the results of diagnostic tests (e.g., 
laboratory tests, hemodynamic studies). 
The following minimum information should be entered into the subject’s medical 
record: 
• The date the subject entered the study and the subject number. 
• The Clinical Investigation Plan number and the name of the Sponsor. 
• The date that Informed Consent was obtained and signed by the patient and 
Investigator. 
• Evidence that the subject meets the study eligibility requirements (e.g., 
medical history, study procedures and/or evaluations). 
• The dates of all study related subject visits. 
• Evidence that required procedures and/or evaluations were completed. 
• Use of any concurrent medications. 
• Documentation of specific device used. 
• Occurrence and status of any adverse events (AEs / SAEs) 
• The date the subject exited the study and a notation as to whether the subject 
completed the study or was discontinued, including the reason for 
discontinuation. 
10.2.2 Data Collection 
The Investigator must maintain detailed records on all subjects who sign the ICF 
and begin the pre-procedure evaluation.  Data for enrolled subjects is transcribed 
onto CRFs provided by the Sponsor or designee.  All data should be transcribed 
completely, promptly and legibly.  Corrections should be made in a manner that 
does not obscure or eliminate the original error, by striking through the original 
data with one line, and initialing and dating the change, along with the reason for 
the change (if not obvious).  Original CRF pages will be collected by the Sponsor 

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or Sponsor’s designee after they are reviewed by the study monitor.  The 
investigator should maintain a copy of all completed CRFs from this study. 
Study exit forms will be completed for all enrolled subjects, regardless if they did 
or did not complete the study (e.g., subject discontinuation, study termination).  
The Sponsor and investigational site will maintain all records pertaining to this 
study in accordance with local and national regulations.  Prior to the destruction 
of study records the Investigator or his representative shall contact the Sponsor to 
ensure that they no longer need to be retained.  In addition, Sponsor shall be 
contacted if the Investigator plans to leave the investigational site so that 
arrangements can be made for the handling or transfer of study records. 
10.3 Ethics Committee and Competent Authority Approval 
Regulatory approvals must be obtained prior to enrollment of the first patient.  The 
Sponsor is responsible for obtaining regulatory and local approvals for the study.  
The Sponsor or its designated representative will require a copy of any IC and CA 
correspondence, as well as the final approval letter from the EC and CA, where 
applicable. 
An Investigator may not make CIP changes without prior approval by the Sponsor.  
All significant CIP changes that may affect the following must be submitted and 
approved by the EC and CA before initiating the change: 
• Validity of the data or information resulting from the completion of the approved 
CIP 
• Relationship of the likely subject risk to benefit relied upon to approve the CIP 
• Scientific soundness of the CIP 
• Rights, safety, or welfare of the human subjects involved in the investigation 
The Sponsor will notify the investigational site of such changes to ensure the study 
continues to be conducted consistent with the approved CIP. 
10.4 Procedure for Amending the CIP 
The process of amending the CIP and/or related documents is the 
responsibility of the sponsor.  The procedure for amending the CIP shall be as 
follows: 
• The Sponsor, Investigator, or other relevant party (e.g. EC, CA, CEDMC) may 
recommend modification of the CIP. 
• The Sponsor will then modify as necessary the CIP and any associated documents 
requiring amendment as a result of the modification(s). 
• The Sponsor or designated CRO will then submit the revised CIP and any other 
affected documents to the EC and CA for approval, per regulation. 
• Once all required approvals are obtained, the site will be trained to the latest 
approved version of the CIP and any other affected documents. 
 
 
 

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10.5 Device Accountability 
The Investigator is responsible for maintaining a Device Accountability Log that 
will track device receipt, device usage for all subjects and device returns to Sponsor 
or designees.  Information tracked will include date of device usage, subject ID, and 
lot number. 

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11. Publication Policy 
The existence of this clinical study is confidential, and it should not be discussed 
with persons outside of the study.  Additionally, the information in this document 
and regarding this study contains trade secrets and commercially sensitive 
information that is confidential and may not be disclosed unless such disclosure is 
required by regional or national law or regulations.  Subject to the foregoing, this 
information may be disclosed only to those persons involved in the study who have 
a need to know, but all such persons must be instructed not to further disseminate 
this information to others.  These restrictions of disclosure will apply equally to all 
future information supplied to you that is indicated as confidential. 
The data generated by this clinical study are the property of the Sponsor and should 
not be disclosed without the prior written permission of FARAPULSE, Inc.  These 
data may be used by FARAPULSE, Inc.  now and in the future for presentation or 
publication at FARAPULSE, Inc.’s discretion or for submission to governmental 
regulatory agencies.  FARAPULSE, Inc.  reserves the right of prior review of any 
publication or presentation of data from the subject investigation. 

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