The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

FARAPULSE FARA-FREEDOM  CLINICAL STUDY SYNOPSIS 
MAY 18, 2022 
CS1170 REVISION D 
 
PAGE 1 
 
 
CONFIDENTIAL  
 
© 2022, Farapulse, Inc. 
 
 
 
 
 
 
 
CS1170 Rev D Clinical Study Synopsis 
 
FARA-FREEDOM:  
A Prospective Open-Label Single Arm  
Post Market Clinical Follow-Up Trial of the  
FARAPULSE Pulsed Field Ablation System in 
Patients with Paroxysmal Atrial Fibrillation 
 
SPONSOR: 
FARAPULSE, INC. 
3715 HAVEN AVE.  SUITE 110 
MENLO PARK, CA 94025 
USA 
 
ISSUE DATE: 18MAY 2022 
 
 
This study is to be performed in accordance with Good Clinical Practice (GCP), the ethical 
principles that have their origin in the Declaration of Helsinki, International Conference on 
Harmonisation E6 and ANSI / AAMI / ISO Standards 14155:2020. 
 
This document contains confidential and proprietary information and may not be copied or 
reproduced in whole or in part without the express written permission of FARAPULSE, INC., 
MENLO PARK, CA. 
 
 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
 MAY 18, 2022 
CS1170 REVISION D 
 
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© 2022, Farapulse, Inc. 
Revision History 
Rev 
DCO 
Description of Changes 
Effective Date 
Prepared By 
B 
21-289 
To match the updated protocol 
 18Aug2021 
A. Achyutha 
B 
21-302 
Administrative changes: Deleted 
“in either the Pulsed Field or 
Thermal 
Groups” In section 5.2 Index 
Procedure, Pg #4 which was 
inadvertently missed during the 
review of the document. 
Formatted 
document throughout to have same 
font and size for consistency.
27 Aug 2021 
J. Kothule 
C 
21-323 
Aligning with the protocol change 
  19Sep2021 
J. Kothule 
D 
22-126 
Aligning with the protocol change 
Page #3: Update to reflect the 
increase in total sites from 15 to 25
Page #11: CT was added as 
approved procedure to exclude 
presence of LAA thrombus
18 May 2022 
A. Vanderper 
 
 
 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
 MAY 18, 2022 
CS1170 REVISION D 
 
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© 2022, Farapulse, Inc. 
Executive Summary 
SPONSOR NAME: 
FARAPULSE, Inc. 
TITLE OF STUDY: 
A Prospective Open-Label Single Arm Post Market Clinical Follow-Up 
Trial of the FARAPULSE Pulsed Field Ablation System in Patients 
with Paroxysmal Atrial Fibrillation 
 
REFERENCE CIP 
NUMBER / REVISION: 
CS1169 Rev D 
OBJECTIVE: 
The purpose of the study is to provide ongoing post-market 
demonstration of the safety and performance of the FARAPULSE 
Pulsed Field Ablation System in the treatment of patients with 
paroxysmal atrial fibrillation (PAF). 
NAME OF 
INVESTIGATIONAL 
DEVICE: 
FARAPULSE Pulsed Field Ablation System 
 FARAWAVE™ Pulsed Field Ablation Catheter 
 FARASTAR™ Pulsed Field Ablation Generator 
 
FARADRIVE™ Steerable Sheath 
 
DESIGN: 
Subjects will undergo percutaneous endocardial ablation for 
pulmonary vein isolation using the FARAPULSE Pulsed Field 
Ablation System. Subjects with typical right-sided (isthmus-
dependent) atrial flutter (AFL) may undergo ablative interruption of 
the cavo-tricuspid isthmus (CTI). Class I / III antiarrhythmic drugs 
(AADs) will be discontinued at Day 60 ± 10, subject to Investigator 
discretion Subjects will then be followed at 7 days, 30 days, 90 days, 6 
months, and 12 months for adverse events (AEs), : Subjects will be 
monitored with weekly scheduled plus symptom-driven event 
monitoring, as well as 6 and 12-month Holter monitoring, for freedom 
from recurrent arrhythmia (atrial fibrillation [AF], AFL or atrial 
tachycardia [AT]) after the Blanking Period (Days 0 - 90). 
STUDY POPULATION: Subjects with documented PAF who have had ≥ 2 episodes within 6 
months of enrollment. 
PLANNED 
ENROLLMENT: 
180 subjects  
CLINICAL SITES: 
Up to 25 enrolling centers. 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
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DURATION OF 
SUBJECT 
PARTICIPATION: 
The enrollment period is estimated to take 12 months and subjects will 
be followed for up to 13 months. There will be a 3-month period of 
site close-out visits, for a planned study duration of approximately 34 
months 
Coronavirus Disease 2019 (COVID 19)-related disruptions may alter 
this timeframe. 
Subject participation is anticipated to be 13 ± 1 months to allow for 
screening, pre-procedural diagnostic procedures, treatment and 12 ± 1 
months of study follow-up. 
 
PLANNED 
PROCEDURES: 
Index Procedure / Rescheduled Index Procedure: All subjects will 
be screened for atrial thrombus just prior to or at the time of the Index 
Procedure and will be rescheduled if positive.  
PVI: Subjects will undergo an attempt to isolate all pulmonary veins 
or their anatomic equivalent with the FARAPULSE Pulsed Field 
Ablation System. 
CTI: Subjects with a past history of CTI-mediated (typical) AFL, who 
manifest typical AFL during a procedure or within the Blanking 
Period, or who have inducible typical flutter, may undergo ablation of 
the CTI at the discretion of the Investigator using any approved RF 
catheter during the Index / Rescheduled Index Procedure or any re-
ablation procedure.  
Other Ablation: Other ablation is not permitted under this protocol 
except when the Investigator determines that subject welfare requires 
ablation for an accessory pathway, atrioventricular nodal reentrant 
tachycardia (AVNRT), treatment-emergent left-sided AFL or 
incessant AT. 
 
RE-ABLATION 
PROCEDURE 
 
Re-ablation under this protocol requires documentation of Detectable 
AF, AFL or AT.  
Any re-ablation procedure for AF, AFL or AT during study follow-up 
constitutes a Treatment Failure. 
However, CTI ablation or re-ablation for right-sided typical AFL may 
be performed at any time during study follow-up and does not 
constitute a Treatment Failure. 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
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CS1170 REVISION D 
 
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© 2022, Farapulse, Inc. 
ANTIARRHYTHMIC 
DRUGS 
 
Antiarrhythmic drugs (AADs), except for amiodarone, may be utilized 
during the Blanking Period at the Investigator’s discretion. On Day 60 
± 10 each subject will be contacted by telephone to stop all AADs. 
Class I / III AADs should be stopped at the Day 60 Assessment. 
However, at the Investigator’s discretion, Class I / III AADs may be 
continued up to Day 90 without creating a primary performance 
endpoint failure. 
The use of amiodarone at any time during the study, except intra-
procedurally to control an arrhythmia, or the use of Class I / III AADs 
after Day 90, constitute a Treatment Failure. 
PRIMARY SAFETY 
ENDPOINT: 
The primary safety endpoint is the Composite Safety Endpoint (CSE) 
defined as the proportion of Safety Subjects with one or more of the 
following device- or procedure-related SAEs as adjudicated by the 
CEC based on protocol definitions. 
 
Early onset (within 7 days of an index or Rescheduled Index 
procedure: 
 
Death  
 Myocardial infarction  
 Persistent phrenic nerve palsy  
 Stroke  
 Transient ischemic attack (TIA) 
 Peripheral or organ thromboembolism  
 
Cardiac tamponade / perforation 
 
Pericarditis 
 
Pulmonary edema 
 Vascular access complications  
 Heart block  
 
Gastric motility/pyloric spasm disorders  
Late onset (any time through the completion of 12 month follow-up 
visit) 
 Pulmonary vein stenosis  
 
Atrio-esophageal fistula  
ADDITIONAL SAFETY 
ANALYSES: 
1. Severe Ablation Complications 
2. Nonserious / Serious CSEs 
3. Post-Blanking Direct Current Cardioversions 
4. Post-Blanking Arrhythmia Hospitalizations 
5. Any Related SAE 
6. Any Related Stroke or TIA 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
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PRIMARY 
EFFECTIVENESS 
ENDPOINT: 
The primary performance endpoint is Treatment Success in Modified 
Intent-to-Treat (mITT) subjects, defined as: 
Acute Procedural Success, AND 
1. Chronic Success, defined as freedom from: 
a. At the Index / Rescheduled Index Procedure: Use of a non-PFA 
treatment modality for PVI 
b. After the Blanking Period: 
i. Occurrence of any Detectable AF, AFL or AT (excluding 
CTI-dependent AFL confirmed by EP study) 
ii. Cardioversion for AF, AFL or AT (excluding for CTI-
dependent AFL) 
iii. Use of any Type I or Type III antiarrhythmic medication for 
the treatment of AF, AFL or AT 
c. At any time:  
i. Re-ablation for AF, AFL or AT (other than for CTI-
dependent AFL) 
Use of amiodarone, except intra-procedurally to control an arrhythmia 
ADDITIONAL 
EFFECTIVENESS 
ANALYSES: 
 
1. Acute Procedural Success 
2. Acute Vein Success 
3. Chronic Success  
4. Chronic Success Allowing Re-ablation 
5. Chronic Success Allowing AADs 
6. Treatment Success Allowing Re-ablation 
7. Treatment Success Allowing AADs 
8. Treatment Success with PVI/CTI Only 
9. Early Recurrence of AF 
10. Rate of Re-ablation 
11. AF Symptom Assessment 
PROCEDURAL 
ASSESSMENTS: 
 
1. Assessments of duration for procedure components 
a. Procedure time (initiation of venous access to venous access 
closure). 
b. Left atrial dwell time (total time an ablation catheter is in the left 
atrium [LA]) 
c. Total ablation time (first ablation to last ablation) 
d. Fluoroscopy time (total duration of exposure). 
2. Characterization of lesion sets: 
a. PVI ablations 
b. CTI ablations 
c. For subjects undergoing required LA ablations for an accessory 
pathway, AVNRT, left-sided AFL or incessant AT, a description 
of lesion sets utilized
QUALITY OF LIFE 
MEASURES 
Subjects will undergo assessment with the EQ-5D-3 L instrument and 
Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire at 
baseline and 12 months. 

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
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CS1170 REVISION D 
 
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SAMPLE SIZE 
CONSIDERATIONS 
 
Sample size requirements for safety: Sample size is estimated 
assuming an underlying CSE rate of 9% compared to a performance 
goal (PG) of 17% using a binomial exact test. Assuming 80% power 
and one-sided Type I error of 2.5%, a minimum sample size of 150 is 
required. 
Sample size requirements for performance: Sample size is 
estimated assuming an expected percent success of 65% compared to 
a PG of 50% using a binomial exact test. Assuming 80% power and 
one-sided Type I error of 2.5%, a minimum sample size of 85 is 
required. 
Number of subjects: The sample requires 150 analyzable subjects to 
meet both safety and performance calculations. To allow for up to 
15% subject losses, the study size has been set at approximately 180 
subjects. 
CLINICAL EVENTS 
COMMITTEE 
 
An independent panel of 3 electrophysiologists will review AEs, 
adjudicate seriousness and relatedness of potential SAEs and 
adjudicate primary safety and performance outcomes. 
ARRHYTHMIA CORE 
LABORATORY 
 
A qualified Arrhythmia Core Lab (ACL) will be established to 
receive, review and assess all protocol-stipulated ECGs, EMs and 
Holter monitors. 
INCLUSION 
CRITERIA: 
Study subjects are required to meet all the following inclusion criteria 
to participate in this study: 
1. Patients with PAF that meets all the following criteria: 
a. Paroxysmal: AF that terminates spontaneously or with 
intervention within 7 days of onset. 
b. Frequency: 
i. Physician documentation of recurrent PAF (two or 
more episodes) within 6 months, AND 
ii. At least one (1) documented episode by an approved 
recording device within 12 months of enrollment 
 
c. Drug Failed atrial fibrillation drug (AAD) treatment, 
meaning therapeutic failure of at least one AAD (class I – 
IV) for efficacy and / or intolerance. 
2.Patients who are ≥ 18 and ≤ 80 years of age on the day of enrollment. 
3. Patient participation requirements: 
a. Is willing and capable of providing Informed Consent to 
undergo study procedures. 
b. Is willing to participate in all examinations and follow-up 
visits and tests associated with this clinical study.

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
 MAY 18, 2022 
CS1170 REVISION D 
 
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© 2022, Farapulse, Inc. 
EXCLUSION CRITERIA: 
Subjects will be excluded from participating in this study if they meet any 
one of the following exclusion criteria: 
 
1. Atrial fibrillation that is any of the following: 
a. Persistent (both early and longstanding)  by diagnosis or 
continuous duration > 7 days 
b. Secondary to electrolyte imbalance, thyroid disease, alcohol 
or other reversible / non-cardiac causes 
c. Requires four (4) or more direct-current  cardioversions in the 
preceding 12 months 
2. Any of the following atrial conditions: 
a. Left atrial anteroposterior diameter ≥ 5.5 cm 
b. Any prior atrial endocardial or epicardial ablation procedure, other 
than right sided cavotricuspid isthmus ablation or for right sided 
SVT 
c. Any prior atrial surgery 
d. Interatrial septal patch or interatrial shunt 
e. Atrial myxoma 
f. Current LA thrombus 
g. LA appendage closure, device or occlusion 
h. Any PV abnormality, stenosis or stenting (common and middle 
PVs are admissible) 
 
3. At any time, one or more of the following cardiovascular 
procedures, implants or conditions: 
a. Sustained ventricular tachycardia or any ventricular fibrillation 
b. Hemodynamically significant valvular disease 
c. Clinically significant hypertrophic cardiomyopathy 
d. Any prosthetic heart valve, ring or repair including balloon 
aortic valvuloplasty 
e. Contraindication to femoral venous access 
4. Any of the following procedures, implants or conditions: 
a. At baseline: 
i. Congestive heart failure with New York Heart Association 
(NYHA) Class III or IV 
ii. Left ventricular ejection fraction (LVEF) < 35% 
iii. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 
mmHg on two BP measurements at baseline assessment) 
iv. Implantable loop recorder or insertable cardiac monitor 
b. Within the 3 months preceding the Consent Date: 
i. Myocardial infarction 
ii. Unstable angina 
iii. Percutaneous coronary intervention 
iv. Implantation of a pacemaker, cardioverter defibrillator or cardiac 
resynchronization therapy device 
v. Heart failure hospitalization 
vi. Treatment with amiodarone 
vii. Pericarditis or symptomatic pericardial effusion

FARAPULSE FARA-FREEDOM CLINICAL STUDY SYNOPSIS 
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CS1170 REVISION D 
 
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viii. Gastrointestinal bleeding 
c. Within the 6 months preceding the Consent Date: 
i. Heart surgery 
ii. Stroke, TIA or intracranial bleeding 
iii. Any thromboembolic event 
iv. Carotid stenting or endarterectomy 
 
5. Diagnosed disorder of blood clotting or bleeding diathesis 
6. Contraindication to, or unwillingness to use, systemic anticoagulation 
7. Patient who is not on anticoagulation therapy for at least 3 weeks prior to 
the ablation procedure 
8. Women of childbearing potential who are pregnant, lactating, not 
using birth control or planning to become pregnant during the 
anticipated study period 
9. Medical conditions that would prevent participation in the study, 
interfere with assessment or therapy, significantly raise the risk of 
study participation, or confound data or its interpretation, including 
but not limited to: 
a. Body mass index (BMI) > 45.0 
b. Solid organ or hematologic transplant, or currently being 
evaluated for an organ transplant 
c. Severe lung disease, pulmonary hypertension, or any lung 
disease associated with chronic abnormal blood gases or requiring 
supplemental oxygen 
d. Renal insufficiency with an estimated glomerular filtration rate 
(eGFR) < 30 mL/min/1.73 m2,  or any history of renal dialysis 
or renal transplant  
e. Active malignancy or history of treated malignancy within 24 
months of enrollment (other than cutaneous basal cell or 
squamous cell carcinoma) 
f. Active systemic infection 
g. COVID-19 disease 
I. 
Current confirmed, active COVID-19 disease 
II. 
Current positive test for SARS-CoV-2 
III. 
Confirmed COVID-19 disease not clinically resolved at 
least 3 months prior to the Consent Date 
 
h. Other uncontrolled medical conditions that may modify 
device effect or increase risk, including uncontrolled diabetes 
mellitus, untreated sleep apnea or active alcohol abuse 
 
i. Predicted life expectancy less than one (1) year 

FARAPULSE FARA-FREEDOM  CLINICAL STUDY SYNOPSIS 
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EXCLUSION CRITERIA 
(CONTINUED): 
10. Clinically significant psychological condition that in the 
investigator’s opinion would prohibit the subject's ability to 
meet the protocol requirements. 
11. Current or anticipated enrollment in any other clinical study. 
(data collection for registries or retrospective studies is 
permitted)

FARAPULSE FARA-FREEDOM  CLINICAL STUDY SYNOPSIS 
MAY 18, 2022 
CS1170, REVISION D 
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Schedule of Event 
Assessment
Baseline1
Index 
Procedure
Pre- 
Discharge
Day 7 
(7-11 
days)
Day 30 
(± 7 
days)
Day 60 
(± 10 
days)
Re-
Ablation 
Procedures 
Day 90 
(90 ± 14 
days)
Month 6 
(180 ± 
30 days) 
Month 12
(360 ± 30 
days) 
Unscheduled
Informed consent, baseline 
assessments
X2 
 
 
 
 
 
 
 
 
 
 
Anti-arrhythmic drugs 
(AADs)
X 
 
X 
X 
X 
D/C 
AADs
X 
X 
X 
X 
X 
Recurrent arrhythmia, 
cardioversions, ablations, 
hospital admissions
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
Pregnancy test 
X3 
X3 
 
 
 
 
X3 
 
 
 
 
12-lead ECG
X
X
X
X
X
X
Event monitors 
Training 
 
Training 
 
 
 
 
Weekly + symptomatic 
transmissions
X 
72-Hour continuous ECG 
(Holter)
Training 
 
Training 
 
 
 
 
 
X 
X 
 
TEE/CT/ICE to exclude LA 
thrombus
 
X4 
 
 
 
 
X4 
 
 
 
 
NIHSS
X
X
Radiologic examination of 
diaphragm
 
X 
 
 
 
 
X 
X5 
X5 
X5 
 
Post-procedure assessments 
of PVI and CTI ablation
 
X 
 
 
 
 
X 
 
 
 
 
AF Symptom, EQ-5D-3 L 
and AFEQT assessments
X 
 
 
 
 
 
 
 
 
X 
 
Neuro assessment 
 
 
X6 
 
 
 
 
 
 
 
 
Adverse events 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
1   All Baseline Assessments must be generated in the window beginning 30 days prior to the Consent Date and ending on the date of the Index Procedure. 
2   Baseline assessments include the inclusion/exclusion criteria and the data stipulated in Section 4.6.1 
3   Females of childbearing potential only. The pre-procedural pregnancy test is not required if the Index Procedure / Rescheduled Index Procedure is within 30 days of the baseline pregnancy test. 
4   Performed at the beginning of the procedure prior to ablation. See Section 5.3 for managing subjects whose procedure is delayed by intracardiac thrombus. 
5   Only if resolution of phrenic nerve palsy has not yet been demonstrated. May be performed either by fluoroscopic sniff test or inspiration/expiration CXR. 
6 If the post-procedure NIHSS score has increased by 1 or more points or if there is a clinical suspicion of stroke/TIA, then a consulting neurologist will perform a stroke assessment and include the 
results of a concurrent brain MRI. If stroke is diagnosed, a Modified Rankin Scale assessment will be performed prior to discharge and again at 3 months.