A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

 
Protocol Number: PF109                                        Form/Template 92120219_Rev/Ver H 
    Confidential     
                           REPLACE Study Protocol, 92796655, Rev/Ver C 
Page 1 of 111 
 
 
Medical Device Clinical Trial Protocol 
 
Protocol Number: PF109 
 
A Real-world Study of the FARAPULSE Pulsed Field Ablation System in 
A Chinese Population with Paroxysmal Atrial Fibrillation  
 
Investigational Device: FARAPULSETM Pulsed Field Ablation System 
 
Specifications and Models:  
 
 
Class III medical device requiring clinical trial:  Yes□  No☒ 
 
Protocol version and date: Ver C, June 15th, 2022 
 
Clinical trial site：Boao Super Hospital 
Component Name 
Model 
FARASTAR Pulsed Field Ablation Generator System 
FARASTAR  Pulsed Field Ablation Generator 
61M401 
FARASTAR Recording System Module (RSM) 
61M407 
FARASTAR Stimulation Module Cable 
61M404 
FARASTAR EGM Cable 
61M405 
FARASTAR Stimulation Module Auxiliary Cable 
61M408 
FARASTAR  Cable Set  
61M406 
FARASTAR Stimulation Module Male Cable 
61M409 
FARASTAR Stimulation Module Female Cable 
61M410 
FARASTAR Stimulation Module Y-Cable, Long 
61M411 
FARASTAR Stimulation Module Y-Cable, Short 
61M412 
FARASTAR Recording System Module Catheter Pin Cable 
61M413 
FARASTAR Recording System Module ECG Trunk Cable 
61M415 
FARASTAR Recording System Module ECG Output Module 
61M416 
FARASTAR Recording System Module EGM Input Module 
61M417 
FARAWAVE Pulsed Field Ablation Catheter 
FARAWAVE Pulsed Field Ablation Catheter, 35mm 
41M402 
FARAWAVE Pulsed Field Ablation Catheter, 31mm 
41M401 
FARASTAR Catheter Connection Cable 
41M404 
FARADRIVE  Steerable Sheath  
21M402 

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
Confidential      
                        REPLACE Study Protocol, 92796655, Rev/Ver C  
Page 2 of 111 
  
 
Principal Investigator: Chen Minglong 
 
Sponsor: BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC 
China”) 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
Confidential      
                        REPLACE Study Protocol, 92796655, Rev/Ver C  
Page 3 of 111 
  
A Real-world Study of the FARAPULSE Pulsed Field Ablation System in 
A Chinese Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
PF109 
CLINICAL INVESTIGATION PLAN 
 
 
 
 
 
 
 
 
Sponsored By 
 
BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
Section A, 2nd Floor, No. 68 Rijing Road, Free Trade Zone, Shanghai, China 
200131 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
Confidential      
                        REPLACE Study Protocol, 92796655, Rev/Ver C  
Page 4 of 111 
  
 
 
 
Contact Information 
Role 
Contact  
Clinical Contact 
Peng Lv  
Senior Clinical Trial Manager 
Boston Scientific China 
Section A, 2nd Floor, No. 68 Rijing Road, Free Trade Zone, 
Shanghai, China 200131 
Email: Peng.Lv@bsci.com  
Protocol Contact 
Xiuyue Jia 
Medical Affairs Manager 
Boston Scientific China 
Section A, 2nd Floor, No. 68 Rijing Road, Free Trade Zone, 
Shanghai, China 200131 
Email: XIUYUE.JIA@bsci.com 
Principal 
Investigator(s) 
Chen Minglong 
Vendors/Labs 
Vendors/Labs involved in this study may refer to the operating 
manual 
 
 
 

Protocol Number: PF109                                                                                                       Form/Template 92120219_Rev/Ver H 
Confidential      
                                                                                      REPLACE Study Protocol, 92796655, Rev/Ver C 
Page 5 of 111 
 
 
Original Release: November, 18th, 2021  
Current Version: June, 15th, 2022  
 
 
 
Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification 
for 
Modification 
 
Ver A 
November 
18th 2021 
92120219_ 
Rev/Ver G 
NA 
NA  
Initial Release  
Ver B 
December 
22nd 2021 
92120219_ 
Rev/Ver G 
Cover Page 
Delete “Co-Priciple Investigator: 
Fang Pihua” 
Investigator Change 
Ver B 
December 
22nd 2021 
92120219_ 
Rev/Ver G 
Table Contact 
Information 
Delete “Co-Priciple Investigator(s) 
Fang Pihua” 
Investigator Change 
Ver B 
December 
22nd 2021 
92120219_ 
Rev/Ver G 
Section 10.1 
Delete “for PV dimensions”  
PV dimension may not 
be present in the 
cardiac CT report. 
Ver B 
December 
22nd 2021 
92120219_ 
Rev/Ver G 
Section 10.4 
Revise “establishing PV 
dimensions” to “assessing PV” 
PV dimension may not 
be present in the 
cardiac CT report. 
Ver B 
December 
22nd 2021 
92120219_ 
Rev/Ver G 
Section 11.2 
Revise sequence number 
Sequence number 
error 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Throughout 
To comply updated BSC template 
Version. 
Per BSC procedures 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 15.2, 
Section 18.2, 
Section 18.3, 
To comply updated Chinese GCP 
implemented since May 1st, 2022 
To comply with 
updated Chinese GCP  

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
Confidential      
                        REPLACE Study Protocol, 92796655, Rev/Ver C  
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Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification 
for 
Modification 
 
Section 18.6, 
Section 26 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Cover page, 
Section 2. 
Section 5 
Delete “FARADRIVE Steerable 
Sheath (Opaque Shaft)” 
This model will be 
halted and will not be 
used in this study. 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 2, 
Section 8.3 
Revise “valve area < 1.5 cm” to 
“valve area < 1.5 cm2” 
Typo 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 6.2 
Section 11.1 
Section 25.2 
Add supplementary intrudction to 
AAD withdrew after blanking 
period 
Accurate definition 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 8.1 
Revise “8.4” to “8.3” 
Typo 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 10.1 
Delete the “X” represented for 
Device Deficiency in Baseline visit 
Typo 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 10.1, 
Section 10.4 
The indication for pregnancy test is 
revised to be females of childbearing 
potential 
Safety cosideration 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 10.3 
Individuals that can sign ICF are 
revised to be the subject or legal 
representative competent and/or an 
authorized designee. 
To be consistent with 
context in Section 19. 

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
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                        REPLACE Study Protocol, 92796655, Rev/Ver C  
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Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification 
for 
Modification 
 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 10.14 
Delete “IRB” 
Not appliable 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 11.1, 
Section 25.2 
The definition for total procedure 
time is revised to be from the 
initiation of interventional venous 
access puncture to all devices 
remove from the body. 
Specify the definition 
for the total procedure 
time. 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 12.1 
Revise “Medidata” to “iMedidata” 
Typo 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 20.1 
Add “Safety Monitoring Process” 
Section” 
Be consistent with 
Chinese Version 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 25 
Add eCRF, GCPand NMPA; Delete 
IRB and REB 
Abbreviation Revision 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Section 25.2 
Revise the definition of Pulmonary 
edema 
To be consistent with 
the definition in 
Section 6.2. 
Ver C 
June 15th 
2022 
92120219_
Rev/Ver H 
Throughout 
Standard the wording for “eCRF” 
and “EDC system” 
Accurate terminology 
 
 
 

Protocol Number: PF109                                         Form/Template 92120219_Rev/Ver H 
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                        REPLACE Study Protocol, 92796655, Rev/Ver C 
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2. Protocol Synopsis 
A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
Study Objective To observe the safety and effectiveness of the FARAPULSE Pulsed Field 
Ablation System for treatment of recurrent, symptomatic Paroxysmal 
Atrial Fibrillation (PAF) in a Chinese population in the real world. 
Indication for 
Use  
FARAPULSE Pulsed Field Ablation System is intended for the isolation 
of pulmonary veins for the treatment of PAF. 
(Commercial) 
Device/System 
applied as 
Standard of 
Care and sizes, 
if applicable 
o
Component Name 
Model 
FARASTAR Pulsed Field Ablation Generator System 
FARASTAR  Pulsed Field Ablation Generator 
61M401 
FARASTAR Recording System Module (RSM) 
61M407 
FARASTAR Stimulation Module Cable 
61M404 
FARASTAR EGM Cable 
61M405 
FARASTAR Stimulation Module Auxiliary Cable 
61M408 
FARASTAR  Cable Set  
61M406 
FARASTAR Stimulation Module Male Cable 
61M409 
FARASTAR Stimulation Module Female Cable 
61M410 
FARASTAR Stimulation Module Y-Cable, Long 
61M411 
FARASTAR Stimulation Module Y-Cable, Short 
61M412 
FARASTAR Recording System Module Catheter Pin Cable 
61M413 
FARASTAR Recording System Module ECG Trunk Cable 
61M415 
FARASTAR Recording System Module ECG Output Module 
61M416 
FARASTAR Recording System Module EGM Input Module 
61M417 
FARAWAVE Pulsed Field Ablation Catheter 
FARAWAVE Pulsed Field Ablation Catheter, 35mm 
41M402 
FARAWAVE Pulsed Field Ablation Catheter, 31mm 
41M401 
FARASTAR Catheter Connection Cable 
41M404 
FARADRIVE  Steerable Sheath  
21M402 
Study Design 
This is a retrospective and/or prospective single-center single-arm 
observational study. 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
 
*The definitions of ATTEMPT and TREATMENT refer to Section 9.4 
Figure 7.1-1: REPLACE Study Design 
Planned 
Number of 
Subjects 
At least 30 ATTEMPT and TREATMENT subjects  
Planned 
Number of Sites 
/ Countries 
1 site 
Primary 
Endpoint 
Primary Effectiveness Endpoint: 
Acute Procedural Success: Proportion of subjects that achieve electrical 
isolation* of all pulmonary veins (PVs) using FARAPULSE Pulsed Field 
Ablation system only. 
* Electrical isolation of a PV is recommended to be demonstrated by 
entrance block after a 20-minute waiting period at least if the subject is 
enrolled prospectively, otherwise the way to confirm electrical isolation 
should be recorded, including whether there is a waiting period and its 
duration. If exit block testing is performed, the PV will only be considered 
isolated if both entrance and exit block testing was successful. 
Primary Safety Endpoint: 
Occurrence of the acute serious procedure-related and/or device-related 
adverse events at 7 days post index procedure: 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
• 
Death  
• 
Myocardial infarction 
• 
Stroke/ Transient ischemic attack (TIA) 
• 
Peripheral or organ thromboembolism  
• 
Cardiac tamponade/perforation 
• 
Pulmonary edema 
• 
Vascular access complications  
• 
Heart block* 
• 
Gastric motility/pyloric spasm disorders  
• 
Pericarditis 
• 
Atrial esophageal fistula 
• 
Severe PV stenosis  
• 
Phrenic nerve palsy 
*Heart block not attributable to medication effect or vasovagal reaction. 
Secondary 
Endpoints 
Secondary Effectiveness Endpoints: 
1. Chronic Success: Proportion of subjects that free from effectiveness 
events defined as failure as below at 12 months post-procedure. 
       Effectiveness events determining a failure are defined as:  
a) Fail to achieve electrical isolation of all PVs using FARAPULSE 
Pulsed Field Ablation system only. 
b) After the Blanking Period (90 days post the procedure) to 12-month 
after the procedure: 
• 
Occurrence of any Detectable atrial fibrillation (AF), atrial flutter 
(AFL)* or atrial tachycardia (AT) captured by one of the 
following methods:  ≥ 30 seconds in duration recording from 24-
hour Holter Monitor or ≥ 10 seconds recording from 12-lead 
Electrocardiography (ECG); 
• 
Any cardioversion for AF, AFL* or AT; 
• 
Use of any Class I or Class III antiarrhythmic drugs (AADs) for 
the treatment of AF, AFL* or AT. 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
c) At any time through 12 months after the procedure:  
• 
Re-ablation for AF, AFL* or AT; 
• 
Use of amiodarone, except intra-procedurally to control an 
arrhythmia. 
2. Proportion of PVs that achieve electrical isolation by using the 
FARAPULSE Pulsed Field Ablation System only.   
3. Chronic success allowing AADs. 
*excluding cavotricuspid isthmus (CTI)-dependent flutter confirmed by 
electrophysiology study 
Secondary Safety Endpoint: 
Proportion of subjects that free from primary safety events defined as 
above through 7 days after the procedure and free from the following 
serious procedure-related and/or device-related adverse events at any time 
through the completion of 12-month follow-up visit. 
• 
Atrial esophageal fistula  
• 
Severe PV stenosis  
• 
Persistent phrenic nerve palsy* 
*The study will collect information on phrenic nerve palsy observed 
before the end of the index procedure and, in case of occurrence, will 
track information for potential recovery during data collection at the 
study visits. 
Method of 
Assigning 
Patients to 
Treatment 
This is a real-world study, subjects who sign the consent form and meet 
all key eligibility criteria will be enrolled. 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
Follow-up 
Schedule 
This is a retrospective and/or prospective observational study. For 
retrospectively enrolled subjects, data will be collected from each 
patient’s scheduled and unscheduled follow-up visits for 12 months post-
procedure per the standard of care follow-up schedule as defined by their 
center that performs the clinical follow-up visits.  
For prospectively enrolled subjects, data collection at the following visits 
are recommended:  
• 
Baseline Visit 
• 
Procedure 
• 
7 days after the procedure (7-10 days)                 Telephone contact 
• 
1 month after the procedure (30 ±7 days)           Telephone contact 
• 
3 months after the procedure (91-104 days)         Clinic visit 
• 
6 months after the procedure (180 ± 30 days)       Clinic visit 
• 
12 months after the procedure (365 ± 30 days)     Clinic visit 
Study Duration This is a retrospective and/or prospective study. The 12-month follow-up 
data will be collected after the procedure. The study duration is estimated 
up to 18 months depending on the precent of subjects enrolled 
prospectively. 
Participant 
Duration 
The study duration for subjects enrolled prospectively is expected to be 
approximately 12 months, and up to 12months after the procedure for the 
subjects enrolled retrospectively. 
Key Inclusion 
Criteria 
1. Subjects who are ≥ 18 and ≤ 75 years of age on the day of 
enrollment; 
2. Subjects whose preoperative diagnosis is PAF confirmed by the 
clinician; 
3. De novo ablation procedure for PAF with Class I or IIa 
recommendations* according to 2018 Chinese expert consensus 
on atrial fibrillation therapy; 
4. Subjects who are able and willing to provide the defined 
observational data and/or participate in baseline and follow-up 
evaluations for the full study; 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
5. Subjects who are willing and capable of providing informed 
consent. 
* In 2018 Chinese expert consensus on atrial fibrillation therapy, subjects 
with recurrent, symptomatic PAF and refractory or intolerant to at least 
one class I or class III antiarrhythmic medication are recommended to 
accept ablation therapy under Class I recommendation; Subjects with 
recurrent, symptomatic PAF are recommended to accept ablation therapy 
as the first line therapy under Class IIa recommendation. 
Key Exclusion 
Criteria 
1. Subjects who, in the judgment of the investigator, have a life 
expectancy of less than one year before the procedure; 
2. Women of childbearing potential who are, or plan to become, 
pregnant during the time of the study; 
3. Subjects with any known contraindication to AF ablation with 
FARAPULSE Pulsed Field Ablation system, anticoagulation 
therapy, or contrast media in the judgment of the investigator or 
subjects unwillingness to use systemic anticoagulation 
4. Subjects who are currently enrolled in another investigational 
study or registry that would directly interfere with the current 
study. 
Additional 
Exclusion 
Criteria for 
modified Intent-
to-Treat (mITT) 
set 
1. AF that is any of the following: 
• 
Persistent (both early and longstanding) by diagnosis or 
continuous duration > 7 days 
• 
Requires four or more direct-current cardioversions in the 
preceding 12 months before the procedure. 
• 
Secondary to electrolyte imbalance, thyroid disease, 
alcohol or other reversible/ non-cardiac causes 
2. Any of the following atrial conditions: 
• 
Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT 
or transthoracic echocardiography [TTE]*) 
• 
Any prior atrial endocardial or epicardial ablation 
procedure, other than right sided CTI ablation or for right 
sided supraventricular tachycardia 
• 
Any prior atrial surgery 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
• 
Intra-atrial septal patch or interatrial shunt 
• 
Atrial myxoma 
• 
Current left atrium (LA) thrombus# 
• 
LA appendage closure, device or occlusion, past or 
anticipated 
• 
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: 
• 
Sustained ventricular tachycardia or any ventricular 
fibrillation 
• 
Hemodynamically significant valvular disease: 
a) Valvular disease that is symptomatic  
b) Valvular 
disease 
causing 
or 
exacerbating 
congestive heart failure 
c) Aortic stenosis: if already characterized, valve area 
< 1.5 cm2 or gradient > 20 mmHg 
d) Mitral stenosis: if already characterized, valve area 
< 1.5 cm2 or gradient > 5 mmHg 
e) Aortic or mitral regurgitation associated with 
abnormal 
LV 
function 
or 
hemodynamic 
measurements 
• 
Hypertrophic cardiomyopathy 
• 
Any prosthetic heart valve, ring or repair including balloon 
aortic valvuloplasty 
• 
Pacemaker, implantable cardioverter defibrillator or 
cardiac resynchronization therapy devices 
• 
Any inferior vena cava (IVC) filter, known inability to 
obtain vascular access or other contraindication to femoral 
access 
• 
History of rheumatic fever 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
• 
History of congenital heart disease with any residual 
anatomic or conduction abnormality 
4. Any of the following procedures, implants or conditions: 
• 
At baseline or assessment before the procedure: 
a) New York Heart Association (NYHA) Class III/IV 
b) Left ventricular ejection fraction (LVEF) < 40% 
c) Symptomatic 
hypotension 
or 
Uncontrolled 
hypertension (Systolic blood pressure > 160 
mmHg or Diastolic blood pressure > 95 mmHg on 
two blood pressure measurements at baseline 
assessment) 
d) Symptomatic resting bradycardia 
e) Implantable loop recorder or insertable cardiac 
monitor 
• 
Within the 3 months preceding the procedure: 
a) Myocardial infarction or Unstable angina or 
Percutaneous coronary intervention 
b) Heart failure hospitalization 
c) Treatment with amiodarone 
d) Pericarditis or symptomatic pericardial effusion 
e) Gastrointestinal bleeding 
• 
Within the 6 months preceding the procedure: 
a) Heart surgery 
b) Stroke, TIA or intracranial bleeding 
c) Any thromboembolic event 
d) Carotid stenting or endarterectomy 
5. Diagnosed disorder of blood clotting or bleeding diathesis 
6. Subject who is not on anticoagulation therapy for at least 3 
weeks prior to the ablation procedure 
7. Medical conditions assessed before the procedure that would 
prevent participation in the study, interfere with assessment or 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
therapy, significantly raise the risk of study participation, or 
modify outcome data or its interpretation, including but not 
limited to: 
• 
Body Mass Index (BMI) > 40.0 kg/m2 
• 
Solid organ or hematologic transplant, or currently being 
evaluated for an organ transplant 
• 
Severe lung disease, pulmonary hypertension, or any lung 
disease involving abnormal blood gases or requiring 
supplemental oxygen 
• 
Renal insufficiency with an estimated glomerular filtration 
rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal 
dialysis or renal transplant 
• 
Active malignancy or history of treated malignancy within 
24 months of enrollment (other than cutaneous basal cell 
or squamous cell carcinoma) 
• 
Clinically significant gastrointestinal problems involving 
the esophagus or stomach including severe or erosive 
esophagitis, uncontrolled gastric reflux, gastroparesis, 
esophageal candidiasis or active gastroduodenal ulceration  
• 
Active systemic infection 
• 
COVID-19 disease 
a) Current confirmed, active COVID-19 disease 
b) Current positive test for SARS-CoV-2 
c) Confirmed COVID-19 disease not clinically 
resolved at least 3 months prior to the procedure 
• 
Other uncontrolled medical conditions that may modify 
device effect or increase risk, including uncontrolled 
diabetes mellitus (HgbA1c > 8.0% if test result already 
obtained), untreated obstructive sleep apnea or active 
alcohol abuse 
8. Clinically significant psychological condition that in the 
Investigator’s opinion would prohibit the subject's ability to meet 
the protocol requirements 
9. Employees/family members of: 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
• 
Boston Scientific or any of its affiliates or contractors 
• 
The Investigator, sub-Investigators, or their medical office 
or practice, or healthcare organizations at which study 
procedures may be performed 
10. Subjects known to require or have accepted ablation outside the 
PV region during the procedure except CTI region ablation. 
*TTE obtained ≤ 6 months prior to procedure will be acceptable, unless a cardiac event 
has occurred (e.g. MI, acute heart failure or acute onset heart failure) between the date 
of the exam and the procedure. In this case, a new TTE is needed to confirm eligibility 
for mITT. The most recent report before the procedure will be used. LA anteroposterior 
diameter measured by M-mode from the parasternal long-axis view will be used.  
 #The absence of thrombus must be confirmed by means of a trans-esophageal 
echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac 
Echography (ICE) during the procedure. 
￥ Cardiac CT/MRI obtained ≤ 3 months prior to procedure will be acceptable. 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
There are no formal hypotheses testing in this small sample size 
observational study. 
Statistical Test 
Method 
Descriptive statistics will be conducted for the endpoint events. 
Explorative statistical analysis might be produced if appropriate, such as 
Bayesian estimation of the study results using ADVENT data as the prior. 
Primary effectiveness endpoints will be summarized for TREATMENT 
subjects in modified Intent-to-Treat (mITT) set.  
Secondary 
effectiveness 
endpoints 
will 
be 
summarized 
for 
TREATMENT subjects in Intent-to-Treat (ITT) set and mITT set 
respectively. 
Primary and secondary safety endpoints will be summarized for 
ATTEMPT and TREATMENT subjects in  ITT set.  
The additional endpoints will be summarized for TREATMENT subjects 
in ITT set. 
Sample Size 
Parameters 
No formal sample size calculation is performed because there is no 

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A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese 
Population with Paroxysmal Atrial Fibrillation 
(REPLACE Study) 
formal hypothesis testing in the study. The following table provides a 
95% confidence interval (exact methods) for a sample size of 30 if there 
are 0 ~ 3 primary safety events. 
  
Events 
Rates (n=30) 
Lower 95%CI 
Upper 95%CI 
0 
0% 
0% 
11.6% 
1 
3.3% 
0.1% 
17.2% 
2 
6.7% 
0.8% 
22.1% 
3 
10% 
2.1% 
26.5% 
 
 
 
 

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3. Table of Contents 
1. 
COVER PAGE ....................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................4 
3. 
TABLE OF CONTENTS .......................................................................................................19 
3.1. Table of Figures .....................................................................................................24 
3.2. Table of Tables ......................................................................................................24 
4. 
INTRODUCTION ................................................................................................................25 
4.1. Background ............................................................................................................25 
4.1.1. 
Background and Rationale ......................................................................25 
4.1.2. 
Irreversible Electroporation ....................................................................25 
4.1.3. 
Summary of Clinical Studies about FARAPULSE Pulsed Field 
Ablation System used for PAF ................................................................26 
4.2. Study Rationale .....................................................................................................30 
5. 
(COMMERCIAL) DEVICE DESCRIPTION (PART OF STANDARD OF CARE) .......................30 
5.1. Commercial Device Under Study ........................................................................30 
5.1.1. 
Names of Investigational Devices ...........................................................30 
5.1.2. 
Intended Use ............................................................................................31 
5.1.3. 
FARAPULSE Pulsed Field Ablation System .........................................31 
5.1.3.1. 
FARAWAVE Pulsed Field Ablation Catheter .......................33 
5.1.3.2. 
FARASTAR Pulsed Field Ablation Generator system ..........34 
5.1.3.3. 
FARADRIVE Steerable Sheath..............................................35 
5.2. Required Medical Equipment ..............................................................................36 
5.3. Required Procedures ............................................................................................36 
5.3.1. 
TEE/ICE...................................................................................................36 
5.3.2. 
Pulsed Field Ablation for PVI .................................................................36 
5.3.3. 
Additional Ablation ..................................................................................37 
5.4. Required Medications ...........................................................................................37 
5.4.1. 
Anti-Arrthythmic Drugs (AADs) .............................................................37 
5.4.1.1. 
AADs prior to index procedure ...............................................37 
5.4.1.2. 
AADs post Index Procedure during the 90-day blanking 
period .......................................................................................37 
5.4.1.3. 
AADs post blanking period .....................................................37 
5.4.2. 
Anticoagulation ........................................................................................37 

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5.4.2.1. 
Pre-ablation .............................................................................37 
5.4.2.2. 
Intra ablation...........................................................................38 
5.4.2.3. 
After ablation...........................................................................38 
6. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................................38 
6.1. Study Objectives ....................................................................................................38 
6.2. Study endpoints .....................................................................................................40 
6.2.1. 
Primary Endpoints ...................................................................................40 
6.2.1.1. 
Primary Effectiveness Endpoint .............................................40 
6.2.1.2. 
Primary Safety Endpoint ........................................................40 
6.2.2. 
Secondary Endpoints ...............................................................................43 
6.2.2.1. 
Secondary Effectiveness Endpoints........................................43 
6.2.2.2. 
Secondary Safety Endpoints ...................................................43 
6.2.3. 
Other Endpoints .......................................................................................44 
7. 
STUDY DESIGN .................................................................................................................44 
7.1. Scale and Duration ................................................................................................44 
7.2. Treatment Assignment..........................................................................................45 
7.2.1. 
Target and Non-target Lesions................................................................45 
7.3. Justification for the Study Design ........................................................................45 
7.4. Method to control biases .......................................................................................45 
8. 
SUBJECT SELECTION ........................................................................................................46 
8.1. Study Population and Eligibility ..........................................................................46 
8.2. Inclusion Criteria ..................................................................................................46 
8.3. Exclusion Criteria .................................................................................................47 
9. 
SUBJECT ACCOUNTABILITY .............................................................................................51 
9.1. Point of Enrollment ...............................................................................................51 
9.2. Withdrawal ............................................................................................................52 
9.3. Lost to Follow-Up ..................................................................................................52 
9.4. Subject Status and Classification .........................................................................52 
9.4.1. 
Screening Failure ....................................................................................53 
9.4.2. 
INTENT ...................................................................................................53 
9.4.3. 
ATTEMPT ................................................................................................53 
9.4.4. 
TREATMENT ..........................................................................................54 
9.5. End-of-Study Definition .......................................................................................54 
9.6. End of Study Action Plan .....................................................................................54 

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10. STUDY METHODS .............................................................................................................54 
10.1. Data Collection ......................................................................................................54 
10.2. Study Candidate Screening ..................................................................................57 
10.2.1. Strategies for Recruitment and Retention...............................................57 
10.3. Informed Consent .................................................................................................57 
10.4. Baseline Visit .........................................................................................................57 
10.5. Procedure Visit ......................................................................................................58 
10.5.1. Index procedure .......................................................................................58 
10.5.1.1. Pulmonary vein isolation ........................................................59 
10.5.1.2. Pulmonary vein isolation validation.......................................59 
10.5.1.3. Pulmonary vein isolation conclusion .....................................60 
10.5.1.4. Additional ablations ................................................................60 
10.5.2. Data collection during procedure visit ....................................................60 
10.6. Seven Day Follow-up Visit (7-10 days) ................................................................61 
10.7. One Month Follow-up Visit (30 ± 7 days) ...........................................................62 
10.8. Three Month Follow-up Visit (91-104 days) .......................................................62 
10.9. Six Month Follow-up Visit (180 ± 30 days) .........................................................63 
10.10. Twelve Month Follow-up Visit (365 ± 30 days) ................................................64 
10.11. Unscheduled Visit ...............................................................................................64 
10.12. Re-ablation Procedure ........................................................................................65 
10.13. Study Completion ...............................................................................................65 
10.14. Unforeseen Circumstances (Natural Disaster/Global Pandemic) ..................65 
10.15. Source Documents ..............................................................................................66 
10.16. Local vendor documentation .............................................................................67 
11. STATISTICAL CONSIDERATIONS ......................................................................................68 
11.1. Endpoints ...............................................................................................................68 
11.1.1. Primary Endpoints ...................................................................................68 
11.1.1.1. Primary Safety Endpoint ........................................................68 
11.1.1.2. Primary Effectiveness Endpoint .............................................68 
11.1.2. Secondary Endpoints ...............................................................................69 
11.1.2.1. Secondary Safety Endpoints ...................................................69 
11.1.2.2. Secondary Effectiveness Endpoint 1 ......................................69 
11.1.2.3. Secondary Effectiveness Endpoint 2 ......................................70 
11.1.2.4. Secondary Effectiveness Endpoint 3 ......................................70 
11.1.3. Additional Endpoints ...............................................................................70 
11.2. General Statistical Methods .................................................................................71 

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11.2.1. Analysis Sets .............................................................................................71 
11.2.2. Control of Systematic Error/Bias ............................................................71 
11.2.3. The Method of Handling Missing Value and Outliers ...........................71 
11.2.4. Number of Subjects per Investigative Site ..............................................72 
11.3. Data Analyses. .......................................................................................................72 
11.3.1. Primary Endpoints/Measurements ..........................................................72 
11.3.2. Secondary Endpoints/Measurements ......................................................72 
11.3.3. Additional Endpoints/Measurements ......................................................72 
11.3.4. Interim Analyses ......................................................................................73 
11.3.5. Subgroup Analyses ..................................................................................73 
11.3.6. Univariable Analyses ...............................................................................73 
11.3.7. Changes to Planned Analyses .................................................................73 
12. DATA MANAGEMENT .......................................................................................................73 
12.1. Data Collection, Processing, and Review ............................................................73 
12.2. Data Retention .......................................................................................................74 
12.3. Technical Source Forms .......................................................................................74 
13. AMENDMENT ....................................................................................................................75 
14. DEVIATIONS .....................................................................................................................75 
15. COMPLIANCE ....................................................................................................................76 
15.1. Statement of Compliance ......................................................................................76 
15.2. Investigator Responsibilities ................................................................................76 
15.2.1. Delegation of Responsibility ...................................................................78 
15.3. Ethics Committee ..................................................................................................78 
15.4. Sponsor Responsibilities .......................................................................................78 
15.4.1. Role of Boston Scientific Representatives .............................................79 
15.5. Insurance ................................................................................................................80 
16. MONITORING ....................................................................................................................80 
17. POTENTIAL RISKS AND BENEFITS ...................................................................................80 
17.1. Instructions for Use ...............................................................................................80 
17.2. Risks associated with Participation in the Clinical Study .................................80 
17.3. Risk Minimization Actions ...................................................................................81 
17.4. Anticipated Benefits ..............................................................................................81 

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18. SAFETY REPORTING .........................................................................................................81 
18.1. Reportable Events by investigational site to Boston Scientific .........................81 
18.2. Definitions and Classification ..............................................................................82 
18.3. Relationship to Study Device(s) and/or Study Procedure .................................85 
18.4. Investigator Reporting Requirements .................................................................87 
18.5. Device Deficiencies ................................................................................................89 
18.6. Reporting to ECs/ Investigators ...........................................................................90 
18.7. Subject Death Reporting ......................................................................................90 
19. INFORMED CONSENT........................................................................................................91 
20. COMMITTEES ...................................................................................................................93 
20.1. Safety Monitoring Process ....................................................................................93 
20.2. Steering Committee ...............................................................................................93 
21. SUSPENSION OR TERMINATION .......................................................................................93 
21.1. Premature Termination of the Study ..................................................................93 
21.1.1. Criteria for Premature Termination of the Study...................................93 
21.2. Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval ................................................................................................................94 
21.3. Requirements for Documentation and Subject Follow-up ................................94 
21.4. Criteria for Suspending/Terminating a Study Site ............................................94 
22. STUDY REGISTRATION AND RESULTS .............................................................................94 
22.1. Study Registration .................................................................................................94 
22.2. Clinical Investigation Report ...............................................................................95 
22.3. Publication Policy ..................................................................................................95 
23. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................95 
23.1. Subject Reimbursement........................................................................................95 
23.2. Compensation for Subject’s Health Injury ........................................................95 
24. BIBLIOGRAPHY .................................................................................................................96 
25. ABBREVIATIONS AND DEFINITIONS .................................................................................97 
25.1. Abbreviations ........................................................................................................97 
25.2. Definitions ..............................................................................................................99 

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26. APPENDICES ...................................................................................................................103 
 
3.1. Table of Figures 
Figure 5.1-1: FARAPULSE Pulsed Field Ablation System Components ........................ 32 
Figure 5.1-2: FARAWAVE Pulsed Field Ablation Catheter ............................................ 33 
Figure 5.1-3: FARAWAVE Pulsed Field Ablation Catheter - Deployed States ............. 34 
Figure 5.1-4: FARADRIVE Steerable Sheath .................................................................... 35 
Figure 7.1-1: REPLACE Study Design ............................................................................... 45 
 
3.2. Table of Tables 
Table 4.1-1. Summary of FARAPULSE clinical trials for PAF ....................................... 28 
Table 5.1-1 FARAPULSE Pulsed Field Ablation System Components ........................... 31 
Table 6.1-1 Overview of Primary and Secondary Objectives and Endpoints ................. 38 
Table 6.2-1 Composite Safety Endpoint Definitions .......................................................... 40 
Table 8.2-1 Inclusion Criteria .............................................................................................. 47 
Table 8.3-1 Exclusion Criteria ............................................................................................. 48 
Table 10.1-1 Data Collection Schedule ............................................................................... 55 
Table 10.15-1 Source Documentation Requirements ........................................................ 66 
Table 18.2-1 Safety Definitions ............................................................................................ 81 
Table 18.3-1 Criteria for Assessing Relationship of Study Device(s) or Procedure to 
Adverse Even ...................................................................................................... 85 
Table 18.4-1 Investigator Reporting Requirements .......................................................... 88 
Table 25.1-1 Abbreviations .................................................................................................. 97 
Table 25.2-1 Definitions ........................................................................................................ 99 
 

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4. Introduction 
4.1. Background 
4.1.1. Background and Rationale 
AF is the most common sustained cardiac arrhythmia, affecting approximately 33.5 million 
people worldwide estimated at 2010[1]. The currently estimated prevalence of AF in adults is 
between 2% and 4%, and a 2.3-fold rise is expected, owing to extended longevity in the general 
population and intensifying search for undiagnosed AF[2]. According to the atrial fibrillation 
prevalence survey of adults in China in 2021, it is estimated that there are about 7.9 million 
patients with atrial fibrillation in China[3] . The annual risk of AF-related stroke is 5% per year 
and 1 of every 6 strokes diagnosed occurs in the presence of AF[4]. 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 LA, tachycardia-induced cardiomyopathy 
and reduced left ventricular function (heart failure). AF remains a significant cause of 
morbidity and mortality in industrialized societies. 
At present, radiofrequency ablation and cryoablation are the main energy forms for atrial 
fibrillation ablation, but both ablation mechanisms rely on heat conduction and have no tissue 
selectivity. If the ablation is insufficient, the prevalence of electrical reconnection of 
pulmonary vein is high; if the ablation is excessive, there is a risk of adjacent injury. According 
to 2018 Chinese expert consensus statement on atrial fibrillation therapy, the incidence of 
complications after radiofrequency ablation of atrial fibrillation is about 6.29%, and the late 
recurrence rate of atrial arrhythmia is about 25%-40%[1]. Thus, it has become a mission for 
cardiac electrophysiologists to find a strategy to improve the safety and efficacy of atrial 
fibrillation ablation. 
4.1.2. Irreversible Electroporation 
In 2007, Al-Sakere, et al.[5] described irreversible electroporation (IRE) 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 [6,7,8,9] . IRE ablation 
typically spares the extracellular matrix, which facilitates rapid wound healing[10,11,12,13,14]. 
In 2011, Thomson, et al.[15] reported a case-series study (N=38) assessing the safety of IRE for 
treating liver, kidney or lung cancers in humans. The first four patients showed signs of 
transient ventricular arrhythmia, so subsequent patients were all treated using ECG-
synchronized delivery of electroporation pulses. There were 2 further arrhythmias and 2 cases 
of inadvertent damage to neighboring organs. Approximately 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 investigated the potential effectiveness 
and safety of epicardial electroporation in AF ablation procedures using porcine models. In 
2011, Wittkampf, et al. [16] (N=10) used a circular ablation catheter and showed that PVI was 

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achieved in all animals, with no sign of stenosis at 3-week follow-up. In 2014, Van Driel, et 
al.[17] (N=6) confirmed this result out to 3-month follow-up. In 2014, Neven, et al [18] (N=5) 
showed that electroporation lesion depth depended on the level of electrical energy applied, 
reaching 8 mm at 300 joules. In 2015, Van Driel, et al.[19] (N=20) showed that electroporation 
could create deep lesions close to the phrenic nerve without damage to the nerve. In 2014, 
Neven, et al.[20] similarly showed that neighboring coronary arteries were undamaged by 
electroporation (N= 5). These animal studies suggest that IRE can safely create deep lesions in 
heart tissue without harming adjacent tissues. 
4.1.3. Summary of Clinical Studies about FARAPULSE Pulsed Field Ablation 
System used for PAF 
The FARAPULSE Pulsed Field Ablation system has accumulated large amount of clinical 
data. Its pre-market studies include IMPULSE, PEFCAT, PEFCAT II and ADVENT studies 
(Table 4.1-1). In addition, there are also some observational trials with small sample size 
published aiming to observe its clinical safety and efficacy. 
In these clinical studies, the primary safety endpoint was defined as the occurrence of 
predefined serious adverse events at 7 or 30 days after the procedure. The acute procedural 
success, PVI durability, long-term success and therapeutic success were often designed as the 
primary or secondary efficacy endpoints. Acute procedural success rate was defined as the 
proportion of subjects that achieved PVI with FARAPULSE Pulsed Field Ablation system 
only; PVI durability was defined as proportion of subjects with durable PVI in the remapping 
evaluation at 2-3 months after the procedure; Long-term success rate was defined as proportion 
of subjects free from post-blanking AF, AFL or AT; Therapeutic success rate was defined as 
the proportion of subjects free from post-blanking AF, AFL or AT, post-blanking electrical 
cardioversion, post-blanking ablation for AF, AFL or AT, and at any time ablation with a non-
study device. 
IMPULSE study 
The IMPULSE study was a prospective multi-center single-arm study, aiming to observe the 
safety and efficacy of the FARAPULSE Pulsed Field Ablation system in the treatment of 
PAF[21]. Forty patients with drug-refractory PAF accepted FARAPULSE Pulsed Field 
Ablation system ablation. All subjects received electrophysiological remapping at 3 months 
after the procedure to assess PVI durability and were then followed up for 12 months. The 
primary safety endpoint was the incidence of serious adverse events within 7 days after the 
procedure, and the primary efficacy endpoint was acute procedural success rate. The secondary 
efficacy endpoints included chronic procedural success rate at 12 months after the procedure. 
The results showed that the occurrence of serious adverse events was 2.5% (1/40), including 
one subject reporting asymptomatic pericardial effusion. The acute procedural success rate was 
100% (40/40), the PVI durability at 3 months after procedure was 41.2% (14/34), and the long-
term success rate was 77.5% (31/40). This study provided preliminary data of the safety and 
efficacy of the FARAPULSE Pulsed Field Ablation system in clinical use and provide 
references for optimizing the ablation parameters. 
PEFCAT and PEFCAT II studies 
The PEFCAT study was a prospective multi-center single-arm study, aiming to further observe 
the safety and efficacy of the FARAPULSE Pulsed Field Ablation system in the treatment of 

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PAF with optimized parameters[22]. Seventy-one patients with drug-refractory PAF accepted 
FARAPULSE Pulsed Field Ablation system ablation. Invasive remapping was performed at 
75 days after the procedure, and reconnected PVs were reisolated with PFA or radiofrequency 
ablation. After a 90-day blanking period, arrhythmia recurrence was assessed over 1-year 
follow-up. The primary safety endpoint was the incidence of serious adverse events within 30 
days after the procedure, the primary efficacy endpoint was the acute procedural success rate, 
and the secondary efficacy endpoints included the PVI durability at 75 days and the long-term 
success rate at 1 year. The results showed that the incidence of serious adverse events was 
2.8% (2/71), including 1 pericardial tamponade and 1 arteriovenous fistula. The acute 
procedural success rate was 100% (71/71), the PVI durability at 75 days was 75.8% (50/66), 
and the long-term success rate at 1 year was 77.9% (53/68). Additional analysis showed that 
the therapeutic success was 66.2% (45/68). 
The PEFCAT II study was an extending study of the PEFCAT study[23]. It had the same trial 
design with PEFCAT study, except allowing the physicians to use the FARAFLEX catheter 
(another ablation catheter developed by FARAPULSE, Inc) to create focal lesion or tricuspid 
isthmus ablation. Ten patients with PAF were enrolled and the results showed that the primary 
safety endpoint was 0% (0/10), the acute procedural success rate was 100% (10/10), the PVI 
durability at 75 days was 77.8% (7/9), the long-term success rate at 1 year was 90% (9/10), 
and the therapeutic success rate was 80% (8/10).  
Since the PEFCAT and PEFCATII studies have similar study design, the clinical team 
conducted a consolidated analysis to apply CE certification[24]. In this consolidated analysis 
with 81 subjects, the primary safety endpoint was defined as device and/or procedure related 
serious adverse events within 30 days, and the analysis set was the ITT population (81 cases), 
which was defined as all enrolled eligible subjects except those who terminated their 
participation prior to the beginning of the Index Procedure. The primary efficacy endpoint was 
the long-term success rate at 1 year after the procedure, and the analysis set was the mITT 
population (64 cases), which was defined as those ITT subjects who did not undergo 
radiofrequency re-ablations (at any time) or post-blanking PFA ablations. The primary efficacy 
endpoint was statistically analyzed using Kaplan-Meier method. The results showed that the 
primary safety endpoint was 1.2% (1/81), and the primary efficacy endpoint was 82.4% 
(95%CI: 70.5%-89.9%). Other analysis showed the acute procedural success rate was 100% 
(81/81), the PVI durability at 2-3 months after the procedure was 76% (57/75), and the long-
term success rate at 1 year was 79.2% (95% CI: 68.3%-86.7%) in ITT analysis set.  
In summary, the perioperative complications after FARAPULSE Pulsed Field Ablation system 
ablation were rare, and the acute procedural success rate was 100%. PVI durability and long-
term success rate are also quite considerable. 
ADVENT Study 
The ADVENT study (the FDA IDE study) is a prospective multi-center randomized controlled 
non-inferiority adaptive study, aiming to compare the FARAPULSE Pulsed Field Ablation 
system with standard of care ablation with force-sensing radiofrequency catheters and 
cryoballoon catheters indicated for the treatment of PAF[25]. Patients with PAF who meet the 
inclusion and exclusion criteria will be randomly assigned to the PFA group or thermal ablation 
group with a ratio of 1:1, and then be followed up for 1 year. The primary safety endpoint is 
the occurrence of device and/or procedure related serious adverse events within 7 days after 

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the procedure, and the analysis set is the PP population, which is defined as eligible subjects 
who has had a study ablation catheter inserted into the body at an Index/Rescheduled Index 
Procedure. The primary efficacy endpoints include the acute procedural success rate and the 
long-term therapeutic success at 1 year after the procedure in the absence of Class I/III AADs 
treatment after the blanking period, and the analysis set is mITT population, which is defined 
as the eligible subjects who have accepted energy delivery from FARAPULSE Pulsed Field 
Ablation system for PVI. The statistical assumption is that the primary safety endpoint and 
primary efficacy endpoint of the PFA group are not inferior to those of the thermal ablation 
group, and the sample size calculated under non-inferiority model and adaptive design results 
in 900 cases at most. The trial is currently ongoing. 
 
Table 4.1-1. Summary of FARAPULSE clinical trials for PAF 
 
Study 
name 
Sample 
Size 
Trial 
design 
Primary endpoints and 
results 
Other 
endpoints 
and 
results 
IMPULSE 
40 
subjects 
with 
PAF 
A 
prospective 
multicenter 
single-arm 
cohort 
study 
Safety: Serious adverse 
events at 7 days: 2.5% 
(95%CI: 0.1%-13.2%) 
Efficacy: Acute success 
rate: 
100% 
(95%CI: 
89.6%-100%) 
Durable PVI rate at 3 
months: 
41.2% 
(95%CI: 
24.6%-95.3%) 
PEFCAT+ 
PEFCAT II 
81 
subjects 
with 
PAF 
A 
prospective 
multicenter 
single-arm 
cohort 
study 
Safety: Serious adverse 
events in ITT population 
at 30 days: 1.2% (95%CI: 
0.0%-6.7%) 
Efficacy: Freedom from 
AF/AFL/AT 
from 
blanking period to 12 
months 
after 
the 
procedure 
in 
mITT 
population: 
82.4% 
(95%CI: 70.5%-89.9%) 
ITT analysis set: Acute 
success rate: 100% (95%CI: 
95.5%-100%);  
Durable PVI rate at 75 days: 
76.0% 
(95%CI: 
64.7%-
85.1%);  
Long-term success rate from 
blanking 
period 
to 
12 
months: 
79.2% 
(95%CI: 
68.3%-86.7%) 
mITT analysis set: Long-
term success rate after single 
PFA ablation from blanking 
period to 12 months: 69.9% 
(95%CI: 56.9%-79.6%) 
ADVENT 
(In 
progress) 
900 
subjects 
with 
PAF 
A 
prospective 
multicenter 
randomized 
controlled 
non-
inferiority 
adaptive 
study 
Safety: Serious adverse 
events at 7 days 
Efficacy: Freedom from 
AF/AFL/AT 
from 
blanking period to 12 
months 
after 
the 
procedure in absent of 
Class 
I/III 
AADs, 
additional ablation and 
electric 
cardioversion 
after blanking period. 
Acute success rate 
Therapeutic success rate 
In 2019, Reddy VY et al.[26] summarized and reported the preliminary data from IMPULSE 
and PEFCAT studies. The data from 81 subjects showed that the durable PVI rate after PFA 
varied with different phases or parameters (18%-100%), and the durable PVI rate after ablation 
with optimized waveform (biphasic wave; 1800-2000V) was the highest. In 2021, Reddy VY 
et al.[27] summarized and reported the 1-year follow-up data of 121 subjects in the IMPULSE 
study, PEFCAT and PEFCAT II studies, and they also performed subgroup analysis based on 
whether the subjects treated with optimized PFA parameters or not. The statistical results 

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showed that the incidence of the primary safety endpoint (device and/or procedure related 
serious adverse events within 7 days for IMPULSE/within 30 days for PEFCAT) was 2.5% 
(3/121; 2 pericardial effusion and 1 arteriovenous fistula), and no esophagus injury, phrenic 
nerve damage or stroke events were reported. The PVI durability at 2-3 months after the 
procedure was present in 84.1% of patients treated with optimized waveform. At 1 year, the 
Kaplan-Meier estimate for freedom from AF, AFL or AT was 78.5±3.8% and 84.5±5.4% for 
the entire cohort or PFA-optimized waveform cohort, respectively. 
Other studies 
The safety and efficacy of the FARAPULSE Pulsed Field Ablation system in the treatment of 
PAF have also been verified in some other clinical literatures. In 2018, Reddy VY et al.[28] first 
reported the postoperative data of 15 patients with PAF who received the endocardial ablation 
with FARAPULSE Pulsed Field Ablation system. The acute success rate was 100% and no 
adverse events were reported, which initially proved the safety and efficacy of FARAPULSE 
Pulsed Field Ablation system in the treatment of PAF. 
In 2020, Kuroki K et al.[29] compared the changes in PV ostial diameters after radiofrequency 
ablation (RFA) and PFA in 80 patients with PAF (PFA group: 37 cases, RFA group: 43 cases). 
All subjects received left atrial CT evaluations at baseline and 3 months after the procedure, 
and PV ostial diameter was quantitatively and qualitatively analyzed by 2 physicians. The 
results showed the changes in the PV ostial diameters in the PFA group were significantly 
slighter than those in RFA group (PFA vs RFA: Long axis: 0.9%±8.5% vs -11.9% ±16.3%, 
P<0.001; short axis: 3.4%±12.7% vs -12.9%±18.5%, P<0.001). In the RFA group, pulmonary 
vein stenosis was diagnosed as Mild (30% - 49%), Moderate (50% - 69%), or Severe (70% - 
100%) at 9.0%, 1.8%, and 1.2% of patients, respectively, while in the PFA group, only 0.8% 
patents were diagnosed as mild pulmonary vein stenosis. The results of qualitative analysis 
showed that 12% of patients in RFA group and 0% of patients in PFA group were diagnosed 
as ablation related pulmonary vein stenosis. This study indicates that unlike after RFA, the 
incidence and severity of PV narrowing/stenosis after PV isolation is virtually eliminated with 
PFA. 
In 2021, Cochet H et al.[30] and Nakatani Y et al.[31] respectively evaluated the adjacent tissue 
injury and the atrial compliance in 41 PAF patients (PFA group: 18 cases accepted PFA, 
thermal ablation group: 16 cases accepted RFA, 7 cases accepted cryoballoon ablation). All 
subjects accepted MRI evaluation at baseline, acute phase (<3 h) and 3 months after ablation. 
Late gadolinium enhanced (LGE) imaging was used to evaluate adjacent tissues injury, and 
the phrenic nerve damage was evaluated intraoperatively by pacing. No diaphragmatic 
paralysis was reported during ablation in both groups. In the acute phase after ablation, 43% 
of patients in the thermal ablation group showed esophageal lesions adjacent to the ablation 
site, while no esophageal lesion was detected in the PFA group (P < 0.001). Additionally, the 
volume of LGE accumulation after PFA was 60% larger than that after thermal ablation (P < 
0.001), which aligned with the effect of PFA electroporation, however the volume of 
myocardial edema in the PFA group revealed by T2 imaging was 20% smaller than thermal 
ablation group (P = 0.002). There was no sign of microvascular injury or intramural 
hemorrhage in the ablation zone after PFA ablation. The MRI T2 imaging examination 
performed at 3 months after the procedure showed that the majority of acute myocardial LGE 
had disappeared after PFA, while most LGE persisted after the thermal ablation, indicating 

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that the PFA ablation has a specific reparative process involving less chronic fibrosis. In 
addition, the maximum strain on PV antra, the left atrial expansion index, and the left atrial 
emptying fraction declined acutely after PFA and thermal ablation but recovered at chronic 
stage only with PFA.  
In summary, the FARAPULSE Pulsed Field Ablation system has a satisfied efficacy in the 
ablation of PAF. The acute success rates of PVI in different trials were all 100%. The PVI 
durability at 2-3 months after the procedure was present in 84.1% of patients treated with 
optimized waveform. Long-term outcome at 1 year was also comparable with exiting data. In 
addition, the FARAPULSE Pulsed Field Ablation system potentially improved the safety of 
the procedure. The incidence of perioperative serious adverse events was about 0 - 2.5%. No 
esophageal injury, phrenic nerve damage, or stroke were reported. Some clinical studies 
showed that, compared with thermal ablation, FARAPULSE Pulsed Field Ablation system had 
potential advantages in avoiding pulmonary vein stenosis, reducing damage to adjacent tissues, 
and sparing of the left atrial myocardium compliance. 
4.2. Study Rationale 
Catheter ablation for PAF with a variety of energy sources and catheter configurations has 
been demonstrated to be a safe and effective procedure. The FARAPULSE Pulsed Field 
Ablation System has undergone preclinical and clinical testing to demonstrate its preliminary 
safety and effectiveness for isolating PVs quickly and with minimal complications, using a 
standard catheter-based endocardial procedure. The System has undergone preclinical testing 
in representative models to demonstrate that it can isolate PVs quickly, durably and with 
minimal complications, using a standard catheter-based endocardial procedure. Clinical data 
from 121 endocardial ablated human subjects demonstrates the creation durable lesions when 
assessed at 75-day remapping procedures, and the Kaplan-Meier estimate for freedom from 
AF, AFL or AT was 84.5±5.4% for the PFA-optimized waveform cohort with quite few 
complications, which showed the excellent effectiveness and safety of FARAPULSE Pulsed 
Field Ablation System. 
FARAPULSE Pulsed Field Ablation system has produced a large amount of oversea data, and 
the ongoing FDA IDE trial, ADVENT study is a prospective multicenter randomized adaptive 
study, which will produce more clinlical data. The REPLACEstudy will be conducted to 
generate local clinical evidence to support FAREAPULSE Pulsed Field system regulatory 
approval in China. 
5. (Commercial) Device Description (part of Standard of Care)  
5.1. Commercial Device Under Study 
5.1.1. Names of Investigational Devices 
The FARAPULSETM Pulsed Field Ablation system is comprised of the following: 
• 
FARAWAVE™ Pulsed Field Ablation Catheter： 
o FARAWAVE™ Pulsed Field Ablation Catheter, 31mm 
o FARAWAVE™ Pulsed Field Ablation Catheter, 35mm 

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o FARASTAR™ Catheter Connection Cable 
• 
FARASTAR™ Pulsed Field Ablation Generator System: 
o FARASTAR™ Pulsed Field Ablation Generator 
o FARASTAR™ Recording System Module and associated modules and cables 
o FARASTAR™ Stimulation Module Cable and associated cables 
o Other cables 
• 
FARADRIVE™ Steerable Sheath 
5.1.2. Intended Use 
FARAPULSE Pulsed Field Ablation system is intended for the isolation of pulmonary veins 
for the treatment of paroxysmal atrial fibrillation. 
5.1.3. FARAPULSE Pulsed Field Ablation System 
The components, sub-components and model numbers of FARAPULSE Pulsed Field Ablation 
system are listed in Table 5.1-1 and depicted in Figure 5.1-1. 
Table 5.1-1 FARAPULSE Pulsed Field Ablation System Components 
Component Name 
Model 
FARASTAR Pulsed Field Ablation Generator System 
FARASTAR Pulsed Field Ablation Generator 
61M401 
FARASTAR Recording System Module (RSM) 
61M407 
FARASTAR Stimulation Module Cable 
61M404 
FARASTAR EGM Cable 
61M405 
FARASTAR Stimulation Module Auxiliary Cable 
61M408 
FARASTAR Cable Set 
61M406 
FARASTAR Stimulation Module Male Cable 
61M409 
FARASTAR Stimulation Module Female Cable 
61M410 
FARASTAR Stimulation Module Y-Cable, Long 
61M411 
FARASTAR Stimulation Module Y-Cable, Short 
61M412 
FARASTAR Recording System Module Catheter Pin Cable 
61M413 
FARASTAR Recording System Module ECG Trunk Cable 
61M415 
FARASTAR Recording System Module ECG Output Module 
61M416 
FARASTAR Recording System Module EGM Input Module 
61M417 
FARAWAVE Pulsed Field Ablation Catheter 
FARAWAVE Pulsed Field Ablation Catheter, 35mm 
41M402 
FARAWAVE Pulsed Field Ablation Catheter, 31mm 
41M401 
FARASTAR Catheter Connection Cable 
41M404 
FARADRIVE Steerable Sheath  
21M402 

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Figure illustrates how the main FARAPULSE Pulsed Field Ablation system components are connected in a typical Electrophysiology Lab.  The 
blocks labeled EP Lab Stimulator, EP Recording System, and EP Recording System Pin Box are not included with the FARAPULSE Pulsed Field 
Ablation System and are components provided by the Electrophysiology Lab. 
Figure 5.1-1: FARAPULSE Pulsed Field Ablation System Components

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5.1.3.1. FARAWAVE Pulsed Field Ablation Catheter 
The FARAWAVE Pulsed Field Ablation Catheter consists of 2 components: The 
FARAWAVE Pulsed Field Ablation Catheter and the FARASTAR Catheter Connection 
Cable, which are used together. Both components are sterile and single use only.  
The FARAWAVE Pulsed Field Ablation Catheter is offered in 2 different sizes (31-mm and 
35-mm fully deployed diameters) to accommodate varying PV anatomy. Selection of either 
catheter will be at the Investigator’s discretion. The FARAWAVE Pulsed Field Ablation 
Catheter is a multi-electrode catheter that connects electrically to the FARASTAR Pulsed Field 
Ablation Generator (Figure 5.1-2). It consists of a distal section with electrodes arranged on 
splines, a shaft section and a proximal handle with a manually operated deployment control.  
Figure 5.1-2: FARAWAVE Pulsed Field Ablation Catheter 
The FARAWAVE Pulsed Field Ablation Catheter has five variably deployable splines. The 
five splines are undeployed during insertion and removal and during use can deploy 
continuously from an undeployed state through a basket-shaped configuration to a fully 
deployed flower-shaped configuration with five petals (Figure 5.1-3). 

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Figure 5.1-3: FARAWAVE Pulsed Field Ablation Catheter - Deployed States 
 
Each spline has 1 electrode that is separately wired from the others on that spline to facilitate 
connection to a mapping or recording system via a cable supplied with the system. 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 short cable that terminates in a single 
connector for attachment to the FARASTAR Catheter Connection Cable. The other end of the 
Connection Cable attaches to the front panel of the FARASTAR Pulsed Field Ablation 
Generator. The Connection Cable is packaged sterile and is single use only. The PFA energy 
is delivered from the FARASTAR Pulsed Field Ablation Generator over the set of ablation 
catheter electrodes.  
5.1.3.2. FARASTAR Pulsed Field Ablation Generator system 
The FARASTAR Pulsed Field Ablation Generator system consists of the following 
components: 
• 
FARASTAR Pulsed Field Ablation Generator 
• 
FARASTAR Stimulation Module Cable 
• 
FARASTAR EGM Cable 
• 
FARASTAR Recording System Module 
• 
FARASTAR Stimulation Module Auxiliary Cable 
• 
FARASTAR Cable Set 
 
o 
FARASTAR Stimulation Module Male Cable 
o 
FARASTAR Stimulation Module Female Cable 

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o 
FARASTAR Stimulation Module Y-Cable – Long 
o 
FARASTAR Stimulation Module Y-Cable – Short 
• 
FARASTAR Recording System Module Catheter Pin Cable 
• 
FARASTAR Recording System Module ECG Trunk Cable 
• 
FARASTAR Recording System Module ECG Output Module 
• 
FARASTAR Recording System Module EGM Input Module 
  
The FARASTAR Pulsed Field Ablation Generator is a 12 channel Pulsed Electric Field 
Generator (PEF) unit that is used with the FARAWAVE Pulsed Field Ablation Catheter for 
cardiac tissue ablation. The FARASTAR contains a two channel cardiac stimulator that can be 
used for optional synchronous energy delivery. 
The primary function of the FARASTAR Pulsed Field Ablation Generator is to produce and 
deliver PEF energy to the FARAWAVE Pulsed Field Ablation Catheter. The PEF energy is 
delivered in the form of discrete highvoltage pulses using a proprietary algorithm that controls 
the pulse timing, duration and sequencing that is applied to the FARAWAVE Pulsed Field 
Ablation Catheter. The output waveform is biphasic consisting of pulses of equal amplitude 
and opposite polarity that is delivered in a proprietary bipolar sequence between splines of the 
FARAWAVE Pulsed Field Ablation Catheter. The only waveform parameter that can be 
adjusted by the user through the FARASTAR control interface is the pulse voltage which 
ranges from 1.8 kV to 2.0 kV in increments of 0.1 kV. 
5.1.3.3. FARADRIVE Steerable Sheath 
The FARAWAVE Pulsed Field Ablation Catheter is used exclusively with the FARADRIVE 
Steerable Sheath. 
The FARADRIVE Steerable Sheath consists of two primary components, the Steerable Sheath 
and the Dilator, which are used together. Both components are sterile and single use only. The 
FARADRIVE Steerable Sheath is comprised of a distal steerable section and a shaft section 
which connect to the handle. The handle includes a knob to control the deflection of the distal 
tip and a flush port for infusion of saline or contrast. The Dilator is intended for insertion 
through the sheath lumen and includes a shaped tip for dilation for vascular or chamber access 
(Figure 5.1-4). Details regarding the sheath are provided in the FARADRIVE Steerable Sheath 
IFU. 
Figure 5.1-4: FARADRIVE Steerable Sheath 
This is a real-world study. Boston Scientific will not conduct investigational device 
accountability as required per ISO 14155 as all study devices are commercially available 
products and are being used within their approved indication. The study devices shall be 
maintained per each institution's standard practice. 

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5.2. Required Medical Equipment  
The FARAPULSE Pulsed Field Ablation System must be used with additional ancillary 
products to complete an EP ablation procedure, including compatible EP lab stimulator, EP 
recording system and EP recording system Pin Box. Any compatible commercial use 
equipment can be used during the procedure at the investigator’s discretion under standard of 
care at the investigational site. 
The pre-ablation and post-ablation voltage mapping are not required for the PFA procedure. It 
can be done at the investigator’s discretion with any mapping system and catheter available for 
commercial use under standard of care at the investigational site. 
5.3. Required Procedures 
5.3.1. TEE/ICE 
According to Chinese experts consensus statement on AF ablation, transesophageal 
echocardiography (TEE) within 48 hours of the procedure or intracardiac echocardiography 
(ICE) during the procedure is recommended to be utilized prior to transseptal puncture for 
exclusion of LA thrombus.  
5.3.2. Pulsed Field Ablation for PVI 
Physician who is specialists trained, experienced in cardiac ablation procedures to treat cardiac 
arrhythmias, and have been trained with the use of FARAPULSE Pulsed Field Ablation system 
will be selected as the investigator. The PFA workflow is recommended as below but can be 
adjusted based on institutional practice within the scope of approved IFUs. 
Subjects will undergo sedation/anesthesia according to institutional protocol. They will then 
be prepared in conventional sterile fashion for a cardiac catheterization procedure. Femoral 
vein access will be obtained via Seldinger technique. A heparin bolus will be delivered prior 
to or immediately after transseptal puncture. Procedural activated clotting times (ACTs) will 
be regularly monitored. A procedural ACT between 300 seconds and 450 seconds should be 
maintained until all devices are withdrawn from the left atrium. Commercially approved 
diagnostic catheters may be placed before or after transseptal access is established at the 
Investigator’s discretion. Transseptal access to the LA will be obtained using commercially 
approved devices, establishing guidewire access to the LA. The FARADRIVE Steerable 
Sheath will be prepared and advanced via guidewire to the LA.The FARAWAVE Pulsed Field 
Ablation Catheter will then be prepared and advanced to the LA through the FARADRIVE 
Steerable Sheath. After confirming an ACT of 300 or greater, ablation of the PVs to achieve 
isolation will be performed according to the approved IFU documents and institutional 
practice. 
PVI ablation may be repeated at the Investigator’s discretion. Each addressable PV will be 
ablated in turn. The isolating effect of the PVI ablation(s) will be checked periodically and 
then finally twenty minutes after the last PVI ablation. Adenosine may be used for the final 
assessment but is not required. At the conclusion of the PVI ablation procedure, the 
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FARADRIVE Steerable Sheath. The functional status of both phrenic nerves will be assessed 
before the study is concluded. 
5.3.3. Additional Ablation 
Ablation of the CTI may be performed during the procedure using any approved catheter in 
subjects with a past history of CTI-dependent AFL, subjects who manifest typical AFL during 
a procedure or within the Blanking Period, or subjects who have inducible typical flutter. 
Bidirectional block is recommended to be demonstrated after the last CTI ablation. 
5.4. Required Medications 
5.4.1. Anti-Arrthythmic Drugs (AADs) 
5.4.1.1. AADs prior to index procedure 
This is a retrospective and/or prospective real-world study with no key criteria for AADs use. 
Prior AADs therapy will be collected in the Electronic data capture (EDC) system. If 
applicable, administration of amiodarone and stop date will be entered in EDC system. 
5.4.1.2. AADs post Index Procedure during the 90-day blanking period 
Blanking period is defined as the time between Index procedure and 90 calendar days post 
Index procedure. Post-procedure AADs are allowed per physician’s discretion during the 
blanking period. If treatment with AADs is prescribed during the blanking period, it is 
recommended that AADs be selected according to the guidelines or expert consensus 
statements for the Management of Patients with AF. AADs therapy during the blinding period 
will be collected in the EDC system.  
5.4.1.3. AADs post blanking period 
Post-blanking AADs use is determined by per physician’s discretion based on the real-world 
condition of the subject. If the investigator determines that the subject must be prescribed any 
dose of AAD* for treatment of any atrial tachyarrhythmia after the blanking period, the subject 
will be considered a Secondary Effectiveness Failure.  
*AADs for endpoint will consist of all Class I/III medications taken for control of AF/AT/AFL 
recurrence. Treatment with and AAD for conditions other than control of atrial arrhythmia 
recurrence is permitted and will be documented.  
5.4.2. Anticoagulation 
5.4.2.1. Pre-ablation 
Physicians is highly recommended to follow guidelines or expert consensus statements for the 
management of Patients with AF for adequate systemic anticoagulation. For patients with 
anticoagulation therapy before the procedure, an uninterrupted anticoagulation approach is 
recommended. 

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5.4.2.2. Intra ablation 
Physicians is highly recommended to follow guidelines or expert consensus statements for the 
management of Patients with AF and FARAPULSE Pulsed Field Ablation IFUs for adequate 
anticoagulation during procedure. It is recommended that heparin be administered prior to or 
immediately following transseptal puncture or use of the mapping catheter (if available) during 
AF ablation procedures and the heparin is adjusted to achieve and maintain an ACT of at least 
300 seconds. A procedural ACT between 300 seconds and 450 seconds should be maintained 
until all devices are withdrawn from the left atrium. 
5.4.2.3. After ablation 
Adherence to AF anticoagulation guidelines is recommended for subjects who have undergone 
an AF ablation procedure, regardless of the apparent success or failure of the procedure. 
Warfarin or NOAC anticoagulation is recommended for using for at least 2 months after 
ablation. Whether to continue anticoagulation after 2 months is determined by the clinician 
based on the patient's condition. 
6. Study Objectives and Endpoints 
6.1. Study Objectives 
The objective of the study is to observe the safety and effectiveness of the FARAPULSE 
Pulsed Field Ablation system for treatment of recurrent, symptomatic PAF in a Chinese 
population in the real world. The overview of primary and secondary objectives and endpoints 
are summarized in Table 6.1-1. 
Table 6.1-1: Overview of Primary and Secondary Objectives and Endpoints 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Primary Endpoints 
Observe the acute safety of 
the FARAPULSE Pulsed 
Field Ablation system 
The primary safety endpoint is 
defined as occurrence of the acute 
serious procedure-related and/or 
device-related adverse events at 7 
days post index procedure.  
Primary safety events will consist 
of 
a 
composite 
of 
serious 
procedure and/or device-related 
adverse events. 
The 
list 
of 
events 
contributing 
to 
the 
primary safety endpoints 
was selected from those 
typically associated with 
catheter ablation of AF.  
Observe 
the 
acute 
procedural success of the 
FARAPULSE Pulsed Field 
Ablation system 
 
The 
primary 
effectiveness 
endpoint 
is 
acute 
Procedural 
Success, defined as proportion of 
subjects that achieve electrical 
isolation 
of 
all 
PVs 
using 
FARAPULSE 
Pulsed 
Field 
Ablation system only. 
This 
is 
the 
acute 
effectiveness 
endpoint  
recommended 
in 
the 
Chinese guidelines for 
cardiac 
radiofrequency 
catheter Registration. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Secondary Endpoints 
Evaluate 
the 
12-month 
safety of FARAPULSE 
Pulsed 
Field 
Ablation 
system 
The secondary safety endpoint is 
defined as the safety event-free 
rate at 12 months post-procedure. 
Secondary 
safety 
events 
will 
consist of a composite of serious 
procedure and/or device-related 
adverse events.  
The 
list 
of 
events 
contributing to the long-
term safety endpoints 
was selected from those 
typically associated with 
catheter ablation of AF 
detected in the long-term 
period.  
Observe the 12-month 
effectiveness of the 
FARAPULSE Pulsed 
Field Ablation system 
One of the secondary effectiveness 
endpoints is the chronic success, 
defined as the proportion of 
subjects that free from Failure 
events.  
This 
is 
the 
chronic 
success recommended in 
the Chinese guidelines 
for 
cardiac 
radiofrequency catheter 
Registration. 
Observe the 12-month 
effectiveness of the 
FARAPULSE Pulsed 
Field Ablation system 
allowing AADs 
One of the secondary effectiveness 
endpoints is the chronic success 
allowing AADs. 
This is an analysis to 
assess chronic success 
allowing  AADs. 
Observe the acute 
procedural success of the 
FARAPULSE Pulsed 
Field Ablation system 
 
One of the secondary effectiveness 
endpoints is the proportion of PVs 
that achieve electrical isolation 
using FARAPULSE Pulsed Field 
Ablation system only. 
This is an analysis to 
assess acute procedural 
success by proportion of 
PVs. 
Other endpoints 
Observe the improvement 
of AF symptoms 
Descriptive analysis 
of atrial 
fibrillation symptoms at baseline 
versus 
12 
months 
after 
the 
procedure. 
This is an analysis to 
assess AF symptoms 
Observe procedureal 
parameters 
Other endpoints included total 
procedure time, PVI ablation time, 
left 
atrial 
dwell 
time 
and 
fluoroscopy time. 
This is an analysis to 
assess 
procedureal 
parameters 
 

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6.2. Study endpoints 
6.2.1. Primary Endpoints 
6.2.1.1. Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the acute procedural success, defined as the proportion 
of subjects that achieve electrical isolation* of all PVs using FARAPULSE Pulsed Field 
Ablation system only. 
* Electrical isolation of a PV is demonstrated by entrance block after a 20-minute waiting 
period if the subject is enrolled prospectively, otherwise the way to confirm electrical isolation 
should be recorded, including whether there is a waiting period and its duration. If exit block 
testing is performed, the PV will only be considered isolated if both entrance and exit block 
testing was successful. 
6.2.1.2. Primary Safety Endpoint 
The primary safety endpoint is defined as the occurrence of the acute serious procedure-related 
and /or device-related adverse events at 7 days post index procedure based on the definitions 
contained in Table 6.2-1. 
• 
Death  
• 
Myocardial infarction 
• 
Stroke/ TIA 
• 
Peripheral or organ thromboembolism  
• 
Cardiac tamponade / perforation 
• 
Pulmonary edema 
• 
Vascular access complications  
• 
Heart block* 
• 
Gastric motility/pyloric spasm disorders  
• 
Pericarditis 
• 
Atrial esophageal fistula 
• 
Severe PV stenosis  
• 
Phrenic nerve palsy 
*Heart block not attributable to medication effect or vasovagal reaction.  
Table 6.2-1：Composite Safety Endpoint Definitions 
Related SAE 
Description/Criteria 
Death 
AE resulting in subject death 

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Related SAE 
Description/Criteria 
Myocardial 
infarction 
Deﬁned as the presence of any one of the following criteria:  
• 
detection of ECG changes indicative of new ischemia (new ST- T 
wave changes or new LBBB) that persist for more than 1 hour 
• 
development of new pathological Q waves on an ECG 
• 
imaging evidence of new loss of viable myocardium or new 
regional wall motion abnormality 
Phrenic 
nerve 
palsy 
Defined as absent phrenic nerve function as assessed by a change from 
baseline in the elevation of a hemidiaphragm, persisting beyond the end 
of the procedure that is: 
• 
Demonstrated 
radiographically 
by 
either 
an 
inspiration /expiration chest X-ray or fluoroscopic sniff test 
• 
Not due to a demonstrable pulmonary process such as 
atelectasis or pleural disease. 
Unresolved phrenic nerve palsy at 1-month follow-up visit will be 
involved in primary safety events. Phrenic nerve palsy will be evaluated 
at every follow-up visit thereafter and record the recovery time. 
Persistent: Unresolved phrenic nerve palsy at 1-month follow-up visit 
will be reassessed during each follow-up visit. Unresolved phrenic 
nerve palsy at the 12-monthfollow-up visit will be considered as 
persistent phrenic nerve palsy 
Stroke 
Rapid onset of a focal or global neurological deficit with at least one of 
the following:  
• 
Change in level of consciousness 
• 
Hemiplegia, hemiparesis, numbness or sensory loss affecting 
1 side of the body 
• 
Dysphasia or aphasia 
• 
Hemianopia, amaurosis fugax, or  
• 
Other neurological signs or symptoms consistent with stroke  
The diagnosis of stroke requires that there be no other readily 
identifiable non-stroke cause for the clinical presentation (e.g., brain 
tumor, 
trauma, 
infection, 
hypoglycemia, 
peripheral 
lesion, 
pharmacological influences). 
The duration of the defined neurological deficit(s) must be: 
• 
≥ 24-hours; OR  
• 
< 24-hours if  
o Therapeutic intervention(s) were performed (e.g., 
thrombolytic therapy or intracranial angioplasty), OR  
o Available neuroimaging documents a new hemorrhage 
or infarct, OR  
o The neurological deficit results in death. 

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Related SAE 
Description/Criteria 
Transient ischemic 
attack 
Defined as a new focal neurological deficit with: 
• 
Symptom resolution within 24 hours 
• 
No new tissue injury demonstrated (if neuroimaging is 
obtained) 
Peripheral or organ 
thromboembolism 
A cardiac thrombus that occludes a more distal arterial site other than 
the central nervous system (see Stroke). Cutaneous petechiae are 
excluded from this definition. 
Cardiac 
tamponade / 
perforation 
The development of a pericardial effusion post-ablation that results in 
hemodynamic compromise, requires pericardiocentesis or results in a 
1-cm or more pericardial effusion as documented by echocardiography. 
Cardiac tamponade/perforation should also be classiﬁed as “early” or 
“late” depending on whether it is diagnosed during or following initial 
discharge from the hospital. 
Pericarditis 
The development of pericardial inflammation post-ablation that results 
in an effusion that leads to hemodynamic compromise or requires 
pericardiocentesis, prolongs hospitalization by more than 48 hours, 
requires hospitalization, or persists for more than 30 days following the 
ablation procedure. 
Pulmonary edema 
Respiratory compromise resulting from cardiac dysfunction or volume 
overload leading to increased interstitial lung fluid requiring intubation 
or parenteral diuretics. 
Vascular 
access 
complications 
Vascular access complication (e.g., groin hematoma, AV fistula, 
pseudoaneurysm) requiring a significant and invasive intervention 
(e.g., surgical repair, blood transfusion or thrombin injection). 
Heart block  
Impairment of atrium-ventricular conduction that is related to a 
protocol-stipulated cardiac ablation procedure and that requires 
permanent pacing. 
Gastric 
motility/pyloric 
spasm disorders 
Evidence of impaired gastric motility or pyloric spasm that prolongs 
hospitalization, requires hospitalization or persists for more than 30 
days. 
Severe pulmonary 
vein stenosis  
>70% reduction of an ablated measured PV diameter compared to the 
baseline CT/MRI scan, as determined by the CIL. 
Atrio-esophageal 
fistula 
Confirmation of a fistulous connection between the atrium and the 
lumen of the esophagus by radiographic, endoscopic or post-mortem 
examination 
AV = atrioventricular, CIL = Cardiac Imaging Laboratory, CT = computed tomography, ECG 
= electrocardiographic, LBBB = left bundle branch block, MRI = magnetic resonance 
imaging, PV = pulmonary vein, SAE = serious adverse event. 

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6.2.2. Secondary Endpoints 
6.2.2.1. Secondary Effectiveness Endpoints 
1. Chronic Success: Proportion of subjects that free from effectiveness events defined as 
failure as below at 12 months post-procedure. 
    Effectiveness events determining a failure are defined as:  
• 
Fail to achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation 
system only. 
• 
After the Blanking Period (90 days post the procedure) to 12-month after the procedure: 
1) Occurrence of any Detectable AF, AFL* or AT captured by one of the following 
methods:  ≥ 30 seconds in duration recording from 24-hour Holter Monitor or ≥ 10 
seconds recording from 12-lead ECG, or 
2) Any cardioversion for AF, AFL* or AT, or 
3) Use of any Class I or Class III AADs# for the treatment of AF, AFL* or AT. 
• 
At any time through 12 months after the procedure:  
1) Re-ablation for AF, AFL* or AT, or 
2) Use of amiodarone, except intra-procedurally to control an arrhythmia.  
2. Proportion of PVs that achieve electrical isolation by using the FARAPULSE Pulsed Field 
Ablation system only.   
3. Chronic success allowing AADs. 
#It won’t be considered as a failure if the subject has three-month visit happened after 90 days 
post the procedure, but still in the window (<=104 day) with AADs on, and physicians decide 
to take AADs off after this visit. 
*excluding CTI-dependent flutter confirmed by EP study 
6.2.2.2. Secondary Safety Endpoints 
Proportion of subjects that free from primary safety events defined as above through 7 days 
after the procedure and free from the following serious procedure-related and/or device-related 
adverse events at any time through the completion of 12-month follow-up visit. based on the 
definitions contained in Table 6.2-1. 
• 
Atrial oesophageal fistula  
• 
Severe PV stenosis  
• 
Persistent phrenic nerve palsy* 
*The study will collect information on phrenic nerve palsy observed before the end of the index 
procedure and, in case of occurrence, will track information for potential recovery during the 
study visits 

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6.2.3. Other Endpoints 
1. AF Symptom Assessment: AF symptoms will be assessed at baseline and 12 months. 
2. Procedural parameters:  
• 
Total procedure time (initiation of venous access to venous access closure) 
• 
Left atrial dwell time (total time an ablation catheter is in the left atrium [LA]) 
• 
Total PVI ablation time (first ablation to last ablation for PVI) 
• 
Fluoroscopy time (total duration of exposure) 
7. Study Design 
The REPLACE study is a retrospective and/or prospective single-center single-arm 
observational real-world study to observe the safety and effectiveness of the FARAPULSE 
Pulsed Field Ablation system for treatment of recurrent, symptomatic PAF in a Chinese 
population in the real world. Primary endpoints analysis is planned to be conducted after all 
enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects 
underwent study device treatment will be followed up to 12 months after the procedure, and 
the secondary and other endpoints will be analyzed then. The final report will be completed 
then too. 
7.1. Scale and Duration 
Thirty ATTEMPT and TREATMENT subjects will be enrolled in this study. The enrollment 
period for this study is expected up to 6 months depending on the precent of patients enrolled 
prospectively. Each subject will be followed under standard of care after the ablation procedure 
with a follow-up duration of 12 months. The study duration is estimated up to 18 months. 
Primary endpoints analysis is planned to be conducted after all enrolled subjects have 
completed data collection at 1-month follow-up visit. All the subjects underwent study device 
treatment will be followed up to 12 months after the procedure, and the secondary and other 
endpoints will be analyzed then. The final report will be completed then too. 
All the subjects will be enrolled from 1 site. 

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*The definitions of ATTEMPT and TREATMENT refer to Section 9.4. 
Figure 7.1-1: REPLACE Study Design 
 
7.2. Treatment Assignment 
This is a single arm real-world study. All screened subjects who sign the informed consent 
form (ICF) and satisfied with all the key criteria will be considered enrolled. 
7.2.1. Target and Non-target Lesions 
The pulmonary vein isolation for treatment of PAF will be the target lesion. Ablation of the 
CTI may be performed with any approved catheter in subjects who manifest typical AFL 
during a procedure or subjects who have inducible typical flutter. The order to ablate will be 
decided by the operator based on the patient condition. 
7.3. Justification for the Study Design 
The study device, FARAPULSE Pulsed Field Ablation system has got CE mark and 
accumulated amount of clinical safety and effectiveness data. The ongoing ADVENT study, a 
prospective multicenter randomized control study, is powered for non-inferior safety and 
effectiveness margin, which will produce more clinical data. Boston Scientific China asserts 
that this real-world study with about 30 cases is reasonable to obtain local data to support 
FARAPULSE Pulsed Field Ablation system registration in China. 
7.4. Method to control biases 
This is a real-world study. Selection of patients will be made from the Investigational site’s 
routine patients. All patients meeting the key eligibility criteria and having signed the ICF will 
be eligible for enrollment in the study. Control and reduction of potential bias associated with 

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a single-arm study design have been taken into account by defining key inclusion and exclusion 
criteria to represent a population similar to the patients with AF ablation in the real world, and 
defining a mITT set with population similar to the subjects enrolled in ongoing ADVENT trial 
and other trial about AF ablation. 
Every effort will be undertaken to minimize missing or incorrect data. However, some 
missingness is inevitable. The reasons for missing or incorrect data will be described in detail 
and evaluated for assessment of possible bias if appropriate.  
8. Subject Selection  
8.1. Study Population and Eligibility  
Subjects enrolled in the REPLACE study will be clinically indicated for an ablation procedure 
for the treatment of symptomatic, recurrent PAF with Class I or IIa recommendations 
according to 2018 Chinese expert consensus statement on atrial fibrillation therapy. Subjects 
must meet the key inclusion/exclusion criteria as outlined below in Section 8.2 and 8.3. 
Subjects assigned to modified ITT set must meet all the key criteria and additional criteria as 
outlined below in Section 8.3 The subjects selected for participation will be from the 
investigational site’s general patient population. The investigator or its designee has the 
responsibility for screening all potential subjects and selecting those who meet study eligibility 
criteria.  
8.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 8.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 8.3) is 
met.  

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Table 8.2-1: Inclusion Criteria 
Key 
Inclusion 
Criteria 
1. Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment; 
2. Subjects whose preoperative diagnosis is PAF confirmed by the 
clinician; 
3. De novo ablation procedure for PAF with Class I or IIa 
recommendations* according to 2018 Chinese expert consensus on 
atrial fibrillation therapy; 
4. Subjects who are able and willing to provide the defined observational 
data and/or participate in baseline and follow-up evaluations for the 
full study; 
5. Subjects who are willing and capable of providing informed consent. 
* In 2018 Chinese expert consensus on atrial fibrillation therapy, subjects 
with recurrent, symptomatic PAF and refractory or intolerant to at least one 
class I or class III antiarrhythmic medication are recommended to accept 
ablation therapy under Class I recommendation; Subjects with recurrent, 
symptomatic PAF are recommended to accept ablation therapy as the first 
line therapy under Class IIa recommendation. 
8.3. Exclusion Criteria 
Subjects who meet any one of the following key exclusion criteria in Table 8.3-1 cannot be 
included in this study or will be excluded from this clinical study. No vulnerable populations 
will be enrolled in this study. See Section 25.2 for the definition of a vulnerable subject. 
Subjects who meet any one of the following additional exclusion criteria in Table 8.3-1 cannot 
be included in the mITT set or will be excluded from mITT set. 
 
 

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Table 8.3-1: Exclusion Criteria 
Key 
Exclusion 
Criteria 
1. Subjects who, in the judgment of the investigator, have a life 
expectancy of less than one year before the procedure; 
2. Women of childbearing potential who are, or plan to become, 
pregnant during the time of the study; 
3. Subjects with any known contraindication to AF ablation with 
FARAPULSE Pulsed Field Ablation system, anticoagulation therapy, 
or contrast media in the judgment of the investigator or subjects 
unwillingness to use systemic anticoagulation 
4. Subjects who are currently enrolled in another investigational study 
or registry that would directly interfere with the current study. 
Additional 
Exclusion 
Criteria for 
mITT set 
1. AF that is any of the following: 
• 
Persistent (both early and longstanding) by diagnosis or 
continuous duration > 7 days 
• 
Requires four or more direct-current cardioversions in the 
preceding 12 months before the procedure. 
• 
Secondary to electrolyte imbalance, thyroid disease, alcohol 
or other reversible/ non-cardiac causes 
2. Any of the following atrial conditions: 
• 
Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or 
transthoracic echocardiography [TTE]*) 
• 
Any prior atrial endocardial or epicardial ablation procedure, 
other than right sided CTI ablation or for right sided 
supraventricular tachycardia 
• 
Any prior atrial surgery 
• 
Intra-atrial septal patch or interatrial shunt 
• 
Atrial myxoma 
• 
Current left atrium (LA) thrombus# 
• 
LA appendage closure, device or occlusion, past or 
anticipated 
• 
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: 

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• 
Sustained ventricular tachycardia or any ventricular 
fibrillation 
• 
Hemodynamically significant valvular disease: 
a) Valvular disease that is symptomatic  
b) Valvular disease causing or exacerbating congestive 
heart failure 
c) Aortic stenosis: if already characterized, valve area 
< 1.5 cm2 or gradient > 20 mmHg 
d) Mitral stenosis: if already characterized, valve area 
< 1.5 cm2 or gradient > 5 mmHg 
e) Aortic or mitral regurgitation associated with 
abnormal 
LV 
function 
or 
hemodynamic 
measurements 
• 
Hypertrophic cardiomyopathy 
• 
Any prosthetic heart valve, ring or repair including balloon 
aortic valvuloplasty 
• 
Pacemaker, implantable cardioverter defibrillator or cardiac 
resynchronization therapy devices 
• 
Any inferior vena cava (IVC) filter, known inability to obtain 
vascular access or other contraindication to femoral access 
• 
History of rheumatic fever 
• 
History of congenital heart disease with any residual anatomic 
or conduction abnormality 
4. Any of the following procedures, implants or conditions: 
• 
At baseline or assessment before the procedure: 
a) New York Heart Association (NYHA) Class III/IV 
b) Left ventricular ejection fraction (LVEF) < 40% 
c) Symptomatic 
hypotension 
or 
Uncontrolled 
hypertension (Systolic blood pressure > 160 mmHg or 
Diastolic blood pressure > 95 mmHg on two blood 
pressure measurements at baseline assessment) 
d) Symptomatic resting bradycardia 
e) Implantable loop recorder or insertable cardiac 
monitor 
• 
Within the 3 months preceding the procedure: 

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a) Myocardial infarction or Unstable angina or 
Percutaneous coronary intervention 
b) Heart failure hospitalization 
c) Treatment with amiodarone 
d) Pericarditis or symptomatic pericardial effusion 
e) Gastrointestinal bleeding 
• 
Within the 6 months preceding the procedure: 
a) Heart surgery 
b) Stroke, TIA or intracranial bleeding 
c) Any thromboembolic event 
d) Carotid stenting or endarterectomy 
5. Diagnosed disorder of blood clotting or bleeding diathesis 
6. Subject who is not on anticoagulation therapy for at least 3 weeks 
prior to the ablation procedure 
7. Medical conditions assessed before the procedure that would prevent 
participation in the study, interfere with assessment or therapy, 
significantly raise the risk of study participation, or modify outcome 
data or its interpretation, including but not limited to: 
• 
Body Mass Index (BMI) > 40.0 kg/m2 
• 
Solid organ or hematologic transplant, or currently being 
evaluated for an organ transplant 
• 
Severe lung disease, pulmonary hypertension, or any lung 
disease involving abnormal blood gases or requiring 
supplemental oxygen 
• 
Renal insufficiency with an estimated glomerular filtration 
rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal 
dialysis or renal transplant 
• 
Active malignancy or history of treated malignancy within 24 
months of enrollment (other than cutaneous basal cell or 
squamous cell carcinoma) 
• 
Clinically significant gastrointestinal problems involving the 
esophagus or stomach including severe or erosive esophagitis, 
uncontrolled 
gastric 
reflux, 
gastroparesis, 
esophageal 
candidiasis or active gastroduodenal ulceration  
• 
Active systemic infection 
• 
COVID-19 disease 
a) Current confirmed, active COVID-19 disease 

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9. Subject Accountability 
9.1. Point of Enrollment 
Subjects satisfied with all the key criteria will be considered enrolled into the clinical study at 
the time of the study-specific ICF execution. No data collection of study-related testing, 
procedures, etc. can take place until the ICF is signed and dated by the subject.  
It is the investigative site’s responsibility to assess eligibility criteria before obtaining the ICF 
and to document them for each screened patient in the study Screening and Enrollment Log. It 
is the responsibility of the delegated physician investigator to assess final eligibility criteria 
prior to data collection. If the subject is found to be ineligible prior to data collection, it must 
be documented. 
b) Current positive test for SARS-CoV-2 
c) Confirmed COVID-19 disease not clinically resolved 
at least 3 months prior to the procedure 
• 
Other uncontrolled medical conditions that may modify 
device effect or increase risk, including uncontrolled diabetes 
mellitus (HgbA1c > 8.0% if test result already obtained), 
untreated obstructive sleep apnea or active alcohol abuse 
8. Clinically 
significant 
psychological 
condition 
that 
in 
the 
Investigator’s opinion would prohibit the subject's ability to meet the 
protocol requirements 
9. Employees/family members of: 
• 
Boston Scientific or any of its affiliates or contractors 
• 
The Investigator, sub-Investigators, or their medical office or 
practice, or healthcare organizations at which study 
procedures may be performed 
10. Subjects known to require or have accepted ablation outside the PV 
region during the procedure except CTI region ablation. 
*TTE obtained ≤ 6 months prior to procedure will be acceptable, unless a cardiac event has 
occurred (e.g. MI, acute heart failure or acute onset heart failure) between the date of the 
exam and the procedure. In this case, a new TTE is needed to confirm eligibility for mITT. 
The most recent report before the procedure will be used. LA anteroposterior diameter 
measured by M-mode from the parasternal long-axis view will be used.  
 #The absence of thrombus must be confirmed by means of a trans-esophageal 
echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac Echography 
(ICE) during the procedure. 
￥ Cardiac CT/MRI obtained ≤ 3 months prior to procedure will be acceptable. 

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9.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study) 
shall be accounted for and documented. If a subject withdraws from the clinical investigation, 
the reason(s) shall be reported. If such withdrawal is due to problems related to device safety 
or performance, the investigator shall ask for the subject’s permission to follow his/her 
status/condition outside of the clinical study.  
Reasons for withdrawal include but are not limited to physician discretion, subject choice to 
withdraw consent, lost to follow-up or death. While study withdrawal is discouraged, subjects 
may voluntarily withdraw from the study at any time, with or without reason, and without 
prejudice to further treatment. In the event a subject decides to withdraw from the study, or an 
investigator withdraws a subject due to investigator discretion, every effort should be made to 
obtain full information on any on-going reportable Adverse Events/Serious Adverse Events up 
to the point of withdrawal. Additional data may no longer be collected after the point at which 
the subject has been withdrawn from the study or withdraws his/her consent, for whatever 
reason. Data collected up to the point of subject withdrawal may be used for study analysis, 
unless local regulations apply which require removal of the data. All applicable, electronic case 
report forms (eCRFs) up to the point of subject withdrawal and a “Subject End of Study” form 
(or equivalent) must be completed.  
If the withdrawal is due to the investigator’s discretion, the investigator is obligated to follow 
all open reportable Adverse Events until they can be considered as closed or chronic. 
9.3. Lost to Follow-Up 
A participant will be considered lost to follow-up if he/she fails to complete the routine follow-
up visits scheduled visits and is unable to be contacted by the study site staff.  
The following actions must be taken if a participant fails to return to the clinic for a required 
standard of care visit:  
• 
The site will attempt to contact the participant and reschedule the missed visit and 
counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain if the participant wishes to and/or should continue in the study.  
• 
Before a participant is deemed lost to follow-up, the investigator or designee will 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing address 
or local equivalent methods). These contact attempts should be documented in the 
participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  
 
9.4. Subject Status and Classification 
As subjects are evaluated, enrolled and treated in the study, they will be grouped into one of 
the following four categories and analyzed by predefined sets. Categorization will help 
determine how data gathered from them will be stored and evaluated.  
It is the investigational site’s responsibility to list all screened subjects, Screening failure, 
INTENT, ATTEMPT and TREATMENT subjects on the Screening and Enrollment Log. 

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9.4.1. Screening Failure 
A subject who has signed informed consent but is later determined to not meet key eligibility 
criteria will be classified as “Screening Failure”. Subjects not meeting key eligibility criteria 
due to oversight (i.e., I/E violation) will be considered ‘Screening Failure’. There are no 
follow-up reporting requirements for Screening Failure subjects. Subjects determined to be 
Screening Failure will not be used for analysis of the endpoints and do not count toward the 
enrollment ceiling. The original signed Informed Consent must be maintained in the site’s 
subject file. A subject Identification Number (ID) will be assigned in the EDC system.  
For consent ineligible subjects the following forms must be completed: 
• 
Enrollment and End of Study eCRF must be completed  
o Relevant eCRFs for study visits completed through consent ineligible 
determination, including device tracking, if applicable.  
• 
Adverse Event forms for any reportable event, as defined in Section 18.1 for any 
adverse event that occurs after signing the Informed Consent, up to the point of 
subject withdrawal  
9.4.2. INTENT 
A subject who signs informed consent, meets key eligibility criteria, but does not have any 
study devices inserted into the body will be classified as “INTENT.” For prospectively enrolled 
subjects that are enrolled in the study but do not undergo ablation procedure within 30 days 
from consent signature date must not be reconsented and will be withdrawn from the study and 
classified as “INTENT.” These subjects won’t be allowed to be re-enrolled in the study.  
There are no follow-up requirements for INTENT subjects. INTENT subjects will not count 
for analysis of the endpoints and do not count toward the enrollment ceiling. The original 
signed ICF must be maintained in the center’s patient file. A subject ID will be assigned in the 
EDC system.  
For INTENT subjects, at the minimum the following forms must be completed:  
• 
Enrollment and baseline forms such as, but not limited to informed consent, 
enrollment information and other related forms.  
• 
End of Study form;  
• 
Adverse Event forms for any reportable event, as defined in Section 18.1 for any 
adverse event that occurs after signing the Informed Consent, up to the point of 
subject withdrawal  
9.4.3. ATTEMPT 
An ATTEMPT subject is one who signs informed consent, meets eligibility criteria, and has 
any study device inserted into the body but does not receive ablation (PFA energy) with the 
FARAPULSE Pulsed Field Ablation System for PVI. ATTEMPT subjects will be used for 
analysis of the primary and secondary safety endpoints and count toward the enrollment 
ceiling.  
The original signed Informed Consent and any relevant documentation must be maintained in 
the site’s subject file. A subject ID will be assigned in the EDC system. ATTEMPT subjects 
are not allowed to be re-enrolled in the study.  
Prospectively enrolled ATTEMPT subjects will be followed up to 30 days for safety. For 

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retrospectively enrolled ATTEMPT subjects, one-month follow-up data will be collected. 
ATTEMPT subjects will not need to complete data collection of the post-procedure arrythmia. 
All applicable eCRFs, per the protocol, will be completed.  
For ATTEMPT subjects, at the minimum the following forms must be completed: 
• 
Enrollment and baseline forms such as, but not limited to: ICF, enrollment 
information and other related forms.  
• 
End of Study form.  
• 
Protocol Deviation form  
• 
Adverse Event forms for any reportable event, as defined in Section 18.1 for any 
adverse event that occurs after signing the ICF, up to the point of subject withdrawal  
9.4.4. TREATMENT 
Any subject that signs the ICF, meets key eligibility criteria and has the specified study device 
inserted into the body and receives PFA ablation with the FARAPULSE Pulsed Field Ablation 
system will be classified as “TREATMENT”. The data collection of these subjects will be 
performed in accordance with the follow-up schedule and are included in all study analyses. A 
subject ID will be assigned in the EDC system.  
All applicable eCRFs, per the protocol, must be completed for TREATMENT subjects. 
TREATMENT subjects do count towards the enrollment ceiling and will be used for analyses 
of the endpoints. The original signed ICF and any relevant documentation must be maintained 
in the center’s patient file. 
9.5. End-of-Study Definition  
A clinical trial is considered completed when the last participant’s last study data collection 
has occurred.  
A subject is considered to have completed the study if he/she has completed all data collection 
including the last visit or assessment as shown in the Data Collection Schedule shown in Table 
10-1.  
The end of the study is defined as completion of data collection shown in the Data Collection 
Schedule including the 12-month follow-up visit. 
9.6. End of Study Action Plan 
This is a real-world study. All the subjects will continue to accept routine follow-up under 
standard of care.   
10. Study Methods 
10.1. Data Collection 
The data collection schedule is shown in Table 10.1-1. 
 

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Table 10.1-1 Data Collection Schedule 
 
Data Collection 
Baseline 
Visit 
Clinic Visit 
 
Procedure 
Visit 
(Day 0) 
Clinic 
Visit 
Follow-up (FU) Visits 
7 days FU 
(7-10 days) 
Telephone 
interview 
1 M FU 
(30±7 Days) 
Telephone 
interview 
3 M FU 
(91-
104 Days) 
Clinic Visit 
6 M FU 
(180±30 Days) 
Clinic Visit 
12 M FU 
(365±30 Da
ys) 
Clinic Visit 
Unscheduled 
FU 
Clinic Visit   
Informed consent 
X 
 
 
 
 
 
 
 
Baseline information 
including 
demographics 
information 
X 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
 
 
 
 
 
 
Pregnancy test 
X1 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Physical Assessment 
X 
 
 
 
 
 
 
 
Related Blood Tests  
X 
 
 
 
 
 
 
 
Transthoracic 
echocardiogram (TTE) 
X2 
 
 
 
 
 
 
 
Cardiac CT/MRI 
X3 
 
X3 
X3 
X3 
X3 
X3 
X3 
TEE/ICE to exclude 
LA thrombus 
X4 
X4 
 
 
 
 
 
 
Procedural Data 
 
X 
 
 
 
 
 
 
Phrenic Nerve Palsy 
Assessment  
 
X 
X5 
X5 
X5 
X5 
X5 
X5 
AF Symptom 
Assessment 
X 
 
 
 
 
 
X 
 
AADs and 
anticoagulant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
Documentation of 
intervention 
AF/AFL/AT 
 
 
X 
X 
X 
X 
X 
X 

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1   Females of childbearing potential.  
2  TTE obtained ≤ 6 months prior to procedure will be acceptable, unless a cardiac event has occurred (e.g., MI, acute heart failure or acute onset heart 
failure) between the date of the exam and the procedure. In this case, a new TTE is needed. The most recent report before the procedure will be used.  
3  Cardiac CT/MRI obtained ≤ 3 months prior to procedure will be acceptable. Cardiac CT/MRI scan may be considered post-procedure if PV stenosis is 
suspected at the physician’s discretion. 
4   The absence of thrombus must be confirmed by means of a trans-esophageal echocardiogram (TEE) within 48 hours prior to the procedure or Intracardiac 
Echography (ICE) during the procedure. 
5   Phrenic Nerve Palsy Assessment at discharge and at follow-up visits is only applicable for subjects who had phrenic nerve palsy detected during the 
index or repeat procedure. Subjects should be assessed per standard of care; suggested means of assessment include a sniff test or an inhalation-exhalation 
chest radiography of the diaphragm. 
6   If  there is a clinical suspicion of stroke/TIA by the physician, then the data of neuro assessment, including but not limited to specialist consultation and 
brain MRI, will be collected.  
7    Collect results if applicable, the absent of this assessment is not Protocol Deviation. 
 
 
12-lead ECG 
X7 
 
 
 
X 
X 
X 
X7 
24h Holter 
X7 
 
 
 
X7 
X 
X 
X7 
Neuro assessment 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
X6 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
Device Deficiency 
Assessment  
 
X 
X 
X 
X 
X 
X 
X 
Protocol Deviations  
X 
X 
X 
X 
X 
X 
X 
X 

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10.2. Study Candidate Screening 
Investigators are responsible for screening all subjects and selecting those who are appropriate 
for study inclusion. The investigator is expected to follow standard of care testing to diagnose 
and screen subjects for inclusion in the study. A Screening and Enrollment Log will be 
maintained to document select information about candidates who fail to meet the general and 
specific selection criteria, including those enrolled in the study and classified either as Screen 
Failure, INTENT, ATTEMPT or TREATMENT subjects. 
10.2.1. Strategies for Recruitment and Retention 
The subjects selected for participation should be from the investigation site’s general patient 
population, and all the eligible subjects will be ablated and followed up under standard of care 
based on the care as defined by their center that performs the follow-up visits. 
10.3. Informed Consent 
Subjects who are satisfied with all the key eligible criteria and have signed and dated the ICF 
are considered enrolled in the study. In order to determine eligibility of a subject, the 
investigator or designee needs to implement the consent process as well as verify and document 
the subject meets final eligibility criteria prior to collect the predefined data by the protocol. 
Informed consent is required for all subjects prior to their participation in the study. No study-
specific data collection can be conducted prior to the subject providing his/her consent.  
The subject will be given ample time to consider participation and ask questions if necessary. 
An approved ICF shall be signed and personally dated by the subject or legal representative 
competent and/or an authorized designee. The original, signed consent must be kept with the 
subject’s file and a copy must be provided to the subject.  
The index procedure must be performed within 30 days post ICF signature for the subjects 
enrolled prospectively. In case the index procedure has not been performed within this time 
period, the subject will be classified as INTENT (see Section 9.4.2). The same subject cannot 
be considered for re-enrollment as re-enrollment is not allowed for any subjects in this study. 
The site will ensure that originally signed ICFs are filed in subjects’ binders and the ICF 
process is properly documented in the medical file. Originally signed ICFs and the ICF process 
will be made available for review at Monitoring Visits (MVs). 
10.4. Baseline Visit 
Enrolled subjects will have baseline data collected within 30 days of Enrollment. The Baseline 
Visit may be conducted in the same day as the Enrollment, however the Informed Consent 
must be signed and dated prior to data collection. In-person at investigational site is 
recommended. 
The data collection at the Baseline Visit includes: 
• 
Visit date, time and way to collect the data 
• 
Check of eligibility criteria 
• 
Demographics including age at time of the procedure, gender, height, weight, race 
• 
Pertinent medical and cardiovascular history, including, but not limited to: 

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a) Underlying cardiovascular disease, if any; including but not limited to 
hypertension, dyslipidemia, coronary artery disease  
b) Prior surgical interventions and/or cardiac procedures  
c) Detailed history of all arrhythmias  
d) History of other disease 
• 
AADs and Anticoagulation medication history and most recent dose prior to 
enrollment; stop date of amiodarone (if applicable)  
• 
Cardiovascular/Pulmonary Exam at Baseline must be completed by someone 
qualified to perform the physical assessment i.e., physician/medical doctor, nurse 
practitioner (NP) and/or Physician Assistant (PA) and include at least:  
a) Lung auscultation (includes respiratory rate and respiratory rhythm)  
b) Heart auscultation  
• 
Pregnancy test ( women of child-bearing potential) 
• 
Pertinent blood test for screening, including eGFR 
• 
COVID-19 testing by site if available: 
a) PCR for SARS-CoV-2 virus or equivalent testing, or  
b) Confirmation of successful vaccination with National Medical Products 
Administration (NMPA)-approved vaccine 
• 
12-lead ECG and/or Holter before the procedure if applicable 
• 
The following cardiac image will be performed and/or data from existing 
information will be collected: 
a) TTE establishing LVEF, left atrial diameter 
b) Cardiac CT or MRI assessing PV 
c) TEE assess left atrial thrombus (if ICE is not planned during procedure) 
• 
NYHA Classification 
• 
CHA2DS2-VASc score 
• 
AF symptom assessment 
• 
Reportable Adverse Events, if applicable  
• 
Protocol Deviations, if applicable  
10.5. Procedure Visit 
The Index Procedure and/or data collection must occur after all activities and/or data collection 
required for the Baseline Visit are completed. For eligible subjects enrolled retrospectively, 
data collection in Section 10.5.2 may occur in the same day as the Baseline Visit data 
collection. For eligible subjects enrolled prospectively, the procedures in Section 10.5.1 are 
recommended and data collection in Section 10.5.2 will occur as the data collection schedule. 
10.5.1. Index procedure 
The details in workflow can be found in related IFUs. The following manipulations are 
recommended but can be adjusted based reasonable institutional protocol. 

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10.5.1.1. Pulmonary vein isolation 
Use of the FARAWAVE Pulsed Field Ablation system should be restricted to those physicians 
who are specialists trained, experienced in cardiac ablation procedures to treat cardiac 
arrhythmias, and have been trained with the use of these devices. 
Subjects will undergo sedation/anesthesia according to institutional protocol. They will then 
be prepared in conventional sterile fashion for a cardiac catheterization procedure. Femoral 
vein access will be obtained via Seldinger technique. A heparin bolus will be delivered prior 
to or immediately after transseptal puncture. Patients should be anticoagulated to an ACT 
between 300 seconds to 450 seconds prior to insertion of the FARAWAVE Pulsed Field 
Ablation Catheter into the blood pool to avoid thrombus formation. A procedural ACT between 
300 seconds and 450 seconds should be maintained until all devices are withdrawn from the 
left atrium. Pre-ablation and post-ablation voltage map are not required. Commercially 
approved diagnostic catheters may be placed before or after transseptal access is established at 
the Investigator’s discretion. Transseptal access to the LA will be obtained using commercially 
approved devices, establishing guidewire access to the LA. TEE within 48 hours of the 
procedure or ICE during the procedure will be utilized prior to transseptal puncture for 
exclusion of LA thrombus. If the study reveals atrial thrombus, the investigational procedure 
will not begin or will be terminated, no ablation will be performed, and the subject will be 
rescheduled. The FARADRIVE Steerable Sheath will be prepared and advanced via guidewire 
to the LA. The FARAWAVE Pulsed Field Ablation Catheter will then be prepared and 
advanced to the LA through the FARADRIVE Steerable Sheath. After confirming an ACT of 
300 or greater, ablation of the PVs to achieve isolation will be performed according to the 
approved IFU documents and institutional practice. PVI ablation may be repeated at the 
Investigator’s discretion. Each addressable PV will be ablated in turn.  
10.5.1.2. Pulmonary vein isolation validation 
The isolating effect of the PVI ablation(s) will be checked periodically and then finally 20 
minutes after the last PVI ablation. PVI can be confirmed using the physician’s standard 
workflow. If additional ablations are required to seal up gaps or to ablate potential gaps, then 
isolation will be confirmed post additional ablations. Electrical isolation of the veins is 
recommended to be demonstrated by the absence of electrical propagation through the ablation 
lines. Electrical Isolation is recommended to be demonstrated and documented using Entrance 
Block for each pulmonary vein following at least a 20-minute waiting period from the last 
application in each location. Exit block verification is also recommended and may be 
performed per center’s standard of care. If Exit Block verification is attempted, a vein will only 
be considered isolated if Exit Block is also demonstrated and documented on the appropriate 
eCRF. If Exit Block is not attempted, it must be documented on the appropriate eCRF and in 
that case, verification via Entrance Block is sufficient to confirm isolation. If isolation is not 
confirmed after the 20-minute waiting period, the Investigator must perform additional 
ablations to treat any gaps. Entrance Block is recommended to be re-assessed after any 
additional ablations and another 20-minute waiting period is required. Adenosine may be used 
for the final assessment but is not required.  

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10.5.1.3. Pulmonary vein isolation conclusion 
At the conclusion of the PVI ablation procedure, the FARAWAVE Pulsed Field Ablation 
Catheter will be undeployed and withdrawn from the FARADRIVE Steerable Sheath. The 
functional status of both phrenic nerves will be assessed before the study is concluded. If 
phrenic nerve palsy is detected, it will be documented on the appropriate eCRF. All subjects 
presenting with phrenic nerve palsy at the end of the index or repeat procedure will be re-
assessed at the follow-up visits for phrenic nerve palsy. 
10.5.1.4. Additional ablations 
CTI ablation: Ablation of the CTI may be performed using any approved catheter in subjects 
with a past history of CTI-mediated (typical) AFL, subjects who manifest typical AFL during 
a procedure or within the Blanking Period, or subjects who have inducible typical flutter. 
Bidirectional block should be demonstrated after the last CTI ablation. The CTI ablation data 
will be documented in the eCRF and does not constitute a Treatment Failure. 
Other Ablation: Other ablation is not permitted under this protocol except when the 
Investigator determines that subject welfare requires ablation for an accessory pathway, 
AVNRT, treatment-emergent left AFL or incessant AT, using any approved ablation catheter. 
This decision and the associated ablation data will be documented in the eCRF and does not 
constitute an Effectiveness Failure. 
If the subject presents with AF after all ablations are complete, cardioversion should be 
performed and will be noted. Cardioversions during the Index procedure do not signify 
procedural failures and are not to be reported as adverse events. Induction of or spontaneous 
conversion to AF during the procedure will not be considered an adverse event. If at any time 
during the ablation procedure the investigator is unable to continue the ablation with the 
designated investigational catheter (for the PV isolation), the investigator may consider the 
case a procedural failure and complete the case with a device determined best for the subject. 
The point at which failure was determined as well as the rationale must be documented. A 
protocol deviation will be documented in the EDC system. 
10.5.2. Data collection during procedure visit 
The following data related to the procedure will be collected: 
• 
Visit date, time and way to collect the data  
• 
Date of procedure 
• 
Peri-procedural anticoagulation data: 
a) For subjects on a NOAC whether NOAC therapy was interrupted for 
procedure 
b) For subjects on warfarin, a pre-treatment international normalized ratio (INR) 
value 
c) Heparin administration and timing if available 
• 
Identification of devices:   
a) FARAPULSE Pulsed Field Ablation system  
b) Identification of non-study devices if applicable 
• 
Presenting rhythm at the beginning of the procedure  

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• 
Method of delivering sedation or anesthesia for the procedure  
• 
Total Procedure Time  
• 
Total LA dwell time if available* 
• 
Total fluoroscopy time if available*  
• 
Total Ablation Time for PVI if available* 
• 
Total Number of PFA applications for each pulmonary vein  
• 
Cardioversion performed during the procedure, if applicable 
• 
Lesion set data 
*For eligible subjects enrolled retrospectively, these data may not be available, this should 
not be Protocol Deviations. 
At the end of the PVI ablation(s), PVI is recommended to be confirmed by entrance block as 
a minimum.  The following information related to PVI validation will be collected: 
• 
Methods to confirm PVI, including the waiting period 
• 
If Adenosine was administered  
• 
If Isoproterenol was administered  
• 
Acute Isolation Result per PV (Entrance Block at a minimum, and Exit Block, if 
tested)  
• 
Final rhythm at the end of the procedure  
• 
Post-ablation 3D electroanatomical maps (at Investigator discretion) 
• 
Post-ablation fluoroscopic examination of diaphragm motion to assess phrenic 
nerve response if available 
• 
Reportable Adverse Events, if any  
• 
Device deficiencies and malfunctions, if any 
• 
Protocol Deviations, if any 
For subjects who undergo CTI ablation as part of the Index Procedure, the following 
information will be collected: 
• 
Identification of devices 
• 
Total Ablation Time for the CTI if available  
• 
Reportable Adverse Events, if any  
• 
Demonstration of bidirectional block across the CTI with Methodology used (e.g., 
differential pacing or vMap)  
• 
Additional ablation parameters (included but not limited to: RF duration, RF power, 
autotag parameters, contact force) 
10.6. Seven Day Follow-up Visit (7-10 days) 
Discharged subjects will be assessed by a telephone contact 7 days (7-10 days) post-Index 
Procedure. If the patient is still hospitalized, follow-up will be performed as in-hospital visit. 
For eligible subjects enrolled retrospectively, the Seven Day Follow-up Visit data collection 
may occur in the same day as Procedure Visit data collection. For eligible subjects enrolled 
prospectively, the Seven Day Follow-up Visit should occur within 7-10 days post Index 
Procedure. The data collection at the Seven Day Follow-up Visit includes:  
• 
Date and time of visit, way to visit 
• 
Date of discharge (if discharge) 
• 
Rhythm at time of discharge (if discharge, by means of 12-lead ECG and/or Holter 
if applicable) 

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• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention after the procedure 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
Subjects with unresolved phrenic nerve palsy detected at the discharge visit must 
be re-assessed per center’s standard of care to evaluate if the event resolved  
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AADs and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  
• 
Protocol Deviations, if applicable  
 
10.7. One Month Follow-up Visit (30 ± 7 days) 
Discharged subjects will be assessed by a telephone contact one month (30 ± 7 days) post-
Index Procedure. If the patient is still hospitalized, follow-up will be performed as in-hospital 
visit. For eligible subjects enrolled retrospectively, the One-month Follow-up Visit data 
collection may occur in the same day as Seven Day Follow-up Visit data collection. For eligible 
subjects enrolled prospectively, the One Month Follow-up Visit should occur within 30 ± 
7days post Index Procedure. The data collection at the One-Month Follow-up Visit includes: 
• 
Date and time of visit, way to visit 
• 
Date of discharge (if not discharge within 7 days after the procedure) 
• 
Rhythm at time of discharge (by means of 12-lead ECG and/or Holter if applicable) 
• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention after the procedure 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
Subjects with unresolved phrenic nerve palsy detected at the discharge visit must 
be re-assessed per center’s standard of care to evaluate if the event resolved  
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AADs and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  
• 
Protocol Deviations, if applicable  
10.8. Three Month Follow-up Visit (91-104 days) 
Discharged subjects will be assessed in person 3 months (91-104 days) post-Index Procedure. 
For eligible subjects enrolled retrospectively, the Three-Month Follow-up Visit data collection 
may occur at the same day as One Month Follow-up Visit data collection. For eligible subjects 
enrolled and/or followed up prospectively, the Three-Month Follow-up Visit should occur 
within 91-104 days post Index Procedure. The data collection at the Three-Month Follow-up 
Visit includes: 
• 
Date and time of visit, way to collect the data 

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• 
Cardiac physical assessment performed as standard of care including, heart rhythm, 
heart rate, systolic and diastolic blood pressure. 
• 
12-lead ECG  
• 
24-hour Holter Monitor if applicable 
• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
Subjects with unresolved phrenic nerve palsy detected at the discharge visit must 
be re-assessed per center’s standard of care to evaluate if the event resolved  
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AAD and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  
• 
Protocol Deviations, if applicable  
AADs Treatment: Class I/III AADs are recommended be stopped after blanking period, if 
they have not already been discontinued. If the investigator determines that the subject must 
be prescribed any dose of Class I/III AAD for treatment of AF/AFL*/AT after the 3 month 
follow-up visit, the subject will be considered a Secondary Effectiveness Failure. 
* excluding cavotricuspid isthmus (CTI)-dependent flutter confirmed by electrophysiology 
study 
10.9. Six Month Follow-up Visit (180 ± 30 days) 
Discharged subjects will be assessed in person 6 month (180 ± 30 days) post-Index Procedure. 
For eligible subjects enrolled retrospectively, the Six-Month Follow-up Visit data collection 
may occur at the same day as Three-Month Follow-up Visit data collection. For eligible 
subjects enrolled  prospectively, the Six Month Follow-up Visit should occur within 180 ± 30 
days post Index Procedure. The data collection at the Six-Month Follow-up Visit includes: 
• 
Date and time of visit, way to collect the data 
• 
Cardiac physical assessment performed as standard of care including, heart rhythm, 
heart rate, systolic and diastolic blood pressure. 
• 
12-lead ECG  
• 
24-hour Holter Monitor 
• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
Subjects with unresolved phrenic nerve palsy detected at the discharge visit must 
be re-assessed per center’s standard of care to evaluate if the event resolved  
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AADs and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  
• 
Protocol Deviations, if applicable  

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10.10. 
Twelve Month Follow-up Visit (365 ± 30 days) 
Discharged subjects will be assessed in person 12 month (365 ± 30 days) post-Index 
Procedure. For eligible subjects enrolled retrospectively, the Twelve-Month Follow-up Visit 
data collection may occur in the same day as Six-Month Follow-up Visit data collection. For 
eligible subjects enrolled prospectively, the Twelve Month Follow-up Visit should occur 
within 365 ± 30 days post Index Procedure. The data collection at the Twelve-Month Follow-
up Visit includes: 
• 
Date and time of visit, way to collect the data  
• 
Cardiac physical assessment performed as standard of care including, heart rhythm, 
heart rate, systolic and diastolic blood pressure. 
• 
12-lead ECG and/or Holter 
• 
Apply the 24-hour Holter monitor on the subject and instruct subject to submit their 
heart rhythm 
• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
AF symptom assessment 
• 
Subjects with unresolved phrenic nerve palsy detected at the discharge visit must 
be re-assessed per center’s standard of care to evaluate if the event resolved  
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AAD and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  
• 
Protocol Deviations, if applicable  
10.11. 
Unscheduled Visit 
An Unscheduled Follow-up Visit is any subject visit triggered by subject symptoms indicative 
of complications that may be associated with the catheter ablation procedure or cardiac 
arrythmia. In addition to determining the best course of action for the subject (i.e., repeat 
ablation, medication adjustment), during the visit, the following will be collected:  
• 
Date and time of visit, way to collect the data 
• 
Cardiac physical assessment performed as standard of care including, heart rhythm, 
heart rate, systolic and diastolic blood pressure. 
• 
Rhythm at time of visit by means of 12-lead ECG and/or Holter per investigator’s 
discretion 
• 
Recurrent arrhythmia, cardioversions, ablations or hospital admissions including 
occurrence, date, indication and outcome of any intervention 
• 
Any Stroke Evaluation for Neurologic Assessment, if applicable 
• 
Perform Cardiac CT/MRI if PV stenosis is suspected at any time throughout the 
follow-up period  
• 
Medication information, including new, discontinued or changes in study-collected 
medication information (e.g., AAD and NOAC)  
• 
Reportable Adverse Events, including resolution of ongoing events, if applicable  

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• 
Protocol Deviations, if applicable 
10.12. 
Re-ablation Procedure 
Re-ablation under this protocol requires documentation of detectable AF, AFL or AT. When 
performed, PVI re-ablation will be performed utilizing the study ablation catheter or any 
approved catheter at investigator discretion. Any re-ablation procedure for AF, AFL or AT 
during study follow-up constitutes a Secondary Effectiveness Failure, and therefore during 
such procedures other sites may be ablated at investigator discretion. CTI ablation or re-
ablation for right-sided typical AFL may be performed at any time during the study follow-up 
and does not constitute a Secondary Effectiveness Failure. Other sites may be ablated at 
investigator discretion using a commercially available ablation system. 
For subjects undergoing a re-ablation procedure the following data will be collected: 
• 
Date and time of visit, way to collect the data 
• 
Date and time of Re-ablation  
• 
Reason for Re-ablation   
• 
During any re-ablation procedure in which LA access is performed, a mapping 
procedure is recommended to be performed to characterize the reconnection status 
for each originally treated PV to characterize lesion durability. 
• 
For subjects who received ablation of the CTI, the persistence of nonconductivity 
in targeted tissue will be evaluated with either pacing maneuvers or 
electroanatomical mapping. 
• 
Lesion set data 
10.13. 
Study Completion 
Each Treatment subject will be followed until the Twelve-Month Follow-Up Visit is 
completed. The end of the study is defined as completion of the last visit shown in the Data 
Collection Schedule.  
ATTEMPT subjects will be followed up to the One Month Follow-Up Visit. However, 
ATTEMPT subjects will not need to complete post-procedure arrythmia monitoring.  
Even though a subject’s participation in the clinical study has ended, physicians may wish to 
continue standard of care visits outside of the study.  
In case of premature termination of the study, please refer to Section 9. Following 
termination/completion of the study, subjects will be managed according to local institution 
practice.  
Site must complete the “End of Study” eCRF to signify study completion. 
10.14. 
Unforeseen Circumstances (Natural Disaster/Global Pandemic) 
There may be unforeseen circumstances that occur during the course of the study, such as a 
natural disaster (e.g., hurricanes, tornadoes) or a global pandemic (e.g., COVID-19) that 
prevents a subject from attending study visits during the required follow-up window. While 
every attempt should be made to avoid disruptions in collecting study data, it is important to 
collect as much data as possible, by any available means and from any available resources. 
This may include obtaining records from an outside clinic, hospital or other healthcare facility 

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that is not EC approved.  
In the event that study data must be collected remotely, every effort should be made to collect 
the data within the study visit window, if possible. Critical data collected during the study 
includes any procedure or device related adverse events, recurrence of any AF/AT/AFL, and a 
Cardiac CT or MRI (if PV stenosis is suspected). ECG and 24- hour Holter monitors can be 
used to detect any recurrence of AF/AT/AFL. If a Cardiac CT or MRI is required because PV 
stenosis is suspected, the Cardiac CT or MRI may be performed at another healthcare facility 
and the window to conduct this test data collection may be extended by up to one month (30 
days) following the normal study visit window. If the subject is not able to have his/her heart 
rhythm assessed via a 12-lead ECG, it will not be a protocol deviation. 
10.15. 
Source Documents 
Table 10.15-1 summarizes all source data requirements for this protocol. It is preferable that 
original source documents are maintained, when available. In lieu of original source documents, 
certified copies are required to be maintained. A certified copy is a copy (irrespective of the type 
of media used) of the original record that has been verified (i.e., by a dated signature or by 
generation through a validated process) to have the same information, including data that describe 
the context, content, and structure, as the original. Source documentation includes but is not limited 
to those items noted in Table 10.15-1. 
Table 10.15-1: Source Documentation Requirements 
Requirement 
Disposition 
Screening and Enrollment Log 
Retain at Center 
Informed consent documentation process 
and investigator eligibility assessment 
Retain at Center 
Medical history documents pertaining to 
eligibility criteria 
Retain at Center 
Documentation of demographics data 
Retain at Center 
Pregnancy test, if applicable 
Retain at Center 
Physical assessment 
Retain at Center 
Cardiovascular/pulmonary 
examination, 
including but is not limited to: 
• 
Cardiac CT/MRI 
• 
TEE/TTE 
• 
12-lead ECG 
• 
24-hour Holter 
Retain at Center 
Medication Regimen and Changes 
Retain at Center 
Medical history 
Retain at Center 

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Table 10.15-1: Source Documentation Requirements 
Requirement 
Disposition 
Electrocardiographically 
documented 
episodes of AF/AFL/AT can include, but is 
not limited to: 
• 
ECG 
• 
24-hour or longer Holter 
• 
Rhythm Strip – note that if the irregular 
heart rhythm was captured via a 
wearable, the investigator must review 
the rhythm strip, document confirmation 
of atrial fibrillation and sign and date the 
printed rhythm strip. If the rhythm strip 
is 
not 
printed, 
documentation 
of 
investigator review, and confirmation of 
the atrial fibrillation must be located in 
the EMR system. 
Retain at Center 
Neurological 
consultation, 
assessment 
and/or examination, if applicable 
Retain at Center 
Labs 
Retain at Center 
EP lab procedure report 
Retain at Center 
Signed Technical Source Form (TSF) 
Retain at Center 
Adverse events 
Retain at Center 
In the event of a patient death: 
• 
Death narrative 
• 
Relevant medical records 
• 
Death certificate 
• 
Autopsy report, if applicable 
• 
Relevant medical records 
Retain at Center 
 
10.16. 
Local vendor documentation 
This study requires a vendor.  Appropriate certifications and documentation records are 
required to be maintained at the site for vendor.   

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11. Statistical Considerations 
11.1. Endpoints 
11.1.1. Primary Endpoints 
11.1.1.1. Primary Safety Endpoint 
The primary safety endpoint at 30 days consists of acute primary safety endpoint events as 
defined in Section 6, which will be assessed after all the enrolled subjects finishing One-month 
Visit data collection. 
11.1.1.1.1 Hypothesis 
This is an observational real-world study with small sample size, no formal hypothesis is 
performed in this study. 
11.1.1.1.2 Sample Size  
There is no formal hypothesis for this study, thus no sample size calculation is performed in 
this study. The study device has achieved CE mark and accumulated a large amount of clinical 
data. This trial with 30 PAF subjects will be used to produce data in Chinese population. 
The following table provides a 95% confidence interval (exact methods) for a sample size of 
30 if there are 0 ~ 3 primary safety events. 
 
11.1.1.1.3 Statistical Methods 
Descriptive statistics will be conducted for the safety endpoint events. The number, incidence 
(amount of events/number of subjects) and its 95% confidence interval (exact methods) will 
be calculated. The primary safety endpoints will be analyzed for ATTEMPT and 
TREATMENT subjects in the ITT set. Explorative statistical analysis might be produced if 
appropriate, e.g., Bayesian estimation of the study results using FARAPULSE IDE data as the 
prior.  
11.1.1.2. Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the acute procedural success, defined as proportion of 
subjects that achieved PVI with FARAPULSE Pulsed Filed Ablation system only, which will 
be assessed after all the enrolled subjects finishing One-month Visit data collection. 
Safety Events 
Rates (n=30) 
Lower 95%CI 
Upper 95%CI 
0 
0% 
0% 
11.6% 
1 
3.3% 
0.1% 
17.2% 
2 
6.7% 
0.8% 
22.1% 
3 
10% 
2.1% 
26.5% 

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11.1.1.2.1 Hypothesis 
This is an observational real-world study with small sample size; thus, no formal hypothesis is 
performed in this study. 
11.1.1.2.2 Sample Size  
There is no formal hypothesis for this study, thus no sample size calculation is performed in 
this study. The study device has achieved CE mark and accumulated a large amount of clinical 
data. This trial with 30 PAF subjects will be used to produce data in Chinese population. 
11.1.1.2.3 Statistical Methods 
Descriptive statistics will be conducted for the effectiveness endpoint events. The number, 
incidence (amount of events/number of subjects) and its 95% confidence interval (exact 
methods) will be calculated. The primary  effectiveness endpoints will be analyzed for 
TREAMENT subjecs in the mITT set. Explorative statistical analysis might be produced if 
appropriate, e.g., Bayesian estimation of the study results using FARAPULSE IDE data as the 
prior.  
11.1.2. Secondary Endpoints 
11.1.2.1. Secondary Safety Endpoints 
The secondary safety endpoint will evaluate the proportion of subjects that free from primary 
safety events defined in Section 6 through 7 days after the procedure and free from the 
following serious procedure-related and/or device-related adverse events at any time through 
the completion of 12-month follow-up visit, which will be assessed at the time of the twelve-
month analysis: 
• 
Atrial esophageal fistula  
• 
Severe PV stenosis  
• 
Persistent phrenic nerve palsy* 
*The study will collect information on phrenic nerve palsy observed before the end of the index 
procedure and, in case of occurrence, will track information for potential recovery during the 
study visits. 
11.1.2.2. Secondary Effectiveness Endpoint 1 
The first secondary effectiveness endpoint will evaluate the chronic success, which is defined 
as proportion of subjects that free from effectiveness events defined as failure as below at 
twelve months post-procedure. 
Effectiveness events determining a failure are defined as:  
• 
Fail to achieve electrical isolation of all PVs using FARAPULSE Pulsed Filed Ablation 
system only. 
• 
After the Blanking Period to 12-month after the procedure: 

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a) 
Occurrence of any Detectable AF, AFL* or AT captured by one of the following 
methods:  ≥ 30 seconds in duration recording from 24-hour or longer Holter Monitor 
or ≥ 10 seconds recording from 12-lead ECG. 
b) Any cardioversion for AF, AFL* or AT. 
c) 
Use of any Class I or Class III AADs# for the treatment of AF, AFL* or AT. 
• 
At any time through 12 months after the procedure:  
a) 
Re-ablation for AF, AFL* or AT. 
b) Use of amiodarone, except intra-procedurally to control an arrhythmia. 
#It won’t be considered as a failure if the subject has three-month visit happened after 90 
days post the procedure, but still in the window (<=104 day) with AADs on, and 
physicians decide to take AADs off after this visit. 
*excluding CTI-dependent flutter confirmed by EP study 
11.1.2.3. Secondary Effectiveness Endpoint 2 
The second secondary effectiveness endpoint will evaluate the proportion of PVs that achieve 
electrical isolation by using the FARAPULSE Pulsed Field Ablation system only. 
11.1.2.4. Secondary Effectiveness Endpoint 3 
The third secondary effectiveness endpoint will evaluate the chronic success when allowing 
AADs, which is defined as proportion of subjects that free from effectiveness events defined 
as failure as below at 12 months post-procedure. 
Effectiveness events determining a failure are defined as:  
a) Fail to achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation 
system only. 
b) After the Blanking Period to 12-month after the procedure: 
• 
Occurrence of any Detectable AF, AFL* or AT captured by one of the following 
methods:  ≥ 30 seconds in duration recording from 24-hour or longer Holter Monitor 
or ≥ 10 seconds recording from 12-lead ECG. 
• 
Any cardioversion for AF, AFL* or AT. 
c) At any time through 12 months after the procedure:  
• 
Re-ablation for AF, AFL* or AT. 
*excluding CTI-dependent flutter confirmed by EP study 
11.1.3. Additional Endpoints 
1. AF symptoms assessment: Descriptive analysis of atrial fibrillation symptoms at baseline 
versus 12 months after the procedure. 
2. Procedural parameters:  

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• 
Total procedure time (initiation of interventional venous access puncture to all devices 
remove from the body) 
• 
Left atrial dwell time (total time an ablation catheter is in the left atrium) 
• 
Total ablation time (first ablation to last ablation for PVI) 
• 
Fluoroscopy time (total duration of exposure) 
11.2. General Statistical Methods 
Descriptive statistics will be conducted for the primary, secondary and other endpoint events. 
When descriptive statistics are used, continuous variables will be summarized using standard 
quantitative statistics: number of available observations, mean, standard deviation, median, 
quartiles and range (minimum and maximum observed values) and its 95% confidence interval. 
Categorical variables will be summarized using the number, incidence (amount of 
events/number of subjects) and its 95% confidence interval (exact methods). 
Explorative statistical analysis might be produced if appropriate, e.g., Bayesian estimation of 
the study results using FARAPULSE IDE data as the prior.  
11.2.1. Analysis Sets 
ITT set will involve subjects who have signed informed consent and satisfied with all key 
criteria.Primary effectiveness endpoints will be summarized for TREATMENT subjects in 
mITT set.  
Secondary effectiveness endpoints will be summarized for TREATMENT subjects in ITT set 
and mITT set respectively. 
Primary and secondary safety endpoints will be summarized for ATTEMPT and 
TREATMENT subjects in  ITT set.  
The additional endpoints will be summarized for TREATMENT subjects in ITT set. 
11.2.2. Control of Systematic Error/Bias 
This is a real-world study. Selection of patients will be made from the Investigational site’s 
routine patients. All patients meeting the key eligibility criteria and having signed the ICF will 
be eligible for enrollment in the study. Control and reduction of potential bias associated with 
a single-arm study design have been taken into account by defining key inclusion and exclusion 
criteria to represent a population similar to the patients with AF ablation in the real world and 
defining a mITT group with population similar to the subjects enrolled in ongoing ADVENT 
trial and other trials about AF ablation.  
11.2.3. The Method of Handling Missing Value and Outliers 
Every effort will be undertaken to minimize missing or incorrect data. However, some 
missingness is inevitable. The reasons for missing or incorrect data will be described in detail 
and evaluated for assessment of possible bias if appropriate. The distribution of missing and/or 

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incorrect data will be analyzed too, which will be separately analyzed based on whether the 
data is collected prospectively or not. 
For the missing data, only the missing primary endpoint indicators will be carried forward 
during analysis, and the specific carry forward method will be explained in SAP. Sensitivity 
analyses will be performed on the primary safety and effectiveness endpoints to assess the 
impact of missing data on study results. In addition to worst-case missing data filling, Tipping 
Point Analysis will be performed as a post-hoc Analysis to assess the impact of different 
missing data filling methods on the results. 
Error and unreasonable data will be checked and confirmed during data cleansing prior to 
statistical analysis. Error data will be corrected before analysis, and sensitivity analyses will 
be performed to assess the impact of unreasonable data on the stability of the results if 
appropriate. 
11.2.4. Number of Subjects per Investigative Site 
Thirty ATTEMPT or TREATMENT subjects will be enrolled from one site. 
11.3. Data Analyses. 
11.3.1. Primary Endpoints/Measurements  
The primary safety and effectiveness endpoints will be analyzed after all the enrolled subjects 
finishing One-month Visit data collection. The primary safety endpoint will be analyzed for 
ATTEMPT and TREATMENT subjects in ITT set. The primary effectiveness endpoint will 
be analyzed for TREATMENT subjects in mITT set. Descriptive statistics will be conducted 
for the effectiveness endpoint events. The number, incidence (amount of events/number of 
subjects) and its 95% confidence interval will be calculated (exact methods). Explorative 
statistical analysis might be produced if appropriate, e.g., Bayesian estimation of the study 
results using FARAPULSE IDE data as the prior.  
11.3.2. Secondary Endpoints/Measurements 
The primary safety and effectiveness endpoints will be analyzed after all TREATMENT 
subjects finishing Twelve-month Visit data collection. The secondary safety endpoint will be 
analyzed for ATTEMPT and TREATMENT subjects in  ITT set. The secondary effectiveness 
endpoint will be analyzed for TREATMENT subjectsin mITT set and ITT set respectively. 
Descriptive statistics will be conducted for the effectiveness endpoint events. The number, 
incidence (amount of events/number of subjects) and its 95% confidence interval will be 
calculated (exact methods). The final report will be finished then.  
11.3.3. Additional Endpoints/Measurements 
The additional endpoints will be analyzed after all TREATMENT subjects finishing Twelve-
month Visit data collection. The additional endpoints will be analyzed for TREATMENT 
subjects in ITT set. Descriptive statistics will be conducted for the effectiveness endpoint 

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events. The number, incidence (amount of events/number of subjects) and its 95% confidence 
interval will be calculated (exact methods). 
11.3.4. Interim Analyses 
There is no formal statistical hypothesis test in this study, thus interim analysis can be made 
according to actual needs. 
11.3.5. Subgroup Analyses 
The primary and secondary endpoints will be sub analyzed based on the following 
variables,including but not limited to: 
• gender 
• Whether ablation is performed as first-line therapy. 
• Whether the subject is enrolled prospectively. 
 
11.3.6. Univariable Analyses 
Univariable analyse will be performed to assess the impact of potential baseline data and 
clinical characteristics on the primary endpoints. 
11.3.7. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the analyses. 
Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation 
12. Data Management 
12.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure EDC system.  
The clinical database will reside on a production server hosted by iMedidata EDC System. All 
changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the sponsor or its representative. The associated Rave software and database have 
been designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate eCRFs in compliance 
with local regulations. A written signature on printouts of the eCRFs must also be provided if 
required by local regulation. Changes to data previously submitted to the sponsor require a 
new electronic signature by the Investigator acknowledging and approving the changes. 

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Visual and/or electronic data review will be performed to identify possible data discrepancies. 
Manual and/or automatic queries will be created in the Medidata EDC system and will be 
issued to the site for appropriate response. Site staff will be responsible for resolving all queries 
in the database. 
All access to the clinical database will be changed to “Read only” after all data is either “Hard 
Locked” or “Entry Locked”. Once acceptance of the final report or finalization of publications 
(as applicable) is received, final database storage and archiving activities can begin. Once all 
of the closeout activities are completed a request to IT is submitted to have the “Database 
Locked” or Decommissioned and all database access revoked. 
12.2. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain all essential 
study documents and source documentation that support the data collected on the study 
subjects in compliance with applicable regulatory requirements.   
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or his/her 
designee withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility and BSC must receive written 
notification of this custodial change. Sites are required to inform Boston Scientific in writing 
where paper or electronic files are maintained in case files are stored off site and are not readily 
available. 
12.3. Technical Source Forms 
A TSF is developed by Boston Scientific or by the investigational site to capture protocol 
required data elements that are not duplicated in any other source documents. This form is to 
be used by the study sites as a source document. A Boston Scientific representative may 
complete the TSF at the request of the Principal Investigator. The TSF will be reviewed and 
signed for approval by the Principal Investigator or his/her designee at the end of each 
procedure. For eligible subjects enrolled retrospectively, the TSF may not be available, this 
should not be a Protocol Deviation. 
The protocol trained Boston Scientific representative may only use study specific TSFs 
provided and approved by the Boston Scientific study team. Data collected on any site created 
worksheets must not be attributable to the Boston Scientific representative. The Boston 
Scientific representative providing technical support is not part of the site study team.  
General TSF documentation considerations for the protocol trained Boston Scientific 
representative are as follows:  
• 
Data that is collected as part of a clinical study must be attributable to the individual 
collecting/providing the data, and must include the individual’s name, signature, and 
date of signature.  
• 
Boston Scientific Representative involvement with data collection/providing source 
documentation should be minimized.  

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• 
Any source data collected to capture protocol required data elements by a Boston 
Scientific representative must be provided to a member of the study team at the 
conclusion of the visit and retained at the site.  
• 
The Boston Scientific representative and Research Coordinator must make 
arrangements in advance as to how the clinical trial data will be transferred from the 
Boston Scientific representative to a member of the study team.  
• 
The Boston Scientific representative completes the sections of the TSF that are 
appropriate to his/her role only (e.g., technical sections.)  
• 
The Boston Scientific representative signs and dates completed sections of the TSF 
applicable to the Boston Scientific representative role. The Boston Scientific 
representative may assist in obtaining the signature and date of the Investigator or 
clinical research site staff delegated by the Investigator to oversee the study activity.  
Collection and completion of all information on the TSF is the responsibility of the appropriate 
personnel as defined on the TSF. If available, the protocol trained FARAPULSE Pulsed Field 
Ablation system specialist or other protocol trained Boston Scientific representative will 
provide the delegated site personnel with the study related data collected during the case 
directly from FARAPULSE Pulsed Field Ablation system.  
At the conclusion of the procedure, the completed TSF must be signed (and initialed as needed) 
by the following people:  
• 
Delegated Site Personnel completing the forms  
• 
Delegated Investigator conducting and/or supervising the case  
• 
BSC personnel supporting the visit  
13. Amendment 
The investigator should adhere to clinical trial protocol approved by Ethics Committee (EC). 
Any Amendment to the protocol (management information or study process modification, etc.) 
should be completed and reviewed by the sponsor during the study, then should be submitted 
to the EC for approval via the investigator. Only the amendment of protocol is approved by 
EC, the amended ptotocol should be implemented. 
14. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect the 
life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing EC, and the regulatory authority if applicable of any deviation from 
the investigational plan to protect the life or physical well-being of a subject in an emergency, 
and those deviations which affect the scientific integrity of the clinical investigation. Such 
notice shall be given as soon as possible, but no later than 5 working days after the emergency 
occurred, or per prevailing local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using eCRF. Sites may also be 

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required to report deviations to the EC, and the regulatory authority, per local guidelines and 
national/government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including EC notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
The sponsor will not approve protocol waivers.  
15. Compliance 
15.1. Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site can 
be “Authorized to Enroll,” the investigational site must enter into a Clinical Study Agreement 
with the sponsor that details the financing of the study as well as the rights and obligations of 
the investigational site and the investigator. This study will be conducted in accordance with 
related parts in ISO14155, ICH-GCP, ethical principles that have their origins in the 
Declaration of Helsinki, and applicable Chinese laws and regulations. The study shall not begin 
until the required approval/favorable opinion from the EC and/or regulatory authority has been 
obtained, if appropriate. Also, the study shall not begin prior to issuance of the site 
Authorization to Enroll, as provided by the sponsor. Any additional requirements imposed by 
the EC or regulatory authority shall be followed, if appropriate.  
15.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation plan/, 
the spirit of ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, 
any conditions of approval imposed by the reviewing EC, and prevailing local and/or country 
laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• 
Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• 
Prior to beginning the study, sign the Investigator Brochure Signature Page (if 
applicable) and Protocol Signature page documenting his/her agreement to conduct 
the study in accordance with the protocol. 
• 
Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study 
or interpretation of results. 
• 
Make no changes in or deviate from this protocol, except to protect the life and 
physical well-being of a subject in an emergency; document and explain any deviation 

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from the approved protocol that occurred during the course of the clinical 
investigation. 
• 
Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all 
clinical-investigation-related records are retained per requirements. 
• 
Ensure the accuracy, completeness, legibility, and timeliness of the data reported to 
the sponsor in the eCRFs and in all required reports. 
• 
Record, report, and assess (seriousness and relationship to the device/procedure) 
every adverse event as applicable per the protocol and observed device deficiency. 
• 
Report to sponsor, per the protocol requirements, all reportable events. 
• 
Report to sponsor, clinical trial institution, the EC any SAEs , and follow up visit 
will be conducted and reported per protocol according to China regulations. 
• 
Report to sponsor, clinical trial institution and EC when the clinical trial risks are 
identified to outweigh the possible benefits and it is necessary to suspend or terminate 
the clinical trial. Inform subjects of the risk immediately, ensuring that the subjects 
could receive appropriate treatment and follow-up visits. 
• 
Allow the sponsor to perform monitoring and auditing activities and be accessible to 
the clinical research monitor or auditor and respond to questions during monitoring 
visits or audit(s). 
• 
Allow and support regulatory authorities and the EC when performing auditing 
activities. 
• 
Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local EC requirements. 
• 
Provide adequate medical care to a subject during and after a subject’s participation 
in a clinical study in the case of adverse events, as described in the ICF. 
• 
Inform the subject of the nature and possible cause of any adverse events experienced. 
• 
Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• 
Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, 
as needed. 
• 
Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• 
Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together 
with identification and compliance information for concomitant treatment measures 
(contact address and telephone numbers shall be provided). 

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• 
Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical 
investigation. 
• 
Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• 
Ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation. 
All investigators will provide their qualifications and experience to assume responsibility for 
their delegated tasks through up-to-date curriculum vitae or other relevant documentation and 
disclose potential conflicts of interest, including financial, that may interfere with the conduct 
of the clinical study or interpretation of results. 
15.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training, are competent to perform the tasks they have been delegated and adequate 
supervision of those to whom tasks are delegated. Where there is a sub investigator at a site, 
the sub investigator should not be delegated the primary supervisory responsibility for the site. 
The investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  
15.3. Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the EC 
for the clinical investigation before recruiting subjects and implementing all subsequent 
amendments, if required. 
A copy of the written EC and/or competent authority (CA) approval of the protocol (or 
permission to conduct the study) and ICF, must be received by the sponsor before recruitment 
of subjects into the study. Prior approval must also be obtained for other materials related to 
subject recruitment or which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the EC before the changes 
are implemented to the study. All changes to the ICF will be EC approved; a determination 
will be made regarding whether a new ICF needs to be obtained from participants who 
provided consent, using a previously approved ICF.  
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by applicable local/country laws or regulations or EC requirements. Copies of the 
study reports and the EC continuance of approval must be provided to the sponsor.  
15.4. Sponsor Responsibilities 
All information and data sent to Boston Scientific (BSC) concerning subjects or their 
participation in this study will be considered confidential by BSC and will be kept confidential 
in accordance with all applicable laws and regulations. Only authorized BSC personnel and/or 
a BSC representative including, but not limited to Contract Research Organization (CRO), will 

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have access to this information. Authorized regulatory personnel have the right to inspect and 
copy all records pertinent to this study. Study data collected during this study may be used by 
BSC for the purposes of this study, publication, and to support future research and/or other 
business purposes, such as overseeing and improving the performance of its device, new 
medical research and proposals for developing new medical products and procedures. All data 
used in the analysis and reporting of this study or shared with a third-party researcher will be 
without identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
15.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during procedure, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including the 
FARAPULSE Pulsed Field Ablation system and other support equipment).  
At the request of the investigator and while under investigator supervision, trained BSC 
personnel may operate equipment during ablation procedure, assist with the conduct of testing 
specified in the protocol, and interact with the subject to accomplish requested activities. 
Typical tasks may include the following:  
• 
Setting up, calibrating and/or operating parameters to investigator-requested settings 
of the FARAPULSE Pulsed Field Ablation system during the procedure.  
• 
Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel.  
• 
Interaction with Boston Scientific noninvasive equipment and interpretation of 
information contained therein to support the collection of required information by the 
delegated site staff.  
• 
Provide original to clinical site as source documentation, if appropriate. 
• 
Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
• 
Assisting with the collection of study data from the BSC equipment/devices, if 
appropriate. 
• 
Entering technical data on TSF as long as the responsible investigator verifies and 
signs the completed form. 
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following:  
• 
Observing testing or medical procedures to provide information relevant to clinical 
protocol compliance.  
• 
Reviewing collected data and study documentation for completeness and accuracy.  
Boston Scientific personnel will not do the following:  

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• 
Practice medicine  
• 
Provide medical diagnosis or treatment to subjects  
• 
Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the investigator  
• 
Independently collect critical study data (defined as primary or secondary endpoint 
data) without review and approval of the investigator  
• 
Enter data in EDC systems or on paper case report forms  
15.5. Insurance  
Where required by local regulation, proof and type of insurance coverage, by BSC for subjects 
in the study will be obtained. 
16. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The sponsor will put a plan in place to document the specific monitoring requirements.  
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
17. Potential Risks and Benefits 
17.1. Instructions for Use 
Please refer to the Instructions for Use for an overview of anticipated adverse (device) effects, 
and risks associated to the commercial device(s).   
17.2. Risks associated with Participation in the Clinical Study 
This is a real-world observational study. There are no specific tests outside of standard practice 
required by this clinical study protocol. During follow-up visits, the ECG and 24-hour Holter 
pre-defined in the protocol align with routine clinical procedures and guidelines. Therefore, 
there is no foreseen increased risk to subjects for participating in the REPLACE Study. 

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17.3. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject selection 
criteria, close monitoring of the subject's physiologic status during research procedures and/or 
follow-ups and by promptly supplying BSC with all pertinent information required by this 
protocol. 
17.4. Anticipated Benefits 
This is a real-world observational study; subjects may not receive any benefit from 
participating in this study compared to the current standard of care. However, aligning with 
these follow-up schedules will allow physicians to have better knowledge about the patient's 
condition and adjust treatment plans accordingly. Moreover, the data collected in this study 
will be used to support the FARAPULSE Pulsed Field Ablation system registration in China, 
thus more PAF patients will benefit from PFA treatment in the future. 
18. Safety Reporting 
18.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• 
All adverse events 
• 
All serious adverse events 
• 
All Adverse Events related to FARAPULSE Pulsed Field Ablation system 
• 
All Serious Adverse Events related to FARAPULSE Pulsed Field Ablation system 
• 
All Adverse Events related to the Procedure 
• 
All Serious Adverse Events related to the Procedure 
• 
All Device Deficiencies  
• 
Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• 
New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency 
The following clinical events will not be considered adverse events for this clinical study:  
• 
Pre-existing diseases or conditions (including AF, AFL, AT) will not be reported as 
adverse events unless there has been a substantial increase in severity or frequency of 

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the problem as compared to the subject’s baseline which cannot be attributed to the 
expected progression of the disease or condition.  
• 
Pre-planned hospitalizations before the index procedure or for a pre-existing condition.  
• 
AF/AFL/AT episodes with medical intervention or hospitalization due to arrhythmia 
recurrence during the blanking period.  
• 
If an additional ablation procedure is required, this additional ablation procedure 
should only be considered an AE if it is associated with subject worsening condition 
or a new diagnosis. The ablation would be considered a corrective action.  
If the subject experiences a new or worsening arrhythmia between the index procedure and the 
end of study, and the investigator considers this AE to be study related, it needs to be reported. 
Refer to Investigator’s Brochure or IFU as appropriate for the known risks associated with the 
study device(s).  
 
Any reportable event, experienced by the study subject after informed consent, whether prior 
to, during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases and chronic conditions are not reported as AEs unless there is an 
increase in severity or frequency during the course of the investigation. Death should not be 
recorded as an AE, but should only be reflected as an outcome of one (1) specific SAE (see 
Table 18.2-1 for AE definitions). 
Refer to Instructions for Use for the known risks associated with the study device(s). 
 
18.2. Definitions and Classification 
Adverse event definitions are provided in Table 18.2-1. Administrative edits were made on 
the safety definitions from applicable regulations and guidance including (but not limited to) 
21 CFR Part 812, ISO 14155, GCP issued by NMPA and EU MDR 2017/745/MDCG 2020-
10/1 Guidance on Safety Reporting in Clinical Investigations for clarification purposes. 
Table 18.2-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
 
 
 
Any untoward medical occurrence, unintended disease or 
injury, or any untoward clinical signs (including an abnormal 
laboratory finding) in subjects, users or other persons, in the 
context of a clinical investigation, whether or not related to the 
study medical device and whether anticipated or unanticipated.  
NOTE 1: This includes events related to the study medical 
device or 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 the study medical device.  

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Table 18.2-1: Safety Definitions 
Term 
Definition 
Adverse Device Effect 
(ADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Adverse event related to the use of the study medical device 
NOTE 1: This includes any adverse event resulting from 
insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, 
or any malfunction of the study medical device. 
NOTE 2: This definition includes any event resulting from 
use error or from intentional misuse of the study medical 
device. 
NOTE 3: This includes ‘comparator’ if the comparator is a 
medical device. 
Serious Adverse Event 
(SAE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or 
other persons as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, including chronic diseases, or  
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function 
c) fetal distress, fetal death, or a congenital abnormality or birth 
defect including physical or mental impairment. 
NOTE 1: Planned hospitalization for a pre-existing condition, 
or a procedure required by the clinical investigational plan, 
without a serious deterioration in health, is not considered a 
serious adverse event.  
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
Unanticipated Adverse 
Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
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 

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Table 18.2-1: Safety Definitions 
Term 
Definition 
 
plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects.   
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current risk 
assessment. 
NOTE 1: Anticipated serious adverse device effect (ASADE) 
is an effect which by its nature, incidence, severity or outcome 
has been identified in the risk assessment. 
Serious Health Threat 
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration in 
the health in subjects, users or other persons, and that requires 
prompt remedial action 
for other subjects, users or other persons. 
NOTE 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple deaths 
occurring at short intervals. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
An inadequacy of a medical device related to its identity, 
quality, durability, reliability, usability, safety or performance.  
NOTE 1: Device deficiencies include malfunctions, use errors, 
and inadequacy in the information supplied by the 
manufacturer including labelling. 
NOTE 2: This definition includes device deficiencies related 
to the device under study. 
The following definitions will be used for defining hospitalization or prolongation of 
hospitalization for SAE classification purposes: 
Hospitalizations  
Hospitalization does not include: 
• emergency room visit that does not result in in-patient 
admission  
Note: although an emergency room visit does not itself 
meet the definition for hospitalization, it may meet 
other serious criteria (e.g., medical or surgical 
intervention to prevent permanent impairment or 
damage) 

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Table 18.2-1: Safety Definitions 
Term 
Definition 
• elective and pre-planned treatment/surgery for a pre-
existing condition that is documented in the subject’s 
record at the time of consent/enrollment 
• admission for social reasons and/or respite care in the 
absence of any deterioration in the subject’s general 
condition (e.g., subject is homeless, caregiver relief) 
• pre-planned, protocol-specified admission related to 
the clinical study (e.g., procedure required by protocol) 
NOTE 1: If complications or AEs occur during an 
elective/planned (i.e., planned prior to signing ICF) 
hospitalization after signing ICF, the complications and AEs 
must be reported as AEs or SAEs if they meet the protocol-
specified definitions, However, the original elective/planned 
hospitalization(s) itself should not be reported as an SAE. 
Prolongation of 
hospitalization  
In-patient admission to the hospital that is prolonged beyond 
the expected standard duration for the condition under 
treatment. 
Note: new adverse events occurring during the hospitalization 
are evaluated to determine if they prolonged hospitalization or 
meet another SAE criterion. 
 
18.3. Relationship to Study Device(s) and/or Study Procedure 
The Investigator must assess the relationship of the reportable AE to the study device(s), and/or 
study procedure. See criteria in  Table 18.3-1: 

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Table 18.3-1 : Criteria for Assessing Relationship of Study Device(s) or Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
Ref: MDCG 2020-
10/1 
Relationship to the device, comparator or procedures can be excluded 
when: 
- the event has no temporal relationship with the use of the study 
device, or the procedures related to the use of the study device. 
- 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 that cannot 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); 
- the event does not depend on a false result given by the study device 
used for diagnosis, when applicable; - 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. 
Possibly Related 
Ref: MDCG 2020-
10/1 
The relationship with the use of the study device or comparator, or the 
relationship with procedures 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 where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
Probably Related 
Ref: MDCG 2020-
10/1 
The relationship with the use of the study device or, comparator, or the 
relationship with procedures seems relevant and/or the event cannot be 
reasonably explained by another cause. 

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Table 18.3-1 : Criteria for Assessing Relationship of Study Device(s) or Procedure to 
Adverse Event 
Classification 
Description 
Causal 
Relationship 
Ref: MDCG 2020-
10/1 
The serious event is associated with the study device, comparator 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 the study device 
use/application or procedures; 
- the event involves a body-site or organ that 
-the study device or procedures are applied to. 
-the study device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical 
device (if the response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event (when 
clinically feasible); 
- other possible causes (e.g., an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment) 
have been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the study device used for 
diagnosis, when applicable; 
- 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. 
 
Please refer to Section 26 Appendices for Relationship Criteria that to be used in sponsor 
expediting reporting. 
 
18.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 18.4-1.  
Considering that this study is a real-world observational study conducted in Boao, Hainan 
province, and the time limit for reporting adverse events for subjects enrolled retrospectively 
is not stipulated by the current regulations, the sponsor has stipulated the time limit for 
reporting adverse events according to the characteristics and practical operation of this study 
and applicable national regulations. 

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Table 18.4-1: Investigator Reporting Requirements 
Event Classification 
Communication 
Method  
Communication 
Timeline 
post-
market studies*  
(EU 
MDR 
2017/745, 
MDCG 
2020-
10/1MEDDEV 
2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect  
 
Complete AE eCRF 
page with all available 
new 
and 
updated 
information.  
• Within 24 hours of first becoming 
aware of the event for data 
collected prospectively. 
• Within 5 working days of first 
becoming aware of the event for 
data collected retrospectively. 
• Terminating at the end of the study. 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) 
for 
reported event.  
• Upon request of sponsor.  
Serious Adverse Event 
including serious adverse 
effects 
Complete AE eCRF 
page with all available 
new 
and 
updated 
information.  
• Within 24 hours of first becoming 
aware of the event for data 
collected prospectively. 
• Within 5 working days of first 
becoming aware of the event for 
data collected retrospectively. 
•  Reporting required through end of 
study. 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) 
for 
reported event.  
• Upon request of sponsor 
Device Deficiencies 
(including but not 
limited to malfunctions, 
use errors, and 
inadequacy in 
information supplied by 
the manufacturer, 
including labelling) 
Complete eCRF with 
all available new and 
updated information.  
• Within 24 hours of first becoming 
aware of the event for data 
collected prospectively. 
• Within 5 working days of first 
becoming aware of the event for 
data collected retrospectively. 
•  Reporting required through the end 
of the study 

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Event Classification 
Communication 
Method  
Communication 
Timeline 
post-
market studies*  
(EU 
MDR 
2017/745, 
MDCG 
2020-
10/1MEDDEV 
2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
Note:  Any Device 
Deficiency that might 
have led to a serious 
adverse event if 
appropriate action had 
not been taken, 
intervention had not 
occurred, circumstances 
had been less fortunate is 
considered a reportable 
event. 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) 
for 
reported event. 
• Upon request of sponsor  
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF 
page, which contains 
such information as 
date of AE, treatment 
of 
AE 
resolution, 
assessment 
of 
seriousness 
and 
relationship 
to 
the 
device.  
• In a timely manner but recommend 
within 10 business days after 
becoming aware of the information 
• Reporting required through the end 
of the study  
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) 
for 
reported event.  
• Upon request of sponsor 
 
18.5. Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, product 
nonconformities, and inadequacy in the information supplied by the manufacturer) associated 
with the study devices (FARAPULSE Pulsed Field Ablation system) will be documented and 
reported to BSC. All other ablation or diagnostic catheters may be disposed of per standard EP 
practice. Device deficiencies should also be documented in the subject’s source records. 
Device deficiencies are not adverse events. However, an adverse event that results from a 
device deficiency, would be recorded as an adverse event on the appropriate eCRF. 

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18.6. Reporting to ECs/ Investigators 
Boston Scientific is responsible for reporting adverse events and device deficiencies (if 
applicable) to all participating investigators, clinical trial institutions, ethic committees and 
regulatory authorities in compliance with the current Medical Device Good Clinical Practice. 
Please refer to Section 26 Appendices for Template of Report Form for Serious Adverse 
Events. 
Investigator is responsible for reporting all SAEs to the sponsor, the clinical trial institution, 
and the EC within 24 hours of first becoming aware of the event. Investigator shall also follow 
up the SAE according to the study protocol and submit a follow-up report. 
BSC shall notify all participating Chinese study centers if SAEs/SADEs occur which imply a 
possible increase in the anticipated risk of the procedure or use of the device or if the 
occurrence of certain SAEs/SADEs demands changes to the protocol or the conduct of the 
study in order to further minimize the unanticipated risks. 
18.7. Subject Death Reporting  
A subject death during the study should be reported to Boston Scientific as soon as possible 
and, in any event, within three (3) calendar days of site notification. The site’s EC must be 
notified of any deaths in accordance with that site’s EC policies and procedures.  
Notification of death must include a detailed narrative (death letter) that provides detailed 
information describing the circumstances surrounding the death. A death narrative in the local 
language is acceptable, if accompanied by a translation in English. The details listed below 
should be addressed in the death narrative, in order for BSC to understand the circumstance 
surrounding the death: 
• 
Date and time of death  
• 
Place death occurred  
• 
Immediate cause of death  
• 
Rhythm at the time of death, if known (include any available documentation)  
• 
Whether the death was related to the catheter, clinical investigation, procedure, or 
patient condition  
• 
Whether or not the death was witnessed  
• 
Whether the patient had worsening heart failure  
• 
Any other circumstances surrounding the death  
• 
Approximate time interval from the initiating event to death (temporal course) -items 
to consider include, but are not limited to: information regarding last time subject was 
seen by investigator, last office visit, etc.  
• 
Investigator or sub-investigator signature and date  
Also submit the following documentation:  
If the patient expired in the hospital:  

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• 
A copy of the medical records for that admission (e.g., H & P, consults, test results, 
operative reports, and/or progress notes from the hospital chart)  
• 
Death certificate (if available)  
• 
Autopsy report (if applicable)  
If the patient expired outside of the hospital (e.g, home):  
• 
A copy of the most recent clinic visit (if not already submitted to Boston Scientific)  
• 
Death certificate (if available)  
19. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any study devices, study-required 
procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee, as applicable. The ICF must be accepted by BSC or its delegate (e.g. 
CRO), and approved by the site’s EC, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s EC.  Any modification requires acceptance from BSC prior to use of the 
form.  The ICF must be in a language understandable to the subject and if needed, BSC will 
assist the site in obtaining a written consent translation. Translated consent forms must also 
have EC approval prior to their use.  Privacy language shall be included in the body of the form 
or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, as 
well as any other steps required by applicable laws, rules, regulations and guidelines: 
• 
be conducted by the Principal Investigator or designee authorized to conduct the 
process,  
• 
include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• 
avoid any coercion of or undue influence of subjects to participate, 
• 
not waive or appear to waive subject’s legal rights, 
• 
use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• 
provide ample time for the subject to consider participation and ask questions if 
necessary, 
• 
ensure important new information is provided to new and existing subjects throughout 
the clinical study.  

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The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed consent 
process. If a legal representative sign, the subject shall be asked to provide informed consent 
for continued participation as soon as his/her medical condition allows. The original signed 
ICF will be retained by the site and a copy of the signed and dated document and any other 
written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory authority 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g., EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health and 
medical care, that information shall be provided to the affected subject(s) in written form via 
a revised ICF or, in some situations, enrolled subjects may be requested to sign and date an 
addendum to the ICF. In addition to new significant information during the course of a study, 
other situations may necessitate revision of the ICF, such as if there are amendments to the 
applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the EC. The new version of the ICF must be approved by the EC. 
Acceptance by Boston Scientific is required if changes to the revised ICF are requested by the 
site’s EC. The EC will determine the subject population to be re-consented. 
There are special circumstances in which the willingness of individual subjects to participate 
in the study could be unduly influenced or unknown. 
Subject Needing Legally Authorized Representative: 
• 
Informed consent may be given by the legally authorized representative only if a 
subject is unable to make the decision to participate in a clinical investigation (e.g., 
infant, child and juvenile, seriously ill or unconscious subject, mentally ill person, 
mentally handicapped person). In such cases, the subject shall also be informed about 
the clinical study within his/her ability to understand.                                                                            
• 
Where the subject's mental and/or physical capacity may deteriorate over the course 
of the subject's participation in the study rendering the subject incapable of rendering 
reliable responses to study activities, the subject may appoint/designate at the initial 
informed consent, an individual to provide responses in the case of incapacity, 
deterioration or death of the subject.  
Unable to Read or Write: 
• 
Informed consent shall be obtained through a supervised oral process if a subject or 
legally authorized representative is unable to read or write. An independent and 
impartial witness shall be present throughout the process. The written ICF and any 
other information shall be read aloud and explained to the prospective subject or 
his/her legally authorized representative and, whenever possible, either one shall sign 
and personally date the ICF. The witness also signs and personally dates the ICF 
attesting that the information was accurately explained, and that informed consent was 
freely given. 

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20. Committees 
20.1. Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operation group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source documents and other data information. The BSC Medical Safety and Safety 
Trial Operations team include health care providers with expertise in cardiac electrophysiology  
and with the necessary therapeutic and subject matter expertise to evaluate and classify the 
events into the categories outlined above. 
 
20.2. Steering Committee  
A Steering Committee composed of the sponsor’s Clinical Management and the study 
Principal Investigator has been convened for this study. Responsibilities for the Committee 
include oversight of the overall conduct of the study with regards to protocol development, 
study progress, subject safety, overall data quality and integrity, and first line review and final 
decision making of independent medical reviewer recommendations, as well as disseminating 
any study results through appropriate scientific sessions and publications. Steering Committee 
members may participate in the review and approval of all requests for data analysis, abstract 
and manuscript preparation, and submission. 
21. Suspension or Termination 
21.1. Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of study termination. 
21.1.1. Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the following: 
• 
Suspicion of an unacceptable risk, including serious health threat. In this case, the 
sponsor shall suspend the clinical investigation while the risk is assessed. The sponsor 
shall terminate the clinical investigation if an unacceptable risk which cannot be 
controlled is confirmed. 
• 
Instructions bby the EC or regulatory authorities to suspend or terminate the clinical 
investigation. 
• 
An enrollment rate far below expectation that prejudices the conclusion of the study.  
• 
A decision on the part of Boston Scientific to suspend or discontinue 
development/marketing of the device. 

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21.2. Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval 
Any investigator, or associated EC or regulatory authority may discontinue participation in the 
study or withdraw approval of the study, respectively, with suitable written notice to Boston 
Scientific. Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of these occurrences. 
21.3. Requirements for Documentation and Subject Follow-up 
In the event of premature study termination, a written statement as to why the premature 
termination has occurred will be provided to all participating site(s) by Boston Scientific. The 
EC and regulatory authorities, as applicable, will be notified. Detailed information on how 
enrolled subjects will be managed thereafter will be provided.  
In the event an EC terminates participation in the study, participating investigators, associated 
ECs, and regulatory authorities, as applicable, will be notified in writing. Detailed information 
on how enrolled subjects will be managed thereafter will be provided by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled subjects 
will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents, unless 
this action would jeopardize the rights, safety, or welfare of the subjects. 
21.4. Criteria for Suspending/Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled for a period beyond 3 months 
after site initiation, or if the site has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all study-related documents will be returned to 
BSC unless this action would jeopardize the rights, safety or well-being of the subjects. The 
EC and regulatory authorities, as applicable, will be notified. Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
22. Study Registration and Results  
22.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 

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22.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, EC and regulatory authorities, 
as applicable in accordance with the Boston Scientific Policy and local requirements.  As 
applicable an abbreviated Clinical Investigation Report will be made available on a publicly 
accessible database. 
22.3. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC may submit study results 
for publication (regardless of study outcome) following the conclusion or termination of the 
study. Boston Scientific adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed:  
• 
All authorship and contributorship requirements as described above must be followed. 
• 
BSC involvement in the publication preparation and the BSC Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or Steering 
Committee at the onset of the project. 
• 
The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
The data, analytic methods, and study materials for this clinical trial may be made available to 
other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
23. Reimbursement and Compensation for Subjects 
23.1. Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations. 
23.2. Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health injury 
for study subjects, if required by applicable law.  

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24. Bibliography 
1 
Huang CX, Zhang S, Huang DJ, et al. Atrial fibrillation: current knowledge and treatment 
recommendations. 2018. Chinese Journal of Cardiac Pacing and Electrophysiology,2018, 
32(04): 315-368. 
2 
Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and 
management of atrial fibrillation developed in collaboration with the European 
Association for Cardio-Thoracic Surgery (EACTS):  The Task Force for the diagnosis and 
management of atrial fibrillation of the European Society of Cardiology (ESC) Developed 
with the special contribution of the European Heart Rhythm Association (EHRA) of the 
ESC. Eur Heart J, 2021, 42: 373-498. 
3 
Du X, Guo L, Xia S, et al. Atrial fibrillation prevalence, awareness and management in a 
nationwide survey of adults in China. Heart. 2021. 107(7): 535-541.  
4 
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for 
stroke: the Framingham Study. Stroke 1991;22(8):983-988. 
5 
Al-Sakere B, AndréF, Bernat C, et al. Tumor ablation with irreversible electroporation. 
PLoS One. 2007;2(11): e1135. 
6 
Neumcke, B, Walz, D, Läuger, P. Nonlinear effects in lipid bilayer membranes. III. The 
dissociation field effect. Biophys J. 1970;10(2):172-182. 
7 
Benz R, Beckers F, Zimmermann U. Reversible electrical breakdown of lipid bilayer 
membranes: a charge-pulse relaxation study. J Membr Biol. 1979;48(2):181-204. 
8 
Chang, DC. Cell poration and cell fusion using an oscillating electric field. Biophys J. 
1989;56(4):641-652. 
9 
Chang DC, Reese TS. Changes in membrane structure induced by electroporation as 
revealed by rapid-freezing electron microscopy. Biophys J. 1990;58(1):1-12. 
10 Wendler JJ, Pech M, Blaschke S, et al. Angiography in the isolated perfused kidney: 
radiological evaluation of vascular protection in tissue ablation by nonthermal irreversible 
electroporation. Cardiovasc Intervent Radiol. 2012;35(2):383-390. 
11 Gehl J, Skovsgaard T, Mir LM. Vascular reactions to in vivo electroporation: 
characterization and consequences for drug and gene delivery. Biochim Biophys Acta. 
2002;1569(1-3):51-58. 
12 Kingham TP, Karkar AM, D’Angelica MI et al. Ablation of perivascular hepatic malignant 
tumors with irreversible electroporation. J Am Coll Surg. 2012;215(3):379-387. 
13 Olweny EO, Kapur P, Tan YK et al. Irreversible electroporation: evaluation of nonthermal 
and thermal ablative capabilities in the porcine kidney. Urology. 2013;81(3):679-684. 
14 Maor E, Ivorra A, Leor J, et al. Irreversible electroporation attenuates neointimal 
formation after angioplasty. IEEE Trans Biomed Eng. 2008;55(9):2268-2274. 
15 Thomson KR, Cheung W, Ellis SJ, et al. Investigation of the safety of irreversible 
electroporation in humans. J Vasc Interv Radiol. 2011;22(5):611-621. 
16 Wittkampf FH, van Driel VJ, van Wessel H,  et al. Feasibility of electroporation for the 
creation of pulmonary vein ostial lesions. J Cardiovasc Electrophysiol. 2011;22(3):302-
309. 
17 van Driel VJ, Neven KG, van Wessel H, et al. Pulmonary vein stenosis after catheter 
ablation: electroporation versus radiofrequency. Circ Arrhythm Electrophysiol. 
2014;7(4):734-738. 

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18 Neven K, van Driel V, van Wessel H, et al. Epicardial linear electroporation ablation and 
lesion size. Heart Rhythm. 2014;11(8):1465-1470. 
19 van Driel V, Neven K, van Wessel H, et al. Low vulnerability of the right phrenic nerve 
to electroporation ablation. Heart Rhythm. 2015;12(8):1838-1844. 
20 Neven K, van Driel V,van Wessel H, et al. Safety and feasibility of closed chest epicardial 
catheter ablation using electroporation. Circ Arrhythm Electrophysiol, 2014, 7: 913-919. 
21 Final Clinical Study Report, Document Number CS1009, Rev A. The IMPULSE Study: 
A Safety and Feasibility Study of the FARAPULSE™ Endocardial Ablation System in 
the Treatment of Paroxysmal Atrial Fibrillation. July 27, 2020. 
22 Final Clinical Study Report, Document Number CS1165, Rev A. PEFCAT: A Safety and 
Feasibility Study of the FARAPULSE™ Endocardial Ablation System to Treat 
Paroxysmal Atrial Fibrillation. November 30, 2020. 
23 Final Clinical Study Report, Document Number CS1166, Rev A. PEFCAT II: Expanded 
Safety and Feasibility Study of the FARAPULSE™ Endocardial Multi Ablation System 
to Treat Paroxysmal Atrial Fibrillation. November 30, 2020. 
24 Final Clinical Study Report, Document Number CS1071, Rev B. FARAPULSE™ Pulsed 
Field Ablation system consolidated final clinical study report. November 30, 2020. 
25 Clinical Investigator Plan, Document Number CS0934, Rev C. The FARAPULSE 
ADVENT trial: a prospective randomized pivotal trial of the FARAPULSE Pulsed Field 
Ablation system compared with standard of care ablation in patients with paroxysmal atrial 
fibrillation. March 17, 2021. 
26 Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation 
in Atrial Fibrillation. J Am Coll Cardiol. 2019. 74(3): 315-326. 
27 Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed Field Ablation of PAF: 1-Year Outcomes 
of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021. 7(5): 614-627. 
28 Reddy VY, Koruth J, Jais P, et al. Ablation of Atrial Fibrillation With Pulsed Electric 
Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin 
Electrophysiol. 2018. 4(8): 987-995. 
29 Kuroki K, Whang W, Eggert C, et al. Ostial dimensional changes after pulmonary vein 
isolation: Pulsed field ablation vs radiofrequency ablation. Heart Rhythm. 2020. 17(9): 
1528-1535. 
30 Cochet H, Nakatani Y, Sridi-Cheniti S, et al. Pulsed field ablation selectively spares the 
oesophagus during pulmonary vein isolation for atrial fibrillation. Europace. 2021 . 
31 Nakatani Y, Sridi-Cheniti S, Cheniti G, et al. Pulsed field ablation prevents chronic atrial 
fibrotic changes and restrictive mechanics after catheter ablation for atrial fibrillation[J]. 
Europace, 2021. 
25. Abbreviations and Definitions  
25.1. Abbreviations 
Abbreviations are shown in Table 25.1-1.   
Table 25.1-1: Abbreviations 
Abbreviation/Acronym Term 
AAD  
Anti-Arrhythmic Drug  

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Table 25.1-1: Abbreviations 
Abbreviation/Acronym Term 
ACT 
Activated Clotting Time 
AF  
Atrial Fibrillation  
AFL  
Atrial Flutter  
AT  
Atrial Tachycardia  
AV 
Anterio-Venous 
BMI 
Body Mass Index 
CABG  
Coronary Artery Bypass Grafting  
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CRT  
Cardiac Resynchronization Therapy  
CTI 
Cavotricuspid Isthmus 
CVA  
Cerebral Vascular Accident  
DFU  
Directions for Use  
DMS  
Diaphragm Movement Sensor  
DVT  
Deep Vein Thrombosis  
EC 
Ethics Committee 
ECG 
Electrocardiography 
EDC  
Electronic Data Capture  
eCRF 
Electronic Case Report Form 
eGFR 
Estimated Glomerular Filtration Rate 
EP  
Electrophysiology  
GCP 
Good Clinical Practice 
HRS  
Heart Rhythm Society  
IB  
Investigator’s Brochure  
ICD  
Implantable Cardioverter Defibrillator  
ICE 
Intracardiac echocardiography 
ICF  
Informed Consent Form  
ID 
Identification Number 
IFU  
Instructions for Use  
INR 
International Normalized Ratio 
IVC 
Inferior Vena Cava 
LA  
Left Atrium  
LGE 
Late Gadolinium Enhance 
LVEF  
Left Ventricular Ejection Fraction  
MRI  
Magnetic Resonance Imaging  
MVs 
Monitoring Visits 
NMPA 
National Medical Products Administration 
NOAC 
New oral anticoagulants 
NYHA 
New York Heart Association 
PAF  
Paroxysmal Atrial Fibrillation  
PE  
Pulmonary Embolism  
PFA 
Pulse Field Ablation 
PTCA  
Percutaneous transluminal coronary angioplasty  

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Table 25.1-1: Abbreviations 
Abbreviation/Acronym Term 
PV  
Pulmonary Veins  
PVI  
Pulmonary Vein Isolation  
RFA 
Radiofrequency Ablation 
SADE  
Serious Adverse Device Effect  
SAE  
Serious Adverse Event  
SCE  
Silent Cerebral Event  
SCL  
Silent Cerebral Lesion  
TEE  
Trans-esophageal echocardiography  
TIA  
Transient Ischemic Attack  
TSF 
Technical Source Form 
TTE 
Transthoracic Echocardiography 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
25.2. Definitions 
Terms are defined in Table 25.2-1.  
Table 25.2-1: Definitions 
Term 
Definition 
Activated 
Coagulation/Clotting Time  
ACT is a test that is used to monitor the effectiveness of high dose heparin 
therapy.  
Acute Procedural Success  
Achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation 
only.   
Arterial-Venous Fistula  
Abnormal communication between an artery and a vein.  
Atrioesophageal Fistula  
An atrioesophageal fistula is defined as a connection between the atrium and the 
lumen of the esophagus. Evidence supporting this diagnosis includes 
documentation of esophageal erosion combined with evidence of a fistulous 
connection to the atrium, such as air emboli, an embolic event, or direct 
observation at the time of surgical repair. A CT scan or MRI scan is the most 
common method of documentation of an atrioesophageal fistula.  
Attempt Subject  
Any subject that signs the consent form, meets eligibility criteria and has any 
study device inserted into the body but does not receive any PFA application with 
the study device.  
AV block  
A conduction disturbance that results in the partial inability of an electrical 
impulse generated in the atria to reach the ventricles. Refers to AV block not 
attributable to medication effect or vasovagal reaction.  
Blanking Period  
90-day period between ablation procedure and the initiation of the Long-term 
Effectiveness Evaluation Period during which subjects can be prescribed 
antiarrhythmic drugs as determined necessary by the investigator.  
Cardiac 
tamponade / 
perforation  
The development of a pericardial effusion post-ablation that results in 
hemodynamic compromise, requires pericardiocentesis or results in a 1-
cm or more pericardial effusion as documented by echocardiography. 

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Table 25.2-1: Definitions 
Term 
Definition 
Cardiac tamponade/perforation should also be classiﬁed as “early” or 
“late” depending on whether it is diagnosed during or following initial 
discharge from the hospital.  
Embolism  
The sudden blocking of an artery by a clot or foreign material which has been 
brought to its site of lodgment by the blood current.  
Enrolled Subject  
A subject who is eligible for enrollment and signs an informed consent document 
to participate in the study.  
Hematoma  
A localized collection of blood, usually clotted, in an organ, space or tissue, due 
to a break in the wall of a blood vessel.  
Intent Subject  
Any subject that signs the consent form but does not have any study devices 
inserted into the body. Subjects who are enrolled in the study but do not undergo 
ablation procedure within 30 days from consent signature date may not be 
reconsented and will be withdrawn from the study.  
In-patient Hospitalization  
Hospitalizations ≥24 hours in duration or <24 hours with medical intravenous 
therapy or surgical intervention  
Total procedure time  
Initiation of interventional venous access puncture to all devices remove 
from the body 
LA dwell time  
Total time an ablation catheter is in the left atrium 
Myocardial infarction (in 
the context of AF  
ablation)  
The presence of any one of the following criteria:  
(1) detection of ECG changes indicative of new ischemia (new STT wave 
changes or new LBBB) that persist for more than 1 hour;  
(2) development of new pathological Q waves on an ECG;  
(3) imaging evidence of new loss of viable myocardium or new regional wall 
motion abnormality  
Paroxysmal Atrial 
Fibrillation (PAF)  
Recurrent symptomatic Atrial Fibrillation that terminates spontaneously or with 
intervention within seven days of onset.  
Pericarditis  
Inflammation of the pericardium surrounding the heart. Pericarditis should be 
considered a major complication following ablation if it results in an effusion that 
leads to hemodynamic compromise or requires pericardiocentesis, prolongs 
hospitalization by more than 48 hours, requires hospitalization, or persists for 
more than 30 days following the ablation procedure.  
Phrenic Nerve Palsy  
Phrenic nerve palsy is defined as absent phrenic nerve function demonstrated 
radiographically. A phrenic nerve palsy is considered to be permanent when it is 
documented to be present 12 months or longer following ablation.  
Pneumothorax  
Collapse of the lung due to an abrupt change in the intrapleural pressure within 
the chest cavity.  
Secondary Effectiveness 
Failure  
A Treatment Subject with: 
• 
Fail to achieve electrical isolation of all PVs using FARAPULSE Pulsed 
Field Ablation system only. 
• 
After the Blanking Period (90 days post the procedure) to 12-month 
after the procedure: 

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Table 25.2-1: Definitions 
Term 
Definition 
1) 
Occurrence of any Detectable AF, AFL* or AT captured by 
one of the following methods:  ≥ 30 seconds in duration 
recording from 24-hour or longer Holter Monitor or  ≥ 10 
seconds recording from 12-lead ECG, or 
2) 
Any cardioversion for AF, AFL* or AT, or 
3) 
Use of any Class I or Class III AADs# for the treatment of AF, 
AFL* or AT. 
• 
At any time through 12 months after the procedure:  
1) 
Re-ablation for AF, AFL* or AT, or 
2) 
Use of amiodarone, except intra-procedurally to control an 
arrhythmia.  
#It won’t be considered as a failure if the subject has three-month visit happened 
after 90 days post the procedure, but still in the window (<=104 day) with AADs 
on, and physicians decide to take AADs off after this visit. 
*excluding cavotricuspid isthmus dependent (CTI)-dependent flutter confirmed 
by EP study 
Pseudoaneurysm  
A dilation of an artery with disruption of one or more layers of its walls.  
Pulmonary edema 
Respiratory compromise resulting from cardiac dysfunction or volume overload 
leading to increased interstitial lung fluid requiring intubation or parenteral 
diuretics. 
Severe Pulmonary Vein 
Stenosis  
Severe pulmonary vein stenosis is defined as a reduction of the diameter of a PV 
or PV branch. PV stenosis can be categorized as mild <50%, moderate 50%–
70%, and severe ≥70% reduction in the diameter of the PV or PV branch. A 
severe PV stenosis will count towards the primary safety endpoint if it is 
confirmed by imaging.  
Source Data 
Ref: ISO 14155  
All information in original records of clinical findings, observations, or other 
activities in a clinical investigation, necessary for the reconstruction and 
evaluation of the clinical study (original records or certified copies).  
Source Document  
Ref: ISO 14155 
Printed, optical or electronic document containing source data. Examples: 
Hospital records, laboratory notes, device accountability records, radiographs, 
records kept at the investigation site, and at the laboratories involved in the 
clinical study.  
Vulnerable Population 
Ref: ISO 14155 
Individuals who are unable to fully understand all aspects of the 
investigation that are relevant to the decision to participate, or who could 
be manipulated or unduly influenced as a result of a compromised 
position, expectation of benefits or fear of retaliatory response. 
Stroke  
Rapid onset of a focal or global neurological deficit with at least one of the 
following:  
• 
Change in level of consciousness 
• 
Hemiplegia, hemiparesis, numbness or sensory loss affecting 1 side of 
the body 
• 
Dysphasia or aphasia 
• 
Hemianopia, amaurosis fugax, or  
• 
Other neurological signs or symptoms consistent with stroke  

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Table 25.2-1: Definitions 
Term 
Definition 
The diagnosis of stroke requires that there be no other readily identifiable non-
stroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, 
hypoglycemia, peripheral lesion, pharmacological influences). 
The duration of the defined neurological deficit(s) must be: 
• 
≥ 24-hours; OR  
• 
< 24-hours if  
o 
Therapeutic 
intervention(s) 
were 
performed 
(e.g., 
thrombolytic therapy or intracranial angioplasty), OR  
o 
Available neuroimaging documents a new hemorrhage or 
infarct, OR  
o 
The neurological deficit results in death.  
Thrombus  
An aggregation of blood factors, primarily platelets and fibrin with entrapment 
of cellular elements, frequently causing vascular obstruction at the point of its 
formation.  
Thromboembolism  
The blockage of a blood vessel lumen by air or solid material such as device 
fragments, blood clot or other tissues that have migrated from another anatomic 
site.  
Transient Ischemic Attack 
(TIA)  
New focal neurological deficit with rapid symptom resolution (usually 1 to 2 
hours), always within 24 hours; neuroimaging without tissue injury  
Treatment Subject  
Any subject that signs the consent form, meets eligibility criteria and has the 
specified study devices inserted into the body and undergoes protocol specific 
treatment for the intended disease.  
Gastric motility/pyloric 
spasm disorders  
Evidence of impaired gastric motility or pyloric spasm that prolongs 
hospitalization, requires hospitalization or persists for more than 30 days. 
Vascular Access 
Complications  
Vascular 
access 
complication 
(e.g., 
groin 
hematoma, 
AV 
fistula, 
pseudoaneurysm) requiring a significant and invasive intervention (e.g., surgical 
repair, blood transfusion or thrombin injection)，prolonging the hospital stay, or 
requiring hospital admission.  
 
 
 
 

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26. Appendices 
Template of Report Form for  
Serious Adverse Events in Clinical Trials of Medical Devices/In Vitro 
Diagnostic Reagents 
Basic Information 
Name of the Clinical 
Trial 
 
Filing No. of the 
Clinical Trial 
 
Type of Report 
□ Initial report □ Follow-up 
report 
□ Summary report 
Date of Report 
Date: （MM/DD/YYYY
） 
Sponsor 
 
Contact Address of the 
Sponsor 
 
Contact Person of the 
Sponsor 
 
Sponsor's Contact 
Number/Mobile Number 
 
Clinical Trial 
Institution 
 
Filing No. of the 
Institution 
 
Clinical Trial Specialty 
 
Principal Investigator 
 
Title 
 
Contact Person 
 
Contact Number 
 
Information of the Investigational Medical Device 
Name of 
Investigational 
Medical Device 
 
Specification and 
Model/Packaging 
Specification 
 
Classification of 
Investigational 
Medical Device 
 
Class III Medical Device 
Requiring Approval of 
Clinical Trial 
□Yes □ No 
Batch Number 
 
Date of 
Production/Expiration Date 
 
Scope of Application 
or Intended Use 
 
Information of the Subject 
No. 
 
Gender 
□Male □Female 
Date of Birth 
Date: （MM/DD/YYYY
） 

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Comorbid Conditions 
and Treatment 
Description 
 
Information of Serious Adverse Events 
Name of Serious 
Adverse Event 
 
Use Date 
Date: （MM/DD/YYYY
） 
Date of Onset 
Date: （MM/DD/YYYY
） 
Date Investigator 
Became Aware of the 
Event 
Date: （MM/DD/YYYY
） 
Date Sponsor Became 
Aware of the Event 
Date: （MM/DD/YYYY
） 
Classification of 
Serious Adverse 
Events 
□ Lead to death_________(DD/MM/YYYY) 
□ Fatal disease or injury 
□ Permanent defects in body structure or body function 
□ An in-patient or prolonged hospitalization 
□ Medical measures are required to avoid permanent defects to body structure or body function 
□ Lead to fetal distress, fetal death or a congenital abnormality or congenital defect 
□ Other_________ 
Measures Taken on 
the Investigational 
Medical Device 
□ Continue to use □ Reduce the use □ Resume after suspending use □ Stop using □ Other 
Outcome 
□ Symptoms disappear (sequelae □Yes □No) □ Symptoms persist □ Symptoms relieved □ 
Symptoms worsening 
□ Death □ Other__________  
Relationship with the 
Investigational 
Medical Device 
□ Definitely related □ Possibly related □ Possibly unrelated □ Definitely unrelated (Note: it 
shall not need to be reported to relevant regulatory department if it is possibly or definitely 
unrelated) 
Device Defects or Not 
□Yes □ No 
Expected or not 
□Yes □ No 
Other Serious Safety 
Risk Information or 
Not 
□Yes □ No 
Serious adverse events occurring on a 
large scale or other major safety issues 
□Yes □ No 
Detailed information of onset and treatment: 
 
 
 
Risk Control Measures 
Taken or to be Taken 
□ Modify the clinical trial protocol □ Modify the informed consent form (ICF) and other 
information provided to the subjects 
□ Modify other relevant documents □ Continue to monitor risks and not take other measures 
temporarily □ Suspend clinical trials of medical devices □ Terminate clinical trials of medical 
devices □ Other_____________________ 
Seal of Sponsor 
Note: The medical devices mentioned in this form include in vitro diagnostic reagents. 

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Completion Instructions: 
I. This form is for sponsor of the clinical trial of medical device (including in vitro 
diagnostic reagents, the same below) to report individual cases of serious adverse events 
related to the investigational medical device during the clinical trial of medical device to the 
provincial drug regulatory departments in the place where the sponsor is located, the 
provincial regulatory departments and health administration departments in the place where 
the clinical trial institution of medical device is located. The written report shall be delivered 
by courier after being affixed with the official seal of the sponsor. The report form for the 
investigator to report serious adverse events shall be determined by the sponsor, information 
of which shall be covered at least in principle. 
II. Serious adverse events related to the investigational medical device refer to the 
events that occur after subjects use the investigational medical device according to the 
clinical trial protocol and are believed to be possibly or definitely related to the 
investigational medical device through analysis. 
III. The sponsor shall report serious adverse events (death or life-threatening) related to 
the investigational medical device within 7 days after being informed of them and report 
serious adverse events (non-death or non-life-threatening) related to the investigational 
medical device within 15 days after being informed of them. The day when the sponsor is 
notified of a serious adverse event is day 0. 
IV. When serious adverse events related to the medical devices used in a blind trial 
occur, in order to identify the correlation between the serious adverse events and the medical 
devices used in the trial, the sponsor shall establish corresponding procedures. The 
unblinding of related individual cases shall only be made to individual special persons, but 
the "blindness" of the cases shall still be kept to those who are responsible for analyzing and 
elaborating on the efficacy results. 
V. When other serious safety risks appear during clinical trials of medical devices, the 
sponsor shall fill in the applicable items in this form and elaborate on the control measures. 
VI. When serious adverse events related to the medical devices used in clinical trials 
occur on a large scale or other major safety issues arise during clinical trials, the sponsor 

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shall tick the applicable items in this form, elaborate on the occurrence and handling, and 
take such risk control measures as suspending or terminating clinical trials of medical 
devices, etc. 
VII. Filling Requirements 
1. This form shall be filled in by the sponsor, the content of which shall be not only true, 
accurate and complete, but also consistent with source data of the clinical trial. 
2. This form includes the following four parts: basic information, information of the 
investigational medical devices, information of subjects and information of serious adverse 
events. 
3. Basic information 
3.1 Name of the clinical trial: It refers to the name of the clinical trial of medical device 
stated on the Filing Form for Clinical Trial of Medical Device. 
3.2 Filing No. of the clinical trial: It refers to the filing number stated on the Filing 
Form for Clinical Trial of Medical Device. 
3.3 Report type 
3.3.1 Initial report: It refers to the report submitted when the sponsor is informed of the 
serious adverse events related to the investigational medical device for the first time. 
3.3.2 Follow-up report: It refers to the report submitted when important changes take 
place during follow-up of the serious adverse events. 
3.3.3 Summary report: It refers to the last report after the disappearance/relief of serious 
adverse events. 
3.4 Report date: It refers to the exact day when this form is filled in. 
3.5 Sponsor: It refers to the sponsor who reports serious adverse events, which shall be 
consistent with that stated on the Filing Form for Clinical Trial of Medical Device. The 
official seal shall be affixed. 
3.6 Contact address of the sponsor: It refers to the contact address of the entity which 
reports adverse events of medical device. 

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3.7 Contact person of the sponsor: It refers to the person who is responsible for 
monitoring adverse events in clinical trial of medical device and works for the sponsor that 
takes charge of reporting serious adverse events. 
3.8 Sponsor's contact number/mobile number: It refers to the telephone number of the 
monitoring department which is responsible for monitoring adverse events in clinical trial of 
medical device and under jurisdiction of the sponsor that takes charge of reporting serious 
adverse events. 
3.9 Clinical trial institution: It refers to the clinical trial institution of medical device that 
reports the onset of serious adverse events. And it shall be consistent with that stated on the 
Filing Form for Clinical Trial of Medical Device. 
3.10 Filing No. of the institution: It refers to the filing number of the clinical trial 
institution of medical device that reports the onset of serious adverse events in the filing 
system of the drug regulatory departments. And it shall be consistent with that stated on the 
Filing Form for Clinical Trial of Medical Device. 
3.11 Clinical trial specialty: It refers to the filing name of the clinical trial specialty 
where the reported serious adverse events occur in the filing system of the drug regulatory 
departments. And it shall be consistent with that stated on the Filing Form for Clinical Trial 
of Medical Device. 
3.12 Principal investigator: It refers to the principal investigator from the clinical trial 
institution of medical device that reports the onset of serious adverse events. And it shall be 
consistent with that stated on the Filing Form for Clinical Trial of Medical Device. 
3.13 Title: It refers to the title of the principal investigator of the clinical trial institution 
of medical device that reports the onset of serious adverse events. 
3.14 Contact person: It refers to the contact person of the clinical trial institution of 
medical device that reports the onset of serious adverse events. The contact person can be 
either the principal investigator or clinician among investigators authorized by the principal 
investigator. 

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3.15 Contact number: It refers to the contact telephone number of the contact person 
from the clinical trial institution of medical device that reports the onset of serious adverse 
events. 
4. Information of the investigational medical device 
4.1 Name of investigational medical device: It refers to the name of the investigational 
medical device related to the reported serious adverse events. And it shall be consistent with 
that stated on the Filing Form for Clinical Trial of Medical Device. 
4.2 Specification and model/packaging specification: It refers to the specification and 
model of the investigational medical device or the packaging specification of the 
investigational in vitro diagnostic reagent involved in the reported serious adverse events, 
which shall be consistent with the specification and model of the investigational medical 
device or the packaging specification of the investigational in vitro diagnostic reagent stated 
on the Filing Form for Clinical Trial of Medical Device. 
4.3 Classification of investigational medical device: It refers to the classification of the 
investigational medical device related to the reported serious adverse events. And it shall be 
consistent with that stated on the Filing Form for Clinical Trial of Medical Device. 
4.4 Class III medical device requiring approval of clinical trial: It refers to whether the 
investigational medical device related to the reported serious adverse events belongs to Class 
III medical device requiring approval of clinical trial. And it shall be consistent with that 
stated on the Filing Form for Clinical Trial of Medical Device. 
4.5 Batch No.: It refers to the batch number of the investigational medical device related 
to the reported serious adverse events. And it shall be consistent with that stated on the label 
or packaging mark used for the investigational medical device. 
4.6 Date of production/expiration date: It refers to the date of production and period 
during which the quality of the investigational medical device can be guaranteed under 
specified conditions. And it shall be consistent with that stated on the label or packaging 
mark used for the investigational medical device. 
4.7 Scope of application or intended use: It refers to the scope of application or intended 
use of the investigational medical device. 

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When multiple investigational medical devices are involved, more lines can be added as 
appropriate. 
5. Information of subjects 
5.1 No.: It refers to the number of the subject involved in the reported serious adverse 
events in clinical trial. 
5.2 Gender: It refers to the gender of the subjects involved in the reported serious 
adverse events. 
5.3 Date of birth: It refers to the date of birth of the subject involved in the reported 
serious adverse events in clinical trial. 
5.4 Comorbid conditions and treatment: It refers to the comorbid conditions and 
treatment of the subject involved in the reported serious adverse events in clinical trial, which 
shall be filled in according to the medical record of the subject. If the subject has no 
comorbid conditions and treatment, please fill in "None". 
6. Information of serious adverse events 
6.1 Name of serious adverse events: It refers to the name of the reported serious adverse 
event, which shall be a medical term with priority given to medical diagnosis. 
6.2 Use date: It refers to the exact use date of the investigational medical device related 
to the reported serious adverse events. 
6.3 Onset date: It refers to the onset date of the reported serious adverse event. 
6.4 Date investigator became aware of the event: It refers to the exact date when the 
investigator becomes aware of the reported serious adverse events. 
6.5 Date sponsor became aware of the event: It refers to the exact date when the 
investigator reports the serious adverse events to the sponsor. 
6.6 Classification of serious adverse events: It refers to the classification of the reported 
serious adverse events. If "Other" is ticked, the specific situation shall be indicated. 

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6.7 Measures taken on the investigational medical device: They refer to the measures 
taken by investigators on the investigational medical device related to serious adverse events. 
If "Other" is ticked, the specific measures shall be indicated. 
6.8 Outcome: It refers to the outcome of the subjects when this form is filled in. If 
"Symptoms disappear" is ticked, whether there are sequelae shall be further chosen. If 
"Other" is ticked, the specific situation shall be indicated. 
6.9 Relationship with the investigational medical device: It refers to the correlation 
between the reported serious adverse events and the investigational medical device. 
6.9.1 Related to the investigational medical device: (1) there is a reasonable time 
relationship between the two; (2) it belongs to the known risk of the investigational medical 
device or can be explained by the mechanism of the investigational medical device; (3) the 
injury is reduced or disappeared after stopping use; (4) the injury appears again after reuse; 
(5) it cannot be explained by other influencing factors. It shall be determined as "definitely 
related" when five of them are met at the same time and "possibly related" when two of them 
are met. 
6.9.2 Unrelated to the investigational medical device: (1) there is no reasonable time 
relationship between the two; (2) this adverse event is a type of event that is unlikely to be 
caused by the investigational medical device; (3) this adverse event can be explained by 
combination of device/drug, disease progress of the patient and other treatment effects. It 
shall be determined as "definitely unrelated" when three of them are met at the same time and 
"possibly unrelated" when one of them is met. 
6.10 Device defects or not: It refers to whether the reported serious adverse events are 
caused by device defects of the investigational medical device. 
6.11 Expected or not: It refers to whether the reported serious adverse events are the 
expected serious adverse events of investigational medical device. 
6.12 Other serious safety risk information: It refers to whether the reported content 
belongs to other serious safety risk information. 
6.13 Serious adverse events occurring on a large scale or other major safety issues: It 
refers to whether it belongs to serious adverse events occurring on a large scale or other 

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major safety issues that require suspension or termination of clinical trials according to the 
clinical trial protocol, characteristics of medical devices, product risks, literature data, etc. in 
combination with the number of cases previously reported and their specific situation. 
6.14 Detailed information of onset and treatment: It refers to the onset of the reported 
serious adverse events and the treatment conducted by the investigator. 
6.14.1 It is necessary to describe the participation of subjects in clinical trial of medical 
device. 
6.14.2 It is necessary to describe the use of the investigational medical device. For 
active and passive medical devices, the following shall be described: specific operation and 
use of the investigational medical device, unexpected results, (possible) injury to subjects, 
rescue measures taken and results, etc. For in vitro diagnostic medical devices, the following 
shall be described: patient diagnosis and treatment information (such as disease and 
medication), sample testing process and results, abnormal conditions found, measures taken, 
final result determination, and impact on clinical diagnosis and treatment. 
6.14.3 The occurrence and handling of serious adverse events shall be described. 
6.14.4 In case of any serious adverse events occurring on a large scale, the situation of 
the subjects involved in the serious adverse events shall be summarized in detail. 
6.15  Risk control measures taken or to be taken: They refer to the risk control measures 
taken or to be taken for serious adverse events. If "Other" is ticked, the specific measures 
shall be described, such as strengthening the training of investigators, paying close follow-up 
visits, etc