PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

FARAPULSE, INC. 
 
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PROTOCOL NO.  CS0267 
 
 
CONFIDENTIAL 
 
 
 
 
 
 
 
PEFCAT: A Safety and Feasibility Study of the FARAPULSE™ 
Endocardial Ablation System to Treat Paroxysmal Atrial 
Fibrillation  
 
 
 
CLINICAL INVESTIGATION PLAN (CIP) NUMBER: CS0267 REVISION D 
 
 
 
SPONSOR: 
FARAPULSE, INC. 
(FORMERLY IOWA APPROACH, INC.) 
3715 HAVEN AVE.  SUITE 110 
MENLO PARK, CA 94025 
USA 
 
 
 
 
 
ISSUE DATE: 26 FEBRUARY 2019 
 
 
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. 
 
 

FARAPULSE, INC. 
 
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CONFIDENTIAL 
Table of Contents 
1. 
PRIMARY STUDY CONTACTS .....................................................................................5 
2. 
EXECUTIVE SUMMARY ...............................................................................................6 
SUBJECTS WITH DOCUMENTED DRUG-RESISTANT (CLASS I-IV) SYMPTOMATIC PAF 
WHO HAVE HAD ≥ 2 EPISODES WITHIN 6 MONTHS OF ENROLLMENT. .................................6 
ABBREVIATIONS ................................................................................................................12 
3. 
INTRODUCTION.........................................................................................................13 
3.1 
BACKGROUND AND RATIONALE ............................................................ 13 
3.2 
SURGICAL AND CATHETER ABLATION ................................................... 14 
3.3 
IRREVERSIBLE ELECTROPORATION (IRE) ............................................... 16 
3.4 
SUMMARY OF FARAPULSE CLINICAL STUDIES .................................... 16 
3.5 
COMPLICATIONS OF CATHETER BASED AND SURGICAL ABLATION ........... 19 
4. 
INVESTIGATIONAL DEVICE ......................................................................................20 
4.1 
NAME OF INVESTIGATIONAL DEVICE ..................................................... 20 
4.2 
INTENDED USE .................................................................................... 20 
4.3 
CLASSIFICATION .................................................................................. 20 
4.4 
SYSTEM COMPONENTS: FARAPULSE ENDOCARDIAL ABLATION SYSTEM
 .......................................................................................................... 21 
4.4.1 FARAWAVE ENDOCARDIAL ABLATION CATHETER SYSTEM........22 
4.4.2 FARASTAR ENDOCARDIAL GENERATOR SYSTEM ........................23 
4.4.3 FARADRIVE DEFLECTABLE SHEATH SYSTEM ..............................24 
4.5 
DEVICE ACCOUNTABILITY .................................................................... 24 
4.6 
RETURN OF DEVICES ............................................................................ 25 
5. 
STUDY OBJECTIVES..................................................................................................25 
5.1 
STUDY DESIGN .................................................................................... 25 
5.2 
SELECTION AND WITHDRAWAL OF SUBJECTS ......................................... 25 
5.2.1 INCLUSION CRITERIA ......................................................................25 
5.2.2 EXCLUSION CRITERIA .....................................................................26 
5.3 
STUDY ENDPOINTS............................................................................... 28 
5.3.1 PRIMARY SAFETY ENDPOINT ..........................................................28 
5.3.2 SECONDARY SAFETY ENDPOINT .....................................................30 
5.3.3 PRIMARY FEASIBILITY ENDPOINT ...................................................30 
5.3.4 SECONDARY FEASIBILITY ENDPOINT ..............................................30 
5.3.5 ADDITIONAL ENDPOINTS ................................................................31 
5.4 
SAMPLE SIZE ....................................................................................... 31 
5.5 
INVESTIGATIONAL  SITES ...................................................................... 31 
5.6 
DURATION OF SUBJECT PARTICIPATION ................................................. 31 
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. ............................................................... 31 
5.7 
WRITTEN INFORMED CONSENT ............................................................. 31 
5.8 
ENROLLMENT ...................................................................................... 32 
5.9 
WITHDRAWAL OF SUBJECTS ................................................................. 32 
5.10 
LOST TO FOLLOW-UP ........................................................................... 32 
5.11 
SUBJECT CONFIDENTIALITY .................................................................. 33 
5.12 
SCHEDULE OF EVENTS AND ASSESSMENTS ............................................. 33 

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5.12.1 BASELINE ........................................................................................33 
5.12.2 PROCEDURE ....................................................................................33 
5.12.3 PRE-DISCHARGE AND 7 DAY FOLLOW UP .......................................34 
5.12.4 30 DAY FOLLOW-UP .......................................................................35 
5.12.5 75 DAY FOLLOW-UP .......................................................................35 
5.12.6 90-DAY FOLLOW-UP ......................................................................36 
5.12.7 6 MONTH FOLLOW-UP.....................................................................36 
5.12.8 12 MONTH FOLLOW-UP ..................................................................37 
5.13 
UNSCHEDULED VISIT ........................................................................... 38 
5.14 
STUDY EXIT OR PREMATURE WITHDRAWAL........................................... 38 
5.15 
SCHEDULE OF STUDY ASSESSMENTS ..................................................... 39 
6. 
RISK BENEFIT ASSESSMENT ....................................................................................40 
6.1 
RISKS ................................................................................................. 40 
6.1.1 POTENTIAL ADVERSE EVENTS ........................................................40 
6.2 
BENEFITS ............................................................................................ 41 
7. 
STATISTICAL ANALYSIS AND ENDPOINT ASSESSMENT ...........................................42 
7.1 
GENERAL STATISTICAL CONSIDERATIONS .............................................. 42 
7.2 
SAMPLE SIZE JUSTIFICATION................................................................. 42 
7.3 
DEMOGRAPHIC, SAFETY, FEASIBILITY AND EFFECTIVENESS DATA ........... 43 
7.4 
IMPUTATION FOR MISSING DATA .......................................................... 43 
7.5 
ASSESSMENT OF FEASIBILITY ................................................................ 43 
7.5.1 PRIMARY FEASIBILITY ENDPOINT ...................................................43 
7.5.2 SECONDARY FEASIBILITY ENDPOINT ..............................................43 
7.5.3 ADDITIONAL ENDPOINTS ................................................................44 
7.6 
ASSESSMENT OF SAFETY ...................................................................... 44 
7.6.1 PRIMARY SAFETY ENDPOINT ..........................................................44 
7.6.2 SECONDARY SAFETY ENDPOINT .....................................................44 
7.7 
FINAL CLINICAL REPORT ...................................................................... 45 
A FINAL CLINICAL REPORT WILL BE PREPARED AT THE CONCLUSION OF THE STUDY.  
COPIES OF THE FINAL REPORT WILL BE PROVIDED TO THE INVESTIGATOR 
AND THEIR IRB/EC AND TO THE COMPETENT AUTHORITY, AS APPLICABLE.
 .......................................................................................................... 45 
8. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ...............................................45 
8.1 
GENERAL ............................................................................................ 45 
8.2 
ADVERSE EVENT REPORTING ................................................................ 48 
8.3 
DEVICE DEFICIENCIES / MALFUNCTIONS ................................................ 49 
8.4 
REPORTING TO ETHICS COMMITTEE / COMPETENT AUTHORITY ................ 50 
9. 
MONITORING ............................................................................................................50 
9.1 
STUDY MONITORING ............................................................................ 50 
10. 
STUDY MANAGEMENT..............................................................................................51 
10.1 
KEY CONTRIBUTORS ............................................................................ 51 
10.1.1 STUDY SPONSOR .............................................................................51 
10.1.2 CRO ...............................................................................................51 
10.1.3 CLINICAL SITE ................................................................................52 
10.2 
ETHICAL CONSIDERATIONS ................................................................... 52 
10.2.1 STUDY CONDUCT ............................................................................52 

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10.2.2 ETHICS REVIEW ..............................................................................52 
10.2.3 INFORMED CONSENT .......................................................................52 
10.2.4 COVERAGE OF EXPENSES ................................................................53 
10.2.5 CONFIDENTIALITY ..........................................................................53 
10.3 
INSURANCE ......................................................................................... 53 
10.4 
AUDITS AND INSPECTIONS .................................................................... 53 
10.5 
SPONSOR RESPONSIBILITIES .................................................................. 53 
10.6 
MONITOR RESPONSIBILITIES ................................................................. 54 
10.7 
INVESTIGATOR RESPONSIBILITIES.......................................................... 55 
10.8 
INVESTIGATOR TRAINING ..................................................................... 57 
10.9 
SITE TRAINING .................................................................................... 57 
10.10 CLINICAL EVENTS COMMITTEE AND DATA AND SAFETY MONITORING 
BOARD ............................................................................................... 57 
10.11 DATA MANAGEMENT ........................................................................... 58 
10.12 STUDY SUSPENSION OR EARLY TERMINATION ........................................ 58 
10.13 CRITERIA FOR SUSPENDING/ TERMINATING A STUDY CENTER.................. 59 
10.14 FINAL CLINICAL REPORT ...................................................................... 59 
10.15 DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN ......................... 59 
11. 
REGULATORY CONSIDERATIONS .............................................................................59 
11.1 
MAINTAINING RECORDS ....................................................................... 59 
11.2 
DATA HANDLING AND RECORD KEEPING ............................................... 60 
11.2.1 SOURCE DOCUMENTS .....................................................................60 
11.2.2 DATA COLLECTION .........................................................................60 
11.3 
ETHICS COMMITTEE (EC) AND COMPETENT AUTHORITY (CA) APPROVAL 61 
11.4 
DEVICE ACCOUNTABILITY .................................................................... 61 
12. 
PUBLICATION POLICY ..............................................................................................61 
13. 
BIBLIOGRAPHY .........................................................................................................63 
 
 
 

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CONFIDENTIAL 
1. Primary Study Contacts 
 
SPONSOR 
FARAPULSE, Inc. 
3715 Haven Ave.  Suite 110 
Menlo Park, CA 94025, USA 
 
PRINCIPAL INVESTIGATORS 
 
 
 
Pr. Petr Neuzil 
Nemocnice Na Homolce 
Roentgenova 2 
Prague 150 30 
Tel: +420 257 272 211 
 
Pr. Pierre Jaïs 
Hopital cardiologique du Haut-Leveque 
Avenue de Magellan 
33600 Pessac 
France 
Tel: +33 5 57 62 31 72 
 
CLINICAL RESEARCH 
ORGANIZATION 
MedPass International SAS 
95b Boulevard Pereire 
75017 Paris, France 
 
LEGAL REPRESENTATIVE 
 
 
 
 
ECG CORE LAB 
MedPass Limited 
Windsor House 
Bretforton, 
Evesham, 
Worcs. 
WR11 7JJ – United Kingdom 
 
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 
 
 
 
 

FARAPULSE, INC. 
 
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CONFIDENTIAL 
2. Executive Summary 
SPONSOR NAME: 
FARAPULSE, Inc. 
TITLE OF STUDY: 
PEFCAT: A Safety and Feasibility Study of the FARAPULSE 
Endocardial Ablation System to Treat Paroxysmal Atrial 
Fibrillation 
PROTOCOL 
NUMBER:  
CS0267   
OBJECTIVE: 
The objective of the safety and feasibility study is to demonstrate 
that the endocardial creation of electrically isolating lesions via 
pulsed electric field (PEF) catheter ablation applied using the 
FARAPULSE Endocardial Ablation System is a feasible and 
safe treatment for paroxysmal atrial fibrillation (PAF). 
CLINICAL 
HYPOTHESIS: 
Endocardial creation of electrically isolating lesions in cardiac 
tissue via PEF catheter ablation using the FARAPULSE 
Endocardial Ablation System is a feasible and safe treatment for 
paroxysmal atrial fibrillation (AF). 
 
NAME OF 
INVESTIGATIONAL 
DEVICE: 
FARAPULSE Endocardial Ablation System  
• 
FARAWAVE™ Endocardial Ablation Catheter System  
• 
FARASTAR™ Endocardial Generator System  
• 
FARADRIVE™ Deflectable Sheath System 
 
DESIGN: 
Prospective, multi-center, safety and feasibility study.  Subjects 
will undergo percutaneous PEF ablation for pulmonary vein 
isolation.  Subjects will then be followed at 7 days, 30 days, 75 
days, 90 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 drug-resistant (Class I-IV) 
symptomatic PAF who have had ≥ 2 episodes within 6 months of 
enrollment. 
PLANNED 
ENROLLMENT: 
Up to 80 subjects 
CLINICAL SITES: 
Nemocnice Na Homolce, Prague, Czech Republic 
Hopital cardiologique du Haut-Leveque, Pessac, France 

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PROTOCOL NO.  CS0267 
 
 
CONFIDENTIAL 
DURATION OF 
PARTICIPATION: 
 
 
 
 
 
PLANNED 
PROCEDURE: 
Subjects will be followed at 7 days, 30 days, 75 days, 90 days, 6 
months and 12 months with a 90-day blanking period for recurrent 
atrial fibrillation or atrial tachycardia following the initial PEF 
catheter ablation procedure. 
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. 
 
Subjects will undergo an attempt to isolate all 4 pulmonary veins 
or their anatomic equivalent. Subject with a past history of or 
having inducible isthmus-mediated flutter will undergo 
interruption of the cavo-tricuspid isthmus at the discretion of the 
investigator. Additional lesions may be made at the discretion of 
the investigator. 
 
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:   
 
Early onset (within 30 days of any endocardial ablation for atrial 
fibrillation) 
• Death  
• Myocardial infarction (MI)  
• Persistent diaphragmatic paralysis  
• Stroke or transient ischemic attack (TIA)  
• Peripheral or organ thromboembolism  
• Pericarditis 
• Cardiac tamponade / perforation  
• Vascular access complications  
• Hospitalization (initial or prolonged)*  
• Heart block  
Late onset (any time during follow-up) 
• Pulmonary vein (PV) stenosis (> 70% diameter reduction 
from baseline)  
• Atrio-esophageal fistula  
* Excludes hospitalization (initial & prolonged) solely due to 
arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence 
or due to non-urgent cardioversion (pharmacological or 
electrical). Hospitalization excludes visits to hospital-
associated outpatient facilities such as clinics or emergency 
wards.  

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CONFIDENTIAL 
SECONDARY 
SAFETY  
ENDPOINT: 
1. The proportion of subjects reporting one or more device- or 
procedure-related SAEs, as assessed at 30 days, 75 days, 6 
months and 12 months of follow-up. 
2. The proportion of subjects with stroke or TIA through 12 
months 
3. The proportion of subjects with major bleeding related to 
anticoagulation treatment through 12 months 
4. The proportion of subjects requiring cardioversion through 
12 months 
5. The proportion of subjects requiring an arrhythmia-related 
hospitalization through 12 months 
 
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 Ablation System during the first procedure, as 
clinically assessed by entrance and/or exit block performed ≥ 20 
minutes after the last PVI lesion is made. 
 
SECONDARY 
FEASIBILITY 
ENDPOINT: 
 
 
1. The proportion of subjects that achieve Chronic Procedural 
Success (CPS) defined as persistent electrical isolation of 
all initially ablated pulmonary veins assessed during an 
electroanatomical mapping procedure performed 75 days 
following the index procedure. Chronic Procedural Success 
will be subdivided by single procedure and reablated 
subjects.  
2. 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 
blanking period at Months 6 and 12 and will be subdivided 
by on / off AFDs (Atrial Fibrillation Drugs) post blanking 
period. 

FARAPULSE, INC. 
 
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CONFIDENTIAL 
 
ADDITIONAL 
ENDPOINTS: 
 
 
 
 
Additional endpoints will include: 
1. Proportion of all ablated pulmonary veins that are isolated 
at the index procedure using the study device. 
2. Proportion of all ablated pulmonary veins acutely isolated 
using the study device that remain isolated at the 75-day 
remapping procedure. 
 
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 PAF 
who have: 
a. Confirmed AF: Documentation may include ECG, 
transtelephonic monitor (TTM), Holter monitor, 
implanted devices, telemetry strip or similar, recorded 
within one year prior to enrollment and showing at 
least 30 seconds of AF. 
b. Frequent AF, defined as ≥ 2 episodes within 6 months 
of enrollment. 
c. Failed AFD, meaning therapeutic failure of at least 
one antiarrhythmic drug (AFD; class I – IV) for 
efficacy and / or intolerance 
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. Use of amiodarone within 3 months prior to enrollment  
2. Atrial fibrillation that is any of the following 
a. Persistent (by diagnosis or duration > 7 days) 
b. Secondary to electrolyte imbalance, thyroid disease, 
alcohol abuse or other reversible / non-cardiac 
causes 
c. Requires ≥ 3 cardioversions in the preceding 12 
months 
3. Cardiac anatomical exclusions by imaging within 3 months 
prior to enrollment: 
a. Left atrial anteroposterior diameter ≥ 5.0 cm as 
documented by transthoracic echocardiography 
(TTE) or computed tomography (CT) 
b. Left ventricular ejection fraction ≤ 40% as 
documented by TTE 
4. Any of the following cardiac procedures, implants or 
conditions: 
a. Clinically significant arrhythmias other than AF 
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, ICD or CRT 
j. Significant or symptomatic hypotension 
k. Bradycardia or chronotropic incompetence 
l. History of pericarditis 
m. History of rheumatic fever 
5. Any of the following within 3 months of 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  
6. History of blood clotting or bleeding abnormalities. 

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7. Contraindication to, or unwillingness to use, systemic 
anticoagulation  
8. Contraindications to CT or MRI 
9. Sensitivity to contrast media not controlled by 
premedication 
10. Women of childbearing potential who are pregnant, 
lactating or not using birth control 
11. Serious or untreated medical conditions that would prevent 
participation in the study, interfere with assessment or 
therapy, or confound data or its interpretation, including but 
not limited to 
a. Solid organ or hematologic transplant, or currently 
being evaluated for an organ transplant 
b. Severe lung disease, pulmonary hypertension, or 
any lung disease involving abnormal blood gases or 
significant dyspnea 
c. Chronic renal insufficiency of < 60 mL/min/1.73 
m2, any history of renal dialysis, or history of renal 
transplant  
d. Active malignancy or history of treated cancer 
within 24 months of enrollment 
e. Clinically significant gastrointestinal problems 
involving the esophagus, stomach and/or untreated 
acid reflux 
f. Clinically significant infection 
g. Predicted life expectancy less than one year 
12. Clinically significant psychological condition that in the 
investigator’s opinion would prohibit the subject's ability to 
meet the protocol requirements 
13. Current or anticipated enrollment in any other clinical study 
14. Body Mass Index (BMI) > 35 
15. Distorted cardiac anatomy due to congenital heart disease 
 
 
 

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Abbreviations 
ACT Activated clotting time 
AE 
Adverse Event 
AF 
Atrial fibrillation 
AFD Atrial Fibrillation Drug 
AFL 
Atrial flutter 
APS 
Acute procedural success 
AT 
Atrial tachycardia 
CHF 
Congestive heart failure 
CPS 
Chronic procedural success 
CT 
Computed tomography 
DCCV Direct current cardioversion 
ECG Electrocardiogram 
INR 
International normalized ratio 
LA 
Left atrium 
MI 
Myocardial infarction 
MRI 
Magnetic resonance imaging 
NYHA New York Heart Association 
PAF 
Paroxysmal atrial fibrillation 
PEF 
Pulsed electric field 
PTT 
Prothrombin time 
PV 
Pulmonary vein 
PVI  
Pulmonary vein isolation 
PVS 
Pulmonary vein stenosis 
TEE 
Transesophageal echocardiography 
TIA 
Transient ischemic attack 
TTE 
Transthoracic echocardiography 
TTM Transtelephonic monitor 
 
 
 
 

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3. Introduction 
3.1 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 mortality rate for patients with atrial fibrillation is 
twice that of patients in whom normal sinus rhythm is maintained.  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).  Last, AF remains an extremely 
costly public health burden, with annual per patient cost of care approaching €3000 
(approximately U.S.  $3200).7 Atrial fibrillation is characterized by abnormalities in 
electrical impulse formation or conduction within the heart; these abnormalities 
disrupt the heart’s coordinated mechanical contraction and can result in reduced or 
insufficient cardiac output or other complications.8 Symptoms arising from this 
arrhythmia include palpitations, shortness of breath, fatigue, syncope, or intolerance 
to exertion. 
According to the Heart Rhythm Society (HRS) 2012 Consensus Statement on 
Catheter and Surgical Ablation of Atrial Fibrillation, AF is clinically stratified by 
whether episodes are self-terminating (paroxysmal) or continuous (persistent or 
permanent AF).9 Paroxysmal AF (PAF) is defined as recurrent AF (≥2 episodes) 
that terminates spontaneously within 7 days, or within 48 hours if terminated by 
pharmacologic or electrical cardioversion.  Persistent AF is defined as continuous 
AF that is sustained beyond 7 days, or less than 7 days but terminated by 
pharmacologic or electrical cardioversion.  Longstanding persistent AF is defined as 
continuous AF of greater than 12 months’ duration.  Permanent AF is defined as AF 
in a patient in whom a decision has been made not to restore or maintain sinus 
rhythm by any means. 
Initial treatment of PAF is typically directed toward heart rate or rhythm control 
with drug therapy and direct current cardioversion (DCCV).  As a reasonable 
alternative to restoring sinus rhythm via long-term pharmacologic therapy, catheter 
ablation is being performed with greater frequency.  Three recent small randomized 
trials in patients with PAF demonstrated that catheter ablation was superior to 
antiarrhythmic therapy in the prevention of recurrent AF.10, 11, 12 This was followed 
by the more recent Navistar ThermoCool® Catheter and EZ Steer ThermoCool® 
NAV Catheter PMA submission substantiating the findings in a larger series.13 
Although it is still the consensus recommendation that catheter ablation should not 
be considered a first line therapy for atrial fibrillation,13 there is evidence that 
maintenance of sinus rhythm has important effects on mortality.  In the Atrial 

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Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, in 
which 4,060 AF patients with high risk for stroke and death were randomized to 
either rhythm control or rate control by antiarrhythmic drugs, there were no 
significant differences in all-cause death between the two strategies.14 However, a 
new on-treatment analysis of the AFFIRM study revealed that the presence of sinus 
rhythm was associated with a significant reduction in mortality, whereas the use of 
antiarrhythmic drugs increased mortality by 49%,15 suggesting that the beneficial 
effect of sinus rhythm restoration on survival might be offset by the adverse effects 
of antiarrhythmic drugs.   
Ablation treatment paradigms have evolved over time, and current strategies 
emphasize isolation of the pulmonary veins (PVI) as the cornerstone of catheter 
ablation of AF.  Energy sources for endocardial lesion creation have included 
radiofrequency, cryo (freezing), laser, ultrasound and microwave.  New ablation 
techniques and devices continue to develop with the objective of improving safety 
and efficacy, while reducing procedure time (complexity).  In elite single-center 
reports, the success rate for eliminating symptomatic AF (inclusive of both PAF and 
continuous AF subjects) varies from 55% - 77%, with many patients requiring 
multiple procedures.16, 17, 18, 19 Retreatment rates as high as 40% have been 
reported.20 
Understanding the need for creating electrical isolation of the pulmonary veins, 
treatment paradigms have focused on creating circumferential lesions or wide 
circumferential lesion sets that block electrical continuity between the pulmonary 
veins and the left atrium.  In a wide circumferential ablation (WACA) procedure, 
operators must form a contiguous line of electrical block around ipsilateral 
pulmonary veins using fluoroscopic guidance and electroanatomical mapping 
technologies.  A limited assessment of lesion formation and position is determined 
by monitoring voltage reduction of the local electrogram at the target site.  
Electrical gaps in lesion sets occur frequently, leading to recurrent AF and/or 
creation of substrate susceptible to reentrant atrial tachycardias.21 Ablation 
technologies that rely upon indirect assessment of lesion formation are challenged 
to deliver improved durability and therefore long-term efficacy of therapy. 
3.2 Surgical and Catheter Ablation 
Cox and colleagues are credited with developing and demonstrating the efficacy of 
surgical ablation of AF via the "maze" or "Cox-maze" procedure (sometimes also 
referred to as the “traditional maze” or “cut-and-sew maze”), an open-heart cardiac 
surgery procedure intended to eliminate AF, by a series of incisional scars in both 
atria, to block abnormal electrical circuits (atrial macroreentry), a requisite AF 
mechanism.  During the Cox-Maze Procedure, areas of cardiac tissue are isolated, 
either by cut and sew methods or electrosurgically, creating a “maze” which 
prevents propagation of ectopic AF impulses22, 23 notes: “While few patients are 
candidates for a stand-alone surgical procedure to cure AF using the maze or LA 
ablation techniques, these approaches can be an effective adjunct to coronary 
bypass or valve repair surgery to prevent recurrent postoperative AF.” 

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Reported failure rates for the maze procedure are as high as 30%.  Jais 2002 
summarized the conclusions from surgical treatments for AF.24 
• reduction of the atrial tissue mass available for fibrillation is effective in 
preventing maintenance of AF;  
• the left atrium plays a dominant role in maintenance and initiation of AF; 
• limited lesions placed around pulmonary veins can be as effective as complex 
ablation schema (maze)and safer. 
However, Wisser 2007 reported results of a small non-randomized study comparing 
two groups of patients, all treated surgically for permanent AF at the same time as 
other major heart surgery.  Group 1 (N=29) received a classic maze procedure: 
freedom from AF at 19 months follow up was 86%.  Group 2 (N=43) received 
epicardial pulmonary vein isolation treatment, and freedom from AF at follow up 
was 59%.  This difference was statistically significant.   
Due to the extreme complexity of the “cut and sew” Cox-Maze procedure, few 
surgeons perform the surgery.  Instead, minimally invasive surgical techniques have 
been developed.  The FAST trial randomized antiarrhythmic drug-refractory AF 
patients to minimally invasive surgical ablation or catheter ablation.25  Outcomes 
for efficacy and safety during a 12-month follow-up demonstrated an overall 
increased freedom from AF in the minimally invasive surgery group compared to 
the catheter ablation cohort; however, the surgical ablation group had significantly 
more procedural-related adverse events compared to catheter ablation (23.0% 
versus 3.2%).   
During the past decade, the evolution of catheter-based energy delivery (such as 
radiofrequency and cryothermia) has evolved as a non-surgical means to create 
similar lesions in the walls of the atria (i.e., Cox maze IV ablation-assisted 
procedure).26  However, electrophysiologists have found it challenging to replicate 
the Cox Maze III in its entirety.   
Pulmonary vein isolation (PVI), which is the cornerstone of the mini-maze 
procedure and catheter ablations, essentially creates “boxes” around the four 
pulmonary veins.  PVI catheter ablation as a treatment for paroxysmal AF is 
associated with a high rate of success, in excess of 70%; however, outcomes for 
treating persistent AF with PVI are substantially lower and often require multiple 
procedures to maintain long-term freedom from atrial arrhythmias.  While electrical 
isolation of the pulmonary veins (PVs) is central to catheter ablation strategies, foci 
and/or substrate outside the PVs, particularly in the LAA, have been identified as a 
key mechanism in the maintenance of persistent AF.27, 28, 29, 30 
The literature suggests that catheter ablation is more efficacious for those patients 
with paroxysmal AF in comparison to those with persistent forms of AF.31 This 
may in part be due to the finding that in many of these patients, and with new 
mapping technologies, specific foci may be identified and treated.32, 33 

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3.3 Irreversible Electroporation (IRE)  
Al-Sakere 200734 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 apoptosis.35 36 37 38 IRE ablation typically spares the 
extracellular matrix, which facilitates rapid wound healing.39, 40, 41, 42, 43 
Thomson 201144 reported a case-series study (N=38) assessing the safety of 
irreversible electroporation (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 201145 (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 201446 (N=6) confirmed this result out to 
3-month follow up.  Neven 201447 (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. 
 
3.4 
Summary of FARAPULSE Clinical Studies 
3.4.1 FARAPULSE Endocardial Ablation Clinical Studies 
 
FARAPULSE IMPULSE Clinical Study 
FARAPULSE, Inc, has 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; the same system 
which will be used in the subject investigation.  Thirty-eight (38) patients have been 
enrolled between January and November of 2018.  All patients were discharged in 
good condition.  One patient was treated for tamponade at the conclusion of the 
index procedure.  The event was resolved.  One patient was treated for a 
supraventricular tachycardia seven months post procedure.  The event was resolved.  
One patient underwent extended hospitalization for an early AF recurrence one day 

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post procedure.  The event was resolved.  At the conclusion of the index procedure 
all (100%) pulmonary veins (PVs) were isolated using the FARAPULSE device.  
Twenty-four (24) patients have returned for the protocol-defined 3-month 
remapping procedure to assess chronic PV isolation.  Among these patients, 61% of 
PVs remained isolated at the 3-month remapping procedure.  All PVs in eight (8) 
patients remained isolated.  These results support both the safety and performance 
of the system. 
 
 
 
 

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FARAPULSE PEFCAT Clinical Study (same as subject investigation) 
FARAPULSE, Inc, has also initiated a safety and feasibility study at Na Homolce 
Hospital in Prague, Czech Republic under the “PEFCAT” Protocol, CS0267. This 
safety and feasibility study is the same investigation that is being proposed for 
Pessac, France. This study is being conducted using the FARAPULSE Endocardial 
Ablation System; the same system which will be used in the subject investigation.  
Sixteen (16) patients have been enrolled at Na Homolce between October and 
November of 2018.  All patients were discharged in good condition.  One patient 
was treated for an air embolism during the index procedure.  This event was 
resolved..  At the conclusion of the index procedure all pulmonary veins (PVs) were 
isolated using the FARAPULSE device.   
 
3.4.2 
FARAPULSE Epicardial Ablation Clinical Studies 
 
FARAPULSE FIM Epicardial Clinical Study 
In addition, FARAPULSE has shown the preliminary safety and feasibility of 
Pulsed Electrical Field ablation in an earlier clinical study using the FARAPULSE 
Cardiac Ablation System for epicardial ablation between September 2016 and 
March 2017. The data collected in this first study using the epicardial system has 
supported and informed the design of the FARAPULSE Endocardial Ablation 
System.  Below is a summary of FARAPULSE’s First-in-Man (FIM) clinical study 
entitled, “First in Human- Phase 1 / 1A safety study of the FARAPULSE, Inc. 
Cardiac Ablation System used for cardiac tissue ablation for the treatment of atrial 
fibrillation through open heart surgical procedure.”  
 
This first study was initiated at the Italian Hospital, Asuncion Paraguay in 
September 2016.  Seven (7) patients were enrolled in the study, each patient had 
been diagnosed with paroxysmal, persistent and/or continuous atrial fibrillation and 
was scheduled for a cardiac surgery procedure. The purpose of this FIM study was 
to investigate the safety and acute technical feasibility of the FARAPULSE Cardiac 
Ablation System to perform epicardial cardiac ablation in treating patients with 
atrial fibrillation (AF). 
 
Following Ethics Committee approval, patient consent and enrollment in the study, 
clinical evaluations were conducted and data collected at the following intervals: 
pre-procedure (baseline), post-procedure, hospital discharge, and 30 day, 3-months 
(optional), and 6-months post-procedure. The FARAPULSE procedural clinical 
data were collected and recorded on standardized case report forms at the clinical 
study site.  
 
There were no device or ablation procedure-related adverse events reported within 
7-days post-procedure or at time of discharge. Also, there were no device 
malfunctions.  Additionally, electrical isolation of the pulmonary veins and the 
posterior left atrium using the FARAPULSE Cardiac Ablation System was 
achieved in three of seven (3/7) patients. These findings demonstrate the safety and 
feasibility of applying pulse electrical field energy to the heart to ablate electrically 

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active myocardium and isolate the pulmonary veins. The same application of 
energy has been used for endocardial ablation in atrial fibrillation in the IMPULSE 
study. 
 
FARAPULSE IMPACT Clinical Study 
In addition, FARAPULSE, Inc. is conducting a safety and feasibility study of the 
FARAPULSE Cardiac Ablation System at Na Homolce Hospital in Prague, Czech 
Republic and CHU Bordeaux in Pessac, France under the “IMPACT” Protocol, 
CS0172.  Seven (7) patients have been enrolled between December 2017 and 
March 2018, four (4) in Prague and three (3) in Bordeaux.  All patients were 
discharged in good condition.  One femoral hematoma was noted, which was not 
investigational device related.  The event was resolved.  One hospitalization for 
atrial tachycardia was noted eight months post procedure.  The event was resolved.   
 
At the conclusion of the index procedure the posterior left atrium and PVs were 
isolated in six (6) of seven (7) patients.  Six (6) patients have reached the 3-month 
follow-up assessment.  The posterior left atrium and PVs were electrically isolated 
in one of these patients.  In two of the remaining patients there was a small 
electrical gap, which was closed at the 3-month follow-up using a commercial 
radiofrequency catheter.  In one of these patients, the gap had been present at the 
conclusion of the index procedure; in the other patient the gap had developed 
during the follow-up period.  Three (3) patients undergoing remapping required 
multiple radiofrequency lesions at the three-month follow-up.  Patients in this 
protocol will undergo follow-up at 30 days, 3 months, 6 months, and 12 months. 
 
3.5 Complications of Catheter Based and Surgical Ablation 
The risks and complications associated with thermal or non-thermal cardiac 
ablation depend on the complexity of the procedure.  The most common 
complications due to cardiac ablations include bleeding, cardiac tamponade, 
stroke/TIA, pulmonary vein stenosis, phrenic nerve injury, thromboembolism, air 
embolism, post-procedural arrhythmias, and vascular complications.  Further, 
recurrences of atrial fibrillation (AF) or atrial tachycardia after an initial AF 
catheter ablation procedure (20 – 40% of patients48) are common. 
Gelsomino 201449 noted in a study of SAEs (Serious Adverse Event) rates for 
studies of convergent AF ablation (N=335) (Table 1).  There were 3 early deaths 
(0.9%) and three conversions to sternotomy and cardiopulmonary bypass (0.9%).  
There were no late deaths or thromboembolic events.  These SAE rates include both 
catheter ablation and surgical ablation procedures in the reviewed studies.  
Expected adverse event rates from an isolated surgical procedure are likely to be 
lower. 

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Table 1: Data from Gelsomino 2014 – Adverse Event Rates for 
Surgical Ablation 
Event 
Frequency (%) 
Bleeding 
6 (1.8%) 
Tamponade 
4 (1.2%) 
Pleural effusion 
1 (0.3%) 
Hemothorax 
1 (0.3%) 
Pneumothorax 
1 (0.3%) 
Pneumonia 
1 (0.3%) 
 
In conclusion, potential risks related to the FARAPULSE Endocardial Ablation 
System are expected to be no different from those products that are approved and 
available on the market for catheter-based or surgical ablation procedures.  
FARAPULSE  testing of the Endocardial Ablation System will ensure the safe use of 
the device during clinical investigation as well as compliance with the applicable 
parts of the Medical Device Directive 93/42/EEC.  FARAPULSE will also ensure, 
through its Risk Management System, that the residual risks have been reduced as 
low as possible.  The prior clinical experience using the FARAPULSE Endocardial 
Ablation System as well as a review of the complications associated with catheter-
based cardiac ablation procedures support the execution of this study to further assess 
the safety and feasibility of the FARAPULSE Endocardial Ablation System.   
 
4. Investigational Device 
4.1 Name of Investigational Device 
FARAPULSE Endocardial Ablation System 
4.2 Intended Use 
The FARAPULSE Endocardial Ablation System is indicated for cardiac tissue 
ablation for the treatment of paroxysmal atrial fibrillation.   
 
4.3 Classification 
The FARAPULSE Endocardial Ablation System is comprised of the FARAWAVE 
Endocardial Ablation Catheter System, the FARASTAR Endocardial Generator 
System, and the FARADRIVE Deflectable Sheath System. 
 
The FARAWAVE Endocardial Ablation Catheter System is classified as a Class III 
medical device.  Per  MDD 93/42/EEC Annex IX Rule 6 applies to the ablation 
catheter, 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. 
 
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, 

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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 System 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. 
 
4.4 System Components: FARAPULSE Endocardial Ablation System 
The FARAPULSE Endocardial Ablation System used in the subject clinical 
investigation consists of the FARAWAVE Endocardial Ablation Catheter System, 
the FARASTAR Endocardial Generator System, and the FARADRIVE Deflectable 
Sheath System (Figure 1).  Model (REF#) numbers of the components used in this 
study are detailed in Table 2. 
 
Table 2: Components and Model Numbers of the FARAPULSE Endocardial 
Ablation System 
System Components  
System Model 
Number (REF#) 
FARAWAVE Endocardial Ablation Catheter System  
 
1.  Ablation Catheter (31 mm or 35 mm) 
2.  Extension Cable 
40T401 and 40T404 
 
 FARASTAR Endocardial Generator System 
 
1.  Pulsed Electric Field Generator (PEFG) 
2.  Two Coaxial Cables 
3.  Two Pace Filter Boxes 
4.  Two Catheter Switch Boxes 
60T401 
FARADRIVE Deflectable Sheath System (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 
 
CE Marked Devices That May be Used in Conjunction with FARAPULSE Endocardial 
Ablation System 
*Oscor Destino™ Twist UniDirectional Deflectable Guiding Sheath 
St. Jude BRK 98cm Transseptal Needle 
MicroPace StimCor Cardiac Stimulator 
 

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Figure 1. FARAPULSE Endocardial Ablation System Components.  
Note: Blue dotted box shows the sterile, single-use components of the system 
 
4.4.1 
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 flower-shaped configuration with 
five petals, a shaft section, and a proximal handle with a manually operated 
deployment control (Figure 2).  Each petal 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 (also part of the Endocardial Ablation 

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Catheter System) with numbered connectors on each of its ends.  These connect to 
the multi-channel Endocardial Generator. The Pulsed Electric Field energy is 
delivered via the PEF 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 Endocardial Generator.   
Additional details are provided in the IFU LBL0195 for the specific use and 
procedural steps of the Endocardial Ablation Catheter System. 
 
 
Figure 2: Representative Illustration of Deployed Endocardial Ablation Catheter 
with Fully Deployed Distal “flower” Section.  
Provided in 31mm and 35mm Deployed Diameters 
  
4.4.2 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 (2 units), and Switch Box (2 units).  The Endocardial 
Generator System is designed to deliver Pulsed Electric Field (PEF) energy to 
endocardial sites in the heart via the Endocardial Ablation Catheter System and 
other compatible devices (refer to IFU LBL0195 for the specific use and 
procedural steps of the Endocardial Ablation Catheter System, LBL0193 for the 
Deflectable Sheath System and LBL0198 for the Endocardial Generator System).   
The Pulsed Electric Field 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 PEFG 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 button on the 

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PEFG 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. 
 
4.4.3 FARADRIVE Deflectable Sheath System 
The FARAWAVE Endocardial Ablation Catheter is used with the FARADRIVE 
Deflectable Sheath System 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 System consists of two (2) components: 
Deflectable Sheath and Dilator, which are used together.  Both components are 
sterile and single use only (Figure 3). 
The 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 3: Deflectable Sheath and Dilator 
 
4.5 Device Accountability 
The FARAPULSE Endocardial Ablation System will be housed 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 Ablation System 

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identification number (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. 
4.6 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. 
 
5. Study Objectives 
The objective of the safety and feasibility study is to demonstrate that the endocardial 
creation of electrically isolating lesions via pulsed electric field (PEF) catheter 
ablation applied using the FARAPULSE Endocardial Ablation System is a feasible 
and safe treatment for paroxysmal atrial fibrillation (PAF).  
5.1 Study Design 
This is a prospective, multi-center, intention-to-treat safety and feasibility study.  
Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation.  
Subjects will then be followed at 7 days, 30 days, 75 days, 90 days, 6 months, and 
12 months for adverse events, recurrence of arrhythmia after a 90-day blanking 
period and other relevant outcome measures.  
5.2 Selection and Withdrawal of Subjects 
5.2.1 
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 PAF; who have: 

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a. Confirmed AF: Documentation may include ECG, transtelephonic monitor 
(TTM), Holter monitor, implanted devices, telemetry strip or similar, 
recorded within one year prior to enrollment and showing at least 30 seconds 
of AF. 
b. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment. 
c. Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug 
(AFD; class I – IV) for efficacy and / or intolerance 
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. 
5.2.2 Exclusion Criteria 
Subjects will be excluded from participating in this study if they meet any one of the 
following exclusion criteria: 
 
1. Use of amiodarone within 3 months prior to enrollment  
2. Atrial fibrillation that is any of the following 
a. Persistent (by diagnosis or duration > 7 days) 
b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other 
reversible / non-cardiac causes 
c. Requires ≥ 3 cardioversions in the preceding 12 months 
3. Cardiac anatomical exclusions by imaging within 3 months prior to enrollment: 
a. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by 
transthoracic echocardiography (TTE) or computed tomography (CT) 
b. Left ventricular ejection fraction ≤ 40% as documented by TTE 
4. Any of the following cardiac procedures, implants or conditions: 
a. Clinically significant arrhythmias other than AF 
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, ICD or CRT 
j. Significant or symptomatic hypotension 
k. Bradycardia or chronotropic incompetence 
l. History of pericarditis 
m. History of rheumatic fever 
5. Any of the following within 3 months of enrollment: 
a. Myocardial infarction 
b. Unstable angina 

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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  
6. History of blood clotting or bleeding abnormalities. 
7. Contraindication to, or unwillingness to use, systemic anticoagulation  
8. Contraindications to CT or MRI 
9. Sensitivity to contrast media not controlled by premedication 
10. Women of childbearing potential who are pregnant, lactating or not using birth 
control 
11. Serious or untreated medical conditions that would prevent participation in the 
study, interfere with assessment or therapy, or confound data or its 
interpretation, including but not limited to 
a. Solid organ or hematologic transplant, or currently being evaluated for an 
organ transplant 
b. Severe lung disease, pulmonary hypertension, or any lung disease 
involving abnormal blood gases or significant dyspnea 
c. Chronic renal insufficiency of  < 60 mL/min/1.73 m2, any history of renal 
dialysis, or history of renal transplant  
d. Active malignancy or history of treated cancer within 24 months of 
enrollment 
e. Clinically significant gastrointestinal problems involving the esophagus, 
stomach and/or untreated acid reflux 
f. Clinically significant infection 
g. Predicted life expectancy less than one year 
12. Clinically significant psychological condition that in the investigator’s opinion 
would prohibit the subject's ability to meet the protocol requirements 
13. Current or anticipated enrollment in any other clinical study 
14. Body Mass Index (BMI) > 35 
15. Distorted cardiac anatomy due to congenital heart disease 
 
 
 

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5.3 Study Endpoints 
5.3.1 
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:   
 
Early onset (within 30 days of any endocardial ablation for atrial fibrillation) 
• Death  
• Myocardial infarction (MI)  
• Persistent diaphragmatic paralysis  
• Stroke or transient ischemic attack (TIA)  
• Peripheral or organ thromboembolism  
• Pericarditis 
• Cardiac tamponade / perforation  
• Vascular access complications  
• Hospitalization (initial or prolonged)*  
• Heart block  
Late onset (any time during follow-up) 
• Pulmonary vein (PV) stenosis (> 70% diameter reduction from 
baseline)  
• Atrio-esophageal fistula  
*   Excludes hospitalization (initial & prolonged) solely due to arrhythmia 
(AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent 
cardioversion (pharmacological or electrical). Hospitalization excludes 
visits to hospital-associated outpatient facilities such as clinics or 
emergency wards. 
 
 
 

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 Table 3.  Primary AE Safety Endpoint Definitions 
 
Primary 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 
Change in baseline diaphragmatic function as 
evidenced by elevation of the diaphragm above the 
normal range but not due to a pulmonary process 
such as atelectasis. 
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. 
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 
Vascular access complication (e.g. groin 
hematoma, AV fistula, pseudoaneurysm) requiring 
intervention (e.g. surgical repair, blood 
transfusion) or admission or prolonged 
hospitalization. 
Hospitalization (initial or prolonged) 
*excludes hospitalization (initial or prolonged) 
solely due to arrhythmia (AF/AFL/AT) recurrence 

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Primary Adverse Event 
Description/Criteria 
or due to non-urgent cardioversion 
(pharmacological or electrical) 
Heart block  
Impairment of AV conduction requiring 
intervention due to 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. 
 
 
5.3.2 Secondary Safety Endpoint 
1. The proportion of subjects reporting one or more device- or procedure-
related SAEs, as assessed at 30 days, 75 days, 90 days, 6 months and 12 
months of follow-up. 
2. The proportion of subjects with stroke or TIA through 12 months 
3. The proportion of subjects with major bleeding related to anticoagulation 
treatment through 12 months 
4. The proportion of subjects requiring cardioversion through 12 months 
5. The proportion of subjects requiring an arrhythmia-related hospitalization 
through 12 months 
 
5.3.3 
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 Ablation System during the first procedure, as clinically assessed by 
entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is 
made.  
5.3.4 Secondary Feasibility Endpoint 
1. The proportion of subjects that achieve Chronic Procedural Success (CPS) 
defined as persistent electrical isolation of all initially ablated pulmonary 
veins assessed during an electroanatomical mapping procedure performed 75 
days following the index procedure. Chronic Procedural Success will be 
subdivided by single procedure and reablated subjects. 
2. 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 

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Therapeutic success will be assessed from the end of the blanking period at 
Months 6 and 12, and will be subdivided by on / off AFDs post blanking period. 
5.3.5 Additional Endpoints 
1. Proportion of all ablated pulmonary veins that are isolated at the index 
procedure using the study device. 
2. Proportion of all ablated pulmonary veins acutely isolated using the study 
device that remain isolated at the 75 day remapping procedure. 
 
5.4 Sample Size 
Up to 80 subjects will be enrolled in this clinical safety and feasibility study.  
5.5 Investigational  Sites 
The clinical study will be conducted at Nemocnice Na Homolce in Prague, Czech 
Republic and at Hopital cardiologique du Haut-Leveque, Pessac, France. 
5.6 Duration of Subject Participation 
Subjects will be followed at 7 days, 30 days, 75 days, 90 days, 6 months and 12 
months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 
90 days following the index PEF catheter ablation procedure. 
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. 
5.7 Written Informed Consent 
All subjects must provide written Informed Consent using the Ethics Committee 
approved Informed Consent Form before undergoing any study related procedures.  
Subjects cannot be asked to sign the Informed Consent document until the study has 
been fully approved by the institution’s EC and by the Competent Authority, if 
applicable, and the Sponsor or their CRO representative has received and reviewed 
the EC-approved Informed Consent Form.  Subjects who meet the general entry 
criteria will be asked to sign a Patient Informed Consent form 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 consent form and discuss it with their family and physician.  The subject shall 
be informed that his/ her participation in the clinical investigation is confidential.  
The Informed Consent Form must be read and understood by the subject and the 
subject’s questions answered.  The form 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 Informed Consent Form.  A copy of the 
approved Informed Consent Form along with a copy of each patient’s signed 
consent form will be maintained by the Investigator in a designated clinical study 

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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 Patient Informed Consent Form, 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 the site.   
5.8 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 Informed Consent 
Form. 
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. 
5.9 Withdrawal of Subjects 
Subjects may voluntarily withdraw from the study at any time for any reason.  In 
addition, 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 
Subjects with an ongoing AE at the time of withdrawal should be followed on study 
until the clinical event has been resolved or is stable if possible. 
5.10 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. 

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5.11 Subject Confidentiality 
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.  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 case report forms.  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. 
5.12 Schedule of Events and Assessments 
Subjects will complete the following visits and assessments as indicated below and 
in Table 4.   
5.12.1 Baseline 
The following baseline data will be collected: 
• Medical history 
• Medication history  
• Pregnancy test (if applicable) 
• 12-lead ECG 
• Cardiac CT or MRI 
• TEE or other imaging modality for exclusion of left atrial thrombus 
• NYHA Classification 
• Anticoagulation Monitoring: For subjects on dabigatran, perform a PTT and, 
if required, a thrombin time and for subjects on warfarin, assessment of INR 
therapeutic levels (maintain as clinically indicated) 
5.12.2 Procedure 
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 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 will then be prepared 
and advanced via guidewire to the left atrium.  Commercially approved 
multielectrode pacing catheters will then be placed in the coronary sinus and right 
ventricle via conventional technique.  A baseline electrophysiological assessment 
of pulmonary vein connection to the left atrium will be made and documented via 
commercially approved diagnostic catheter placement in each addressable 

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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. 
The FARAWAVE Ablation Catheter will then be prepared and advanced over the 
guidewire to the left atrium.  The guidewire will be advanced into a target 
pulmonary vein, the catheter splines will be deployed 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 demonstrate placement of the catheter at the ostium.  Cardiac 
pacing capture from the external cardiac stimulator will be obtained via 
connection to the coronary sinus and right ventricular pacing catheters.  Once 
pacing capture is confirmed, ablation will be performed.  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.  Ablation dose will be selected at the investigator’s discretion in 
accordance with LBL0198.   
After ablation of each addressable pulmonary vein, the FARAWAVE Ablation 
Catheter will be undeployed and removed.  A post-ablation assessment of 
pulmonary vein isolation will be performed as was done pre-ablation.   
For a detailed description of procedure workflow refer to LBL0193 
(FARADRIVE Deflectable Sheath System), LBL0195 (FARAWAVE 
Endocardial Catheter Ablation System), and LBL0198 (FARASTAR Endocardial 
Generator System).  Procedural details will be captured on the Procedural Data 
CRF.  The following procedural data will be collected: 
• Medications administered 
• Pregnancy test (if applicable) 
• Pre- and post-ablation 3D electroanatomical maps 
• Fluoroscopic examination of diaphragm motion 
• Anticoagulation monitoring (ACT for procedural monitoring) 
• Adverse Events 
5.12.3 Pre-Discharge and 7 Day Follow Up 
Prior to hospital discharge (or 7 Day ± 2 days Follow Up) the following data will 
be collected: 
• Medications including use, changes in or discontinuation of anticoagulation, 
rate control and/or antiarrhythmic medications 
• Cardiac rhythm as determined by a 12-lead ECG 
• Cardioversion(s) 
• Heart failure status as assessed by NYHA classification 

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• Anticoagulation Monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Adverse Events 
5.12.4 30 Day Follow-Up 
Discharged subjects will return for an office visit 30 days (± 7 days) post-ablation 
treatment.  Subjects that continue to be hospitalized 30 days post-ablation will 
have their 30-Day Follow-Up assessment performed at discharge.  At a minimum, 
the following data will be collected at the 30 Day Follow-Up visit: 
• Medications including 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 since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
• Anticoagulation Monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Any hospital readmissions, including admission and discharge dates, since 
discharge from the original procedure 
• Adverse Events 
5.12.5 75 Day Follow-Up 
Subjects will return for an office visit at 75 days (± 15 days) post index ablation. 
At a minimum, the following data will be collected at the 75-day follow-up visit: 
• Medications including use, changes in or discontinuation of anticoagulation, 
rate control and/or antiarrhythmic medications 
• Pregnancy test (if applicable) 
• Cardiac rhythm as determined by a 12-lead ECG 
• Cardiac CT or MRI scan to assess the patency of the pulmonary veins 
• 3D electroanatomical remapping procedure to assess electrical isolation of the 
pulmonary veins.  Any electrical gaps may be closed at the investigator’s 
discretion using a commercially approved ablation device.  This will consist 
of placement of catheters in the left atrium via femoral access and transseptal 
puncture using conventional electrophysiology techniques.  Any electrical 
gaps may be closed at the investigator’s discretion using the study device or, if 
clinically necessary, using a commercially approved ablation device (which 
constitutes a therapeutic treatment failure). 

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• An Event Monitor will be provided to be used up to the 12-month follow-up 
visit for weekly scheduled and ad hoc symptomatic monitoring.  Subjects will 
retain this device through the 12-month follow-up,  ECG data from this 
monitor will be analyzed by a contract core lab.  Investigational sites will be 
provided with the Event Monitor device and instructions for its use by the 
contract core lab.  The investigational sites will then provide the device and 
instructions for use to the subject.  The Event Monitor will be returned at the 
end of the subject’s follow-up using shipping materials provided by the core 
lab. 
• Cardioversions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
• Fluoroscopic Examination of Diaphragm Motion if the procedural 
examination indicates diminished phrenic nerve response 
• Anticoagulation Monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Any additional ablation procedures performed 
• Any hospital readmissions, including admission and discharge dates, since the 
previous visit 
• Adverse Events 
5.12.6 90-Day Phone Call 
In case the 75-day follow-up visit and electroanatomical re-mapping procedure  
occur earlier than planned, the subject will be contacted by phone to collect 
information on any hospitalizations, repeat ablations, adverse events and/or 
symptoms of AF, AFL, or AT at 90 days post index procedure. 
5.12.7 6 Month Follow-up 
Subjects will return for an office visit 6 months (180 days ± 30 days) post-
ablation treatment.  At a minimum, the following data will be collected at 6 
months: 
• Medications including 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 
• Cardiac rhythm as determined by a 24-hour continuous ECG monitor.  ECG 
data from this monitor will be analyzed by a contract core lab.  Investigational 
sites will be provided with the continuous ECG monitor device and 
instructions for its use by the contract 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 then returned to 
the core lab with shipping materials provided by the core lab. 

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• Event Monitor provided at the 75-day follow-up visit will be reviewed for 
weekly scheduled and ad hoc symptomatic monitoring.  ECG data from this 
monitor will be analyzed by a contract core lab.   
• Cardioversions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
• Fluoroscopic Examination of Diaphragm Motion if the procedural 
examination indicates diminished phrenic nerve response 
• Anticoagulation Monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Any additional ablation procedures performed 
• Any hospital readmissions, including admission and discharge dates, since the 
previous visit 
• Adverse Events 
5.12.8 12 Month Follow-Up 
Subjects will return for an office visit 12 months (365 days ± 30 days) post-
ablation treatment.  At a minimum, the following data will be collected at 12 
months: 
• Medications including 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 
• Cardiac rhythm as determined by a 24-hour continuous ECG monitor.  ECG 
data from this monitor will be analyzed by a contract core lab.  Investigational 
sites will be provided with the continuous ECG monitor device and 
instructions for its use by the contract 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 then returned to 
the core lab with shipping materials provided by the core lab. 
• Event Monitor provided at the 75-day follow-up visit will be reviewed for 
weekly scheduled and ad hoc symptomatic monitoring.  ECG data from this 
monitor will be analyzed by a contract core lab.  The Event Monitor will be 
returned at the end of the subject’s follow-up using shipping materials 
provided by the core lab. 
• Cardioversions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
• Fluoroscopic Examination of Diaphragm Motion if the procedural 
examination indicates diminished phrenic nerve response 

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• Anticoagulation monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Any additional ablation procedures performed 
• Any hospital readmissions, including admission and discharge dates, since the 
previous visit 
• Adverse Events 
5.13 Unscheduled Visit 
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: 
• Medications including 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 
• Event Monitor provided at any previous follow-up visit will be reviewed for 
weekly scheduled and ad hoc symptomatic monitoring. ECG data from this 
monitor will be analyzed by a contract core lab. 
• Cardioversions since last visit 
• Heart failure status as assessed by NYHA classification at the time of visit 
• Anticoagulation monitoring: For subjects on anticoagulants, assessment of 
INR/PTT therapeutic levels as applicable/required (maintain as clinically 
indicated) 
• Any additional ablation procedures performed 
• Any hospital readmissions, including admission and discharge dates, since the 
previous visit 
• Adverse Events 
5.14 Study Exit or Premature Withdrawal 
Once the subject has completed the final follow-up visit they can be exited from the 
study provided that they do not have any conditions that require continued follow-
up. 
If a patient withdraws from the study prematurely or is withdrawn based on the 
judgement of investigator, the site will document the reason for withdrawal and 
inform the Sponsor.  These patients will continue to be followed for safety through 
the 12-month timepoint. 
 

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5.15 Schedule of Study Assessments 
Table 4: Summary of Study Assessments 
Assessment 
Baseline 
Procedure 
PreDischarge 
/ 7 Days 
30 Days Post-
Procedure/ 
Discharge* 
75 Days 
 
90 
Days**** 
6 Month 
12 Month 
Unscheduled 
Visit Timeframe (days) 
 
 
7±2 
30±7 
75±15 
90 ±7 
180±30 
365±30 
- 
Medical History 
X 
 
 
 
 
 
 
 
 
Medication History (current) 
X 
 
 
 
 
 
 
 
 
Medications 
 
X 
X 
X 
X 
 
X 
X 
X 
Pregnancy test (for females of 
childbearing potential) 
X 
X 
 
 
X 
 
 
 
 
12-lead ECG 
X 
 
X 
X 
X 
 
X 
X 
X 
24-Hour Continuous ECG 
Monitor (e.g., Holter) 
 
 
 
 
 
 
X 
X 
 
Cardiac CT or MRI 
X 
 
 
 
X 
 
 
 
 
TEE or other imaging 
modality (to exclude left atrial 
thrombus) 
X 
 
 
 
 
 
 
 
 
Electroanatomical Mapping 
 
X 
 
 
X 
 
 
 
 
Event Monitor 
 
 
 
 
X 
 
X 
X 
X 
Record DC Cardioversions at 
Discharge or since Last Visit 
 
 
 
X 
 
X 
 
X 
 
X**** 
 
X 
 
X 
 
X 
NYHA Classification 
X 
 
X 
X 
X 
 
X 
X 
X 
Fluoroscopic Examination of 
Diaphragm Motion 
 
X 
 
 
X*** 
 
X*** 
X*** 
 
Anticoagulation Monitoring 
X** 
X** 
X** 
X** 
X** 
 
X** 
X** 
X** 
Adverse Events 
 
X 
X 
X 
X 
X**** 
X 
X 
X 
Phone Consultation 
 
 
 
 
 
X**** 
 
 
 
* Whichever is later 
** INR or PTT (as applicable for patient on heparin or NOACs); ACT for procedural monitoring 
***If the procedural study indicates decreased phrenic nerve function  
****If the 75-day follow-up occurs earlier than planned; the patient will be contacted for a telephone follow-up consultation..

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6. Risk Benefit Assessment 
The Sponsor has conducted an analysis of the benefits and risks of the FARAPULSE 
Endocardial 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. 
 
6.1 Risks 
The risk profile associated with the FARAPULSE Endocardial 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 
paroxysmal atrial fibrillation.   
6.1.1 
Potential Adverse Events 
The following anticipated adverse events have been identified as possible 
complications of percutaneous atrial fibrillation ablation procedures and these and 
others may be associated with the FARAPULSE Endocardial Ablation System: 
• Access site complications (e.g., hematoma, pseudo-aneurysm) 
• Air embolism 
• 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 
• Cardiac arrest or cardiac failure  
• Catheter entrapment 
• Cardiogenic shock 
• Conduction system injury resulting in sinus arrest or heart block, either 
transient or permanent 
• Congestive heart failure  
• Death 
• Drug allergic reaction or side effects (e.g., from contrast, steroids, analgesics, 
anesthetics, anticoagulants, sedatives, etc.) 
 
• Esophageal injury, ulcer or fistula 
• Hemorrhage 
• Hemodynamic compromise 
• Hemopericardium 
• Hemoperitoneum 

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• Hemothorax 
• Local infection, systemic infection, and/or sepsis 
• Myocardial infarction / transient ischemia 
• Nerve damage 
• Organ failure 
• Pain 
• Perforation (e.g., of diaphragm, heart, liver, lung, and/or vessels). 
• Pericardial irritation 
• Pericardial effusion 
• Pericarditis 
• Peritonitis 
• Phrenic nerve injury 
• 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 or open-heart surgery to remove retained catheter 
• Thrombosis 
• Thromboembolism 
• Vessel damage, dissection, or occlusion. 
 
6.2 Benefits 
The FARAPULSE Endocardial 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 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.   
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. 
7. Statistical Analysis and Endpoint Assessment 
7.1 General Statistical Considerations 
The primary objective of this study is to further characterize the safety and 
feasibility of the FARAPULSE Endocardial Ablation System in subjects with 
paroxysmal atrial fibrillation. 
This is a feasibility study with no formal hypothesis testing and therefore no 
required sample size.  Study results will be presented using descriptive statistics.  
Results from this study will be used to inform and design additional clinical studies. 
All subjects will be followed on an Intent-to-Treat basis.  The device performance 
will be assessed based on an intent-to-treat analysis of the primary safety and 
feasibility endpoints, and secondary feasibility endpoints.  A per protocol analysis, 
along with other secondary analyses, will also be reported. 
An intent-to-treat analysis of device performance will be assessed as the number of 
patients in whom all pulmonary veins are electrically isolated using only the study 
device at the completion of the index procedure.   
All subjects who meet enrollment criteria for the study and undergo catheterization 
and ablation procedures with the FARAPULSE Endocardial Ablation System shall 
be included in the Intent-to-Treat cohort/population. This will exclude any patients 
in whom exclusion criteria were identified prior to any ablation with the study 
device. 
Demographic, baseline clinical and disease characteristics, procedural results and 
primary, secondary and all additional endpoints will be summarized using 
descriptive statistics. 
7.2 Sample Size Justification 
The subject investigation is an expansion of the PEFCAT safety and feasibility 
study.  A total of up to 80 patients will be studied at two centers to allow for 
continued assessment of the FARAPULSE Endocardial Ablation System and gain 
additional investigator experience.  The subject investigation will be used to inform 

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the clinical dosage and procedural requirements to support a subsequent Pilot 
Study.  
The safety and feasibility of the device will be analyzed before embarking on larger 
fully powered clinical studies to analyze safety and effectiveness of the 
FARAPULSE Endocardial Ablation System. 
The sample size of up to 80 patients at two sites will allow event rate estimates for 
safety and device performance and associated confidence intervals.  Two 
participating centers allow the collection of safety and feasibility data from multiple 
clinical users.  These data will be used to inform the statistical powering of a future 
pilot study.  
7.3 Demographic, Safety, Feasibility and Effectiveness Data 
Demographic and baseline clinical and disease characteristics will be summarized 
in tables.  For continuous variables, the summary will include number, mean, and 
standard deviation and 95% bilateral confidence intervals, where pertinent.  
Summaries for categorical variables will include the number and percent of subjects 
in each category. 
7.4 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. 
7.5 Assessment of Feasibility 
7.5.1 
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 Ablation System during the first procedure, as clinically assessed by 
entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is 
made. 
7.5.2 Secondary Feasibility Endpoint 
1. The proportion of subjects that achieve Chronic Procedural Success (CPS) 
defined as persistent electrical isolation of all initially ablated pulmonary veins 
assessed during an electroanatomical mapping procedure performed 75 days 
following the index procedure. Chronic Procedural Success will be subdivided 
by single procedure and reablated subjects. 
2. 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 

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Therapeutic success will be assessed from the end of the blanking period at 
Months 6 and 12, and will be subdivided by on / off AFDs post blanking period. 
 
7.5.3 
Additional Endpoints 
1. Proportion of all ablated pulmonary veins that are isolated at the index 
procedure using the study device. 
2. Proportion of all ablated pulmonary veins acutely isolated using the study 
device that remain isolated at the 75 day remapping procedure. 
 
7.6 Assessment of Safety 
7.6.1 
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:   
 
Early onset (within 30 days of any endocardial ablation for atrial fibrillation) 
• Death  
• Myocardial infarction (MI)  
• Persistent diaphragmatic paralysis  
• Stroke or transient ischemic attack (TIA)  
• Peripheral or organ thromboembolism  
• Pericarditis 
• Cardiac tamponade / perforation  
• Vascular access complications  
• Hospitalization (initial or prolonged)*  
• Heart block  
Late onset (any time during follow-up) 
• Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)  
• Atrio-esophageal fistula  
* Excludes hospitalization (initial & prolonged) solely due to arrhythmia 
(AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent 
cardioversion (pharmacological or electrical). Hospitalization excludes visits to 
hospital-associated outpatient facilities such as clinics or emergency wards. 
7.6.2 Secondary Safety Endpoint 
1. The proportion of subjects reporting one or more device- or procedure-related 
SAEs, as assessed at 30 days, 75 days, 6 months and 12 months of follow-up. 
2. The proportion of subjects with stroke or TIA through 12 months 
3. The proportion of subjects with major bleeding related to anticoagulation 
treatment through 12 months 
4. The proportion of subjects requiring cardioversion through 12 months 

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5. The proportion of subjects requiring an arrhythmia-related hospitalization 
through 12 months 
 
7.7 
Final Clinical Report 
A final clinical report will be prepared at the conclusion of the study.  Copies of the 
final report will be provided to the investigator and their IRB/EC and to the 
Competent Authority, as applicable. 
 
8. Adverse Events and Serious Adverse Events 
Definitions below are as per the ISO 14155:2011 
 
8.1 General 
Adverse Event (AE): 
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. 
 
Serious Adverse Event (SAE): 
•   led to death, 
• led to 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. 
• led to fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE: 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.  
Adverse Device Effect (ADE): 

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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 
 
Serious Adverse Device Effect (SADE): 
Adverse device effect that has resulted in any of the consequences characteristic of 
a serious adverse event 
 
Unanticipated Serious Adverse Device Effect (USADE): 
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. 
NOTE:     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. 
 
Device Deficiency: 
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. 
 
Use Error: 
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. 
 
Malfunction: 
Failure of an investigational medical device to perform in accordance with its 
intended purpose when used in accordance with the instructions for use or CIP. 
 
Causality Relationship: 

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The investigator will assess the causality of all adverse events in relation to the 
research, i.e., the relationship between the AE / SAE and the investigational device 
or any other study-related procedures. 
Each SAE will be classified 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; 
• 
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; 

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• 
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); 
• 
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. 
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 adverse device effect (UADE).  An UADE is defined as “any serious 
adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.” 
 
8.2 Adverse Event Reporting 
All AEs, including all SAEs, will be monitored from the time of enrollment through 
discharge for this study.  All AEs must be recorded in the patient chart and 
appropriate Case Report Form (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 relationship between the AE and the study 
device. 
All AEs should be followed until the event is resolved or judged to be chronically 
stable.  The investigational site will provide relevant follow-up information to the 
Sponsor or designee upon request. 

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The investigator should report to the Sponsor or its designee the following events, 
whether expected or not, in the corresponding CRF, with the exception of AEs / SAEs 
detected before the patients has signed the Informed Consent Form.   
• AEs 
• SAEs 
• Device Deficiencies or Malfunctions that did not but might have led to a 
SAE if such an event were to recur: 
o Suitable action had not been taken, or 
o Intervention had not been made or 
• New findings/updates in relation to already reported events. 
If an AE / SAE is present at the beginning of study prior to the subject providing 
signed Informed Consent to participate in the study, only its worsening should be 
reported.  
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.  
This reporting should be done by faxing / emailing the completed CRF pages to the 
CRO and Sponsor:  
CRO:  
MedPass International SAS  
Fax:    
+33 (0)1 40 53 81 11 
  
Sponsor: 
FARAPULSE, Inc. 
Email:  
clinical@farapulse.com  
 
 
 
Contact: 
Mr.  Christopher Schneider 
 
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.  
 
8.3 
Device Deficiencies / 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. 

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8.4 
Reporting to Ethics Committee / Competent Authority  
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.  
 
9. Monitoring 
9.1 Study Monitoring 
Clinical monitors, qualified by training and experience, will be responsible for 
monitoring and overseeing the conduct of the study.  The clinical monitors will 
evaluate compliance with the protocol, any specific recommendations made by the 
site’s Ethics Committee (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 Informed Consent Form was 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 Case Report Forms 
(CRFs) are in agreement with the source documentation and other records.  The 
Investigator will make available to the clinical monitor for review all Informed 
Consent Forms, 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 
with source documents including, but not limited to, medical records, office/ clinic 
notes, procedure reports, laboratory results, physician and nursing progress notes.  

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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. 
It is important that the Investigator and other relevant site personnel, including the 
research study coordinator, 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.   
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.  
10. 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 Contract Research Organizations (CROs).  Together, the Sponsor, consultants 
and CRO will ensure that the study is conducted according to the approved Clinical 
Investigational Plan, Ethics Committee approved Informed Consent Form 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. 
 
10.1   Key Contributors 
10.1.1 Study Sponsor 
FARAPULSE, Inc. 
3715 Haven Ave.  Suite 110 
Menlo Park, CA 94025, USA 
Phone: 617-686-7661 
Email: kschneider@farapulse.com 
10.1.2 CRO 
MedPass International SAS 
95b Boulevard Pereire 
75017 Paris, France 
Tel No: +33 1.42.12.83.30 
 

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10.1.3 Clinical Site 
The multi-center study will be conducted at the Nemocnice Na Homolce located 
in Prague, Czech Republic and Hopital cardiologique du Haut-Leveque in Pessac, 
France. 
 
10.2 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. 
10.2.1 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 Competent Authority and the local Ethics 
Committee.  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. 
10.2.2 Ethics Review 
Before any subject can be enrolled in this study, the local or national Ethics 
Committee and the Competent Authority (CA) must review and approve the 
Clinical Investigation Plan and the Informed Consent Form to be used.  A subject 
cannot be asked to sign the Informed Consent Form until the study has been fully 
approved by the institution’s Ethics Committee and by the CA, if applicable.  The 
Sponsor or their designated CRO (MedPass International) will require a copy of 
any Ethics Committee correspondence, as well as the final Ethics Committee 
approval letter and the final Ethics Committee approved Informed Consent Form 
(ICF), and approvals for Clinical Investigation Plan and ICF revisions on 
amendments from the Ethics Committee. The Sponsor or their designated CRO 
(MedPass International) will keep all of the Competent Authority correspondence, 
as well as the CA approval letter. 
10.2.3 Informed Consent 
Subjects will not sign the Informed Consent Form until the study has been fully 
approved by the institution’s Ethics Committee and the Sponsor or their CRO 
representative (MedPass International) has received and reviewed the specific 
Ethics Committee-approved Informed Consent Form.  When the Investigator has 
determined the eligibility of a specific subject to enter the study, the Informed 
Consent Form must be completed.  The Informed Consent Form must be read and 

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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 Informed Consent Form. 
10.2.4 Coverage of Expenses 
Study participants will be reimbursed for travel costs related to study hospital 
visits. 
10.2.5 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 representative (MedPass International), 
Investigators and Site personnel will make every reasonable effort to protect the 
confidentiality of all subjects participating in the study. 
 
10.3 Insurance 
The Sponsor will maintain the appropriate and necessary insurance coverage for 
the duration of the study. 
 
10.4 Audits and Inspections 
The Principal Investigator will also allow representatives of the governing Ethics 
Committee (EC), Competent Authority (CA), the U.S.  Food and Drug 
Administration (FDA), 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 Clinical Investigation 
Plan, completeness and exactness of the data being entered onto the CRFs and 
compliance with FDA or other regulatory agency regulations. 
 
The Principal Investigator will inform the Sponsor or the Sponsor’s designee 
(MedPass International) should they be audited or inspected by any regulatory 
agencies.  The Sponsor or the Sponsor’s designee (MedPass International) will 
also inform the site if they are made aware of a pending audit or inspection by a 
regulatory agency. 
 
10.5 Sponsor Responsibilities 
Sponsor has the overall responsibility for  the study and will: 
• Select qualified Principal Investigator, clinical investigators and study site. 
• Select qualified monitors. 
• Provide the Clinical Investigation Plan and any subsequent amendments. 

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• Provide appropriate information and Investigational system training to the 
Investigator and study site staff. 
• Ensure that all deviations from the Clinical Investigation Plan 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 adverse events and all adverse device effects (ADEs) are 
reported and reviewed with the Investigator(s), and where appropriate, that all 
serious adverse events (SAEs) and all serious adverse device effects (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 Ablation System Instructions for Use, the Clinical Investigation 
Plan, CRF instructions, CRFs and requirements for obtaining informed consent. 
• Provide the FARAPULSE Endocardial Ablation System to the participating 
study site, in quantities to support study activities. 
• Coordinate ongoing communication with CRO(s), consultants and study site to 
resolve any problems concerning the protocol or data collection 
• 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 binder to site. 
10.6 Monitor Responsibilities 
The Sponsor has contracted MedPass International as the Clinical Monitor to 
support the Sponsor in implementing and monitoring the clinical investigation until 
its termination.  Clinical monitors, qualified by training and experience, will be 
responsible for monitoring and overseeing the conduct of the study. 
Site Initiation Visit: 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 Informed Consent Form, the CRFs, CRF 
Instructions, the Instructions for Use and the Institution and/ or Investigator 
Agreement. 

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Site Monitoring: The clinical monitors will conduct routine on-site monitoring 
visits and phone calls to evaluate compliance with the Clinical Investigation Plan 
(CIP), any specific recommendations made by the site’s Ethics Committee (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 Form was properly obtained 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 Case Report Forms (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 Informed 
Consent Forms, 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 
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. 
10.7 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 (CTA) 
• Signed Financial Disclosure Form 
• Signed Clinical Investigation Plan Signature Page 
• Investigator and Co-Investigator’s current Curriculum Vitae 

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• 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 Clinical Investigation Plan, 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 Clinical Investigation Plan (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. 
• Ensure that appropriate Ethics Committee and Competent Authority  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 Ethics 
Committee Informed Consent Form. 
• 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 

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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. 
 
10.8 Investigator Training 
The participating investigator will be trained in the use of the FARAPULSE 
Endocardial 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. 
10.9 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 
investigator and study personnel on the Clinical Investigation Plan, 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. 
10.10 Clinical Events Committee and Data and Safety Monitoring Board 
A Clinical Events Committee (CEC) will convene during the study to classify and 
adjudicate all procedure-related and serious adverse events reported in the subject 
investigation.  The CEC will consist of physicians who have no formal involvement 
or conflict of interest with the subjects, the investigator, or the designated CRO 
(MedPass International), and will be appointed by the Sponsor.  The CEC will be 
provided with case summaries and relevant source documents in order to adjudicate 
the adverse events. 

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In addition, a Data and Safety Monitoring Board (DSMB) will convene to review 
safety data and trends during the conduct of the study.  The DSMB will meet, at a 
minimum, after the enrollment of every twentieth (20th) patient until the conclusion 
of enrollment up to a total of 80 patients.  The DSMB will be empowered to 
terminate or pause the study if it identifies a trend that indicates a danger to patient 
safety.  In particular, the DSMB will consider safety trends in the context of 
different versions of the device (e.g. 35mm vs. 31mm FARAWAVE Endocardial 
Ablation Catheters). 
10.11 Data Management 
Patient Case Report Forms (CRFs) will be provided 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 Clinical Investigation Plan, including laboratory results, supporting 
medical records, and signed Informed Consent Forms.  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 (MedPass 
International). 
10.12 Study Suspension or Early Termination 
The study can be discontinued at the discretion of the Investigator or study Sponsor 
for reasons including, but not limited to, the following: 
• 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 Ablation System making treatment without the 
FARAPULSE Endocardial 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 

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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.   
10.13 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 Case Report Forms prior to scheduled monitoring 
visits; 
• Failure to obtain written Informed Consent; 
• Failure to report SAEs/ UADEs to Sponsor within 24 hours of knowledge; 
• Loss of (or unaccounted for) investigational product inventory or repeated failure 
of device accountability. 
10.14 Final Clinical Report 
A Final Clinical Report will be prepared even if the study is prematurely 
terminated.  The Final Clinical Report will be submitted to the participating 
Investigator, and regulatory agencies, as required. 
10.15 Deviations from the Clinical Investigation Plan 
The Investigator is not allowed to deviate from the approved Clinical Investigation 
Plan except in emergency circumstances. 
The Investigator must notify the Sponsor and the CRO of any deviation from the 
Clinical Investigation Plan and document the reason for the deviation. 
The Investigator shall notify the Sponsor and the reviewing Ethics Committee of 
any deviation from the Clinical Investigation Plan, 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.  
11. Regulatory considerations 
11.1 Maintaining Records 
The Sponsor and CRO will maintain copies of critical correspondence, clinical data, 
shipment of devices, serious adverse device effects and other records related to the 
clinical study. 

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11.2  Data Handling and Record Keeping 
11.2.1 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. 
11.2.2 Data Collection 
The Investigator must maintain detailed records on all subjects who sign the 
Informed Consent Form 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 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 

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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. 
11.3 Ethics Committee (EC) and Competent Authority (CA) Approval 
Regulatory approvals must be obtained prior to enrolment 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 Ethics 
Committee and Competent Authority correspondence, as well as the final approval 
letter from the Ethics Committee and Competent Authority, where applicable. 
An Investigator may not make Clinical Investigation Plan (CIP)  changes without 
prior approval by the Sponsor.  All significant (CIP) changes that may affect the 
following must be submitted and approved by the Ethics Committee and Competent 
Authority 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. 
11.4 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. 
12.   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 

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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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13. Bibliography 
 
1  
Page RL.  Newly Diagnosed Atrial Fibrillation.  New England Journal of 
Medicine, 351(23):2408–16, 2004. 
2  
Feinberg WM, Cornell ES, Nightingale SD, et al.  Relationship between 
Prothrombin Activation Fragment F1.2 and International Normalized Ratio in 
Patients with Atrial Fibrillation.  Stroke Prevention in Atrial Fibrillation 
3  
Fuster, V, Ryden, L, Asinger, R, et al.  ACC/AHA/ESC Guidelines for the 
Management of Patients with Atrial Fibrillation: Executive Summary.  J Am 
Coll Cardiol, 2001;38:1231-65. 
4  
Go AS, Hylek EM, and et al.  Phillips KA.  Prevalence of diagnosed atrial 
fibrillation in adults: national implications for rhythm management and stroke 
prevention: the anticoagulation and risk factors in atrial fibrillation (atria) 
study.  JAMA, 285:2370–5, 2001. 
5  
Miyasaka Y., Barnes ME., et al.  Secular Trends in Incidence of Atrial 
Fibrillation in Olmsted County, Minnesota, 1980 to 2000, and Implications on 
the Projections for Future Prevalence.  Circulation.  2006;114:119-125.   
6  
Wolf PA, Abbott RD, Kannel WB.  Atrial fibrillation as an independent risk 
factor for stroke: the Framingham Study.  Stroke 1991;22:983– 8. 
7  
Le Heuzey JY, Paziaud O, Piot O, et al.  Cost of care distribution in atrial 
fibrillation patients: the COCAF study.  Am Heart J 2004;147:121– 6. 
8  
Zipes DP and Wellens HJ.  What have we learned about cardiac arrhythmias? 
Circulation, 102:IV–52–IV57, 2000. 
9  
Calkins, et al.  HRS/EHRA/ECAS Expert Consensus Statement on Catheter 
and Surgical Ablation of Atrial Fibrillation: Recommendations for Personnel, 
Policy, Procedures and Follow-Up.  Heart Rhythm 2007; 4(6):e1-46. 
10  
Jais P, Cauchemez B, MacLe L, Daoud E, Waldo AL, Ruskin J, Hocini M, 
O’Neill MD, Clementy J, Haissaguerre M.  Atrial fibrillation ablation vs 
antiarrhythmic drugs: A multicenter randomized trial.  Heart Rhythm 
2006;3(Suppl):S1–S460. 
11  
Pappone C, Augello G, Sala S, Gugliotta F, Vicedomini G, Gulletta S, Paglino 
G, Mazzone P, Sora N, Greiss I, et al.  A randomized trial of circumferential 
pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal 
atrial fibrillation: the APAF Study.  J Am Coll Cardiol 2006;48:2340 –2347. 
12  
Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, 
Bash D, Schweikert R, Brachmann J, Gunther J, et al.  Radiofrequency 
ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial 
fibrillation: a randomized trial.  JAMA 2005;293:2634 –2640. 
13  
Wilber, David et al.: Comparison of Antiarrhythmic Drug Therapy and 
Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial 
Fibrillation A Randomized Controlled Trial.  JAMA.  2010;303(4):333-340 
14  
Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, 
Kellen JC, Greene HL, Mickel MC, Dalquist JE, et al.  A comparison of rate 
control and rhythm control in patients with atrial fibrillation.  N Engl J Med 
2002;347:1825–1833. 
 

FARAPULSE, INC. 
 
PAGE 64 of 66 
PROTOCOL NO.  CS0267 
 
 
CONFIDENTIAL 
 
15  
Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, 
Josephson RA, Kellen JC, Klein RC, Krahn AD, et al.  Relationships between 
sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up 
Investigation of Rhythm Management (AFFIRM) Study.  Circulation 
2004;109:1509–1513. 
16  
Oral H., Pappone C., et al.  Circumferential pulmonary-vein ablation for 
chronic atrial fibrillation.  N Engl J Med, 2006;354:934–941. 
17  
Jais P., Cauchemez B., et al.  Catheter ablation versus antiarrhythmic drugs 
for atrial fibrillation: the A4 study.  Circulation, 2008;118:2498-505. 
18  
Jais P., Cauchemez B., et al.  Catheter ablation versus antiarrhythmic drugs 
for atrial fibrillation: the A4 study.  Circulation, 2008;118:2498-505. 
19  
Stabile G., Bertaglia E., et al.  Catheter ablation treatment in patients with 
drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, 
controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation 
Study).  Eur Heart J., 2006;216-21. 
20  
Kobza R, Hindricks G, Tanner H, et al.  Late recurrent arrhythmias after 
ablation of atrial fibrillation: incidence, mechanisms, and treatment.  Heart 
Rhythm 2004;1:676-683. 
21  
Wright, Mathew et al.  State of the Art: Catheter Ablation of Atrial 
Fibrillation.  J Cardiovasc Electrophysiol, Vol.  19, pp.  583-592, June 2008. 
22  
Wisser W1, et al.  Permanent chronic atrial fibrillation: is pulmonary vein 
isolation alone enough? Ann Thorac Surg.  2007 Oct;84(4):1151-7 
23  
Fuster V, Rydén LE et al.  2011 ACCF/AHA/HRS focused updates 
incorporated into the ACC/AHA/ESC 2006 guidelines for the management of 
patients with atrial fibrillation: a report of the American College of 
Cardiology Foundation/American Heart Association Task Force on practice 
guidelines.  Circulation.  2011 Mar 15;123(10):e269-367 
24  
Jaïs P1, Weerasooriya R, et al.  Ablation therapy for atrial fibrillation (AF): 
past, present and future.  Cardiovasc Res.  2002 May;54(2):337-46. 
25  
Boersma, L.V., et al., Atrial fibrillation catheter ablation versus surgical 
ablation treatment (FAST): a 23center randomized clinical trial.  Circulation, 
2012.  125(1): p.  23-30. 
26  
Damiano, R.J., Jr., et al., The Cox maze IV procedure:  predictors of late 
recurrence.  J Thorac Cardiovasc Surg, 2011.  141(1): p.  113-21.   
27  
Tilz, R.R., et al., Catheter ablation of long3standing persistent atrial 
fibrillation: a lesson from circumferential pulmonary vein isolation.  J 
Cardiovasc Electrophysiol, 2010.  21(10): p.  1085-93. 
28  
Takahashi, Y., et al., Disconnection of the left atrial appendage for elimination 
of foci maintaining atrial fibrillation.  J Cardiovasc Electrophysiol, 2005.  
16(8): p.  917-9. 
29  
Hocini, M., et al., Localized reentry within the left atrial appendage: 
arrhythmogenic role in patients undergoing ablation of persistent atrial 
fibrillation.  Heart Rhythm, 2011.  8(12): p.  1853-61. 
 

FARAPULSE, INC. 
 
PAGE 65 of 66 
PROTOCOL NO.  CS0267 
 
 
CONFIDENTIAL 
 
30  
Di Biase, L., et al., Left atrial appendage: an underrecognized trigger site of 
atrial fibrillation.  Circulation, 2010.  122(2): p.  109-18. 
31  
Calkins, H., et al.,2012 HRS/EHRA/ECAS Expert Consensus Statement on 
Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for 
patient selection, procedural techniques, patient management and follow up, 
definitions, endpoints, and research trial design.  Europace, 2012.  14(4): p.  
528-606. 
32  
Haissaguerre, M., et al., Spontaneous initiation of atrial fibrillation by ectopic 
beats originating in the pulmonary veins.  N Engl J Med, 1998.  339(10): p.  
659-66. 
33  
Jais, P., et al., A focal source of atrial fibrillation treated by discrete 
radiofrequency ablation.Circulation, 1997.95(3): p.572-6. 
34  
Al-Sakere B, Andre´ F, et al.  Tumor Ablation with Irreversible 
Electroporation.  PLoS ONE 2(11): e1135. 
35  
Neumcke, B., Walz, D., L~uger, P.  1970.  Non linear effects in lipid bilayer 
membranes.  III.  The dissociation field effect.  Biophys.  J.  10:172 
36  
Benz R, Beckers F, Zimmermann U.  Reversible electrical breakdown of lipid 
bilayer membranes: a charge-pulse relaxation study.  J Membr Biol.  1979 Jul 
16;48(2):181-204. 
37  
Chang, D.  C.  1989a.  Cell poration and cell fusion using an oscillating 
electric field.  Biophys.  J.  56:641-652. 
38  
D.C.  Chang, T.S.  Reese Changes in membrane structure induced by 
electroporation as revealed by rapid-freezing electron microscopy.  
Biophysical Journal, Volume 58, Issue 1, July 1990, Pages –12 
39  
Wendler JJ, Pech M, Blaschke S et al (2012) Angiography in the isolated 
perfused kidney: radiological evaluation of vascular protection in tissue 
ablation by nonthermal irreversible electroporation.  Cardiovasc Intervent 
Radiol 35:383–390 
40  
Gehl J1, Skovsgaard T, Mir LM.  Vascular reactions to in vivo 
electroporation: characterization and consequences for drug and gene 
delivery.  Biochim Biophys Acta.  2002 Jan 15;1569(1-3):51-8. 
41  
Kingham TP, Karkar AM, D’Angelica MI et al (2012) Ablation of 
perivascular hepatic malignant tumors with irreversible electroporation.  J Am 
Coll Surg 215:379–387 
42  
Olweny EO, Kapur P, Tan YK et al (2013) Irreversible electroporation: 
evaluation of nonthermal and thermal ablative capabilities in the porcine 
kidney.  Urology 81:679–684 
43  
Maor E, Ivorra A, Leor J, Rubinsky B.  Irreversible electroporation attenuates 
neointimal formation after angioplasty.  IEEE Trans Biomed Eng.  2008 
Sep;55(9):2268-74. 
44  
Thomson KR1, Cheung W, et al.  Investigation of the safety of irreversible 
electroporation in humans.  J Vasc Interv Radiol.  2011 May;22(5):611-21 
 

FARAPULSE, INC. 
 
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PROTOCOL NO.  CS0267 
 
 
CONFIDENTIAL 
 
45  
Wittkampf FH1, van Driel VJ, et al.  Feasibility of electroporation for the 
creation of pulmonary vein ostial lesions.  J Cardiovasc Electrophysiol.  2011 
Mar;22(3):302-9. 
46  
Van Driel VJ, Neven KG, Pulmonary vein stenosis after catheter ablation: 
electroporation versus radiofrequency.  Circ Arrhythm Electrophysiol.  2014; 
7(4):734-8. 
47  
Neven K, van Driel V, et al.  Epicardial linear electroporation ablation and 
lesion size.  Heart Rhythm.  2014; pii: S1547-5271(14)00459-7. 
48  
Kobza R, Hindricks G, Tanner H, et al.  Late recurrent arrhythmias after 
ablation of atrial fibrillation: incidence, mechanisms, and treatment.  Heart 
Rhythm 2004;1:676-683. 
49  
Gelsomino S1, Van Breugel HN, et al.  Hybrid thoracoscopic and transvenous 
catheter ablation of atrial fibrillation.  Eur J Cardiothorac Surg.  2014 
Mar;45(3):401-7.