The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

 
 
 
FARAPULSE, INC. 
 
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PROTOCOL NO.  CS0188, REV D 
 
 
CONFIDENTIAL 
 
 
 
 
 
The IMPULSE Study: A Safety and Feasibility Study of the 
FARAPULSE Endocardial Ablation System to Treat Atrial 
Fibrillation 
 
 
 
 
 
PROTOCOL NUMBER: CS0188, REVISION D 
 
 
 
SPONSOR: 
FARAPULSE, INC. 
(FORMERLY IOWA APPROACH, INC.) 
3715 HAVEN AVE.  SUITE 110 
MENLO PARK, CA 94025 
USA 
 
 
 
 
 
ISSUE DATE: 11 MARCH 2019 
 
 
This document contains confidential and proprietary information and may not be copied or 
reproduced in whole or in part without the express written permission of FARAPULSE, INC., 
MENLO PARK, CA. 
 
 

 
 
 
FARAPULSE, INC. 
 
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Table of Contents 
1. 
PRIMARY STUDY CONTACTS ............................................................................... 5 
2. 
EXECUTIVE SUMMARY ........................................................................................ 6 
3. 
INTRODUCTION ................................................................................................. 13 
3.1 
BACKGROUND AND RATIONALE ............................................................ 13 
3.2 
SURGICAL AND CATHETER ABLATION ................................................... 15 
3.3 
IRREVERSIBLE ELECTROPORATION (IRE) ............................................. 16 
3.4 
COMPLICATIONS OF CATHETER BASED AND SURGICAL ABLATION ......... 17 
4. 
INVESTIGATIONAL DEVICE ................................................................................. 18 
4.1 
NAME OF INVESTIGATIONAL DEVICE ..................................................... 18 
4.2 
INTENDED USE .................................................................................... 18 
4.3 
CLASSIFICATION.................................................................................. 18 
4.4 
SYSTEM COMPONENTS: FARAPULSE ENDOCARDIAL ABLATION SYSTEM
 .......................................................................................................... 18 
4.4.1 ENDOCARDIAL ABLATION CATHETER SYSTEM ........................... 19 
4.4.2 ENDOCARDIAL GENERATOR SYSTEM ........................................ 21 
4.4.3 DEFLECTABLE SHEATH SYSTEM ............................................... 21 
4.5 
DEVICE ACCOUNTABILITY .................................................................... 22 
4.6 
RETURN OF DEVICES .......................................................................... 22 
5. 
STUDY OBJECTIVES ......................................................................................... 23 
5.1 
STUDY DESIGN .................................................................................... 23 
5.2 
SELECTION AND WITHDRAWAL OF SUBJECTS ....................................... 23 
5.2.1 INCLUSION CRITERIA ................................................................ 23 
5.2.2 EXCLUSION CRITERIA ............................................................... 24 
5.3 
STUDY DESIGN ................................................................................... 25 
5.3.1 DESCRIPTION OF STUDY DESIGN .............................................. 25 
5.4 
STUDY ENDPOINTS ............................................................................. 25 
5.4.1 PRIMARY SAFETY ENDPOINT .................................................... 25 
5.4.2 SECONDARY SAFETY ENDPOINT ............................................... 28 
5.4.3 PRIMARY FEASIBILITY ENDPOINT .............................................. 28 
5.4.4 SECONDARY FEASIBILITY ENDPOINTS ....................................... 28 
5.4.5 ADDITIONAL OBSERVATIONS..................................................... 29 
5.5 
SAMPLE SIZE ...................................................................................... 29 
5.6 
INVESTIGATIONAL SITES ...................................................................... 29 
5.7 
DURATION OF SUBJECT PARTICIPATION ............................................... 29 
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. .............................................................. 29 
5.8 
WRITTEN INFORMED CONSENT ............................................................ 29 
5.9 
ENROLLMENT ...................................................................................... 30 
5.10 
WITHDRAWAL OF SUBJECTS ................................................................ 31 
5.11 
LOST TO FOLLOW-UP .......................................................................... 31 
5.12 
SUBJECT CONFIDENTIALITY ................................................................. 31 
5.13 
SCHEDULE OF EVENTS AND ASSESSMENTS .......................................... 31 

 
 
 
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5.13.1 BASELINE ................................................................................ 32 
5.13.2 PROCEDURE ............................................................................ 32 
5.13.3 PRE-DISCHARGE / 7 DAY FOLLOW-UP ...................................... 32 
5.13.4 1 MONTH FOLLOW-UP ............................................................. 33 
5.13.5 3 MONTH FOLLOW-UP ............................................................. 33 
5.13.6 6 MONTH FOLLOW-UP .............................................................. 34 
5.13.7 12 MONTH FOLLOW-UP ........................................................... 35 
5.14 
UNSCHEDULED VISIT ........................................................................... 36 
5.15 
STUDY EXIT OR PREMATURE WITHDRAWAL.......................................... 36 
5.16 
SUMMARY OF STUDY ASSESSMENTS ................................................... 37 
6. 
RISK BENEFIT ASSESSMENT ............................................................................. 38 
6.1 
RISKS ................................................................................................. 38 
6.1.1 POTENTIAL ADVERSE EVENTS .................................................. 39 
6.2 
BENEFITS ........................................................................................... 40 
7. 
STATISTICAL ANALYSIS AND ENDPOINT ASSESSMENT ....................................... 41 
7.1 
GENERAL STATISTICAL CONSIDERATIONS ............................................ 41 
7.2 
SAMPLE SIZE JUSTIFICATION ............................................................... 41 
7.3 
DEMOGRAPHIC, SAFETY, FEASIBILITY AND EFFICACY DATA .................. 41 
7.4 
IMPUTATION FOR MISSING DATA .......................................................... 42 
7.5 
DATA POOLING ................................................................................... 42 
7.6 
ASSESSMENT OF FEASIBILITY .............................................................. 42 
7.6.1 PRIMARY FEASIBILITY ENDPOINT .............................................. 42 
7.6.2 SECONDARY FEASIBILITY ENDPOINT ......................................... 42 
7.7 
ASSESSMENT OF SAFETY .................................................................... 42 
7.7.1 PRIMARY SAFETY ENDPOINT .................................................... 42 
7.7.2 SECONDARY SAFETY ENDPOINT ............................................... 43 
7.8 
FINAL CLINICAL REPORT ..................................................................... 43 
8. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS .......................................... 43 
8.1 
GENERAL ............................................................................................ 43 
8.2 
ADVERSE EVENT REPORTING .............................................................. 47 
9. 
MONITORING .................................................................................................... 49 
9.1 
STUDY MONITORING ........................................................................... 49 
10. STUDY MANAGEMENT....................................................................................... 50 
10.1 
KEY CONTRIBUTORS ........................................................................... 50 
10.1.1 STUDY SPONSOR ..................................................................... 50 
10.1.2 AUTHORIZED CRO/REPRESENTATIVE ....................................... 50 
10.1.3 CLINICAL SITES ........................................................................ 51 
10.2 
ETHICAL CONSIDERATIONS .................................................................. 51 
10.2.1 STUDY CONDUCT ..................................................................... 51 
10.2.2 ETHICS REVIEW ....................................................................... 51 
10.2.3 INFORMED CONSENT ................................................................ 51 
10.2.4 COVERAGE OF EXPENSES ........................................................ 52 
10.2.5 CONFIDENTIALITY..................................................................... 52 
10.3 
INSURANCE ......................................................................................... 52 

 
 
 
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10.4 
AUDITS AND INSPECTIONS ................................................................... 52 
10.5 
SPONSOR RESPONSIBILITIES ............................................................... 52 
10.6 
MONITOR RESPONSIBILITIES................................................................ 53 
10.7 
INVESTIGATOR RESPONSIBILITIES ........................................................ 55 
10.8 
INVESTIGATOR TRAINING ..................................................................... 56 
10.9 
SITE TRAINING .................................................................................... 56 
10.10 CLINICAL EVENTS COMMITTEE............................................................. 57 
10.11 DATA MANAGEMENT ........................................................................... 57 
10.12 STUDY SUSPENSION OR EARLY TERMINATION ...................................... 57 
10.13 CRITERIA FOR SUSPENDING/ TERMINATING A STUDY CENTER .............. 58 
10.14 FINAL REPORT .................................................................................... 58 
10.15 DEVIATIONS FROM THE INVESTIGATIONAL PLAN .................................... 58 
11. REGULATORY CONSIDERATIONS ....................................................................... 59 
11.1 
MAINTAINING RECORDS ...................................................................... 59 
11.2 
DATA HANDLING AND RECORD KEEPING .............................................. 59 
11.2.1 SOURCE DOCUMENTS .............................................................. 59 
11.2.2 DATA COLLECTION ................................................................... 59 
11.3 
ETHICS COMMITTEE (EC) AND COMPETENT AUTHORITY (CA) APPROVAL
 .......................................................................................................... 60 
11.4 
DEVICE ACCOUNTABILITY .................................................................... 60 
12. PUBLICATION POLICY ....................................................................................... 60 
13. BIBLIOGRAPHY ................................................................................................. 62 
 
 
 

 
 
 
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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 REPRENTATIVE 
 
 
 
 
 
ECG CORE LAB 
MedPass Limited 
Windsor House 
Bretforton, 
Evesham, 
Worcs. 
WR11 7JJ – United Kingdom 
 
 
 
MDT – Medical Data Transfer, s.r.o. 
Zabrdovicka 2, 615 00 Brno 
Czech Republic 
Contact: Veronika Bolkova 
Tel: +420 725 069 195 
iowa@mdtekg.cz 
 
 
 
 
 

 
 
 
FARAPULSE, INC. 
 
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2. Executive Summary 
SPONSOR NAME: 
FARAPULSE, Inc. 
TITLE OF STUDY: 
 The IMPULSE Study: A Safety and Feasibility Study of the 
FARAPULSE Endocardial Ablation System to Treat Atrial 
Fibrillation 
PROTOCOL 
NUMBER:  
CS0188 
OBJECTIVE: 
The objective of the safety and feasibility study is to 
demonstrate that the endocardial creation of electrically 
isolating lesions via pulsed electric field (PEF) catheter 
ablation applied using the FARAPULSE Endocardial 
Ablation System is a feasible and safe treatment for 
paroxysmal atrial fibrillation (PAF). 
CLINICAL 
HYPOTHESIS: 
Endocardial creation of electrically isolating lesions in 
cardiac tissue via PEF catheter ablation using the 
FARAPULSE Endocardial Ablation System is a feasible 
and safe treatment for paroxysmal atrial fibrillation (AF). 
 
NAME OF 
INVESTIGATIONAL 
DEVICE: 
FARAPULSE Endocardial Ablation System  
• faraWave Endocardial Ablation Catheter System  
• faraStar Endocardial Generator System  
• faraDrive Deflectable Sheath System 
DESIGN: 
Prospective, single-arm, multi-center, safety and 
feasibility study.   
STUDY 
POPULATION 
Subjects will be consented to undergo PEF catheter 
ablation using the FARAPULSE Endocardial Ablation 
System.  Subjects with symptomatic PAF who have had 
at least one AF episode documented within one (1) year 
prior to enrollment and who have failed at least one 
antiarrhythmic drug (AAD [class I or III, or atrioventricular 
(AV) nodal blocking agents such as beta blockers and 
calcium channel blockers] as shown by recurrent 
symptomatic AF or intolerance to the AAD or AV nodal 
blocking agents). 

 
 
 
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PLANNED 
ENROLLMENT: 
Up to 50 subjects 
CLINICAL SITES: 
Up to 3 clinical sites in Europe 
DURATION OF 
PARTICIPATION: 
Subjects will be followed at 7 days, 30 days, 3 months, 6 
months and 12 months with a blanking period for recurrent 
atrial fibrillation or atrial tachycardia of 3 months following 
the PEF catheter ablation procedure. 
The enrollment period is estimated to take 6 months and 
subjects will be followed for up to 12 months.  The total 
study duration will be approximately 18 months. 

 
 
 
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PRIMARY SAFETY 
ENDPOINT: 
The primary safety endpoint for this study is the incidence 
of early-onset (within 7 days of the PEF ablation 
procedure) primary adverse events (AEs).   
 
• Death  
• Myocardial infarction (MI)  
• Pulmonary vein (PV) stenosis†  
• Diaphragmatic paralysis  
• Atrio-esophageal fistula†  
• Transient Ischemic Attack (TIA)  
• Stroke/Cerebrovascular accident (CVA) 
Thromboembolism  
• Pericarditis requiring intervention (major)  
• Cardiac Tamponade/Perforation  
• Pneumothorax  
• Vascular Access Complications  
• Pulmonary edema     
• Hospitalization (initial and prolonged)*  
• Heart block  
*Excludes hospitalization (initial & prolonged) solely due to 
arrhythmia 
(AF/Atrial 
Flutter/Atrial 
Tachycardia) 
recurrence 
or 
due 
to 
non-urgent 
cardioversion 
(pharmacological or electrical). 
†Pulmonary vein (PV) stenosis or atrio-esophageal fistula 
that occurs greater than one week (7 days) post-procedure 
shall be deemed a Primary AE. 
 

 
 
 
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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 PEF ablation procedure 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 percutaneous 
endocardial creation of an electrically isolating lesions 
around the ostia of the pulmonary veins (PVI) using the 
FARAPULSE Endocardial Ablation System.  Specifically, 
the ability of the device to create a contiguous line of 
electrically impervious tissue in the specified region inside 
the left atrium. 
 
 
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 
assessed during an electroanatomical mapping 
procedure performed 3-months following the 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 
study: 
 
1. 
Patients with PAF who have had at least one AF 
episode documented within one (1) year prior to 
enrollment.  Documentation may include ECG, 
transtelephonic monitor (TTM), Holter monitor 
(HM), or telemetry strip.   
2. 
Patients 
who 
have 
failed 
at 
least 
one 
antiarrhythmic drug (AAD; class I or III, or AV 
nodal blocking agents such as beta blockers and 
calcium channel blockers) as shown by recurrent 
symptomatic AF, or intolerance to the AAD or AV 
nodal blocking agents. 
3. 
Patients who are ≥ 18 and ≤ 70 years of age on 
the day of enrollment. 
4. 
Antero-posterior 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. 
Left 
ventricular ejection 
fraction 
≥40% 
as 
documented by TTE within 12 months prior to the 
procedure. 
7. 
Received a standard cardiac work up and is an 
appropriate candidate for an investigational 
procedure as determined by study investigators. 
8. 
Subject is willing and capable of providing 
Informed Consent to undergo study procedures 
and participate in all examinations and follow-up 
visits and tests associated with this clinical study. 
 
 

 
 
 
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EXCLUSION 
CRITERIA 
Subjects will be excluded from participating in this study if 
they meet any one of the following exclusion criteria: 
 
1. 
Patients on amiodarone at any time during the 
past 3 months prior to enrollment.   
2. 
AF secondary to electrolyte imbalance, thyroid 
disease, or reversible or non-cardiac cause.   
3. 
AF episodes lasting > 7 days. 
4. 
Previous ablation for AF.   
5. 
Patient has a prosthetic heart valve. 
6. 
Patient has a left atrial appendage device 
7. 
Prior history of pericarditis or pericarditis within 3 
months based on the TTE examination. 
8. 
Subject is a woman of child bearing age 
9. 
Prior history of rheumatic fever. 
10. Prior history of medical procedure involving 
instrumentation of the left atrium (previous 
ablation, Atrial septal defect ASD closure, left 
atrial appendage occlusion) 
11. History of severe chronic gastrointestinal 
problems involving the esophagus, stomach 
and/or untreated acid reflux 
12. History of abnormal bleeding and/or clotting 
disorder.   
13. Active malignancy or history of treated cancer 
within 24 months of enrollment.   
14. Clinically significant infection or sepsis.   
15. History of stroke or TIA within prior 6 months 
16. New York heart Association (NYHA) class IIIb or 
IV congestive heart failure and/or any heart 
failure hospitalization within 3 months prior to 
enrollment.   
17. Body mass index > 35. 
18. Estimate glomerular filtration rate (eGFR) < 60 
mL/min/1.73 m2 or has ever received dialysis. 
19. History of untreated and serious hypotension, 
bradycardia or chronotropic incompetence.   
20. Any of the following within 3 months of 
enrollment: 

 
 
 
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-Major surgery except for the index procedure 
-Myocardial infarction 
-Unstable angina 
-Percutaneous coronary intervention (e.g., 
CABG or PTCA) 
-Sudden cardiac death event 
-Left atrial thrombus that has not resolved as 
shown by TEE or CT 
-Implant of pacemaker, ICD or CRT. 
21. Solid organ or hematologic transplant, or 
currently being evaluated for an organ transplant 
22. History of pulmonary hypertension with 
Pulmonary systolic artery pressure >50 mm Hg, 
severe Chronic Obstructive Pulmonary Disease 
or restrictive lung disease. 
23. Patients with any other significant uncontrolled or 
unstable medical condition (such as uncontrolled 
brady-arrhythmias, ventricular arrhythmias, 
hyperthyroidism or significant coagulation 
disorder). 
24. Life expectancy less than one year. 
25. Clinically significant psychological condition that 
in the physician's opinion would prohibit the 
subject's ability to meet the protocol 
requirements. 
26. History of blood clotting or bleeding 
abnormalities. 
27. Contraindication to anticoagulation (i.e., heparin, 
dabigatran, Vitamin K Antagonists such as 
warfarin). 
28. Enrolled in another cardiac clinical study that 
would interfere with this study. 
 

 
 
 
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3. Introduction 
3.1 Background and Rationale 
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, 
affecting approximately 2.2 million people in the United States and 4.5 
million in the European Union.1, 2.  The incidence increases with advancing 
age, affecting 6% of the population over age 60 and 10% of the population 
over age 803, 4.  Age-adjusted population trending projects 16 million people 
in the United States will have AF by 20505.  Atrial fibrillation remains a 
significant cause of morbidity and mortality in industrialized societies.  The 
mortality rate for patients with atrial fibrillation is twice that of patients in 
whom normal sinus rhythm is maintained.  The annual risk of AF related 
stroke is 5% per year and one of every six strokes diagnosed occurs in the 
presence of AF.6 Therefore, patients with AF require long-term 
anticoagulation to prevent embolic events.  Failure to manage AF may also 
lead to anatomic and electrical remodeling of the left atrium, tachycardia-
induced cardiomyopathy, and reduced left ventricular function (heart failure).  
Last, AF remains an extremely costly public health burden, with annual per 
patient cost of care approaching €3000 (approximately U.S.  $3200).7 Atrial 
fibrillation is characterized by abnormalities in electrical impulse formation or 
conduction within the heart; these abnormalities disrupt the heart’s 
coordinated mechanical contraction and can result in reduced or insufficient 
cardiac output or other complications.8 Symptoms arising from this 
arrhythmia include palpitations, shortness of breath, fatigue, syncope, or 
intolerance to exertion. 
According to the Heart Rhythm Society (HRS) 2012 Consensus Statement 
on Catheter and Surgical Ablation of Atrial Fibrillation, AF is clinically 
stratified by whether episodes are self-terminating (paroxysmal) or 
continuous (persistent or permanent AF).9 Paroxysmal AF (PAF) is defined 
as recurrent AF (≥2 episodes) that terminates spontaneously within 7 days, 
or within 48 hours if terminated by pharmacologic or electrical cardioversion.  
Persistent AF is defined as continuous AF that is sustained beyond 7 days, 
or less than 7 days but terminated by pharmacologic or electrical 
cardioversion.  Longstanding persistent AF is defined as continuous AF of 
greater than 12 months’ duration.  Permanent AF is defined as AF in a 
patient in whom a decision has been made not to restore or maintain sinus 
rhythm by any means. 
Initial treatment of PAF is typically directed toward heart rate or rhythm 
control with drug therapy and direct current cardioversion (DCCV).  As a 
reasonable alternative to restoring sinus rhythm via long-term 
pharmacologic therapy, catheter ablation is being performed with greater 
frequency.  Three recent small randomized trials in patients with PAF 
demonstrated that catheter ablation was superior to antiarrhythmic therapy 

 
 
 
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in the prevention of recurrent AF.10, 11, 12 This was followed by the more 
recent Navistar ThermoCool® Catheter and EZ Steer ThermoCool® NAV 
Catheter PMA submission substantiating the findings in a larger series.13 
Although it is still the consensus recommendation that catheter ablation 
should not be considered a first line therapy for atrial fibrillation,13 there is 
evidence that maintenance of sinus rhythm has important effects on 
mortality.  In the Atrial Fibrillation Follow-up Investigation of Rhythm 
Management (AFFIRM) trial, in which 4,060 AF patients with high risk for 
stroke and death were randomized to either rhythm control or rate control by 
antiarrhythmic drugs, there were no significant differences in all-cause death 
between the two strategies.14 However, a new on-treatment analysis of the 
AFFIRM study revealed that the presence of sinus rhythm was associated 
with a significant reduction in mortality, whereas the use of antiarrhythmic 
drugs increased mortality by 49%,15 suggesting that the beneficial effect of 
sinus rhythm restoration on survival might be offset by the adverse effects of 
antiarrhythmic drugs.   
Ablation treatment paradigms have evolved over time, and current 
strategies emphasize isolation of the pulmonary veins (PVI) as the 
cornerstone of catheter ablation of AF.  Energy sources for endocardial 
lesion creation have included radiofrequency, cryo (freezing), laser, 
ultrasound and microwave.  New ablation techniques and devices continue 
to develop with the objective of improving safety and efficacy, while 
reducing procedure time (complexity).  In elite single-center reports, the 
success rate for eliminating symptomatic AF (inclusive of both PAF and 
continuous AF subjects) varies from 55% - 77%, with many patients 
requiring multiple procedures.16, 17, 18, 19 Retreatment rates as high as 40% 
have been reported.20 
Understanding the need for creating electrical isolation of the pulmonary 
veins, treatment paradigms have focused on creating circumferential lesions 
or wide circumferential lesion sets that block electrical continuity between 
the pulmonary veins and the left atrium.  In a wide circumferential ablation 
(WACA) procedure, operators must form a contiguous line of electrical block 
around ipsilateral pulmonary veins using fluoroscopic guidance and 
electroanatomical mapping technologies.  A limited assessment of lesion 
formation and position is determined by monitoring voltage reduction of the 
local electrogram at the target site.  Electrical gaps in lesion sets occur 
frequently, leading to recurrent AF and/or creation of substrate susceptible 
to reentrant atrial tachycardias.21 Ablation technologies that rely upon 
indirect assessment of lesion formation are challenged to deliver improved 
durability and therefore long-term efficacy of therapy. 

 
 
 
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3.2 Surgical and Catheter Ablation 
Cox and colleagues are credited with developing and demonstrating the 
efficacy of surgical ablation of AF via the "maze" or "Cox-maze" procedure 
(sometimes also referred to as the “traditional maze” or “cut-and-sew 
maze”), an open-heart cardiac surgery procedure intended to eliminate AF, 
by a series of incisional scars in both atria, to block abnormal electrical 
circuits (atrial macroreentry), a requisite AF mechanism.  During the Cox-
Maze Procedure, areas of cardiac tissue are isolated, either by cut and sew 
methods or electrosurgically, creating a “maze” which prevents propagation 
of ectopic AF impulses22, 23 notes: “While few patients are candidates for a 
stand-alone surgical procedure to cure AF using the maze or LA ablation 
techniques, these approaches can be an effective adjunct to coronary 
bypass or valve repair surgery to prevent recurrent postoperative AF.” 
Reported failure rates for the maze procedure are as high as 30%.  Jais 
2002 summarized the conclusions from surgical treatments for AF.24 
• reduction of the atrial tissue mass available for fibrillation is effective in 
preventing maintenance of AF;  
• the left atrium plays a dominant role in maintenance and initiation of AF; 
• limited lesions placed around pulmonary veins can be as effective as 
complex ablation schema (maze)and safer. 
However, Wisser 2007 reported results of a small non-randomized study 
comparing two groups of patients, all treated surgically for permanent AF at 
the same time as other major heart surgery.  Group 1 (N=29) received a 
classic maze procedure: freedom from AF at 19 months follow up was 86%.  
Group 2 (N=43) received epicardial pulmonary vein isolation treatment, and 
freedom from AF at follow up was 59%.  This difference was statistically 
significant.   
Due to the extreme complexity of the “cut and sew” Cox-Maze procedure, 
few surgeons perform the surgery.  Instead, minimally invasive surgical 
techniques have been developed.  The FAST trial randomized 
antiarrhythmic drug-refractory AF patients to minimally invasive surgical 
ablation or catheter ablation.25  Outcomes for efficacy and safety during a 
12-month follow-up demonstrated an overall increased freedom from AF in 
the minimally invasive surgery group compared to the catheter ablation 
cohort; however, the surgical ablation group had significantly more 
procedural-related adverse events compared to catheter ablation (23.0% 
versus 3.2%).   
During the past decade, the evolution of catheter-based energy delivery 
(such as radiofrequency and cryothermia) has evolved as a non-surgical 
means to create similar lesions in the walls of the atria (i.e., Cox maze IV 

 
 
 
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ablation-assisted procedure).26  However, electrophysiologists have found it 
challenging to replicate the Cox Maze III in its entirety.   
Pulmonary vein isolation (PVI), which is the cornerstone of the mini-maze 
procedure and catheter ablations, essentially creates “boxes” around the 
four pulmonary veins.  PVI catheter ablation as a treatment for paroxysmal 
AF is associated with a high rate of success, in excess of 70%; however, 
outcomes for treating persistent AF with PVI are substantially lower and 
often require multiple procedures to maintain long-term freedom from atrial 
arrhythmias.  While electrical isolation of the pulmonary veins (PVs) is 
central to catheter ablation strategies, foci and/or substrate outside the PVs, 
particularly in the LAA, have been identified as a key mechanism in the 
maintenance of persistent AF.27, 28, 29, 30 
The literature suggests that catheter ablation is more efficacious for those 
patients with paroxysmal AF in comparison to those with persistent forms of 
AF.31 This may in part be due to the finding that in many of these patients, 
and with new mapping technologies, specific foci may be identified and 
treated.32, 33 
3.3 Irreversible Electroporation (IRE)  
Al-Sakere 200734 described irreversible electroporation as a non-thermal 
tissue ablation technique in which intense short duration electrical fields are 
used to permanently open pores in cell membranes, thus producing non-
thermal tissue ablation.  Their study, using a mouse model, showed 
complete regression in 92% of treated tumors.  IRE ablation has a tissue 
specific mechanism of ablation.  The tissue injury from IRE ablation occurs 
at the cellular level with loss of homeostasis leading to necrosis or 
apoptosis.35 36 37 38 IRE ablation typically spares the extracellular matrix, 
which facilitates rapid wound healing.39, 40, 41, 42, 43 
Thomson 201144 reported a case-series study (N=38) assessing the safety 
of irreversible electroporation (IRE) for treating liver, kidney or lung cancers 
in humans.  The first four patients showed signs of transient ventricular 
arrhythmia, so subsequent patients were all treated using Electrocardiogram 
(ECG)-synchronized deliver of electroporation pulses.  There were two 
further arrhythmias, and two cases of inadvertent damage to neighboring 
organs.  68% of tumors were completely ablated.  The authors concluded 
that IRE is safe for clinical use, provided ECG-synchronized delivery is 
used.   
A research group led by FHM Wittkampf in Utrecht has been investigating 
the potential effectiveness and safety of epicardial electroporation in AF 
ablation procedures using porcine models.  Wittkampf 201145 (N=10) used a 
circular ablation catheter and showed that PVI was achieved in all animals, 
with no sign of stenosis at 3-week follow up.  Van Driel 201446 (N=6) 
confirmed this result out to 3-month follow up.  Neven 201447 (N=5) showed 

 
 
 
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that electroporation lesion depth depended on the level of electrical energy 
applied, reaching 8 mm at 300 joules. 
Van Driel 2015 (N=20) showed that electroporation could create deep 
lesions close to the phrenic nerve without damage to the nerve.  Neven 
2014 similarly showed that neighboring coronary arteries were undamaged 
by electroporation (N= 5).  These animal studies suggest that irreversible 
electroporation can safely create deep lesions in heart tissue when applied 
epicardially without harming adjacent tissues. 
3.4 Complications of Catheter Based and Surgical Ablation 
The risks and complications associated with thermal or non-thermal cardiac 
ablation depend on the complexity of the procedure.  The most common 
complications due to cardiac ablations include bleeding, cardiac tamponade, 
stroke/TIA, pulmonary vein stenosis, phrenic nerve injury, 
thromboembolism, air embolism, post-procedural arrhythmias, and vascular 
complications.  Further, recurrences of atrial fibrillation (AF) or atrial 
tachycardia after an initial AF catheter ablation procedure (20 – 40% of 
patients48) are common. 
Gelsomino 201449 noted in a study of SAEs (Serious Adverse Event) rates 
for studies of convergent AF ablation (N=335) (Table 1).  There were 3 early 
deaths (0.9%) and three conversions to sternotomy and cardiopulmonary 
bypass (0.9%).  There were no late deaths or thromboembolic events.  
These SAE rates include both catheter ablation and surgical ablation 
procedures in the reviewed studies.  Expected adverse event rates from an 
isolated surgical procedure are likely to be lower. 
Table 1: Data from Gelsomino 2014 – Adverse Event Rates for 
Surgical Ablation 
Event 
Frequency (%) 
Bleeding 
6 (1.8%) 
Tamponade 
4 (1.2%) 
Pleural effusion 
1 (0.3%) 
Hemothorax 
1 (0.3%) 
Pneumothorax 
1 (0.3%) 
Pneumonia 
1 (0.3%) 
 
In conclusion, risks related to the FARAPULSE Endocardial Ablation 
System are expected to be no different from those of the products approved 
and available on the market for catheter-based or surgical 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 Endocardial Ablation System 
4.2 Intended Use 
The FARAPULSE Endocardial Ablation System is indicated for cardiac 
tissue ablation for the treatment of atrial fibrillation.   
 
4.3 Classification 
The FARAPULSE Endocardial Ablation System is comprised of the 
Endocardial Ablation Catheter System, the Endocardial Generator System, 
and the Deflectable Sheath System. 
 
The Endocardial 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 Endocardial 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.   
 
The Deflectable Sheath System is classified as a Class III medical device.  
Per MEDDEV 2.4/1 Rev.  9 June 2010, Rule 6 applies to the Deflectable 
Sheath System, which defines it as a surgically invasive device intended for 
transient use (<60 min) that specifically controls, diagnoses, monitors or 
corrects a defect of the heart or of the central circulatory system through 
direct contact with these parts of the body. 
 
4.4 System Components: FARAPULSE Endocardial Ablation System 
The FARAPULSE Endocardial Ablation System used for this clinical 
investigation consists of the Endocardial Ablation Catheter System, the 
Endocardial Generator System, and the Deflectable Sheath System (See 
Figure 1).  Model numbers of the components used in this study are in 
Table 2: Components and Model Numbers of FARAPULSE Endocardial 
Ablation System. 

 
 
 
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Table 2: Components and Model Numbers of the FARAPULSE 
Endocardial Ablation System 
Components & Sub Components 
Model Number (REF#) 
 Endocardial Ablation Catheter System 
1.  Ablation Catheter 
2.  Extension Cable 
40T401 
 Endocardial Generator System 
1.  Pulsed Electric Field Generator (PEFG) 
2.  Two Coaxial Cables 
3.  Two Pace Filter Boxes 
60T401 
Deflectable Sheath System 
1.  Sheath 
2.  Dilator 
20T401 
 
Figure 1: Endocardial Ablation System and compatible device 
connections.  The blue dotted box shows the sterile, single-use 
components of the system. 
 
4.4.1 Endocardial Ablation Catheter System 
The Endocardial Ablation Catheter System consists of two (2) 
components: Ablation Catheter and Extension Cable, which are used 
together.  These components are sterile and single use only.  
The Ablation Catheter is a multi-electrode catheter that connects 
electrically to the Endocardial Generator System.  It consists of a multi-

 
 
 
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electrode  ablation catheter with electrodes arranged on splines .  The 
Ablation Catheter consists of a distal section with five splines that deploy 
into a flower-shaped configuration with five petals, a shaft section, and a 
proximal handle with a manually operated deployment control (See Figure 
2).  The handle includes a flush port for saline infusion, a deployment 
control knob with a guidewire lumen hub that can be connected to a 
hemostasis valve, and a cable with connectors.  The catheter connectors 
connect to an Extension cable (also part of the Endocardial Ablation 
Catheter System) with numbered connectors on each of its ends.  These 
connect to the multi-channel Endocardial Generator . Pulsed Electric Field 
energy is delivered over the set of ablation catheter electrodes.The 
Extension Cable referred to above is a single-use sterile cable that 
provides additional cable length to connect to the Endocardial Generator.   
 
 
 
 
 
 
 
 
 
Figure 2: Deployed Endocardial Ablation Catheter illustrating the fully 
deployed distal “flower” section 
 

 
 
 
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4.4.2 Endocardial Generator System  
The Endocardial Generator System is part of the FARAPULSE 
Endocardial Ablation System.  It consists of five components – Pulsed 
Electric Field Generator (PEFG), BNC Coaxial cable (2 units), and Pace 
Filter Box (2 units).  The Endocardial Generator System is designed to 
deliver pulsed electric field energy to endocardial sites in the heart via the 
Endocardial Ablation Catheter System and other compatible devices (refer 
to IFU LBL0195 for the specific use and procedural steps of the 
Endocardial Ablation Catheter System, LBL0193 for the Deflectable 
Sheath System and LBL0198 for the Endocardial Generator System).  The 
Endocardial Generator System is indicated for use in conjunction with the 
Endocardial Ablation Catheter System. 
The Pulsed Electric Field Generator is a 16-channel output unit that 
generates a pulsed voltage waveform that can be delivered to the ablation 
catheter electrodes. As an input, a compatible cardiac stimulator unit for 
cardiac pacing is applied to the cardiac chambers via pacing catheters 
and to the PEFG with a coaxial cable to synchronize the application of 
therapeutic 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.   
 
The faraStar Generator currently utilizes the Generator Mode 1 ablation 
delivery mode. An updated ablation delivery mode, Generator Mode 2, will 
be implemented upon Regulatory approval. Generator Mode 2 minimizes 
muscular contractions during ablation and does not require use of a 
paralytic agent during the procedure.  
Details regarding the updated ablation delivery mode is provided in the 
faraStar Endocardial Generator System User Manual LBL0198. 
 
4.4.3 Deflectable Sheath System 
The Deflectable Sheath System consists of two (2) components: 
Deflectable Sheath and Dilator, which are used together.  Both 
components are sterile and single use only (See Figure 3). 
The Deflectable Sheath comprises a distal deflectable section and a shaft 
section connecting to a handle.  The handle includes a knob for control of 
the deflection and a flush port for infusion of saline or contrast.  The 
Dilator goes through the sheath lumen and includes a shaped tip for 
dilation for vascular or chamber access. 

 
 
 
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Figure 3: Deflectable Sheath and Dilator 
 
4.5 Device Accountability 
The FARAPULSE Endocardial Ablation System will be housed in a secure 
location and access will be controlled.  Records will be maintained to 
document the physical location of inventory from shipment and removal 
from Sponsor 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 Endocardial 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 

 
 
 
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responsible for device accountability and disposition of all used and unused 
devices.  The study Sponsor or its designated representative will conduct 
device reconciliation at the completion of subject enrollment or at the 
conclusion of the study. 
 
5. Study Objectives 
The objective of the safety and feasibility study is to demonstrate that the 
endocardial creation of electrically isolating lesions via pulsed electric field 
(PEF) catheter ablation applied using the FARAPULSE Endocardial Ablation 
System is a feasible and safe treatment for paroxysmal atrial fibrillation (PAF). 
5.1 Study design 
The IMPULSE Study is a prospective, observational, multi-center, intention-
to-treat study using the FARAPULSE Endocardial Ablation System in 
subjects with paroxysmal atrial fibrillation who consented to undergo 
percutaneous PEF ablation. 
5.2 Selection and Withdrawal of Subjects 
5.2.1 Inclusion Criteria 
All subjects are required to meet all the following inclusion criteria to be 
considered eligible for participation in this study: 
 
1. Patients with PAF who have had at least one AF episode documented 
within one (1) year prior to enrollment.  Documentation may include 
ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry 
strip.   
2. Patients who have failed at least one antiarrhythmic drug (AAD; class I 
or III, or AV nodal blocking agents such as beta blockers and calcium 
channel blockers) as shown by recurrent symptomatic AF, or 
intolerance to the AAD or AV nodal blocking agents. 
3. Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment. 
4. Antero-posterior 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. Left ventricular ejection fraction ≥40% as documented by TTE within 12 
months prior to the procedure. 
7. Received a standard cardiac work up and is an appropriate candidate 
for an investigational procedure as determined by study investigators. 

 
 
 
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8. Subject is willing and capable of providing Informed Consent to undergo 
study procedures and participate in all examinations and follow-up visits 
and tests associated with this clinical study. 
5.2.2 Exclusion Criteria 
Subjects will be excluded from participating in this study if they meet any 
one of the following exclusion criteria: 
1. Patients on amiodarone at any time during the past 3 months prior to 
enrollment.   
2. AF secondary to electrolyte imbalance, thyroid disease, or reversible or 
non-cardiac cause.   
3. AF episodes lasting > 7 days. 
4. Previous ablation for AF.   
5. Patient has a prosthetic heart valve. 
6. Patient has a left atrial appendage device 
7. Prior history of pericarditis or pericarditis within 3 months based on the 
TTE examination. 
8. Subject is a woman of child bearing age 
9. Prior history of rheumatic fever. 
10. Prior history of medical procedure involving instrumentation of the left 
atrium (previous ablation, Atrial septal defect ASD closure, left atrial 
appendage occlusion) 
11. History of severe chronic gastrointenstinal problems involving the 
esophagus, stomach and/or untreated acid reflux 
12. History of abnormal bleeding and/or clotting disorder.   
13. Active malignancy or history of treated cancer within 24 months of 
enrollment.   
14. Clinically significant infection or sepsis.   
15. History of stroke or TIA within prior 6 months 
16. New York heart Association (NYHA) class IIIb or IV congestive heart 
failure and/or any heart failure hospitalization within 3 months prior to 
enrollment.   
17. Body mass index > 35. 
18. Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has 
ever received dialysis. 
19. History of untreated and serious hypotension, bradycardia or 
chronotropic incompetence.   
20. Any of the following within 3 months of enrollment: 
-Major surgery except for the index procedure 

 
 
 
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-Myocardial infarction 
-Unstable angina 
-Percutaneous coronary intervention (e.g., CABG or PTCA) 
-Sudden cardiac death event 
-Left atrial thrombus that has not resolved as shown by TEE or CT 
-Implant of pacemaker, ICD or CRT. 
21. Solid organ or hematologic transplant, or currently being evaluated for 
an organ transplant. 
22. History of pulmonary hypertension with Pulmonary systolic artery 
pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease 
or restrictive lung disease. 
23. Patients with any other significant uncontrolled or unstable medical 
condition (such as uncontrolled brady-arrhythmias, ventricular 
arrhythmias, hyperthyroidism or significant coagulation disorder). 
24. Life expectancy less than one year. 
25. Clinically significant psychological condition that in the physician's 
opinion would prohibit the subject's ability to meet the protocol 
requirements. 
26. History of blood clotting or bleeding abnormalities. 
27. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K 
Antagonists such as warfarin). 
28. Enrolled in another cardiac clinical study that would interfere with this 
study. 
5.3 Study Design 
5.3.1 Description of Study Design 
Prospective, single-arm, multi-center, safety and feasibility study.  
Subjects will be consented to undergo percutaneous PEF ablation using 
the FARAPULSE Endocardial Ablation System.  Subjects will be followed 
at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking 
period for recurrent atrial fibrillation or atrial tachycardia of 3 months 
following the PEF catheter ablation procedure.   
5.4 Study Endpoints 
5.4.1 Primary Safety Endpoint 
The primary safety endpoint for this study is the incidence of early-onset 
(within 7 days of the PEF ablation procedure) primary adverse events 
(AEs).   
• Death  

 
 
 
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• Myocardial infarction (MI)  
• Pulmonary vein (PV) stenosis†  
• Diaphragmatic paralysis  
• Atrio-esophageal fistula†  
• Transient Ischemic Attack (TIA)  
• Stroke/Cerebrovascular accident (CVA) Thromboembolism  
• Pericarditis requiring intervention (major)  
• Cardiac Tamponade/Perforation  
• Pneumothorax  
• Vascular Access Complications  
• Pulmonary edema     
• Hospitalization (initial and prolonged)*  
• Heart block  
*Excludes hospitalization (initial & prolonged) solely due to arrhythmia 
(AF/AFL/AT) recurrence or due to non-urgent cardioversion 
(pharmacological or electrical). 
†Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs 
greater than one week (7 days) post-procedure shall be deemed a 
Primary AE. 
See Table 3 for a summary of the primary AE safety endpoint definitions. 
 
 

 
 
 
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Table 3.  Primary AE Safety Endpoint Definitions 
 
 
 

 
 
 
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Table 3.  Primary AE Safety Endpoint Definitions (cont.) 
 
 
 
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; 
• 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. 
5.4.3 Primary Feasibility Endpoint 
Proportion of subjects that achieve procedural success.  Procedural 
success is defined as the percutaneous endocardial creation of an 
electrically isolating lesions around the ostia of the pulmonary veins (PVI) 
using the FARAPULSE Endocardial Ablation System.  Specifically, the 
ability of the device to create a contiguous line of electrically impervious 
tissue in the specified region inside 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 assessed during an electroanatomical mapping 
procedure performed 3-months following the index procedure. 

 
 
 
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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.  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.  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 recurrence of 
AF following the blanking period, these subjects will be considered 
therapeutic failures.Finally, any subject death after the blanking interval 
and prior to the Month 12 visit will be adjudicated by the CEC.   
 
5.5 Sample Size 
Up to 50 subjects will be enrolled in this clinical study. 
5.6 Investigational Sites 
The clinical study will be conducted at up to 3 clinical sites in Europe. 
5.7 Duration of Subject Participation 
Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 
months with a blanking period for recurrent atrial fibrillation or atrial 
tachycardia of 3 months following the PEF catheter ablation 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. 
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 

 
 
 
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document until the study 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. 
Written informed consent must be obtained prior to performing any protocol 
driven tests or any procedures that are not standard of care for a 
percutaneous ablation procedure that the subject is scheduled to undergo. 
Once written consent has been obtained, the subject will be entered on a 
Screening Log, which will be maintained at each site.  All subjects who 
provide written informed consent will be entered on the screening log 
regardless of whether or not they are enrolled in the study. 
5.9 Enrollment 
Subjects that meet all of the eligibility criteria and are deemed suitable by 
the investigator will be invited to participate in the study.   
Subjects will be considered enrolled at the time of signing the informed 
consent. 
Each subject will be assigned a unique study identification code to protect 
each subject’s confidential health information.  The unique study identity 

 
 
 
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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 study at any time for any reason.  
In addition, the investigator may withdraw the subject due to any of the 
following situations: 
• adverse event (AE); or 
• 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 study. 
5.12 Subject Confidentiality 
All information concerning subjects or their participation in this study will be 
considered confidential.  Only authorized Sponsor and designated 
representative personnel and designated consultants and regulatory 
agencies will have access to these confidential files.  Enrolled subjects will 
be assigned 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.   

 
 
 
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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 LBL0193 
(Deflectable Sheath System, LBL0195 (Endocardial Catheter Ablation 
System), and LBL0198 (Endocardial Generator System).  Procedural 
details will be captured in study CRF.  The following procedural data will 
be collected: 
• Medications administered 
• Pre- and post-ablation electroanatomical maps 
• Anticoagulation monitoring (e.g.  ACT) 
• Adverse event(s) 
 
5.13.3 Pre-Discharge / 7 Day Follow-Up 
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); 
• 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); 
• Cardiac rhythm as determined by a 12-lead ECG on day of hospital 
discharge; 

 
 
 
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• 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 
• Adverse Events 
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; 

 
 
 
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• 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. 
• An event monitor will be provided to all patients and it will  be used up 
to the 12-month follow-up visit for weekly scheduled and ad hoc 
symptomatic monitoring. ECG data from this monitor will be analyzed 
by a contract core lab. Investigational sites will be provided with the 
event monitor device and instructions for its use by the contract core 
lab.  The investigational sites will then provide the device and 
instructions for use to the subject. 
• Patients will undergo an electroanatomical remapping procedure to 
assess electrical isolation of the pulmonary veins.  Any electrical gaps 
may be closed at the investigator’s discretion using a commercially 
approved ablation device.  This will consist of placement of catheters in 
the left atrium via femoral access and transseptal puncture using 
conventional electrophysiology techniques. 
• 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; 

 
 
 
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• Heart failure status as assessed by NYHA classification at the time of 
visit; 
• the provided event monitor will be reviewed and then continue to be 
used up to the 12-month for weekly scheduled monitoring and to 
capture AF episodes.  
• A 24-hour continuous ECG (Holter) will be performed. Investigational 
sites will be provided with the Holter device and instructions for its use 
by the contract core lab. The Holter monitoring service will be available 
to provide any necessary assistance with the use of the Holter device 
and to reinforce the need to adhere to the protocol for the full 24 hours. 
The 24-hour continuous ECG data will be analyzed by a contract core 
lab. 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 
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; 
• At the the 12-month follow-up visit, the provided event monitor will be 
reviewed for any captured AF episodes and will be collected by sites. 
• A 24-hour continuous ECG (Holter) will be performed. Investigational 
sites will be provided with the Holter device and instructions for its use 
by the contract core lab. The Holter monitoring service will be available 
to provide any necessary assistance with the use of the Holter device 
and to reinforce the need to adhere to the protocol for the full 24 hours. 

 
 
 
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The 24-hour continuous ECG data will be analyzed by a contract core 
lab. 
• Any hospital readmissions, including admission and discharge dates, 
since the previous visit; and 
• Adverse events. 
5.14 Unscheduled Visit 
Any unscheduled follow-up visits that occur throughout the study, other than 
routine follow-up visits per the institution’s or investigator’s normal standard 
of care, shall be documented.  At the minimum, the following data will be 
collected: 
• 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 study provided that they do not have any conditions that require 
continued follow-up. 

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5.16 Summary of Study Assessments 
Table 4: Summary of Study Assessments 
Assessment 
Baseline  Procedure 
 
7 Days 
30 Days 
Post-
Procedure/ 
Discharge* 
3 Month 
(End of 
Blanking 
Period) 
6 Month 
12 
Month 
Unscheduled 
Visit Timeframe (days) 
 
 
7±2 
30±7 
90±14 
180±30 
365±30 
- 
Medical History 
X 
 
 
 
 
 
 
 
Medication History (current) 
X 
 
 
 
 
 
 
 
Medications 
 
X 
X 
X 
X 
X 
X 
X 
Pregnancy test (for females of 
childbearing potential) 
X 
 
 
 
X 
 
 
 
12-lead ECG 
X 
 
X 
X 
X 
X 
X 
X 
24-Hour Continuous ECG 
Monitor (e.g., Holter) 
 
 
 
 
 
X 
X 
 
Cardiac CT or MRI 
X 
 
 
 
X 
 
 
 
TEE (to exclude left atrial 
thrombus) 
X 
 
 
 
 
 
 
 
3D Electroanatomical Mapping 
 
X 
 
 
X 
 
 
 
Event Monitor 
 
 
 
 
X 
X 
X 
 
Record DC Cardioversions Since 
Last Visit 
 
 
X 
X 
X 
X 
X 
X 
NYHA Classification 
X 
 
X 
X 
X 
X 
X 
X 
Fluoroscopic Examination of 
Diaphragm Motion 
 
 
 
 
 
 
X** 
 
Anticoagulation Monitoring 
 
X** 
X** 
X** 
X** 
X** 
X** 
X** 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
* Whichever is later 
** As needed

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6. Risk Benefit Assessment 
The Sponsor has conducted an analysis of the benefits and risks of the FARAPULSE Endoc
procedure as described below.  The  
conclusion of this review is that this research study is justified because the overall 
potential benefit to the population outweighs its risks. 
 
6.1 Risks 
The risk profile associated with the FARAPULSE Endocardial Ablation 
System and the ablation procedure is expected to be minimal and 
consistent with other similar percutaneous devices currently in clinical use 
for percutaneous cardiac ablation.   
 
 

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6.1.1 Potential Adverse Events 
The following anticipated events have been identified as possible 
complications of percutaneous atrial fibrillation ablation procedures and 
these and others may be associated with the FARAPULSE  
Endocardial Ablation System: 
• Access site complications (e.g., hematoma, pseudo-aneurysm) 
• Air embolism 
• Anemia 
• Arrhythmia, potentially requiring cardioversion 
 
• 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  
 
• Death 
 
• Esophageal injury 
• Hemorrhage 
• Hemodynamic compromise 
• Hemopericardium 
• Hemoperitoneum 
• Hemothorax 
• Hypotension 
• 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 

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• Pneumoperitoneum 
• Pneumothorax 
• Pulmonary vein stenosis 
• Risk of cancer or birth defect/harm to fetus from x-ray exposure 
• Skin burns/irritation from x-ray exposure  
• Stroke/transient ischemic attack 
• Surgical or open-heart surgery to remove retained catheter 
• Thrombosis 
• Thromboembolism 
• Vessel damage, dissection, or occlusion. 
• Phrenic nerve injury 
• Conduction system injury resulting in sinus arrest or heart block, either 
transient or permanent 
 
6.2 Benefits 
The FARAPULSE Endocardial 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 percutaneous ablation catheters.  More specifically: 
• The device system is used during percutaneous endocardial ablation 
procedures like other commercially approved catheter systems.   
• The device system is composed of similar biocompatible materials 
• The device system is a non-thermal ablation technology with targeted 
tissue specific mechanism of ablation 
• The device uses the standard percutaneous techniques for ablation 
procedures. 
• The device utilizes a standard irreversible electroporation generator to 
deliver energy in the form of ablation dose.   
 
A fundamental difference between the FARAPULSE Endocardial Ablation 
System and other commercially released ablation systems is that the pulsed 
electric field or irreversible electroporation energy is delivered through 
endocardial electrodes embedded in the catheter that engages the 
pulmonary veins. 
As such, the potential risks are roughly equivalent to those associated with 
commercially released systems being used for percutaneous cardiac 
ablation procedures.  Currently, the complication rates for commercially 
available catheters are low and have declined as physicians have continued 
to learn more about cardiac ablation techniques.  Furthermore, 
FARAPULSE, Inc.  has conducted bench and in-vivo testing to ensure safe 
use of the device during clinical investigation and ultimately will be in 
compliance with Directive 93/42/EEC.  Some tests results are pending and 
will be released before this feasibility study. 

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There are no guaranteed benefits from participation in this study.  
Information gained from the conduct of this study may also be of benefit to 
other persons with the same medical condition. 
7. Statistical Analysis and Endpoint Assessment 
7.1 General Statistical Considerations 
The primary objective of this study is to characterize the safety and 
feasibility of the FARAPULSE Endocardial Ablation System in subjects with 
paroxysmal atrial fibrillation. 
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 IMPULSE Study is a first-in-man study and as such a relatively small 
number of patients, up to 50, will be studied at up to three sites.  Up to 25 
patients may be evaluated with the first dosage using Generator Mode 1. 
Up to 25 additional patients will be evaluated using the updated dosage in 
Generator Mode 2. Up to 50 total patients will be used to inform the clinical 
dosage mode to support a subsequent Pilot Study. Refer to 7.5, Data 
Pooling.  
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 Endocardial Ablation System. 
 
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 Endocardial 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.  

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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 from Generator Mode 1 (up to 25 patients)_and Mode 2 (up to 25 
patients) will be analyzed separately with no pooling of data for the different 
ablation modes. Data for Mode 1 will be pooled from all study sites, and 
likewise for Mode 2.  The basis for pooling is the clinical basis described in 
Meinert50 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). 
7.6 Assessment of Feasibility 
7.6.1 Primary Feasibility Endpoint 
Proportion of subjects that achieve procedural success.  Procedural 
success is defined as the endocardial creation of an electrically isolating 
lesions around the ostia of the pulmonary veins (PVI).  Specifically, the 
ability of the device to create a contiguous line of electrical block in the 
specified region inside the left atrium percutaneously. 
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 assessed at a follow-up electroanatomical remapping 
procedure performed 3-months post index procedure. 
7.7 Assessment of Safety 
7.7.1 Primary Safety Endpoint 
The primary safety endpoint for this study is the incidence of early-onset 
(within 7 days of the PEF ablation procedure) primary AEs.   
• Death  
• Myocardial infarction (MI)  
• Pulmonary vein (PV) stenosis†  
• Diaphragmatic paralysis  
• Atrio-esophageal fistula†  
• Transient Ischemic Attack (TIA)  

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• Stroke/Cerebrovascular accident (CVA) Thromboembolism  
• Pericarditis requiring intervention (major)  
• Cardiac Tamponade/Perforation  
• Pneumothorax  
• Vascular Access Complications  
• Pulmonary edema     
• Hospitalization (initial and prolonged)*  
• Heart block  
 
*Excludes hospitalization (initial & prolonged) solely due to arrhythmia 
(AF/AFL/AT) recurrence or due to non-urgent cardioversion 
(pharmacological or electrical). 
†Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs 
greater than one week (7 days) post-procedure shall be deemed a 
Primary AE. 
 
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 
• 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 study.  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, 

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users or other persons, whether or not related to the investigational medical 
device 
NOTE 1: This definition includes events related to the investigational 
medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to investigational medical devices. 
 
Serious Adverse Event (SAE): 
• led to death, 
• led to serious deterioration in the health of the subject, that either resulted 
in 
o 
a life-threatening illness or injury, or 
o 
a permanent impairment of a body structure or a body 
function, or 
o 
in-patient or prolonged hospitalization, or 
o 
medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or a 
body function, 
• led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not 
considered a serious adverse event. 
 
Adverse Device Effect (ADE): 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device 
 
Serious Adverse Device Effect (SADE): 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event 
 

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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: 
1) Not related: relationship to the device or procedures can be excluded 
when: 
• 
the event is not a known side effect of the product category the 
device belongs to or of similar devices and procedures; 
• 
the event has no temporal relationship with the use of the 
investigational device or the procedures; 

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• 
the serious event does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and is 
biologically implausible; 
• 
the discontinuation of medical device application or the reduction of 
the level of activation/exposure - when clinically feasible – and 
reintroduction of its use (or increase of the level of activation/exposure), 
do not impact on the serious event; 
• 
the event involves a body-site or an organ not expected to be 
affected by the device or procedure; 
• 
the serious event can be attributed to another cause (e.g. an 
underlying or concurrent illness/ clinical condition, an effect of another 
device, drug, treatment or other risk factors); 
• 
harms to the subject are not clearly due to use error; 
• 
In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious event. 
2) Unlikely: the relationship with the use of the device seems not relevant 
and/or the event can be reasonably explained by another cause, but 
additional information may be obtained. 
3) Possible: the relationship with the use of the investigational device is 
weak but cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and 
an effect of another device, drug or treatment). Cases were relatedness 
cannot be assessed or no information has been obtained should also be 
classified as possible. 
4) Probable: the relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably have explained by 
another cause, but additional information may be obtained. 
5) Causal relationship: the serious event is associated with the 
investigational device or with procedures beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
• 
the event has a temporal relationship with investigational device 
use/application or procedures; 
• 
the event involves a body-site or organ that 
• 
the investigational device or procedures are applied to; 
• 
the investigational device or procedures have an effect on; 
• 
the serious event follows a known response pattern to the medical 
device (if the response pattern is previously known); 

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• 
the discontinuation of medical device application (or reduction of 
the level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event (when 
clinically feasible); 
• 
other possible causes (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment) 
have been adequately ruled out; 
• 
harm to the subject is due to error in use; 
• 
In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedures and the serious event. 
If an SAE is determined to be probably or definitely related to the device and 
has not been previously anticipated, the clinical finding would be classified 
as an unanticipated adverse device effect (UADE).  An UADE is defined as 
“any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare 
of subjects.” 
8.2 Adverse Event Reporting 
All AEs, including all SAEs, will be monitored from the time of enrollment 
through discharge for this study.  All AEs must be recorded in the patient 
chart and 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 study device. 
All AEs should be followed until the event is resolved or judged to be 
chronically stable.  The investigational site will provide relevant follow-up 
information to the Sponsor 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 
• 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.  
 

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9. Monitoring 
9.1 Study Monitoring 
Clinical monitors, qualified by training and experience, will be responsible 
for monitoring and overseeing the conduct of the study.  The clinical 
monitors will evaluate compliance with the protocol, any specific 
recommendations made by the site’s Ethics Committee (EC) and the signed 
Investigator Agreement.  Phone contacts and site visits will be conducted to 
ensure that the protocol is being followed and that any protocol deviations 
are properly documented.  Clinical monitoring will include a verification that 
Informed Consent Form was properly obtained for all enrolled study 
participants, a review of clinical records for accuracy and completeness, 
resolution of missing or inconsistent results and a review of source 
documents.  The clinical monitor will verify that the Case Report Forms 
(CRFs) are in agreement with the source documentation and other records.  
The investigator will make available to the clinical monitor for review all 
Informed Consent 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 study, the clinical monitor is required to discuss the situation 
with the investigator and the Sponsor to ensure compliance. 
The Sponsor or its designated representative, qualified by training and 
experience, will be responsible for monitoring and overseeing the conduct of 
the study.  The accuracy of all collected data will be verified for: 
• 
Eligibility criteria 
• 
Baseline characteristics 
• 
Primary safety and feasibility endpoints 
• 
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 

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to source data/ documents for study-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 study. 
If a deficiency is noted during the course of the study the clinical monitor is 
required to discuss the situation with the site and the Sponsor (if required) to 
secure compliance. 
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 study will be qualified 
by education and/ or experience to perform their tasks. 
10.1 Key Contributors 
10.1.1 Study Sponsor 
FARAPULSE, Inc. 
3715 Haven Ave.  Suite 110 
Menlo Park, CA 94025, USA 
Phone: 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 
 

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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 Study Conduct 
The study will be performed in accordance with the relevant parts of the 
Code of Federal Regulations, ICH Guidelines for Good Clinical Practices, 
the European Standard ISO 14155, the Declaration of Helsinki, and any 
regional and/or national regulations.  The clinical investigation shall not 
begin until the required approval has been obtained from the 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 study, 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 study 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 study has been fully approved by the respective institution’s Ethics 
Committee and the Sponsor or their CRO representative (MedPass 
International) has received and reviewed the specific Ethics Committee-
approved Informed Consent Form.  When the investigator has determined 
the eligibility of a specific subject to enter the study, the Informed Consent 
Form must be completed.  The 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 

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performed.  All subjects are to receive copies of their signed Informed 
Consent Form. 
10.2.4 Coverage of Expenses 
Study participants will be reimbursed for travel costs related to study 
hospital visits. 
10.2.5 Confidentiality 
Confidentiality of subjects will be maintained throughout the study.  A 
unique identification code will be assigned to each subject participating in 
this study.  Any data that may be published in abstracts, scientific journals, 
or presented at medical meetings will reference a unique subject code and 
will not reveal the subject’s identity.  The Sponsor and their CRO 
representative (MedPass International) will make every reasonable effort 
to protect the confidentiality of all subjects participating in the study. 
10.3 Insurance 
The Sponsor will maintain the appropriate and necessary insurance 
coverage for the duration of the study. 
10.4 Audits and Inspections 
The principal investigator will also allow representatives of the governing 
EC, Competent Authority (CA), the U.S.  Food and Drug Administration 
(FDA), and other applicable regulatory agencies to inspect all study records, 
CRFs, and corresponding portions of the subject’s office and/or hospital 
medical records at regular intervals throughout the study.  These 
inspections are for the purpose of verifying adherence to the 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 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 

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• 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 
Endocardial Ablation System instructions for use, the Investigational 
Plan, CRF completion guidelines, and guidelines for obtaining informed 
consent 
• Provide the FARAPULSE Endocardial Ablation System to participating 
study sites, in quantities to support study activities 
• 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. 
10.6 Monitor Responsibilities 
The Sponsor has contracted MedPass International as the Clinical Monitor 
to support the Sponsor in implementing and monitoring the clinical 
investigation until its termination.  Clinical monitors, qualified by training and 
experience, will be responsible for monitoring and overseeing the conduct of 
the study. 
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 

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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 study 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. 
If a deficiency is noted during an on-site visit or at any other time during the 
course of the study, the clinical monitor is required to discuss the situation 
with the investigator and the Sponsor, and to subsequently monitor the 
implementation of corrective actions that are required to address the 
situation. 
All monitoring activities will be documented by the clinical monitor 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. 

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10.7 Investigator Responsibilities 
At a minimum, the following documents will be provided by the 
investigational site to the Sponsor prior to study start (consent of the first 
subject): 
• 
Signed Clinical Study 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 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 

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• 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). 
10.8 Investigator Training 
All participating investigators will be trained in the use of the FARAPULSE 
Endocardial Ablation System prior to participating in the study.  Device 
training will be conducted by the Sponsor or its representatives.  All device 
training will be documented in a training log that will be maintained in the 
site regulatory binder. 
10.9 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 study procedures; communicate regularly 

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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. 
10.10 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 (MedPass International), and will be appointed by the 
Sponsor.  The CEC will be provided with case summaries and relevant 
source documents in order to adjudicate the adverse events. 
10.11 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 study.  All data from the study 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 
(MedPass).  Quality assurance 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. 
10.12 Study Suspension or Early Termination 
The study can be discontinued at the discretion of the Investigator or study 
Sponsor for reasons including, but not limited to, the following: 
• Occurrence of adverse events unknown to date in respect to their nature, 
severity, or duration, or the unexpected incidence of known adverse 
events 
• Obtaining new scientific knowledge that shows that the study is no longer 
valid or necessary 
• Data demonstrates a benefit to subjects who undergo percutaneous 
ablation with the FARAPULSE Endocardial Ablation System making 
treatment without the FARAPULSE Endocardial Ablation System 
unethical 
• Insufficient recruitment of subjects 
• Unanticipated adverse device effect (UADE) presenting an unreasonable 
risk to subjects (Sponsor may terminate the study immediately) 

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• 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). 
10.13 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. 
10.14 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. 
10.15 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. 

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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 study. 
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 study files, as well as the results of diagnostic tests 
(e.g., laboratory tests, hemodynamic studies). 
The following minimum information should be entered into the subject’s 
medical record: 
• The date the subject entered the study and the subject number 
• The study protocol number and the name of the Sponsor 
• The date that Informed Consent was obtained 
• Evidence that the subject meet the study eligibility requirements (e.g., 
medical history, study procedures and/or evaluations) 
• The dates of all study related subject visits 
• Evidence that required procedures and/or evaluations were completed 
• Use of any concurrent medications 
• Documentation of specific device used 
• Occurrence and status of any adverse events (AEs) 
• The date the subject exited the study and a notation as to whether the 
subject completed the study or was discontinued, including the reason 
for discontinuation. 
11.2.2 Data Collection 
The investigator must maintain detailed records on all subjects who sign 
the Informed Consent Form and begin the pre-procedure evaluation.  Data 
for enrolled subjects 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 

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monitor.  The investigator should maintain a copy of all completed CRFs 
from this study. 
Study exit forms will be completed for all enrolled subjects, regardless if 
they did or did not complete the study (e.g., subject discontinuation, study 
termination).  The Sponsor and 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 
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 study is confidential, and it should not be 
discussed with persons outside of the study.  Additionally, the information in 

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

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after ablation of atrial fibrillation: incidence, mechanisms, and 
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Wright, Mathew et al.  State of the Art: Catheter Ablation of Atrial 
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2008. 
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Wisser W1, et al.  Permanent chronic atrial fibrillation: is pulmonary 
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