IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

FARAPULSE, INC.  
PROTOCOL NO. CS0172-02, Revision D 
 
PAGE 1 of 59 
CONFIDENTIAL 
 
 
 
 
 
 
 
 
THE IMPACT STUDY: A SAFETY AND FEASIBILITY STUDY OF THE FARAPULSE CARDIAC ABLATION 
SYSTEM TO TREAT ATRIAL FIBRILLATION 
 
ABBREVIATED TITLE: “THE IMPACT STUDY” 
  
 
PROTOCOL NUMBER: CS0172-02, Revision D 
 
 
SPONSOR:  
FARAPULSE, INC. 
(FORMERLY IOWA APPROACH, 
INC.)3715 HAVEN AVE. SUITE 
110 MENLO PARK, CA 
94025, USA 
 
 
 
 
ISSUE DATE: 10 JUNE 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. 

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PROTOCOL NO. CS0172-02, Revision D 
 
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Table of Contents 
1. 
PRIMARY STUDY CONTACTS ...................................................................................................... 5 
2. 
EXECUTIVE SUMMARY ................................................................................................................. 6 
3. 
INTRODUCTION ............................................................................................................................. 12 
3.1 
BACKGROUND AND RATIONALE ...................................................................... 12 
3.2 
SURGICAL ABLATION ........................................................................................ 13 
3.3 
IRREVERSIBLE ELECTROPORATION (IRE): ............................................ 14 
3.4 
COMPLICATIONS OF CATHETER BASED AND SURGICAL EPICARDIAL 
ABLATION ........................................................................................................... 15 
4. 
INVESTIGATIONAL DEVICE ....................................................................................................... 16 
4.1 
NAME OF INVESTIGATIONAL DEVICE .............................................................. 16 
4.2 
INTENDED USE .................................................................................................. 16 
4.3 
CLASSIFICATION ................................................................................................ 16 
4.4 
SYSTEM COMPONENTS: IOWA APPROACH CARDIAC ABLATION SYSTEM 
...................................................................................................... 16 
4.4.1 IOWAPULSE ABLATION CATHETER SYSTEM .................................... 17 
4.4.2 IOWASTAR GENERATOR SYSTEM ...................................................... 18 
4.5 
DEVICE ACCOUNTABILITY ................................................................................ 19 
4.6 
RETURN OF DEVICES........................................................................................ 19 
5. 
TRIAL OBJECTIVES ...................................................................................................................... 20 
5.1 
STUDY DESIGN ................................................................................................... 20 
5.2 
SELECTION AND WITHDRAWAL OF SUBJECTS .............................................. 20 
5.2.1 INCLUSION CRITERIA ........................................................................... 20 
5.2.2 EXCLUSION CRITERIA .......................................................................... 21 
5.3 
TRIAL DESIGN .................................................................................................... 22 
5.3.1 DESCRIPTION OF TRIAL DESIGN ........................................................ 22 
5.4 
TRIAL ENDPOINTS ............................................................................................. 22 
5.4.1 PRIMARY SAFETY ENDPOINT ............................................................. 22 
5.4.2 SECONDARY SAFETY ENDPOINT ....................................................... 24 
5.4.3 PRIMARY FEASIBILITY ENDPOINT ...................................................... 25 
5.4.4 SECONDARY FEASIBILITY ENDPOINTS .............................................. 25 
5.4.5 ADDITIONAL OBSERVATIONS .............................................................. 25 
5.5 
SAMPLE SIZE ..................................................................................................... 26 
5.6 
INVESTIGATIONAL SITES .................................................................................. 26 
5.7 
DURATION OF SUBJECT PARTICIPATION ....................................................... 26 
5.8 
WRITTEN INFORMED CONSENT ...................................................................... 26 
5.9 
ENROLLMENT ..................................................................................................... 27 
5.10 
WITHDRAWAL OF SUBJECTS ........................................................................... 27 
5.11 
LOST TO FOLLOW-UP........................................................................................ 27 
5.12 
SUBJECT CONFIDENTIALITY ............................................................................ 27 
5.13 
SCHEDULE OF EVENTS AND ASSESSMENTS ................................................. 28 
5.13.1 BASELINE .............................................................................................. 28 
5.13.2 PROCEDURE ......................................................................................... 28 

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5.13.3 PRE-DISCHARGE .................................................................................. 28 
5.13.4 1 MONTH FOLLOW-UP ........................................................................ 29 
5.13.5 3 MONTH FOLLOW-UP ........................................................................ 29 
5.13.6 6 MONTH FOLLOW-UP ......................................................................... 30 
5.13.7 12 MONTH FOLLOW-UP ...................................................................... 31 
5.13.8 ELECTRO-ANATOMICAL MAPPING ...................................................... 32 
5.14 
UNSCHEDULED VISIT ........................................................................................ 32 
5.15 
STUDY EXIT OR PREMATURE WITHDRAWAL ................................................. 32 
5.16 
SUMMARY OF TRIAL ASSESSMENTS .............................................................. 33 
6. 
RISK BENEFIT ASSESSMENT ..................................................................................................... 34 
6.1 
RISKS .................................................................................................................. 34 
6.1.1 POTENTIAL ADVERSE EVENTS ........................................................... 34 
6.2 
BENEFITS ............................................................................................................ 36 
7. 
STATISTICAL ANALYSIS AND ENDPOINT ASSESSMENT.................................................... 37 
7.1 
GENERAL STATISTICAL CONSIDERATIONS .................................................... 37 
7.2 
SAMPLE SIZE JUSTIFICATION .......................................................................... 37 
7.3 
DEMOGRAPHIC, SAFETY, FEASIBILITY AND EFFICACY DATA ..................... 37 
7.4 
IMPUTATION FOR MISSING DATA .................................................................... 37 
7.5 
DATA POOLING .................................................................................................. 37 
7.6 
ASSESSMENT OF FEASIBILITY ......................................................................... 38 
7.6.1 PRIMARY FEASIBILITY ENDPOINT ...................................................... 38 
7.6.2 SECONDARY FEASIBILITY ENDPOINT ................................................ 38 
7.7 
ASSESSMENT OF SAFETY ................................................................................ 38 
7.7.1 PRIMARY SAFETY ENDPOINT ............................................................. 38 
7.7.2 SECONDARY SAFETY ENDPOINT ....................................................... 38 
7.8 
FINAL CLINICAL REPORT .................................................................................. 39 
8. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ........................................................ 39 
8.1 
GENERAL ............................................................................................................ 39 
8.2 
ADVERSE EVENT REPORTING ......................................................................... 42 
8.3 
REPORTING TO ETHICS COMMITTEE / COMPETENT AUTHORITY……………..43 
9. 
MONITORING ................................................................................................................................. 43 
9.1 
TRIAL MONITORING ........................................................................................... 43 
10. 
STUDY MANAGEMENT ................................................................................................................ 45 
10.1 
KEY CONTRIBUTORS ........................................................................................ 45 
10.1.1 STUDY SPONSOR ................................................................................. 45 
10.1.2 AUTHORIZED CRO/REPRESENTATIVE ............................................. 45 
10.1.3 CLINICAL SITES .................................................................................... 45 
10.2 
ETHICAL CONSIDERATIONS ............................................................................. 45 
10.2.1 TRIAL CONDUCT ................................................................................... 45 
10.2.2 ETHICS REVIEW.................................................................................... 46 
10.2.3 INFORMED CONSENT ........................................................................... 46 
10.2.4 COVERAGE OF EXPENSES .................................................................. 46 
10.2.5 CONFIDENTIALITY ................................................................................. 46 
10.3 
INSURANCE ........................................................................................................ 47 
10.4 
AUDITS AND INSPECTIONS ............................................................................... 47 
10.5 
STUDY SUSPENSION OR EARLY TERMINATION ............................................ 47 

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10.6 
CRITERIA FOR SUSPENDING/ TERMINATING A STUDY CENTER ................. 46 
10.7 
SPONSOR RESPONSIBILITIES .......................................................................... 48 
10.8 
MONITOR RESPONSIBILITIES ........................................................................... 49 
10.9 
INVESTIGATOR RESPONSIBILITIES .................................................................. 50 
10.10 INVESTIGATOR TRAINING ................................................................................. 51 
10.11 SITE TRAINING ................................................................................................... 52 
10.12 CLINICAL EVENTS COMMITTEE ....................................................................... 52 
10.13 DATA MANAGEMENT ......................................................................................... 52 
10.14 STUDY SUSPENSION OR EARLY TERMINATION ............................................ 53 
10.15 CRITERIA FOR SUSPENDING/ TERMINATING A STUDY CENTER ................. 53 
10.16 FINAL REPORT ................................................................................................... 54 
10.17 DEVIATIONS FROM THE INVESTIGATIONAL PLAN .......................................... 54 
11. 
REGULATORY CONSIDERATIONS ............................................................................................. 54 
11.1 
MAINTAINING RECORDS ................................................................................... 54 
11.2 
DATA HANDLING AND RECORD KEEPING ...................................................... 54 
11.2.1 SOURCE DOCUMENTS ......................................................................... 54 
11.2.2 DATA COLLECTION .............................................................................. 55 
11.3 
ETHICS COMMITTEE (EC) AND COMPETENT AUTHORITY (CA) APPROVAL 
...................................................................................................... 55 
11.4 
DEVICE ACCOUNTABILITY ................................................................................ 56 
12. 
PUBLICATION POLICY ................................................................................................................ 56 
13. 
BIBLIOGRAPHY.............................................................................................................................. 57 

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PROTOCOL NO. CS0172-02, Revision D 
 
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1. Primary Study Contacts 
 
 
SPONSOR 
FARAPULSE, Inc. 
3715 Haven Ave. Suite 110 
Menlo Park, CA 94025, USA 
CLINICAL RESEARCH 
ORGANIZATION 
 
MedPass International SAS 
95b Boulevard Pereire 
75017 Paris, France 
 
LEGAL REPRESENTATIVE 
MedPass Limited 
Windsor House 
Bretforton, 
Evesham, 
Worcs. 
WR11 7JJ – United Kingdom 
 
 
 

FARAPULSE, INC.  
PROTOCOL NO. CS0172-02, Revision D 
 
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CONFIDENTIAL 
 
 
 
2. Executive Summary 
 
SPONSOR NAME: 
FARAPULSE, Inc. 
TITLE OF TRIAL: 
“IMPACT” 
PROTOCOL 
NUMBER: 
CS0172-02, Revision D, VERSION 02 (FR) 
OBJECTIVE: 
The objective of the safety and feasibility trial is to 
demonstrate that the creation of electrically isolating 
lesions via pulsed electric field (PEF) ablation applied 
using the FARAPULSE Cardiac Ablation System during 
concomitant heart surgery is feasible and a safe treatment 
for paroxysmal atrial fibrillation (AF). 
CLINICAL 
HYPOTHESIS: 
Creation of electrically isolating lesions in cardiac tissue 
via ablation using the FARAPULSE Cardiac Ablation 
System during concomitant heart surgery is a feasible and 
safe treatment for paroxysmal AF. 
NAME OF 
INVESTIGATIONAL 
DEVICE: 
FARAPULSE Cardiac Ablation System 
• iowaPulse Cardiac Ablation Catheter System 
• iowaStar Generator System 
DESIGN: 
Prospective, single-arm, multi-center feasibility trial. 
STUDY 
POPULATION 
Subjects will be consented to undergo surgical PEF 
ablation using the FARAPULSE Cardiac Ablation 
System concomitant to heart surgery. 
PLANNED 
ENROLLMENT: 
Up to 25 subjects 
CLINICAL SITES: 
Up to 3 clinical sites in Europe 
DURATION OF 
PARTICIPATION: 
Subjects will be followed at 30 days, 3 months, 6 months 
and 12 months following the index surgical procedure with 
a blanking period for recurrent atrial fibrillation or atrial 
tachycardia of 3 months following the index surgical 
procedure. 
The enrollment period is estimated to take 6 months and 
subjects will be followed for up to 12 months for a total 
duration of approximately 18 months. 

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PRIMARY SAFETY 
ENDPOINT: 
A composite safety endpoint consisting of the proportion 
of subjects that experience one or more of the following 
serious adverse events (SAEs) related to the 
investigational procedure and/or device within 30 days of 
the PEF ablation procedure or hospital discharge, 
whichever is later, except as noted below: 
• Cardiac death 
• Stroke and/or transient ischemic attack (TIA) 
• Myocardial infarction (MI) 
• Excessive bleeding 
• Atrio-esophageal fistula 
• Persistent post-surgical phrenic nerve paralysis at 12 
months 
• Severe pulmonary vein stenosis (>70%) 
SECONDARY 
SAFETY ENDPOINT: 
The proportion of subjects reporting one or more SAEs for 
each follow-up interval. The intervals will include the 
period from: 
• the surgical procedure for the surgical ablation 
through the Day 30 follow-up visit; 
• the Day 30 follow-up visit through the Month 3 follow- 
up visit; 
• the Month 3 follow-up visit through the Month 6 
follow-up visit; and 
• the Month 6 follow-up visit through the Month 12 
follow-up visit. 
PRIMARY 
FEASIBILITY 
ENDPOINT: 
Proportion of subjects that achieve procedural success. 
Procedural success is defined as the creation of an 
electrically isolating “box” lesion encompassing the 
pulmonary veins and posterior left atrium using the study 
device. Specifically, the ability of the device to create a 
contiguous line of electrical block in the specified region of 
the left atrium. 

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SECONDARY 
FEASIBILITY 
ENDPOINTS: 
The secondary feasibility endpoint(s) include: 
• Proportion of subjects that achieve long-term 
technical success. Long-term technical success is 
defined as electrical isolation of the pulmonary veins 
and posterior left atrium assessed at a follow-up 
electro-anatomical remapping procedure performed 
3-months post index procedure. 
ADDITIONAL 
OBSERVATIONS: 
Proportion of subjects that achieve therapeutic success. 
Therapeutic success is defined as freedom from AF, AFL 
(atrial flutter) and AT (atrial tachycardia, not including 
sinus tachycardia) following the blanking interval through 
Month 12. 

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INCLUSION 
CRITERIA 
All subjects are required to meet all the following inclusion 
criteria to be considered eligible for participation in this 
trial: 
1. Patients who are ≥ 18 and ≤ 70 years of age on the 
day of enrollment. 
2. Diagnosis of paroxysmal atrial fibrillation defined as 
symptomatic paroxysmal AF with at least two episodes 
of paroxysmal AF observed within the 12 months 
preceding inclusion. 
3. Patients are resistant to anti-arrhythmic treatments. 
4. Anteroposterior Left atrial diameter ≤ 5.5 cm as 
documented by transthoracic echocardiography (TTE) 
or computed tomography (CT) within 3 months prior to 
the procedure. 
5. Subject has no contraindications to intraoperative 
transesophageal echocardiography; 
6. Subject is scheduled to undergo elective on-pump 
cardiac surgical procedure(s) to be performed 
including open-heart surgery for one or more of the 
following: 
• Mitral valve repair or replacement, 
• Aortic valve repair or replacement 
• Tricuspid valve repair or replacement, or 
• Coronary artery bypass procedures 
7. Left ventricular ejection fraction ≥40% as documented 
by TTE within 12 months prior to the procedure. 
8. Received a standard cardiac work up and is an 
appropriate candidate for an investigational procedure 
as determined by trial investigators. 
9. Subject is willing and capable of providing Informed 
Consent to undergo study procedures and participate 
in all examinations and follow-ups associated with this 
clinical trial. 

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EXCLUSION 
CRITERIA 
Subjects will be excluded from participating in this trial if 
they meet any of the following exclusion criteria: 
1. Abnormal cardiac and/or epicardial anatomy (such as 
adhesion, anomalous coronaries, thickened 
epicardium, etc.) or pericardial reflections on TTE, MRI 
or CT. 
2. Prior left-sided cardiac ablation. 
3. Prior history of open chest surgery and/or any 
procedure where the pericardial space was entered or 
instrumented (pericardiocentesis, catheter mapping 
and /or ablation). 
4. Patient has a prosthetic heart valve. 
5. Patient has a left atrial appendage device 
6. Prior history of pericarditis or pericarditis within 3 
months based on the TTE examination. 
7. Subject is a woman of child bearing age 
8. Prior history of rheumatic fever. 
9. Prior history of medical procedure involving 
instrumentation of the left atrium (previous ablation, 
Atrial septal defect) ASD closure, left atrial appendage 
occlusion) 
10. History of severe chronic gastrointenstinal problems 
involving the esophagus, stomach and/or untreated 
acid reflux 
11. History of abnormal bleeding and/or clotting disorder. 
12. Active malignancy or history of treated cancer within 
24 months of enrollment. 
13. Clinically significant infection or sepsis. 
14. History of stroke or TIA within prior 6 months 
15. New York heart Association (NYHA) class IIIb or IV 
congestive heart failure and/or any heart failure 
hospitalization within 3 months prior to enrollment. 
16. Body mass index > 35. 
17. Estimate glomerular filtration rate (eGFR) < 60 
mL/min/1.73 m2 or has ever received dialysis. 
18. History of untreated and serious hypotension, 
bradycardia or chronotropic incompetence. 
19. Any of the following within 3 months of enrollment: 
- 
Major surgery except for the index procedure 
- 
Myocardial infarction 
- 
Unstable angina 
- 
Percutaneous coronary intervention (e.g., CABG or 
PTCA) 
- 
Sudden cardiac death event 

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- 
Left atrial thrombus that has not resolved as shown 
by TEE or CT 
- 
Implant of pacemaker, ICD or CRT. 
20. Solid organ or hematologic transplant, or currently 
being evaluated for an organ transplant 
21. History of pulmonary hypertension with Pulmonary 
systolic artery pressure >50 mm Hg, severe Chronic 
Obstructive Pulmonary Disease or restrictive lung 
disease. 
22. Patients with any other significant uncontrolled or 
unstable medical condition (such as uncontrolled 
brady-arrhythmias, ventricular arrhythmias, 
hyperthyroidism or significant coagulation disorder). 
23. Life expectancy less than one year. 
24. Clinically significant psychological condition that in the 
physician's opinion would prohibit the subject's ability 
to meet the protocol requirements. 
25. Enrolled in another cardiac clinical trial that would 
interfere with this trial. 
26. Life expectancy less than one year. 
27. Clinically significant psychological condition that in the 
physician's opinion would prohibit the subject's ability 
to meet the protocol requirements. 
28. Enrolled in another cardiac clinical trial that would 
interfere with this trial. 

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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.i,ii. The incidence increases with advancing age, 
affecting 6% of the population over age 60 and 10% of the population over 
age 80iii,iv. Age-adjusted population trending projects 16 million people in the 
United States will have AF by 2050v. 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.vi 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).vii 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.viii 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).ix 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.x,xi,xii 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.xiii 

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Although it is still the consensus recommendation that catheter ablation 
should not be considered a first line therapy for atrial fibrillationxiii, there is 
evidence that maintenance of sinus rhythm has important effects on mortality. 
In the Atrial 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.xiv 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%,xv 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.xvi,xvii,xviii,xix Retreatment rates 
as high as 40% have been reported.xx 
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 electro- 
anatomical 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.xxi 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 Ablation: 
The Maze Procedure involves open heart surgery on cardiopulmonary 
bypass. Areas of cardiac tissue are isolated, either by cut and sew methods 
or electrosurgically, creating a “maze” which prevents propagation of ectopic 
AF impulsesxxii, xxiii 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.xxiv 
• 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. 
3.3 Irreversible Electroporation (IRE): 
Al-Sakere 2007xxv 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.xxvi xxvii 
xxviii xxix IRE ablation typically spares the extracellular matrix, which facilitates 
rapid wound healing.xxx xxxi xxxii xxxiii xxxiv 
Thomson 2011xxxv 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 2011xxxvi (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 2014xxxvii (N=6) confirmed this 
result out to 3-month follow up. Neven 2014xxxviii (N=5) showed that 
electroporation lesion depth depended on the level of electrical energy 
applied, reaching 8 mm at 300 joules. 

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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 Complications of Catheter Based and Surgical Epicardial 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 patientsxxxix) are common. 
Gelsomino 2014xl 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 epicardial ablation procedures in 
the reviewed studies. Expected adverse event rates from an isolated 
epicardial procedure are likely to be lower. 
Table 1: Data from Gelsomino 2014 – Adverse Event Rates for 
Epicardial 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, risks related to the FARAPULSE Cardiac Ablation System are 
expected to be no different from those of the products approved and available 
on the market for concomitant open-heart surgery, ablation procedures. 
FARAPULSE will be conducting bench and in-vivo testing to ensure safe use 
of the device during clinical investigation and ultimately compliance with 
Directive 93/42/EEC. FARAPULSE will also ensure, through its Risk 
Management System, that the residual and controllable risks have been 
minimized or eliminated. 

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4. Investigational Device 
4.1 Name of Investigational Device 
FARAPULSE Cardiac Ablation System. 
4.2 Intended Use 
The FARAPULSE Cardiac Ablation System is indicated for cardiac tissue 
ablation for the treatment of atrial fibrillation. 
 
4.3 Classification 
The FARAPULSE Cardiac Ablation System is comprised of the iowaPulse Cardiac 
Ablation Catheter System and the iowaStar Generator System. 
The iowaPulse Cardiac Ablation Catheter System is classified as a Class III 
medical device. Per MEDDEV 2.4/1 Rev. 9 June 2010, 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 iowaStar Generator System is classified as a Class IIb medical device. Per 
MEDDEV 2.4/1 Rev. 9 June 2010, Rule 9 applies to the generator system, which 
defines it as an active therapeutic device that is intended to administer or 
exchange energy to and from the human body in a potentially hazardous way, 
taking account of the nature, the density and the site of application of the energy. 
 
4.4 System Components: FARAPULSE Cardiac Ablation System 
The FARAPULSE Cardiac Ablation System used for this clinical investigation 
consists of the iowaPulse Cardiac Ablation Catheter System and iowaStar 
Generator System. Model numbers of the components used in this study are in 
Table 2: Components and Model Numbers of FARAPULSE Cardiac Ablation 
System. 
Table 2: Components and Model Numbers of the 
FARAPULSE Cardiac Ablation System 
Components & Sub Components 
Model 
Number 
(REF#) 
iowaPulse Cardiac Ablation Catheter System 
1. Ablation Catheter 
2. Cinch Tool 
50T41 
iowaStar Generator System 
1. Pulsed Electric Field Generator (PEFG) 
2. BNC Coaxial Cable 
70T41 

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Figure 1: FARAPULSE Cardiac Ablation System and compatible 
device connections. The blue dotted box shows the sterile, single- 
use components of the system. 
 
4.4.1 iowaPulse Ablation Catheter System 
The iowaPulse Cardiac Ablation Catheter System consists of two (2) 
components: Ablation Catheter and Cinch Tool, which are used together. 
Both components are sterile and single use only (See Figure 2). 
The Ablation Catheter is a multi-electrode catheter that connects electrically 
to the iowaStar Generator System. It has a total of 12 electrodes and each 
electrode of the ablation catheter consists of a triplet of electrode rings. The 
Catheter consists of a distal end, a midsection with electrodes and a proximal 
end feeding into the handle. The handle consists of a flush port and an 
extension cable with 12 color coded connectors. These (connectors 1 – 4 are 
yellow, connectors 5 – 8 are blue and connectors 9 – 12 are red) connect to 
the multi-channel iowaStar Generator System with the same color coding 
respectively. Pulsed Electric Field energy is delivered over a set of ablation 
catheter electrodes selected on a user interface. 
The Cinch Tool comprises two parallel hollow tubes with an atraumatic distal 
tip. 

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A. Catheter Midsection (looped) – Ablation Catheter 
B. Cinch Tool 
C. Distal End – Ablation Catheter 
D. Proximal End – Ablation Catheter 
E. Handle with flush port 
F. Extension Cable 
G. 12 Connectors 
H. Electrode Triplets 
Figure 2: iowaPulse Cardiac Ablation Catheter System 
 
4.4.2 iowaStar Generator System 
The iowaStar Generator System is part of the FARAPULSE Cardiac Ablation 
System. It consists of two components – Pulsed Electric Field Generator 
(PEFG) and BNC Coaxial cable. The iowaStar Generator System is designed 
to deliver pulsed electric field energy to epicardial sites in the heart via the 
iowaPulse Cardiac Ablation Catheter System and other compatible devices 
(refer to IFU LBL0126 for the specific use and procedural steps of the 
iowaPulse Cardiac Ablation Catheter System and LBL0127 for other 
compatible devices). The iowaStar Generator System is indicated for use in 
conjunction with the iowaPulse Cardiac Ablation Catheter System. 
The Pulsed Electric Field Generator is a 16-channel output unit that 
generates a pulsed voltage waveform that can be delivered over a set of user 
C 
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G 
F 
B 
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selected ablation catheter electrodes. Determination of the active electrodes 
is defined by the physician at the time of treatment to optimize electrical 
contact with the treatment area. As an input, a compatible cardiac stimulator 
unit for cardiac pacing is applied to the surgical site via pacing leads and to 
the PEFG with a coaxial cable to synchronize the application of therapeutic 
energy to the actively paced heart. The PEFG interfaces with the physician to 
acknowledge proper synchronization. The BNC Coaxial Cable is one of the 
components, and it is used to connect the generator to a commercially 
available compatible cardiac stimulator/pacing device. 
4.5 Device Accountability 
The FARAPULSE Cardiac 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 facility through use and/ or return or disposal. 
The site will be responsible for keeping a Device Accountability Log provided 
by the Sponsor or its designated representative in which will be recorded, at a 
minimum, date of receipt, FARAPULSE Cardiac Ablation System 
identification number, expiration date, date of use, subject unique identity 
code and date of disposal of the device. 
If there is a product malfunction or other need to return the system or system 
components to the Sponsor, the Sponsor should be contacted for safe 
product disposal and/ or return details. 
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 in the Case Report 
Forms (CRFs) the lot numbers of the devices used during each case. 
4.6 Return of Devices 
All unused investigational devices will be returned to the study Sponsor upon 
completion of the clinical study. All used investigational devices will be 
returned to the study Sponsor for analysis. Any investigational device that 
fails to perform correctly will be equally returned to the study Sponsor for 
analysis. The Investigator or his/ her designated representative is responsible 
for device accountability and disposition of all used and unused devices. The 
study Sponsor or its designated representative will conduct device 
reconciliation at the completion of subject enrollment or at the conclusion of 
the study. 

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5. Trial Objectives 
The objective of this feasibility and safety trial is to demonstrate that the 
creation of electrically isolating lesions generated by pulsed electric field 
ablation using the FARAPULSE Cardiac Ablation System during 
concomitant heart surgery is feasible and a safe treatment for paroxysmal 
atrial fibrillation. 
5.1 Study design 
The IMPACT Study is a prospective, observational, multi-center, intention-to- 
treat study using the FARAPULSE Cardiac Ablation System in subjects with 
paroxysmal atrial fibrillation who consented to undergo surgical PEF ablation 
concomitant to heart surgery. 
5.2 Selection and Withdrawal of Subjects 
5.2.1 Inclusion Criteria 
All subjects are required to meet all of the following inclusion criteria in order 
to be considered eligible for participation in this trial: 
 
1. Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment. 
2. Diagnosis of paroxysmal atrial fibrillation defined as symptomatic 
paroxysmal AF with at least two episodes of paroxysmal AF observed 
within the 12 months preceding inclusion. 
3. Patients are resistant to anti-arrhythmic treatments. 
4. Anteroposterior Left atrial diameter ≤ 5.5 cm as documented by 
transthoracic echocardiography (TTE) or computed tomography (CT) 
within 3 months prior to the procedure. 
5. Subject has no contraindications to intraoperative transesophageal 
echocardiography; 
6. Subject is scheduled to undergo elective on-pump cardiac surgical 
procedure(s) to be performed including open-heart surgery for one or 
more of the following: 
• Mitral valve repair or replacement, 
• Aortic valve repair or replacement 
• Tricuspid valve repair or replacement, or 
• Coronary artery bypass procedures 
7. Left ventricular ejection fraction ≥40% as documented by TTE within 
12 months prior to the procedure. 
8. Received a standard cardiac work up and is an appropriate candidate 
for an investigational procedure as determined by trial investigators. 

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9. Subject is willing and capable of providing Informed Consent to 
undergo study procedures and participate in all examinations and 
follow-ups associated with this clinical trial. 
5.2.2 Exclusion Criteria 
Subjects will be excluded from participating in this trial if they meet any of the 
following exclusion criteria: 
1. Abnormal cardiac and/or epicardial anatomy (such as adhesion, 
anomalous coronaries, thickened epicardium, etc.) or pericardial 
reflections on TTE, MRI or CT. 
2. Prior left-sided cardiac ablation. 
3. Prior history of open chest surgery and/or any procedure where the 
pericardial space was entered or instrumented (pericardiocentesis, 
catheter mapping and /or ablation). 
4. Patient has a prosthetic heart valve. 
5. Patient has a left atrial appendage device 
6. Prior history of pericarditis or pericarditis within 3 months based on the 
TTE examination. 
7. Subject is a woman of child bearing age 
8. Prior history of rheumatic fever. 
9. Prior history of medical procedure involving instrumentation of the left 
atrium (previous ablation, Atrial septal defect) ASD closure, left atrial 
appendage occlusion) 
10. History of severe chronic gastrointenstinal problems involving the 
esophagus, stomach and/or untreated acid reflux 
11. History of abnormal bleeding and/or clotting disorder. 
12. Active malignancy or history of treated cancer within 24 months of 
enrollment. 
13. Clinically significant infection or sepsis. 
14. History of stroke or TIA within prior 6 months 
15. New York heart Association (NYHA) class IIIb or IV congestive heart 
failure and/or any heart failure hospitalization within 3 months prior to 
enrollment. 
16. Body mass index > 35. 
17. Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has 
ever received dialysis. 
18. History of untreated and serious hypotension, bradycardia or 
chronotropic incompetence. 
19. Any of the following within 3 months of enrollment 
- 
Major surgery except for the index procedure 
- 
Myocardial infarction 
- 
Unstable angina 
- 
Percutaneous coronary intervention (e.g., CABG or PTCA) 
- 
Sudden cardiac death event 

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- 
Left atrial thrombus that has not resolved as shown by TEE or 
CT 
- 
Implant of pacemaker, ICD or CRT. 
 
20. Solid organ or hematologic transplant, or currently being evaluated for 
an organ transplant 
21. History of pulmonary hypertension with Pulmonary systolic artery 
pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease 
or restrictive lung disease. 
22. Patients with any other significant uncontrolled or unstable medical 
condition (such as uncontrolled brady-arrhythmias, ventricular 
arrhythmias, hyperthyroidism or significant coagulation disorder). 
23. Life expectancy less than one year. 
24. Clinically significant psychological condition that in the physician's 
opinion would prohibit the subject's ability to meet the protocol 
requirements. 
25. Enrolled in another cardiac clinical trial that would interfere with this 
trial. 
26. Life expectancy less than one year. 
27. Clinically significant psychological condition that in the physician's 
opinion would prohibit the subject's ability to meet the protocol 
requirements. 
28. Enrolled in another cardiac clinical trial that would interfere with this 
trial. 
5.3 Trial Design 
5.3.1 Description of Trial Design 
Prospective, single-arm, multi-center feasibility trial. Subjects will be 
consented to undergo surgical PEF ablation using the FARAPULSE Cardiac 
Ablation System concomitant to heart surgery. Subjects will be followed at 30 
days, 3 months, 6 months and 12 months following the index surgical 
procedure with a blanking period for recurrent atrial fibrillation or atrial 
tachycardia of 3 months following the index surgical procedure. 
5.4 Trial Endpoints 
5.4.1 Primary Safety Endpoint 
A composite safety endpoint consisting of the proportion of subjects that 
experience one or more of the following serious adverse events (SAEs) 
related to the investigational procedure and/or device within 30 days of the 
PEF ablation procedure or hospital discharge, whichever is later, except as 
noted below: 
• Cardiac death 
• Stroke and/or transient ischemic attack (TIA) 

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• Myocardial infarction (MI) 
• Excessive bleeding 
• Atrio-esophageal fistula 
• Persistent post-surgical phrenic nerve paralysis at 12 months 
• Severe pulmonary vein stenosis (>70%) 
 
Table 3 summarized the primary safety endpoint definitions. 
 
Table 3: Primary Safety Endpoint Definitions 
Potential Serious 
Adverse Event 
Definition 
Cardiac Death 
Excludes all non-cardiac deaths. 
Stroke 
A new focal neurological deficit of presumed vascular 
origin persisting more than 24 hours and with a neuro- 
imaging study that does not indicate a different 
etiology. All patients suspected of having a stroke will 
be evaluated by a neurologist and have appropriate 
imaging tests performed (CT or MRI) as determined by 
a neurologist. 
• The 24-hour criterion is excluded if the subject 
undergoes cerebrovascular surgery or dies during 
the first 24 hours. 
• This stroke definition includes subjects presenting 
with clinical signs and symptoms suggestive of 
subarachnoid hemorrhage, intracerebral 
hemorrhage, or cerebral infarction. 
• Stroke events in cases of blood disorders such as 
leukemia, and strokes secondary to trauma are 
excluded. 
Transient Ischemic 
Attack (TIA) 
A focal ischemic neurological deficit of abrupt onset 
and of presumed vascular etiology that resolves 
completely within 24 hours of onset. All patients 
suspected of having a TIA will be evaluated by a 
neurologist and have appropriate imaging tests 
performed (CT or MRI) as determined by a neurologist. 

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Potential Serious 
Adverse Event 
Definition 
Myocardial 
Infarction* (MI) 
The presence of any one of the following criteria: 
1) detection of ECG changes indicative of new 
ischemia (new ST-T changes or new LBBB), which 
persist for more than one 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. 
Excessive Bleeding* 
Bleeding requiring re-operation or 2 units of PRBC 
transfusion within any 24 hours of the first 7 days 
following the index procedure. 
Atrioesophageal 
Fistula 
An atrial esophageal fistula is defined as a connection 
between the atrium and the lumen of the esophagus. 
Evidence supporting this diagnosis includes 
documentation of esophageal erosion combined with 
evidence of a fistulous connection to the atrium such 
as air emboli, an embolic event, or direct observation 
at the time of surgical repair. A CT scan or MRI scan 
are the most common methods of documentation of an 
atrial esophageal fistula. 
Phrenic Nerve 
Paralysis* 
Absent phrenic nerve function as assessed by a sniff 
test. A phrenic nerve paralysis is defined as permanent 
if it persists for 12 months or longer following ablation. 
Pulmonary Vein 
Stenosis* 
A reduction of the diameter of a PV or first generation 
PV branch. PV stenosis can be categorized as mild 
<50%, moderate 50%-70%, and severe ≥70% based 
on the percentage reduction in the diameter of the PV 
or PV branch. A severe PV stenosis should be 
considered a major complication of AF ablation. 
* 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. 
 
5.4.2 Secondary Safety Endpoint 
The proportion of subjects reporting one or more SAEs for each follow-up 
interval. The intervals will include the period from: 
• The surgical procedure for the surgical PEF ablation through the Day 
30 follow-up visit; 
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• The Month 3 follow-up visit through the Month 6 
follow-up visit; and 
• The Month 6 follow-up visit through the Month 12 
follow-up visit. 
5.4.3 Primary Feasibility Endpoint 
Proportion of subjects that achieve procedural success. Procedural success 
is defined as the creation of an electrically isolating “box” lesion 
encompassing the pulmonary veins and posterior left atrium using the study 
device. Specifically, the ability of the device to create a contiguous line of 
electrical block in the specified region of the left atrium. 
5.4.4 Secondary Feasibility Endpoints 
The secondary feasibility endpoint(s) include: 
• Proportion of subjects that achieve long-term technical success. Long- 
term technical success is defined as electrical isolation of the 
pulmonary veins and posterior left atrium assessed at a follow-up 
electro-anatomical remapping procedure performed 3-months post 
index procedure. 
5.4.5 Additional Observations 
Proportion of subjects that achieve therapeutic success. Therapeutic success 
is defined as freedom from AF, AFL (atrial flutter) and AT (atrial tachycardia, 
not including sinus tachycardia) following the blanking interval through Month 
12. Proportion of subjects that achieve therapeutic success. Therapeutic 
success is defined as freedom from AF, AFL (atrial flutter) and AT (atrial 
tachycardia, not including sinus tachycardia) following the blanking interval 
through Month 12. For subjects to be considered a therapeutic success, they 
will have to be free of a confirmed AF, AFL or AT episode lasting 30 seconds 
or more after completion of the blanking interval. If a qualifying episode of AF, 
AFL or AT is found during the 24-hour continuous ECG monitor at Months 6 
or 12, during any scheduled or unscheduled 12-lead ECG, or during the use 
of an event monitor after the blanking interval, the subject will be considered a 
therapeutic failure. In addition, subjects will be considered a therapeutic 
failure if they have a repeat ablation procedure at any time through Month 12 
or if they received DC cardioversion or Vaughan-Williams Class I or III 
antiarrhythmic drug therapy for the treatment or prevention of AF, AFL or AT 
after the end of the blanking interval through Month 12. However, subjects will 
not be considered therapeutic failures if they received DC cardioversion or 
Vaughan-Williams Class I or III antiarrhythmic drug therapy for treatment of 
non-AF arrhythmias during the blanking period. Finally, any subject death 
after the blanking interval and prior to the Month 12 visit will be adjudicated by 
the CEC. In the absence of evidence regarding the presence or recurrence of 
AF following the blanking period, these subjects will be considered lost to 
follow-up. If, on the other hand, there has been evidence of the presence or 

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recurrence of AF following the blanking period, these subjects will be 
considered therapeutic failures. 
 
5.5 Sample Size 
Up to 25 subjects will be enrolled in this clinical trial. 
5.6 Investigational Sites 
The clinical trial will be conducted at up to 3 clinical sites in Europe. 
5.7 Duration of Subject Participation 
Subjects enrolled in the trial will participate for approximately 18 months. This 
includes the baseline evaluation, the procedure and follow-up evaluations at 1 
month, 3 months, 6 months, 9 months and 12 months post-procedure. 
5.8 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 trial has been fully approved by the respective institution’s 
EC and the Sponsor or their CRO representative has received and reviewed 
the specific 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. If the family of the subject is available, they 
should also be consulted. 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 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 each Investigator in a designated clinical study administrative 
file. The subject and the investigator must sign the consent form prior to 
enrollment. 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. 

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Written informed consent must be obtained prior to performing any protocol 
driven tests or any procedures that are not standard of care for a cardiac 
surgery that the subject is scheduled to undergo. 
Once written consent has been obtained, the subject will be entered on a 
Screening Log, which will be maintained at each site. All subjects who provide 
written informed consent will be entered on the screening log regardless of 
whether or not they are enrolled in the study. 
5.9 Enrollment 
Subjects that meet all 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. 
Each subject will be assigned a unique study identification code to protect 
each subject’s confidential health information. The unique study identity 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 each 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. 
5.10 Withdrawal of Subjects 
Subjects may voluntarily withdraw from the trial 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 
• any other reason determined by the investigator to be in the best 
interest of the subject. 
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 at all possible. 
5.11 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 trial. 
5.12 Subject Confidentiality 
All information concerning subjects or their participation in this trial will be 
considered confidential. Only authorized Sponsor and designated 
representative personnel and designated consultants and regulatory agencies 
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a unique, 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 anonymous identifier should be redacted 
from any x-ray and MRI images submitted from the participating site to the 
Sponsor or the Sponsor’s designated reviewers for analysis. 
5.13 Schedule of Events and Assessments 
Subjects will complete the following visits and assessments as indicated 
below and in Table 4. 
5.13.1 
Baseline 
The following baseline data will be collected: 
• Medical history 
• Medication history 
• Pregnancy test (if applicable) 
• 12-lead ECG 
• Cardiac CT or MRI 
• NYHA Classification 
• TEE or other imaging modality for exclusion of left atrial thrombus 
5.13.2 
Procedure 
For a detailed description of procedure workflow refer to LBL0026 and 
LBL0027. Procedural details will be captured in study CRF. The following 
procedural data will be collected: 
• Medications administered 
• Pre- and post-ablation electro-anatomical maps 
• Anticoagulation monitoring (e.g. ACT) 
• Adverse event(s) 
5.13.3 
Pre-Discharge 
Prior to hospital discharge the following data will be collected: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversion(s) since surgery; 
• For subjects on warfarin, assessment of INR therapeutic levels 
(maintain as clinically indicated); 
• For subjects on dabigatran, perform a PTT and, if required, a thrombin 
time (Section 4.7.2.7 Anticoagulation Regimen); 

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• Cardiac rhythm as determined by a 12-lead ECG on day of hospital 
discharge; 
• Heart failure status as assessed by NYHA classification on day of 
hospital discharge; and Adverse Events. 
5.13.4 
1 Month 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 30 Day 
Follow-Up visit: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversions since last visit; 
• For subjects on anticoagulants, assessment of INR/PTT therapeutic 
levels (maintain as clinically indicated); 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the 
visit; 
• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• Any hospital readmissions, including admission and discharge dates, 
since discharge from the original procedure; and 
5.13.5 
3 Month Follow-Up 
Subjects will return for an office visit at the end of the blanking period (90 
days ± 14 days post-ablation treatment). During the blanking period, any 
recurrence of AF will be documented; however, recurrences of AF, AFL or AT 
during this time will not be considered therapeutic treatment failures. Subjects 
are not permitted to undergo repeat ablation during the blanking period. If a 
repeat ablation procedure is performed during this time, the subjects will be 
considered a therapeutic treatment failure and exited from the study. 
At a minimum, the following data will be collected at the end of the blanking 
period follow-up visit: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversions since last visit; 
• Any additional ablation procedures performed; 
• For subjects on anticoagulants, assessment of INR/PTT therapeutic 
levels (maintain as clinically indicated); 

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• Cardiac rhythm as determined by a 12-lead ECG at the time of the 
visit; 
• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 
• If a subject is symptomatic for AF at the end of the blanking period, an 
event monitor will be provided to be used up to the 6-month follow-up 
visit to capture AF episodes. 
• Patients will undergo an electro-anatomical remapping procedure to 
assess electrical isolation of the posterior left atrium and 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 
transeptal puncture using conventional electrophysiology techniques. 
• Patients will undergo a cardiac CT or MRI scan at 3 months to assess 
the patency of the pulmonary veins. 
5.13.6 
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: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversions since last visit; 
• Any additional ablation procedures performed; 
• For subjects on anticoagulants, assessment of INR/PTT therapeutic 
levels (maintain as clinically indicated); 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the 
visit; 
• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• Cardiac rhythm as determined by a 24-hour continuous ECG monitor 
following the visit for subjects in NSR at the time of the visit; 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 

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5.13.6.1 
Continuous ECG Monitor 
• Each subject will be provided with a 24-hour continuous ECG monitor 
and will be instructed in its use. 
• The monitoring service will be available to provide any necessary 
assistance with the use of the device and to reinforce the need to 
adhere to the protocol for the full 24 hours. 
If a subject has symptomatic AF at the end of the 6-month follow-up visit, an 
event monitor will be provided to be used up to the 12-month follow-up visit to 
capture AF episodes. 
5.13.7 
12 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: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversions since last visit; 
• Any additional ablation procedures performed; 
• For subjects on anticoagulants, assessment of INR/PTT therapeutic 
levels (maintain as clinically indicated); 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the 
visit; 
• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• Cardiac rhythm as determined by a 24-hour continuous ECG monitor 
following the visit for subjects in NSR at the time of the visit; 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 
5.13.7.1 
Continuous ECG Monitor 
• Each subject will be provided with a 24-hour continuous ECG monitor 
and will be instructed in its use. 
• The monitoring service will be available to provide any necessary 
assistance with the use of the device and to reinforce the need to 
adhere to the protocol for the full 24 hours. 
• If a subject has symptomatic AF at the end of the 6-month follow-up 
visit, an event monitor will be provided to be used up to the 12-month 
follow-up visit to capture AF episodes. 

CONFIDENTIAL 
FARAPULSE, INC.  
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5.13.7.2 
Electro-anatomical mapping 
The pre-ablation mapping will be performed using either the Rhythmia System 
and Orion Catheter (Boston Scientific, Natick Massachusetts USA) or the 
CARTO System and Penta-Ray Catheter (Biosense Webster, Diamond Bar 
California USA). These systems and their accessory devices (mapping catheters 
and ECG patches) bear a CE mark. The mapping procedure will begin with 
femoral venous access and introduction of a CE marked transseptal sheath and 
needle (e.g., Agilis, St. Jude Medical, St. Paul Minnesota USA) to gain access to 
the left atrium. The mapping catheter will be introduced and used to collect 
baseline electrograms (EGMs) and demonstrate electrical communication of the 
pulmonary veins to the left atrium. An electro-anatomical map will be created and 
the diagnostic catheters will be withdrawn. This same process will be before and 
after ablation. 
 
5.14 Unscheduled Visit 
Any unscheduled follow-up visits that occur throughout the trial, 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: 
• Use, changes in or discontinuation of anticoagulation, rate control 
and/or antiarrhythmic medications; 
• Cardioversions since last visit; 
• Any additional ablation procedures performed; 
• For subjects on anticoagulants, assessment of INR/PTT therapeutic 
levels (maintain as clinically indicated); 
• Cardiac rhythm as determined by a 12-lead ECG at the time of the 
visit; 
• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 
5.15 Study Exit or Premature Withdrawal 
Once the subject has completed the final follow-up visit they can be exited 
from the trial provided that they do not have any conditions that require 
continued follow-up. 

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  PROTOCOL NO. CS0172-02, Revision D 
 
 
 
5.16 Summary of Trial Assessments 
Table 4: Summary of Trial Assessments 
 
 
 
 
* Whichever is later 
** As needed 
A Within 1 month 
+ e.g., Transesophageal Echocardiogram (TEE), Transthoracic Echocardiogram (TTE), etc. 
 
CONFIDENTIAL 
Assessment 
Baseline 
Procedure 
30 Days 
Post- 
Procedure/ 
Discharge* 
3 Month 
(End of 
Blanking 
Period) 
6 Month 
12 Month 
Unscheduled 
Visit Timeframe (days) 
30±7 
90±14 
180±30 
365±30 
- 
Medical History 
X 
Medication History (current) 
X 
Medications 
X 
X 
X 
X 
X 
X 
Pregnancy test (for females of 
childbearing potential) 
X 
X 
12-lead ECG 
X 
X 
X 
X 
X 
X 
24-Hour Continuous ECG Monitor 
(e.g., Holter) 
X 
X 
Cardiac CT or MRI 
X 
X 
3D Electro-anatomical Mapping 
X 
X 
Event Monitor 
X** 
X** 
Record DC Cardioversions Since Last 
Visit 
X 
X 
X 
X 
X 
NYHA Classification 
X 
X 
X 
X 
X 
X 
Fluoroscopic Examination of 
Diaphragm Motion 
X** 
Objective Imaging Modality+ 
XA+ 
Anticoagulation Monitoring 
X** 
X** 
X** 
X** 
X** 
X** 
Adverse Events 
X 
X 
X 
X 
X 
X 

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6. Risk Benefit Assessment 
The Sponsor has conducted an analysis of the benefits and risks of the 
FARAPULSE Cardiac Ablation System and procedure. A detailed Risk 
Assessment has been completed, and the conclusion of this review is that this 
research study is justified because the overall potential benefit to the 
population outweighs its attendant risks. 
6.1 Risks 
The risk profile associated with the FARAPULSE Cardiac Ablation System and 
the ablation procedure is expected to be minimal and consistent with other 
similar devices currently in clinical use during concomitant heart surgery. 
6.1.1 Potential Adverse Events 
The following anticipated events have been identified as possible 
complications of cardiac surgery and atrial fibrillation ablation procedures and 
these and others may be associated with the FARAPULSE Cardiac Ablation 
System: 
• Air embolism 
• Anemia 
• Arrhythmia, potentially requiring cardioversion 
• Arteriovenous fistulae 
• Arrhythmias, possibly requiring a pacemaker 
• Drug allergic reaction or side effects (e.g., from contrast, steroids, 
analgesics, anesthetics, anticoagulants, sedatives, etc.) 
• Back pain 
• Bed sores 
• Bleeding, hematoma, hemorrhage or aneurysm at vascular access sites 
• Coronary artery or vein injury 
• Cardiac tamponade 
• Cardiac arrest or cardiac failure 
• Catheter entrapment 
• Cardiogenic shock 
• Congestive Heart failure 
• Coupling across/crossing of unintended structures 
• Death 
• Esophageal injury 
• Hemorrhage 
• Hemodynamic compromise 
• Hemopericardium 
• Hemoperitoneum 
• Hemothorax 
• Hypotension 
• Increased defibrillation threshold 

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• 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 
• Pneumomediastinum 
• Pneumopericardium 
• Pneumoperitoneum 
• Pneumothorax 
• 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. 
• Phrenic nerve injury 
• Conduction system injury resulting in sinus arrest or heart block, either 
transient or permanent 
 
Concomitant medicinal and surgical treatments used during the procedure and 
follow-up phase of the clinical study include structural heart surgery for the 
index procedure, anticoagulation, and antiarrhythmic therapy. The 
FARAPULSE Cardiac Ablation System does not have any known interactions 
with these therapies. 
There is no plan within this protocol to combine an endovascular ablative 
procedure with epicardial ablation using the FARAPULSE Cardiac Ablation 
System. However, if ablation using the FARAPULSE Cardiac Ablation 
System were ineffective and atrial fibrillation recurred, further ablative therapy 
may be pursued by the patient’s physician outside the context of this study. 
When further ablation is done with electro-anatomical mapping, a further 
ablation procedure would not introduce any risks over and above those 
already inherent in a second ablation procedure whether done through the 
epicardium or the endocardium. The risks of any second ablative procedure 
are the same as the risks summarized above. 

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6.2 Benefits 
The FARAPULSE Cardiac Ablation System is a Pulsed Electric Field (PEF) 
ablation system that produces contiguous transmural cardiac lesions to treat 
atrial fibrillation using an ablation procedure that is similar to other 
commercially available ablation catheters. More specifically: 
• The device system is used during concomitant heart surgery 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 
tissue specific mechanism of ablation 
• The device uses the standard open heart surgery technique. 
• The device utilizes a standard irreversible electroporation generator to 
deliver energy in the form of ablation dose. 
A fundamental difference between the FARAPULSE Cardiac Ablation System 
and other commercially released ablation systems used during concomitant 
heart surgery is that the pulsed electric field or irreversible electroporation 
energy is delivered through epicardial electrodes embedded in the catheter 
that surrounds the pulmonary veins. 
As such, the potential risks are roughly equivalent to those associated with 
commercially released systems being used for cardiac ablation procedures 
during concomitant heart surgery. Currently, the complication rates for 
commercially available catheters are very 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 ultimately compliance with 
Directive 93/42/EEC. Some tests results are pending and will be released 
before this feasibility study. 
The epicardial ablation capabilities of the system provide several potential 
benefits compared to commercially released systems, including reduced 
procedure time, reduced fluoroscopy time, faster healing, better safety and 
improved long-term clinical outcomes. 
In-vivo research has demonstrated that the system performs as expected and 
supports the risk estimations used and verified effective risk mitigation. All 
potential risks have been evaluated and mitigation strategies have been 
implemented to reduce potential risks to acceptable levels. The Sponsor has 
determined that the potential benefits of the system outweigh the potential 
risks and that the device is therefore safe for human use in the context of a 
clinical investigation. 
There are no guaranteed benefits from participation in this study. It is also 
anticipated that once a physician learning curve is achieved, a reduced 
procedure and fluoroscopy time may be seen, since the energy delivery is 
done in 4 heart beats. Information gained from the conduct of this study may 
also be of benefit to other persons with the same medical condition. 

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7. Statistical Analysis and Endpoint Assessment 
7.1 General Statistical Considerations 
The primary objective of this study is to characterize the safety and feasibility 
of the FARAPULSE Cardiac Ablation System in subjects with paroxysmal 
atrial fibrillation undergoing cardiac surgery. 
The study 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 design additional clinical 
studies. 
All subjects will be followed on an intent-to-treat basis. The device 
performance will be assessed based on a per-protocol analysis of the primary 
safety and feasibility endpoints and secondary efficacy endpoints. An intent-to- 
treat analysis, along with other secondary analyses, will also be completed 
and reported. 
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 IMPACT Study is a first-in-man trial and as such a relatively small number 
of patients, up to 25, will be studied at up to three sites. The safety and 
feasibility of the device will be analyzed before embarking on larger fully 
powered clinical studies to analyze safety and efficacy of the FARAPULSE 
Cardiac Ablation System. 
7.3 Demographic, Safety, Feasibility and Efficacy 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% confidence intervals. 
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 Data Pooling 
Data will be pooled from all trial sites. The basis for pooling is the clinical basis 
described in Meinertxli based on three critical features: all sites used the same 
protocol, the Sponsor monitored the sites to assure protocol compliance, and 
the sites all used the same data gathering mechanism (CRFs and data entry 
methods). 

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7.6 Assessment of Feasibility 
7.6.1 Primary Feasibility Endpoint 
Proportion of subjects that achieve procedural success. Procedural success is 
defined as the creation of an electrically isolating “box” lesion encompassing 
the pulmonary veins and posterior left atrium using the study device. 
Specifically, the ability of the device to create a contiguous line of electrical 
block in the specified region of the left atrium. 
7.6.2 Secondary Feasibility Endpoint 
The secondary feasibility endpoint(s) include: 
• Proportion of subjects that achieve long-term technical success. Long- 
term technical success is defined as electrical isolation of the 
pulmonary veins and posterior left atrium assessed at a follow-up 
electro-anatomical remapping procedure performed 3-months post 
index procedure. 
7.7 Assessment of Safety 
7.7.1 Primary Safety Endpoint 
A composite safety endpoint consisting of the proportion of subjects that 
experience one or more of the following serious adverse events (SAEs) 
related to the investigational procedure and/or device within 30 days of the 
PEF ablation procedure or hospital discharge, whichever is later, except as 
noted below: 
• Cardiac death 
• Stroke and/or transient ischemic attack (TIA) 
• Myocardial infarction (MI) 
• Excessive bleeding or 
• Atrio-esophageal fistula 
• Persistent post-surgical phrenic nerve paralysis at 12 months 
• Severe pulmonary vein stenosis 
All adverse events (AEs) will be adjudicated for seriousness as well as device 
and procedure relatedness. 
7.7.2 Secondary Safety Endpoint 
The proportion of subjects reporting one or more SAEs for each follow-up 
interval. The intervals will include the period from: 
• the surgical procedure for the surgical PEF ablation through the Day 
30 follow-up visit; 
• the Day 30 follow-up visit through the Month 3 follow-up visit; 
• the Month 3 follow-up visit through the Month 6 follow-up visit; and 

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• the Month 6 follow-up visit through the Month 12 
follow-up visit. 
7.8 Final Clinical Report 
A final clinical report will be prepared at the conclusion of the trial. Copies of 
the final report will be provided to each investigator and to the respective 
IRBs/ECs. 
8. Adverse Events and Serious Adverse Events 
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, 
o 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): 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes adverse events resulting from insufficient or 

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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: 
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: 

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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; 
• 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; 

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• 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 trial. All AEs must be recorded in the patient chart 
and Case Report Form (CRF). A description of the event, including the start 
date, resolution date, action taken and the outcome should be provided along 
with the Investigator’s assessment of the relationship between the AE and the 
trial 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 upon request. 
The investigator should report to the Sponsor or its designee the following 
events, whether expected or not, in the corresponding sheet of the CRF, with 
the exception of AEs / SAEs detected before the patients has signed the 
patient consent form.   
• AE 
• SAE 
• Device Deficiencies that did not but might have led to a SAE if: 
o Suitable action has not been taken or 

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o Intervention had not been made or 
o If circumstances had been less fortunate 
o New findings/updated in relation to already reported events. 
If an AE / SAE is present at the beginning of study prior to the subject 
providing signed consent to participate in the study, only its worsening should 
be reported.  
The investigator shall notify the sponsor and the CRO immediately and not 
later than 24 hours after the investigator has become aware of a SAE or 
device deficiency that might have led to a SAE via the Adverse Event Form of 
the CRF.  
This reporting should be done by faxing completed CRF pages to the CRO: 
CRO: 
MedPass International SAS 
Fax: 
+33 (0)1 40 53 81 11 
 
Sponsor: 
FARAPULSE, Inc. 
Fax: 
+1 650 489 1153 
Email: 
kschneider@farapulse.com 
Contact: 
Mr. Christopher Schneider 
 
In the case of a SADE, when possible, the device involved in the failure or 
malfunction is to be returned to the Sponsor for analysis. 
 
8.3  Reporting to Ethics committee / Competent Authority  
Depending on the local requirements or following agreement between both 
parties, the sponsor, its designated representative 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 will be responsible for reporting to 
the National Competent Authority according to national requirements and in 
line with MEDDEV 2.7/3. 
9. Monitoring 
9.1 Trial Monitoring 
Clinical monitors, qualified by training and experience, will be responsible for 
monitoring and overseeing the conduct of the trial. 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 

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properly obtained for all enrolled trial 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 documents, all completed 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 trial, 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 trial. The accuracy of all collected data will be verified for: 
• Eligibility criteria 
• Baseline characteristics 
• Primary safety and feasibility endpoints 
• Adverse events 
• Secondary endpoints 
with source documents including, but not limited to, medical records, office/ 
clinic notes, procedure reports, laboratory results, physician and nursing 
progress notes. Verification and quality of data, monitoring of clinical study 
progress and Investigator compliance with the approved protocol will be 
conducted by the Sponsor or its designated representative. 
The Sponsor or its designated representative must be allowed to visit the 
clinical site and have direct access to all study records throughout the duration 
of the study. The monitor will review all source data and compare them to the 
data documented in the case report forms, in addition to performing a review 
of the Regulatory Binder, and conducting device accountability. The 
Investigator and/ or institution will provide direct access to source data/ 
documents for trial-related monitoring, audits, and regulatory review and 
inspection. 
It is important that the Investigator and relevant study personnel are available 
during the monitoring visits and that sufficient time is devoted to the 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 trial. 
If a deficiency is noted during the course of the trial the clinical monitor is 
required to discuss the situation with the site and the Sponsor (if required) to 
secure compliance. 
 
 

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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 this study, 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 CROs will ensure that the study is conducted according to the Clinical 
Investigational Plan and all applicable and governing regulations. All personnel 
to participate in the conduct of this clinical trial 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: 650-422-3633 
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 
 
10.1.3 
Clinical Sites 
A complete listing of all clinical sites will be maintained by the Sponsor and 
will be available upon request. 
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(s) shall avoid improper influence or inducement of the subject, 
monitor, the clinical investigator(s) or other parties participating in or 
contributing to the clinical investigation. 
10.2.1 
Trial Conduct 
The trial will be performed in accordance with the relevant parts of the 

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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 relevant 
national regulatory authority and the local Ethical 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 trial, the IRB or EC for the 
specific institution must review and approve the protocol and the Informed 
Consent Form to be used. A subject cannot be asked to sign the Informed 
Consent Form until the trial has been fully approved by the institution’s 
Ethics Committee. 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 and approvals for protocol 
and ICF revisions on amendments from each Ethics Committee. 
10.2.3 
Informed Consent 
Subjects cannot be asked to sign the Informed Consent document until the 
trial has been fully approved by the respective institution’s Ethics 
Committee and the Sponsor or their CRO representative. 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 trial, the Informed Consent Form must be completed. The 
consent form must be read and understood by the subject, the subject’s 
questions answered and the form signed by the subject before any study-
related procedures can be performed. All subjects are to receive copies of 
their signed 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 trial. A unique 
identification code will be assigned to each subject participating in this trial. 
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 and their CRO 
representative will make every reasonable effort to protect the 
confidentiality of all subjects participating in the trial. 
 
 

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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 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 trial. These inspections are for the purpose 
of verifying adherence to the protocol, 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 
should they be audited or inspected by any regulatory agencies. The Sponsor 
or the Sponsor’s designee will also inform the site if they are made aware of a 
pending audit or inspection by a regulatory agency. 
10.5 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 ablation for atrial 
fibrillation with the FARAPULSE Cardiac Ablation System making 
treatment without the FARAPULSE Cardiac 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 protocol 
• Persistent non-compliance with regulatory requirements 
If the study is discontinued or suspended prematurely, the Sponsor shall 
promptly inform all clinical investigator(s)/ investigational center(s) of the 
termination or suspension and the reason(s) for this. The national and local 
regulatory authorities shall also be informed promptly and provided with the 
reason(s) for the termination or suspension by the Sponsor or by the clinical 
investigator/ investigation center(s). 
10.6 Criteria for Suspending/ Terminating a Study Center 
Sponsor reserves the right to stop the screening of subjects at a study center 
at any time after the study initiation visit if no subjects have been enrolled or if 

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the center has multiple or severe protocol violations without justification or fails 
to follow remedial actions. 
Possible reasons for suspending/ terminating a 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. 
10.7 Sponsor Responsibilities 
Sponsor has the overall responsibility of the study and will: 
• Select qualified Principal Investigators, clinical investigators and study 
sites 
• Select qualified monitors 
• Provide the Investigational Plan and any subsequent amendments 
• Provide appropriate information and System training to Investigators 
and study site staff 
• Ensure that all deviations from the Investigational Plan are reviewed 
with the appropriate Investigator(s) and reported in the CRF and the 
final 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 
• During the course of the investigation, inform in writing all Investigators 
about adverse events and adverse device effects that have been 
reported to Sponsor (this information shall be sent to each Investigator 
based on perceived risk) 
• Promptly inform the Investigators 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 protocol initiation training to include review of the 
FARAPULSE Cardiac Ablation System instructions for use, the 
Investigational Plan, CRF completion guidelines, and guidelines for 
obtaining informed consent 
• Provide the FARAPULSE Cardiac Ablation System to participating 
study sites, in quantities to support study activities 

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• Coordinate ongoing communication with CRO(s), consultants and study 
sites 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. 
10.8 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 trial. 
Clinical monitors will conduct site initiation visits at each 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 investigational protocol, the 
Investigator’s Brochure, the patient informed consent form, the CRFs, the 
Instructions for Use and the institution and/ or investigator agreement. 
Clinical monitors will ensure that the site facilities are adequate for the conduct 
of this investigation and that resources, laboratories, equipment and personnel 
remain adequate throughout the investigation. 
The clinical monitors will conduct routine on-site monitoring visits and phone 
calls to evaluate compliance with the protocol, any specific recommendations 
made by the site’s Ethics Committee (EC) and the signed Institution and/or 
Investigator Agreement and to ensure that the protocol is being followed and 
that any protocol deviations are properly documented on respective form. 
Clinical monitoring will include a verification that Informed Consent Form was 
properly obtained for all enrolled trial participants, a review of clinical records 
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 and device 
malfunctions to ensure that all information has been reported to the sponsor, 
EC and regulatory authorities as required by this 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 electronically signed 
and dated by the investigator. 
The investigator will make available to the clinical monitor for review all 
Informed Consent documents, all completed 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. 

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If a deficiency is noted during an on-site visit or at any other time during the 
course of the trial, 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 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. 
10.9 Investigator Responsibilities 
At a minimum, the following documents will be provided by the investigational 
site to the Sponsor prior to study start (consent of the first subject): 
• Signed Clinical Trial Agreements 
• Signed Financial Disclosure Form 
• Signed Clinical Investigational Plan Signature Page 
• Relevant regulatory approvals 
• Investigator and Co-Investigator’s current Curriculum Vitae 
• Any other additional documents as required by the Sponsor 
The Investigator is responsible for ensuring that the investigation is conducted 
according to all signed agreements, the study protocol, governing regulations, 
data protection regulations, the 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 resources to conduct the investigation properly 
• Ensure that conducting the investigation will not give rise to a conflict of 
interest 
• 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 Protocol (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 

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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 
• 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 regulatory approval is obtained prior to the start 
of the investigation 
• Provide regulatory approvals to the Sponsor 
• Inform Sponsor about adverse events in a timely manner 
• Endeavor to ensure an adequate recruitment of subjects 
• Ensure that the subject has adequate information to give informed 
consent 
• Ensure that informed consent is obtained and documented 
• Ensure that clinical records are clearly marked to indicate that the subject 
is enrolled in this study 
• Provide subjects with well-defined procedures for any emergency 
situation 
and 
safeguard 
the 
subject’s 
interest. 
Under 
these 
circumstances, deviations from the CIP shall not require the prior 
approval of the Sponsor or the national and local regulatory authorities. 
Such deviations shall not be considered as a breach of agreement but 
shall be documented and reported to Sponsor 
• Ensure that information which becomes available as a result of the 
clinical investigation which may be of importance to the health of a 
subject and the continuation of the investigation shall be made known to 
the Sponsor and, if pertinent to the safety or well-being of the subject, 
and the private clinician 
• Inform the subject and/ or the subject’s physician about any premature 
termination or suspension of the investigation with a rationale for study 
termination 
• Have primary responsibility for the accuracy, legibility and security of all 
investigation data, documents and subject records both during and after 
the investigation 
• Sign each subject’s CRF, as applicable 
• Be responsible for the supervision and assignment of duties at his/ her 
clinical center. 
• Ensure that all investigational devices are kept in a secure location and 
that all Systems are accounted for (number of devices used, discarded 
and returned to Sponsor). 
10.10 Investigator Training 
All participating investigators will be trained in the use of the FARAPULSE 

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Cardiac Ablation System prior to participating in the trial. 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 site regulatory 
binder. 
Cardiothoracic surgeons and electrophysiologists participating in the 
FARAPULSE ablation procedure will undergo training in the use of the 
FARAPULSE Cardiac Ablation System, as well as the workflow of ablation 
procedure. This will involve presentations describing the device and 
procedure, as well as hands on table top training in the use of the device. 
These investigators will also have simulated animal training in a hybrid 
catheterization-surgical laboratory. This will consist of a live pig model that will 
undergo ablation using the investigational device and placement of the device 
via open sternotomy. All technical aspects of the protocol will be exercised in 
this animal training. Other staff involved in this research (e.g., clinical 
coordinators) will undergo training on study documentation (protocol, CRF, 
informed consent, etc.) and execution. All training will be documented and 
completed prior to initiation of this study. 
10.11 Site Training 
To ensure accurate, complete and reliable data, the Sponsor or its 
representatives will provide instructional material to the sites, as appropriate; 
instruct the investigators and study personnel on the protocol, the completion 
of the CRFs, and trial 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. 
10.12 Clinical Events Committee 
A Clinical Events Committee (CEC) will convene during the study to classify 
and adjudicate all procedure-related and serious adverse events reported in 
this clinical study. The CEC will consist of physicians who have no formal 
involvement or conflict of interest with the subjects, the investigators, the 
designated CRO, and will be appointed by the Sponsor. The CEC will consist 
of three members with appropriate medical training and expertise in the fields 
of electrophysiology and cardiothoracic surgery. The CEC will be provided 
with case summaries and relevant source documents in order to adjudicate 
the adverse events. In addition to adverse event classification and 
adjudication, the CEC will have the authority to pause or terminate this 
investigation based on safety if, in its opinion, continuation is not in the best 
interests of the study subjects. 
10.13 Data Management 
Standardized CRFs will be provided to all participating sites. Investigators are 
responsible for the accurate completion and timely submission of the data 
collected during the trial. All data from the trial will be entered from the CRFs 
into a central database. Incoming data will be frequently reviewed to identify 
inconsistent or missing data and any adverse events. Any data issues are to 
be promptly addressed with the investigator by the CRO. Quality assurance 

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procedures will be established to ensure that complete, accurate and timely 
data are submitted, that protocol requirements are followed and that 
complications, adverse events and adverse device effects are correctly 
reported and investigated, as appropriate. Investigators are to maintain all 
source documents as required by the protocol, 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. 
10.14 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 cardiac surgery 
with the FARAPULSE Cardiac Ablation System making treatment without 
the FARAPULSE Cardiac 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 protocol 
• Persistent non-compliance with regulatory requirements 
If the study is discontinued or suspended prematurely, the Sponsor shall 
promptly inform all clinical investigator(s)/ investigational center(s) of the 
termination or suspension and the reason(s) for this. The national and local 
regulatory authorities shall also be informed promptly and provided with the 
reason(s) for the termination or suspension by the Sponsor or by the clinical 
investigator/ investigation center(s). 
10.15 Criteria for Suspending/ Terminating a Study Center 
Sponsor reserves the right to stop the screening of subjects at a 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 a 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. 
 
 

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10.16 Final Report 
A Final Report will be prepared even if the study is prematurely terminated. 
The Final Report will be submitted to each participating Investigator, and 
regulatory agencies, as required. 
10.17 Deviations from the Investigational Plan 
The investigator must notify the Sponsor and the CRO of any deviation from 
the Investigational Plan and document the reason for the deviation. 
The investigator shall notify the Sponsor and the reviewing Ethics Committee 
of any deviation from the Investigational Plan 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. Except in such an emergency, prior approval by the Sponsor is 
required for changes in or deviations from a plan and, if these changes or 
deviations may affect the scientific soundness of the plan or the rights, safety, 
or welfare of human subjects, prior approval of the Ethics Committee and 
regulatory authorities (e.g., FDA in the U.S.) is also required. 
11. 
Regulatory considerations 
11.1 Maintaining Records 
The Sponsor will maintain copies of critical correspondence, clinical data, 
shipment of devices, serious adverse device effects and other records related 
to the clinical trial. 
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 subject medical records, hospital charts, clinic charts, 
investigator subject trial 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 trial and the subject number 
• The trial protocol number and the name of the Sponsor 
• The date that Informed Consent was obtained 
• Evidence that the subject meets the trial eligibility requirements (e.g., 
medical history, study procedures and/or evaluations) 
• The dates of all trial related subject visits 
• Evidence that required procedures and/or evaluations were completed 
• Use of any concurrent medications 

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• Documentation of specific device used 
• Occurrence and status of any adverse events (AEs) 
• The date the subject exited the trial and a notation as to whether the 
subject completed the trial 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 will be transcribed on to CRFs provided by the 
Sponsor. 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 trial. 
Trial exit forms will be completed for all enrolled subjects, regardless if they 
did or did not complete the trial (e.g., subject discontinuation, trial 
termination). The Sponsor and clinical sites will maintain all records 
pertaining to this study in accordance with local and national regulations. 
Prior to the destruction of study records the investigator or his 
representative should contact the Sponsor to ensure that they no longer 
need to be retained. In addition, Sponsor should 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 protocol changes without prior approval by 
Sponsor. All significant protocol 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 protocol; 
• Relationship of the likely subject risk to benefit relied upon to approve the 
protocol; 
• Scientific soundness of the investigational plan; 
• Rights, safety, or welfare of the human subjects involved in the 

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investigation. 
The Sponsor may make certain administrative changes to the protocol without 
prior approval of the relevant Ethics Committee and Competent Authority. The 
Sponsor will notify all investigative sites of such changes to ensure the study 
continues to be conducted consistently across all sites. 
11.4 Device Accountability 
The investigator will be responsible for maintaining a device accountability log 
that will track device usage for all subjects. Information tracked will include 
date of device usage, subject ID, lot number and the occurrence of any device 
malfunctions or failures. 
12. 
Publication Policy 
The existence of this clinical trial is confidential, and it should not be discussed 
with persons outside of the trial. Additionally, the information in this document 
and regarding this trial 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 trial 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 trial are the property of the Sponsor and 
should not be disclosed without the prior written permission of FARAPULSE, 
Inc. These data may be used by FARAPULSE, Inc. now and in the future for 
presentation or publication at FARAPULSE, Inc.’s discretion or for submission 
to governmental regulatory agencies. FARAPULSE, Inc. reserves the right of 
prior review of any publication or presentation of data from this trial. 

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