POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

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POLARxTM Cardiac Cryoablation System Post Market Clinical Study  
 
POLAR SMART 
 
PY007 
 
CLINICAL INVESTIGATION PLAN 
 
NCT#05282823 
 
 
Sponsored By 
Boston Scientific Corporation, Rhythm Management (RM) 
4100 Hamline Avenue North 
St. Paul, MN 55112 
United States 
 
and 
 
Boston Scientific International SA   
2, rue René Caudron   
Parc d’affaires Le Val Saint-Quentin   
78960 Voisins-le-Bretonneux, France    
 
 
 
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. 
 
 
 
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2. Protocol Synopsis 
POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
Study 
Objective(s) 
To collect real-world clinical data on safety, effectiveness and procedural 
success of Boston Scientific Cardiac Cryoablation System (POLARxTM 
System) when used to perform pulmonary vein isolation (PVI) in the 
ablation treatment of De Novo Atrial Fibrillation (AF). 
Indication(s) for 
Use  
Subjects enrolled in this POLAR SMART study will be clinically 
indicated for PVI ablation procedure (in compliance with instructions for 
use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment 
of paroxysmal AF. 
(Commercial) 
Device/System 
applied as 
Standard of 
Care and sizes, 
if applicable 
The Boston Scientific Cardiac Cryoablation System (“Cryoablation 
System”) consists of the following devices and components: 
• POLARx™ and POLARx™ FIT Cryoablation Catheters (“Cryoablation 
Catheter”); 
• POLARMAP™ Catheter (“Cryo Mapping Catheter”); 
• POLARSHEATH™ Steerable Sheath (“Cryo Steerable Sheath”); 
• SMARTFREEZE™ Console (“Console”); 
• Related Accessories, as listed in protocol section 5.1.7. 
Study Design 
POLAR SMART study is a prospective, multicenter, single arm, post-
market study. 
All subjects signing the consent, undergoing the index (ablation) 
procedure and treated with the study devices will be followed up for one 
year. 
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
 
Figure 7.1-1: POLAR SMART Study Design 
Planned 
Number of 
Subjects 
A minimum sample size of 200 subjects treated only with PVI is required.  
The maximum overall study sample size will be limited to ≤ 400 subjects.  
To avoid any center effect and bias, individual centers will not be allowed 
to enroll more than 20 subjects meeting enrollment criteria, unless Boston 
Scientific gives written approval to do so. 
Planned 
Number of Sites 
/ Countries 
Approximately 30 sites in Japan and South Korea will be included in the 
study. 
Primary Safety 
Endpoint 
Safety event free rate at 12 months post-index procedure.  
Primary safety events will consist of a composite of the following 
procedure-related and device-related adverse events.  
Acute primary safety endpoint events, events occurring up to 7 days post-
index procedure or hospital discharge, whichever is later, include:  
• 
Death 
• 
Myocardial infarction (MI) 
• 
Gastroparesis/injury to vagus nerve  
• 
Transient ischemic attack (TIA) 
• 
Stroke/Cerebrovascular accident (CVA) 
• 
Thromboembolism/Air embolism* 
• 
Cardiac tamponade/perforation 
• 
Pneumothorax 
• 
Serious vascular access complications** 
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
• 
Pulmonary edema/heart failure 
• 
AV block not attributable to medication effect or vasovagal 
reaction. 
* Thromboembolic or air embolic events collected in the study refer to any occlusion of 
blood vessel(s) that results in clinical symptoms. 
** Defined as prolongation of hospitalization, requirement of surgical intervention or 
blood transfusion. 
 
Chronic primary safety endpoint events, events occurring through 12 
months post-index procedure, include: 
• 
Atrial esophageal fistula 
• 
Significant pulmonary vein (PV) stenosis (≥ 70% reduction of 
diameter of the PV from baseline*** OR presented by patient’s 
symptoms at 12-Month follow-up and requiring intervention)  
• 
Symptomatic pericardial effusion  
• 
Persistent phrenic nerve injury**** 
 
*** Recommended to use the same imaging method as baseline. 
**** A non-recovered phrenic nerve injury at 12 months post-index procedure will count 
as a chronic primary endpoint. The study will collect information on phrenic nerve palsy 
observed before the end of the index procedure and, in case it occurred, will track 
information for potential recovery during the study visits. 
Primary 
Effectiveness 
Endpoint 
Failure free rate at 12 months post-index procedure.  
Failure defined as: 
• 
Failure to achieve acute procedural success* in the index 
procedure;  
• 
Any documented recurrent AF episode(s), or new onset of atrial 
flutter (AFL) or any other atrial tachycardia (AT) events (≥ 30 
seconds in duration from any clinical recording devices OR from 
a 10-second 12-lead ECG) between Days 91 and 12-Month follow-
up**; 
• 
Any of the following interventions between Days 91 and 12-
Month follow-up: 
 Repeat AF ablation procedure; 
 Electrical and/or pharmacological cardioversion of AF or any 
new AFL, AT; 
 Prescribed a higher dose of any anti-arrhythmic drugs 
(AAD)*** documented at baseline or a new AAD*** not 
documented at baseline.  
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
* Acute procedural success is defined as isolation of all the pulmonary veins or 
anatomical equivalents achieved with the Cryoablation Catheter at the end of the index 
procedure and as demonstrated at minimum by entrance block using the Cryo Mapping 
Catheter  (Other techniques of assessment are per investigator’s discretion).   
** Subjects will be monitored for recurrences/new onset of the arrhythmias by means 
of 12-lead ECG OR any clinical recording devices (for example but not limited to, smart 
watch, 24-hour Holter monitoring, home monitoring systems or implanted devices etc.) 
that are per standard of care (SOC) used by the hospital/clinic. These documentation of 
episodes would need to be verified by investigator and filed in medical records. 
*** AADs for endpoint will consist of all Class I/III and any Class II/IV medications 
taken for control of AF/AFL/AT recurrence. 
Secondary 
Endpoints 
• Rate of documented acute procedural success, defined as PVI 
achieved with the Cryoablation System. Electrical isolation of a PV 
is demonstrated at minimum by entrance block using the Cryo 
Mapping Catheter (Other techniques of assessment are per 
investigator’s discretion). 
• Failure free rate at 6 months post-index procedure.   
 Failure to achieve acute procedural success* in the index 
ablation procedure;  
 Any documented recurrence of AF or new onset of any AFL 
or AT events (≥ 30 seconds in duration from any clinical 
recording devices or from a 10-second 12-lead ECG) between 
Days 91 and 6-Month follow-up**; 
 Any of the following interventions between Days 91 and 6-
Month follow-up: 
o Repeat AF ablation procedure; 
o Electrical and/or pharmacological cardioversion of AF 
or any new AFL, AT; 
o Prescribed a higher dose of any AAD*** documented at 
baseline or a new AAD*** not documented at baseline. 
  
* Acute procedural success is defined as isolation of all the pulmonary veins or 
anatomical equivalents achieved with the Cryoablation Catheter at the end of the index 
procedure and  as demonstrated at minimum by entrance block using the Cryo Mapping 
Catheter  (Other techniques of assessment are per investigator’s discretion).   
** Subjects will be monitored for recurrences/new onset of the arrhythmias by means of 
12-lead ECG OR any clinical recording devices (for example but not limited to, smart 
watch, 24-hour Holter monitoring, home monitoring systems or implanted devices etc.) 
that are per SOC used by the hospital/clinic. These documentation of episodes would 
need to be verified by investigator and filed in medical records. 
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POLAR SMART  
*** AADs for endpoint will consist of all Class I/III and any Class II/IV medications 
taken for control of AF/AFL/AT recurrence. 
Additional 
Endpoints 
Additional endpoints and analyses include, but are not limited to:  
• Procedure times: left atrium (LA) dwell time*, total ablation time, 
number of cryo applications per vein, time to thaw, total 
fluoroscopy time and total procedure time;  
• Time-To-Isolation (TTI) per ablation application, if available; 
• Freedom from recurrence of individual types of AF, or new AFLs 
or ATs between Days 91 and 12-Month follow-up; 
• Analysis of additional ablation techniques performed as there is 
foreseen cavotricuspid isthmus (CTI) and roof line ablation 
performed with other catheters outside PVI; 
• Analysis of different anaesthesia techniques (General anaesthesia 
with or without intubation versus sedation); 
• Freedom from AF recurrence in subjects with anatomical variants 
of PV such as, but not limited to, common ostia, additional 
pulmonary vein or early branching;  
• Freedom from primary effectiveness failure evaluated in subgroups 
of subjects (termination of AAD versus continuation of AAD after 
blanking period); 
• For subjects undergoing 3D mapping with the Boston Scientific 
Rhythmia Mapping System and performing a post-procedural map, 
map information will be collected to determine lesion locations; 
• The percentage of subjects that undergo repeat ablation during the 
course of the clinical follow-up; 
• More than one repeat procedure during the blanking period (within 
90 days post-index procedure); 
• Changes in the quality of life measures (AFEQT and EQ-5D-5L) 
between baseline and 12-Month follow-up; 
• The percentage of subjects experiencing device-related adverse 
events; 
• Comparison of procedural and therapy success between POLAR 
ICE (NCT04250714) and POLAR SMART. 
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
* LA dwell time is defined as time from the Cryoablation Catheter introduced in the left 
atrium (LA) to the last time of Cryoablation Catheter exiting the LA. 
Method of 
Assigning 
Subjects to 
Treatment 
All subjects who meet the eligibility criteria and sign the consent form, 
has the study device inserted into the body and undergoes protocol 
specific treatment (cryoablation) for the intended disease will be assigned 
to the TREATMENT group. 
Follow-up 
Schedule 
Visits schedule:  
• Enrollment and Baseline clinic visit, baseline visit can be on the 
same day as enrollment visit, however the Informed Consent 
must be signed and dated prior to conducting any study related 
activities (up to 90 days before Index Procedure); 
• Index (Ablation) procedure (day 0); 
• Pre-discharge visit must be done before hospital discharge 
(required); 
• 3 months follow-up visit (recommended in-clinic follow-up visit 
if done as per SOC, at a minimum a telephone contact follow-up 
is required); 
• 6 months follow-up visit (optional, this can be either a in-clinic 
follow-up visit or a telephone contact follow-up as per SOC); 
• 12 months in-clinic follow-up visit (required); 
• An additional follow-up visit (any subject visit triggered by subject 
symptoms, clinical events or per SOC that is not already defined as 
one of the study visits at the investigational site).  
Study Duration Enrollment is expected to be completed in approximately 12 months and 
total study duration with all follow-up data collected is estimated to be 
approximately 36 months. 
Participant 
Duration 
The study duration for each subject is expected to be approximately 12 
months. 
Inclusion 
Criteria 
1. Subjects indicated for the treatment of AF with the cryoablation 
system;  
2. Subjects who are willing and capable of providing informed 
consent;  
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
3. Subjects who are willing and capable of participating in all testing 
associated with this clinical study at an approved clinical 
investigational center; 
4. Subjects who are of legal age to give informed consent specific to 
the national law. 
Exclusion 
Criteria 
1. Any known contraindication to an AF ablation or anticoagulation, 
including those listed in the IFU/Tenpubunsyo as legally approved 
conditions; 
2. Any prior LA ablation; 
3. AF secondary to electrolyte imbalance, thyroid disease, or any 
other reversible or non-cardiac cause; 
4. Known or pre-existing severe PV Stenosis; 
5. Evidence of cardiac myxoma, LA thrombus or intracardiac mural 
thrombus; 
6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, 
CABG, PTCA, PCI, ventricular fistula or atrial incision) and any 
surgery within 90 days prior to enrollment; 
7. Any implanted cardiac device (e.g. PM, ICD, CRT, valve 
replacement, LAAO, etc) within 90 days prior to enrollment; 
8. Any planned OR scheduled cardiac device procedure (e.g. PM, 
ICD, CRT, valve replacement, LAAO, etc) during and post PVI 
ablation (during and post-index procedure);  
9. Any planned ablation in LA except PVI procedure and roof line 
ablation; 
10. Any planned ablation in ventricles; 
11. Subjects undergoing atrial septal defect patch or other surgical 
procedures at or near the atrial septal defect;    
 
12. Subjects with severe valvular disease OR with a prosthetic – 
mechanical or biological - heart valve (not including valve repair 
and annular rings); 
13. Presence of any pulmonary vein stents; 
14. Subjects with active systemic infection; 
15. Subjects that have vena cava embolic protection filter devices 
and/or known femoral thrombus; 
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POLARxTM Cardiac Cryoablation System Post Market Clinical Study 
POLAR SMART  
16. Any previous history of cryoglobulinemia; 
17. Subjects that are unable to undergo atrium access safely or operate 
in the atrium as per investigator’s medical judgement; 
18. Subjects with no vascular access or obstruction of the femoral vein; 
19. Subjects with blood coagulation disorders or diseases; 
20. Any prior history of documented cerebral infarct, TIA or systemic 
embolism (excluding a post-operative deep vein thrombosis 
(DVT)) ≤ 180 days prior to enrollment; 
21. Subjects who are hemodynamically unstable; 
22. Subject is unable or not willing to complete follow-up visits and 
examination for the duration of the study; 
23. Subjects with life expectancy ≤ 1 year per investigator’s medical 
judgement; 
24. Women of childbearing potential who are, or plan to become, 
pregnant during the time of the study (assessment per investigator’s 
discretion); 
25. Subjects with unrecovered/unresolved Adverse Events (AE) from 
any previous invasive procedure; 
26. Subjects who are currently enrolled in another investigational study 
or registry that would directly interfere with POLAR SMART 
study. Exception when the subject is participating in a mandatory 
governmental registry, or a purely observational registry with no 
associated treatments. Each instance must be brought to the 
attention of the sponsor for approval. 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
There are no formal hypotheses. 
Statistical 
Analysis 
Methods 
Time-to-event endpoints will be summarized using Kaplan-Meier event-
free rates with 2-sided 95% pointwise log-log confidence limits. 
Summary statistics will be presented for secondary and additional 
endpoints. E.g. event rates and confidence intervals will be provided for 
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3. Table of Contents 
1. 
TITLE PAGE  .......................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................5 
3. 
TABLE OF CONTENTS .......................................................................................................14 
3.1. Table of Figures .....................................................................................................18 
3.2. Table of Tables ......................................................................................................18 
4. 
INTRODUCTION .................................................................................................................19 
4.1. Background ............................................................................................................19 
4.2. Study Rationale .....................................................................................................21 
5. 
DEVICE DESCRIPTION ......................................................................................................21 
5.1. Commercial Device Under Study ........................................................................21 
6. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................................29 
6.1. Study Objective .....................................................................................................29 
6.2. Study Endpoints ....................................................................................................30 
6.2.1. Primary Safety Endpoint ...........................................................................30 
6.2.2. Primary Effectiveness Endpoint ...............................................................31 
6.2.3. Secondary Endpoints ................................................................................31 
6.2.4. Additional Endpoints ................................................................................32 
7. 
STUDY DESIGN .................................................................................................................33 
7.1. Scale and Duration ................................................................................................34 
7.2. Treatment Assignment ..........................................................................................35 
7.3. Justification for the Study Design ........................................................................35 
8. 
SUBJECT SELECTION ........................................................................................................36 
8.1. Study Population and Eligibility ..........................................................................36 
8.2. Inclusion Criteria ..................................................................................................36 
8.3. Exclusion Criteria .................................................................................................37 
9. 
SUBJECT ACCOUNTABILITY .............................................................................................39 
9.1. Point of Enrollment ...............................................................................................39 
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9.2. Withdrawal ............................................................................................................39 
9.3. Lost to Follow-Up ..................................................................................................40 
9.4. Subject Status and Classification .........................................................................40 
9.4.1. Consent Ineligible (Screening Failures) ...................................................40 
9.4.2. Intent .........................................................................................................41 
9.4.3. Attempt .....................................................................................................41 
9.4.4. Treatment ..................................................................................................42 
9.5. End-of-Study Definition........................................................................................42 
10. STUDY METHODS .............................................................................................................42 
10.1. Data Collection ......................................................................................................42 
10.2. Study Candidate Screening ..................................................................................46 
10.3. Informed Consent and Enrollment ......................................................................46 
10.4. Baseline Visit ..........................................................................................................46 
10.4.1. Medications ...............................................................................................47 
10.4.1.1. Anti-Arrhythmic Drugs ............................................................47 
10.4.1.2. Anticoagulation ........................................................................48 
10.5. Index (ablation) Procedure (Day 0) .....................................................................48 
10.5.1.4. 3D mapping ..............................................................................49 
10.6. Pre-Discharge ........................................................................................................53 
10.7. Month 3 Follow-up (91 ± 14 days) .......................................................................54 
10.8. Month 6 Follow-up (180 ± 30 days) .....................................................................55 
10.9. Month 12 Follow-up Visit (365 ± 40 days) ..........................................................55 
10.10. 
Additional Visits ......................................................................................56 
10.11. 
Repeat ablation procedure .....................................................................57 
10.12. 
Study Completion ...................................................................................57 
10.13. 
Unforeseen Circumstances (Natural Disaster/Global Pandemic) ......57 
10.14. 
Source Documents ..................................................................................58 
11. STATISTICAL CONSIDERATIONS ......................................................................................58 
11.1. Endpoints ...............................................................................................................59 
11.1.1. Primary Safety and Effectiveness Endpoints ............................................59 
11.1.1.1. Statistical Methods ...................................................................59 
11.1.1.2. Sample Size ..............................................................................59 
11.1.2. Secondary Endpoints ................................................................................59 
11.2. General Statistical Methods .................................................................................59 
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11.2.1. Analysis Sets .............................................................................................59 
11.2.2. Control of Systematic Error/Bias ..............................................................60 
11.2.3. Number of Subjects per Investigative Site ...............................................60 
11.3 Data Analyses ..........................................................................................................60 
11.3.1. Interim Analyses .......................................................................................60 
11.3.2. Subgroup Analyses ...................................................................................60 
11.3.3. Justification of Pooling .............................................................................60 
11.3.4. Multivariable Analyses .............................................................................61 
11.3.5. Additional Analyses .................................................................................61 
11.3.6. Changes to Planned Analyses ...................................................................62 
12. DATA MANAGEMENT .......................................................................................................62 
12.1. Data Collection, Processing, and Review ............................................................62 
12.2. Data Retention .......................................................................................................63 
12.3. Technical Source Forms .......................................................................................63 
12.4. Quality of Life (QOL) ...........................................................................................64 
13. DEVIATIONS ......................................................................................................................64 
14. COMPLIANCE ....................................................................................................................65 
14.1. Statement of Compliance ......................................................................................65 
14.2. Investigator Responsibilities ................................................................................65 
14.2.1. Delegation of Responsibility ....................................................................67 
14.3. Institutional Review Board/ Ethics Committee ..................................................67 
14.4. Sponsor Responsibilities .......................................................................................67 
14.4.1. Role of Boston Scientific Representatives ...............................................68 
14.5. Insurance ................................................................................................................69 
15. MONITORING ....................................................................................................................69 
16. POTENTIAL RISKS AND BENEFITS ...................................................................................69 
16.1. Instructions for Use (IFU)/ Tenpubunsyo ...........................................................69 
16.2. Risks associated with Participation in the Clinical Study .................................69 
16.3. Risk Minimization Actions ...................................................................................69 
16.4. Anticipated Benefits ..............................................................................................70 
16.5. Risk to Benefit Rationale, if applicable ...............................................................70 
17. SAFETY REPORTING .........................................................................................................70 
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17.1. Reportable Events by investigational site to Boston Scientific .........................70 
17.2. Definitions and Classification ...............................................................................71 
17.3. Relationship to Study Device(s) ...........................................................................73 
17.4. Investigator Reporting Requirements .................................................................75 
17.5. Device Deficiencies ................................................................................................76 
17.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators ...................77 
17.7. Subject Death Reporting ......................................................................................77 
18. INFORMED CONSENT ........................................................................................................78 
19. COMMITTEES ...................................................................................................................79 
19.1. Safety Monitoring Process ....................................................................................79 
19.2. Steering Committee ...............................................................................................79 
19.3. Other Committee ...................................................................................................79 
20. SUSPENSION OR TERMINATION ........................................................................................80 
20.1 Premature Termination of the Study ..................................................................80 
20.1.1 Criteria for Premature Termination of the Study ......................................80 
20.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................80 
20.3 Requirements for Documentation and Subject Follow-up ................................80 
20.4 Criteria for Suspending/Terminating a Study Site ............................................81 
21. STUDY REGISTRATION AND RESULTS .............................................................................81 
21.1. Study Registration .................................................................................................81 
21.2. Clinical Investigation Report ...............................................................................81 
21.3. Publication Policy ..................................................................................................81 
22. BIBLIOGRAPHY .................................................................................................................82 
23. ABBREVIATIONS AND DEFINITIONS .................................................................................83 
23.1. Abbreviations .........................................................................................................83 
23.2. Definitions ..............................................................................................................85 
24. APPENDICES .....................................................................................................................88 
24.1. Quality of Life Instruments ..................................................................................88 
 
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3.1. Table of Figures 
Figure 1: Cryoablation Catheter Distal Tip ....................................................................... 24 
Figure 2: Cryoablation Catheter Handle ............................................................................ 24 
Figure 3:  Mapping Catheter Assembly .............................................................................. 25 
Figure 4:  Cryo Mapping Catheter with Electrode Arrangements .................................. 25 
Figure 5:  Cryo Console ........................................................................................................ 26 
Figure 6:  Diaphragm Movement Sensor (DMS) Display ................................................. 28 
Figure 7:  Esophagus Temperature Sensor (ETS) Display ............................................... 28 
Figure 7.1-1: POLAR SMART Study Design …………………………………………… 35 
 
3.2. Table of Tables 
Table 5.1-1: Cryoablation System Components and Accessories ..................................... 22 
Table 5.1-2: POLARxTM and POLARxTM FIT Cryoablation Catheters Specifications . 24 
Table 5.1-3: Cryo Mapping Catheter Specifications ......................................................... 25 
Table 5.1-4: Cryo Steerable Sheath Specifications ............................................................ 26 
Table 6.2-1 Overview of objectives and endpoints ............................................................. 33 
Table 8.2-1: Inclusion Criteria ............................................................................................. 37 
Table 8.3-1: Exclusion Criteria ............................................................................................ 38 
Table 10.1-1: Data Collection Schedule .............................................................................. 44 
Table 10.14-1: Source Documentation Requirements ....................................................... 58 
Table 17.2-1: Safety Definitions ........................................................................................... 71 
Table 17.3-1: Criteria for Assessing Relationship of Study Device(s) or Procedure to 
Adverse Event .................................................................................................... 74 
Table 17.4-1: Investigator Reporting Requirements ......................................................... 75 
Table 23.1-1: Abbreviations ................................................................................................. 83 
Table 23.2-1: Definition ........................................................................................................ 85 
  
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4. Introduction 
4.1. Background 
Evidences suggest AF is among the most prevalent arrhythmias in the world today. European 
Society of Cardiology (ESC) Guidelines 2020 has summarized (2): “The estimated prevalence 
of AF in adults currently ranges between 2% and 4% (globally, 46.3 million individuals had 
prevalent AF and AFL in 2016)” (3). A 2.3-fold rise (4) is expected in the coming decades 
(5,6) largely owing to extended longevity of the general population and intensifying search for 
undiagnosed AF (7). The age of patients with AF is steadily rising and now averages between 
75 and 85 years of age (8). AF symptoms arise from the rapid, irregular rhythm as well as 
cardiac hemodynamic changes related to uncoordinated atrial contractions. These 
uncoordinated contractions also allow blood to pool in the atria and may ultimately lead to 
thromboembolism and stroke. AF impairs quality of life (9), associates with a five-fold risk of 
stroke, a three-fold incidence of congestive heart failure, and higher mortality. AF is a 
progressive disease, with almost all cases starting as paroxysmal, which then progresses to 
persistent and long-standing persistent types (10).  
 
In Asia, the estimates prevalence of AF have suggested that, by 2050, 72 million individuals 
(11) in Asia will be diagnosed with AF, more than double the combined numbers of patients 
in Europe and the United States. This estimate increase is attributed to the proportionally larger 
aged population in Asian countries. With this, the prevalence of AF is expected to increase in 
Japan and South Korea as the population ages. 
 
Recent results are showing that catheter ablation was effective in recurrence of any AF 
compared to drug treatment over 5 years of follow up (12). Among patients with AF, the 
strategy of catheter ablation, compared with medical therapy, significantly reduce death, 
disabling stroke, serious bleeding, or cardiac arrest if catheter ablation was successfully done 
in a per protocol analysis (13). 
 
Most recent guidelines from the ESC and Japan Circulation Society (JCS)/Japan Heart Rhythm 
Society (JHRS) for the management of AF state that catheter ablation of AF is effective in 
restoring and maintaining sinus rhythm in patients with symptomatic paroxysmal, persistent, 
and probably long-standing persistent AF, in general as second-line treatment after failure of 
or intolerance to antiarrhythmic drug therapy (14). In particular, it has been increasingly 
recognized that focal PV triggers of AF can account for 80 to 95 percent of paroxysmal cases 
that are drug resistant. As outlined in the 2017 Heart Rhythm Society (HRS) consensus 
document (1), electrical isolation of the pulmonary veins is now recognized as the cornerstone 
of AF ablation.  
 
Large randomized controlled trials have confirmed the superiority of catheter ablation in (9) 
maintaining sinus rhythm, as well as improving symptoms, exercise capacity, and quality of 
life (15) in comparison to AADs. In ESC, HRS and JCS/JHRS guidelines(1,2,14,16), catheter 
ablation is strongly recommended for patients with symptomatic AF after an adequate trial of 
AAD therapy.  
 
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With the understanding that PVIs may be the “cornerstone” of ablation strategies, a cryo 
balloon has been developed to provide a “single shot” therapy for isolation of the PVs. By 
navigating the balloon to the ostium of the PV and occluding flow, a PV may be isolated with 
a single cryoablation of 3 to 4 minutes. The currently approved technology (Artic Front™/ 
Arctic Front Advance™ Cryoablation Balloon, Medtronic®) has completed two landmark 
studies demonstrating efficacy for paroxysmal AF management of approximately 70% and 
65% respectively (17,18). In addition to this, the currently approved technology (Artic Front™/ 
Arctic Front Advance™ Cryoablation Balloon, Medtronic®) has also completed a 
postmarketing surveillance study in Japan showing that the success rate in the acute phase of 
PVI was > 99%, and that the sinus rhythm maintenance effect in the 6-month follow-up 
including the 3-month blanking period was good at approximately 88% (19).  
 
Boston Scientific Cardiac Cryoablation System, POLARxTM is available in Europe market 
since 2020 and Japan market since October 2021. The novel POLARxTM showed similar safety 
and efficacy compared to the Arctic Front Cryoballoon. A higher rate of real-time PV 
recordings and significantly lower minimal balloon temperatures were observed using the 
POLARxTM (20,21,22,23).  
 
Complications arising from cryoablation are consistent with those of heat-based therapies. 
Additionally, as the balloon is placed in the right-sided PVs and near the phrenic nerve, 
diaphragm paralysis, (both transient and permanent), has been reported. To mitigate this risk, 
pacing maneuvers and continuous analysis of diaphragmatic movement has been used. 
 
Catheter and sheath performance for cryoablation balloon procedures has not changed since 
the begining, more than ten years ago. Knowing that electrophysiologists are familiar with 
treating AF with cryo‐therapy, the Boston Scientific Cardiac Cryoablation System was 
designed with a clinical user focus and set out to improve the user experience. This was 
accomplished by improving balloon stability and achieving continuous inflation and uniform 
balloon pressure during all phases of the cryoablation, improving sheath maneuverability and 
incorporating general safety/ workflow improvements over current technology. 
 
Extensive pre‐clinical and performance bench testing studies have been performed to date. A 
first-in-man clinical study was completed on 30 patients with one month follow-up in 2018 
and its data has been used to obtain CE-mark. Ongoing trials on safety and effectiveness are 
POLAR ICE, NCT04250714 (completed enrollment of 400 subjects in May 2021) and 
FROZEN-AF, NCT04133168 (completed enrollment of 325 subjects in August 2021). Both 
trials are multicenter, single arm cohort trials with defined measures and follow up schedules 
and subjects are recruited in multiple geographies. POLAR ICE will provide post market data 
for support of continued safety and effectiveness assessment for the Boston Scientific 
Cryoablation System, when used in a clinical trial follow up in SOC indicated patients in 
Europe. POLAR SMART study will provide real-world clinical data on safety, effectiveness 
and procedural success of Boston Scientific Cardiac Cryoablation System when used under 
SOC in Japan and South Korea to support clinical equivalence of results under different clinical 
care and ethnic conditions. 
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4.2. Study Rationale 
The goal of any novel design or therapeutic strategy for AF is to restore normal sinus rhythm 
and to reduce or eliminate the symptoms due to rapid atrial response. 
 
Boston Scientific developed a Cryoablation Balloon that can maintain stability and achieve 
continuous inflation and uniform pressure during the entire procedure. A cryoablation balloon 
that has been designed to maintain uniform pressure is likely to provide improved stability 
during all phases of the cryoablation, improving user experience and preserving the proven 
design validated by the Medtronic® Arctic Front Advance™ Catheter. 
 
Majority of the above BSC POLARxTM system studies data were collected predominantly in 
North American and European populations, it will be necessary to collect systematic scientific 
evidence unique to Japan and South Korea to proactively capture the impact on medical 
outcomes driven by socio-economic, healthcare and epidemiological differences. This 
evidence will be shared with the local electrophysiologist to enable better outcomes. 
Additionally POLAR SMART data can also support post-market clinical follow-up (PMCF) 
data collection. 
 
The POLAR SMART post market study intends to collect real-world clinical data on safety, 
effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System 
(POLARxTM System) when used to perform PVI in the ablation treatment of De Novo AF. 
5. Device Description   
5.1. Commercial Device Under Study 
The Boston Scientific Cardiac Cryoablation System (henceforth “Cryoablation System”) is 
indicated for cryoablation and electrical mapping of the pulmonary veins for PVI in the 
ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo.  
 
Subsequent versions of the Cryoablation System (including but not limited to the already 
commercially released upgrade) and software may be used during this study as they become 
commercially available after regulatory approval in their country. 
 
The article/model names (components) and accessories of the Cryoablation system and their 
associated model numbers are listed in Table 5.1-1. For any upcoming available commercial 
new article/model names and their associated model numbers, only administrative changes are 
required to the table below and these do not qualify to amend the protocol and send for any 
EC/IRB approval. 
 
Please refer to IFU/Tenbubunpsyo for locally approved system overview. 
 
 
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to induce thermal injury and endocardial tissue necrosis when the balloon is in contact with 
cardiac tissue and reaches cryoablation temperatures created by a refrigerant injected from the 
Console into the balloon segment of the POLARx™. The Cryoablation catheter connects to 
the Console with a Cryo-Cable (for N2O delivery and removal) and an Extension Cable (for 
electrical connection via the Interconnection Box). The Cryoablation catheter is designed to be 
used as a circular mapping catheter deployed within the guidewire lumen during ablation 
procedures.  
 
The POLARxTM FIT Cryoablation Catheters are additional models (Short Tip and Long Tip) 
of the POLARxTM cryoablation balloon catheters that are part of the POLARxTM cryoablation 
system. The POLARxTM FIT catheter is identical to the predicate POLARxTM catheter with the 
exception that it can be inflated to a larger balloon diameter of 31 mm. 
 
During an electrophysiology (EP) ablation procedure, the Cryoablation Catheter (including the 
Cryo Mapping Catheter) is inserted through the Cryo Steerable Sheath (POLARSHEATH™) 
into the venous system, directed into the LA and towards the ostium of the target PV. Once 
positioning that occludes the PV has been verified, refrigerant is delivered through the Cryo-
Cable to the injection coil, which directs the flow of refrigerant toward the interior distal 
surface of the balloon. This results in a cooled region at the balloon tissue interface, which 
adheres to the endocardial surface. The low temperature and pressure gradient allows the 
balloon to thermally create transmural, circumferential tissue necrosis (lesions) and interrupt 
electrical conduction.  
 
The Cryoablation Catheter is comprised of the following major components, distal to proximal:  
• 
Atraumatic tip  
• 
Double layer balloon system  
• 
Guide wire lumen  
• 
Internal balloon thermocouple  
• 
Injection coil and manifold for delivery of the refrigerant; liquid nitrous oxide (N2O)  
• 
Catheter shaft; to retrieve the expanded N2O gas  
• 
Catheter handle  
• 
Distal handle connections  
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Figure 1: Cryoablation Catheter Distal Tip 
 
Figure 2: Cryoablation Catheter Handle 
 
Table 5.1-2: POLARxTM Cryoablation Catheter Specifications 
Balloon diameter 
28 mm 
Nominal Distal Tip Length     
M004CRBS2000 (Short tip) 
 
5 mm  
M004CRBS2100 (Long tip) 
12 mm  
Shaft diameter 
0.164 in /12.5 F 
Working length 
99 cm 
 
Table 5.1-2: POLARxTM FIT Cryoablation Catheter Specifications 
Inflated Balloon diameter 
28/31 mm 
Nominal Distal Tip Length     
M004CRBS2010 (Short tip) 
 
5 mm  
M004CRBS2110 (Long tip) 
12 mm  
Shaft diameter 
0.167 in /12.7 F 
Working length 
99 cm 
5.1.2. POLARMAP™ Mapping Catheter (Cryo Mapping Catheter) 
The Cryo Mapping Catheter is a single-use, sterile, multi-electrode, diagnostic catheter 
designed to map cardiac signals during ablation procedures. The catheter is provided in a 20 
mm diameter with 8 evenly spaced radiopaque electrodes. The proximal end of the handle 
contains an electrical connection that integrates with EP lab recording systems.  Once deployed 
through the central guidewire lumen of the Cryoablation Catheter and into the PV, a circular 
shape is established such that the electrodes contact the endocardial surface. This allows for 
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Table 5.1-4: Cryo Steerable Sheath Specifications 
Inner diameter 
0.165 in / 13.2 F 
Outer diameter 
0.208 in / 16.0 F 
Working length 
68 cm 
Total length 
82 cm 
Dilator working length 
85 cm 
Reach at 90° 
4.6 cm 
Guidewire compatibility 
0.035 in 
5.1.4. SMARTFREEZE™ Cryo Console (Console) 
The Console is a device that uses N2O provided from a refillable cylinder to safely pressurize 
(inflate) and cool the Cryoablation Catheter to cryogenic ablative temperatures. The Console 
houses the electrical components and software/firmware needed to perform cryoablation 
procedures. It controls the delivery, recovery, and disposal of N2O (cryoablation refrigerant) 
safely and efficiently. The Console user interface provides a means for initiating and ceasing 
refrigerant delivery. Once the command is received from the console, N2O is delivered as a 
chilled liquid to the Cryoablation Catheter for a programmable time duration. The user 
interface also displays key information allowing the operator to focus attention on critical tasks 
and speed up the overall procedure. 
 
Figure 5:  Cryo Console 
 
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The Esophageal Temperature Sensor Cable enables the connection of a commercially available 
400 series temperature probe to be connected to the Console. 
5.1.7. Other Cryoablation System Components 
5.1.7.1. Inter Connection Box (ICB) 
The ICB interfaces the Cryoablation Catheter with the Console. It receives the Catheter 
monitoring signals, DMS data, as well as information from other proprietary devices such as 
an esophageal temperature probe, a tip pressure sensor and various other safety systems.  The 
ICB then transmits this information to the Console for display and user analysis. 
5.1.7.2. Console Foot Switch 
The Console Foot Switch interfaces with the Console and allows the user to inflate the 
Cryoablation Catheter, start and stop flow of N2O (cryoablation) as well as deflate the 
Cryoablation Catheter at the conclusion of the ablation. 
5.1.7.3. Console Scavenging Hose 
The Console Scavenging Hose is a flexible N2O exhaust line that connects to the hospital gas 
scavenging system and allows removal of N2O gas. 
5.1.7.4. Cryo Cable 
The Cryo Cable is a sterile, single-use cable that provides the connectivity between the 
Cryoablation Catheter to the Console to support the delivery of liquid refrigerant and the 
evacuation of remaining N2O gas.  
5.1.7.5. Cryoablation Catheter Electrical Cable 
The Cryoablation Catheter Electrical Cable is a sterile, single-use cable that provides the 
connectivity between the Cryoablation Catheter and the Console ICB.  
5.1.7.6. Cryo Mapping Catheter EP Electrical Cables 
The EP Electrical Cable is a sterile, single-use accessory for the Cryo Mapping Catheter and 
is designed to interface (connect) the Cryo Mapping Catheter with EP recording systems.  
6. Study Objectives and Endpoints 
6.1. Study Objective 
The study objective is to collect real-world clinical data on safety, effectiveness and procedural 
success of Boston Scientific Cardiac Cryoablation System (POLARxTM System) when used to 
perform PVI in the ablation treatment of De Novo AF. 
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6.2. Study Endpoints 
6.2.1. Primary Safety Endpoint 
The primary safety endpoint will be evaluated by the safety event free rate at 12 months post-
index procedure.  
Primary safety events will consist of a composite of the following procedure-related and 
device-related adverse events.  
Acute primary safety endpoint events, events occurring up to 7 days post-index procedure or 
hospital discharge, whichever is later, include:  
• Death 
• Myocardial infarction (MI) 
• Gastroparesis / injury to vagus nerve   
• Transient ischemic attack (TIA) 
• Stroke / Cerebrovascular accident (CVA) 
• Thromboembolism / Air embolism* 
• Cardiac tamponade / perforation 
• Pneumothorax 
• Serious vascular access complications** 
• Pulmonary edema / heart failure 
• AV block not attributable to medication effect or vasovagal reaction 
* Thromboembolic or air embolic events collected in the study refer to any occlusion of blood vessel(s) that 
results in clinical symptoms. 
** Defined as prolongation of hospitalization, requirement of surgical intervention or blood transfusion. 
Chronic primary safety endpoint events, events occurring through 12 months post-index 
procedure, include: 
• Atrial esophageal fistula 
• Significant PV stenosis (≥ 70% reduction of diameter of the PV from baseline*** OR 
presented by patient’s symptoms at 12-Month follow-up and requiring intervention) 
• Symptomatic pericardial effusion  
• Persistent phrenic nerve injury**** 
*** Recommended to use the same imaging method as baseline. 
**** A non-recovered phrenic nerve injury at 12 months post-index procedure will count as a chronic primary 
endpoint. The study will collect information on phrenic nerve palsy observed before the end of the index 
procedure and, in case it occurred, will track information for potential recovery during the study visits. 
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6.2.2. Primary Effectiveness Endpoint 
The primary effectiveness endpoint will be evaluated by the failure free rate collected at 12 
months post-index procedure.  
  Failure defined as: 
• Failure to achieve acute procedural success* in the index procedure;  
• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices OR from a 10-second 12-lead 
ECG) between Days 91 and 12-Month follow-up; 
• Any of the following interventions between Days 91 and 12-Month follow-up: 
o Repeat AF ablation procedure; 
o Electrical and/or pharmacological cardioversion for AF or new AFL, AT; 
o Prescribed a higher dose of any AAD*** documented at baseline or a new 
AAD*** not documented at baseline.  
 
* Acute procedural success is defined as isolation of all the pulmonary veins or anatomical equivalents achieved 
with the Cryoablation Catheter at the end of the index procedure and as demonstrated at minimum by entrance 
block using the Cryo Mapping Catheter (Other techniques of assessment are per investigator’s discretion).   
** Subjects will be monitored for recurrences/new onset of the arrhythmias by means of 12-lead ECG OR any 
clinical recording devices (for example but not limited to, smart watch, 24-hour Holter monitoring, home 
monitoring systems or implanted devices etc.) that are per standard of care (SOC) used by the hospital/clinic. 
These documentation of episodes would need to be verified by investigator and filed in medical records. 
*** AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of 
AF/AFL/AT recurrence 
6.2.3. Secondary Endpoints 
• Rate of documented acute procedural success, defined as pulmonary vein isolation 
achieved with the Cryoablation System. Electrical isolation of a PV is demonstrated 
at minimum by entrance block using the Cryo Mapping Catheter (Other techniques of 
assessment are per investigator’s discretion). 
• Failure free rate collected at 6 months post-index procedure.   
o Failure to achieve acute procedural success* in the index procedure;  
o Any documented recurrent AF episode(s), or new onset of AFL or AT events 
(≥ 30 seconds in duration from any clinical recording devices OR from a 10-
second 12-lead ECG) between Days 91 and 6-Month follow-up**; 
o Any of the following interventions between Days 91 and 6-Month follow-up: 
 Repeat AF ablation procedure; 
 Electrical and/or pharmacological cardioversion for AF or new AFL, 
AT; 
 Prescribed a higher dose of any AAD*** documented at baseline or a 
new AAD*** not documented at baseline.  
 
* Acute procedural success is defined as isolation of all the pulmonary veins or anatomical equivalents achieved 
with the Cryoablation Catheter at the end of the index procedure and as demonstrated at minimum by entrance 
block using the Cryo Mapping Catheter  (Other techniques of assessment are per investigator’s discretion). 
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** Subjects will be monitored for recurrences/new onset of the arrhythmias by means of 12-lead ECG OR any 
clinical recording devices (for example but not limited to, smart watch, 24-hour Holter monitoring, home 
monitoring systems or implanted devices etc.) that are per standard of care (SOC) used by the hospital/clinic. 
These documentation of episodes would need to be verified by investigator and filed in medical records. 
*** AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of 
AF/AFL/AT recurrence 
6.2.4. Additional Endpoints 
Additional endpoints and analyses include, but are not limited to:  
• Procedure times: LA dwell time*, total ablation time, number of cryo applications per 
vein, time to thaw, total fluoroscopy time and total procedure time;  
• TTI per ablation application, if available; 
• Freedom from recurrence of individual types of AF, or new AFLs or ATs between 
Days 91 and 12-Month follow-up; 
• Analysis of additional ablation techniques performed as there is foreseen CTI and roof 
line ablation performed with other catheters outside PVI; 
• Analysis of different anaesthesia techniques (General anaesthesia with or without 
intubation versus sedation); 
• Freedom from AF recurrence in subjects with anatomical variants of PV such as, but 
not limited to, common ostia, additional pulmonary vein or early branching; 
• Freedom from primary effectiveness failure evaluated in subgroups of subjects 
(termination of AAD versus continuation of AAD after blanking period); 
• For subjects undergoing 3D mapping with the Boston Scientific Rhythmia Mapping 
System and performing a post-procedural map, map information will be collected to 
determine lesion locations; 
• The percentage of subjects that undergo repeat ablation during the course of the 
clinical follow-up; 
• More than one repeat procedure during the blanking period (within 90 days post-index 
procedure);  
• Changes in the quality of life measures (AFEQT and EQ-5D-5L) between baseline 
and 12 months follow up;  
• The percentage of subjects experiencing device-related adverse events; 
• Comparison of procedural and therapy success between POLAR ICE 
(NCT04250714) and POLAR SMART. 
* LA dwell time is defined as time from the Cryoablation Catheter introduced in the LA to the last time of 
Cryoablation Catheter exiting the LA. 
 
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All subjects signing the consent, undergoing the index (ablation) procedure and treated with 
the study devices will be followed up for one year. 
7.1. Scale and Duration 
• A minimum sample size of 200 subjects treated only with PVI is required. The 
maximum overall study sample size will be limited to ≤ 400 subjects.  
• To avoid any center effect and bias, individual centers will not be allowed to enroll 
more than 20 subjects meeting enrollment criteria, unless Boston Scientific gives 
written approval to do so. The enrollment period is approximately 12 months. 
• Approximately 30 sites in Japan and South Korea. 
• Total expectation duration of study with all follow-up data collected is estimated to 
be approximately 36 months. 
• The study duration for each subject is expected to be approximately 12 months. 
Each subject will be followed up at: 
o Enrollment and Baseline clinic visit, baseline visit can be the same day as 
enrollment visit, however the Informed Consent must be signed and dated 
prior to conducting any study related activities (up to 90 days before Index 
Procedure); 
o Index (Ablation) procedure (day 0); 
o Pre-discharge visit must be done before hospital discharge (required); 
o 3 months follow-up visit (recommended in-clinic follow up visit if done as 
per SOC, at a minimum a telephone contact follow-up is required.) This 
telephone contact follow-up would only be required if in-clinic follow-up 
was not done; 
o 6 months follow-up visit (optional, this can be either a in-clinic follow-up 
visit or a telephone contact follow-up as per SOC)  
o 12 months in-clinic follow-up visit (required); 
o An additional follow-up visit at the investigational site is any subject visit 
triggered by subject symptoms, clinically events or per SOC that is not 
already defined as one of the study visits.  
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Figure 7.1-1: POLAR SMART Study Design 
7.2. Treatment Assignment 
All subjects who meet the eligibility criteria and sign the consent form will be considered 
enrolled in the study. Subjects will be classified based on subject status and classification (see 
Section 9.4). 
7.3. Justification for the Study Design 
According to the most recent guidelines, catheter ablation has deemed effective in restoring 
and maintaining sinus rhythm and reducing symptoms in subjects with symptomatic recurrent 
AF. The main goal of the study is to demonstrate the procedural success under real world 
conditions and document safety in a post market setting.  
 
POLAR SMART is a prospective, multicenter, single arm, post-market study to collect real-
world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac 
Cryoablation System (POLARxTM System) when use to perform PVI in the ablation treatment 
of De Novo AF.  
 
The study is intended for collecting data in South Korea and Japan. Health care utilization, 
health economic and ethnic differences may have an impact on therapy in real world settings. 
PMCF data are helping to understand differences and equalities across patient cohorts from 
different enrollment regions and may support local guideline adjustments.  
 
The subject population has been chosen based on clinically indication for PVI ablation 
procedure (in compliance with IFU / Tenpubunsyo as legally approved conditions). This study 
will collect real-world data on acute and chronic safety and effectiveness and extend the follow 
up to 12 months. In addition, adverse events will be collected through the follow-up period and 
will be compared to rates from literature 
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De novo subjects are selected where a cryoballoon will be used for first PVI. To determine the 
performance of the Cryoablation Balloon Catheter, an analysis of the ability to electrically 
isolate a targeted PV acutely will be completed. PVI measurements will be taken post cryo 
application to assess entrance block at the minimum. 
 
In comparison to available alternative systems, the novel POLARxTM showed similar safety 
and efficacy compared to the Medtronic fourth generation of arctic front cryoballoon (AF-
CB4). A higher rate of real-time PV recordings and significantly lower minimal balloon 
temperatures were observed using the POLARxTM (20).  
 
This study is further contributing to the PMCF data collection, mandated under MDR, on the 
“POLARxTM Cardiac Cryoablation Catheter System”. This study protocol and procedures have 
been designed to minimize any study burden for study subjects, including the selection and 
training of investigators. Patients may benefit from more advanced technology which is 
especially focused on procedure success and timing. 
 
This study will also allow to capture roof-line ablations as part of prophylactic treatment in 
addition to PVI. This additional ablation has increasing importance in Japanese daily clinical 
routine. It is unknown to what extend these techniques are used and how those are impacting 
safety and efficacy of Cryoablation based PVI only. This study will allow an increased sample 
size in order to provide information on changes in clinical practice when PVI Cryoablation is 
used in combination with roof line ablation.   
 
8. Subject Selection  
8.1. Study Population and Eligibility  
Subjects enrolled in this POLAR SMART study will be clinically indicated for PVI ablation 
procedure (in compliance with IFU/Tenpubunsyo as legally approved conditions) for the 
treatment of paroxysmal AF. 
Subjects have to meet the study inclusion/exclusion criteria as outlined below in section 8.2 
and 8.3. The subjects selected for participation will be from the investigator’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 
Inclusion 
Criteria 
1. Subjects indicated for the treatment of AF with the cryoablation 
system;  
2. Subjects who are willing and capable of providing informed consent;  
3. Subjects who are willing and capable of participating in all testing 
associated with this clinical study at an approved clinical 
investigational center; 
4. Subjects who are of legal age to give informed consent specific to the 
national law. 
 
8.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 8.3-1) cannot be included in this 
study or will be excluded from this clinical study. 
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Table 8.3-1: Exclusion Criteria 
Exclusion 
Criteria 
1. Any known contraindication to an AF ablation or anticoagulation, 
including those listed in the IFU/Tenpubunsyo as legally approved 
conditions; 
2. Any prior LA ablation; 
3. AF secondary to electrolyte imbalance, thyroid disease, or any other 
reversible or non-cardiac cause; 
4. Known or pre-existing severe PV Stenosis; 
5. Evidence of cardiac myxoma, LA thrombus or intracardiac mural 
thrombus; 
6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, 
PTCA, PCI, ventricular fistula or atrial incision) and any surgery within 
90 days prior to enrollment; 
7. Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, 
LAAO, etc) within 90 days prior to enrollment; 
8. Any planned OR scheduled cardiac device procedure (e.g. PM, ICD, 
CRT, valve replacement, LAAO, etc) during and post PVI ablation 
(during and post-index procedure);  
9. Any planned ablation in LA except PVI procedure and roof line 
ablation; 
10. Any planned ablation in ventricles; 
11. Subjects undergoing atrial septal defect patch or other surgical 
procedures at or near the atrial septal defect;    
12. Subjects with severe valvular disease OR with a prosthetic – 
mechanical or biological - heart valve (not including valve repair and 
annular rings); 
13. Presence of any pulmonary vein stents; 
14. Subjects with active systemic infection; 
15. Subjects that have vena cava embolic protection filter devices and/or 
known femoral thrombus; 
16. Any previous history of cryoglobulinemia; 
17. Subjects that are unable to undergo atrium access safely or operate in 
the atrium as per investigator’s medical judgement; 
18. Subjects with no vascular access or obstruction of the femoral vein; 
19. Subjects with blood coagulation disorders or diseases; 
20. Any prior history of documented cerebral infarct, TIA or systemic 
embolism (excluding a post-operative DVT) ≤ 180 days prior to 
enrollment; 
21. Subjects who are hemodynamically unstable; 
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Exclusion 
Criteria 
22. Subject is unable or not willing to complete follow-up visits and 
examination for the duration of the study; 
23. Subjects with life expectancy ≤ 1 year per investigator’s medical 
judgement; 
24. Women of childbearing potential who are, or plan to become, pregnant 
during the time of the study (assessment per investigator’s discretion); 
25. Subjects with unrecovered/unresolved AEs from any previous invasive 
procedure; 
26. Subjects who are currently enrolled in another investigational study or 
registry that would directly interfere with POLAR SMART study. 
Exception when the subject is participating in a mandatory 
governmental registry, or a purely observational registry with no 
associated treatments. Each instance must be brought to the attention 
of the sponsor for approval. 
9. Subject Accountability 
9.1. Point of Enrollment 
Investigators will select subjects who are appropriate for study inclusion as per eligibility 
criteria as specified under section 8.2 and 8.3. Subjects who have given written informed 
consent are considered enrolled in the study. No protocol-related activities can take place or 
no data from the subject can be collected until the Informed Consent Form (ICF) is signed and 
dated by the subject. Screening tests that are part of SOC can be used to determine pre-
eligibility. Data from examination performed prior to consent/enrollment (e.g. TTE) will be 
collected as medical history data after the subject is consented/enrolled in the study. It is the 
investigator’s site responsibility to assess eligibility criteria before obtaining the ICF. 
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 as standard of care practice. Withdrawn subjects will not be replaced. 
 
Reasons for withdrawal include but are not limited to physician discretion, change in 
inclusion/exclusion status, subject choice to withdraw consent, lost to follow-up, or death. 
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason, and without prejudice to further treatment. All applicable case report 
forms up to the point of subject withdrawal and a “End of Study” form must be completed.   
 
Every effort should be made to obtain full information on any ongoing reportable adverse 
events up to the point of withdrawal. All open reportable adverse events should be closed or 
documented as chronic. Data collected up to the point of subject withdrawal may be used,  
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unless any local regulations apply. Additional data may no longer be collected after the point 
at which a subject has been withdrawn from the study or withdraws his/her consent, for 
whatever reason.  
9.3. Lost to Follow-Up 
A subject will be considered lost to follow-up if he/she fails to return to scheduled visits as per 
Data Collection Schedule (Table 10.1-1), and is unable to be contacted by the study site staff. 
The following actions must be taken if a subject fails to return to the clinic for a required study 
visit: 
• The site will attempt to contact the subject to reschedule the missed visit and counsel 
the subject on the importance of maintaining the assigned visit schedule and ascertain 
if the subject wishes to and/or should continue in the study. 
• Before a subject is deemed lost to follow-up, the investigator or designee will make 
every effort to regain contact with the subject (3 attempts, including telephone calls 
and/or a certified letter to the participant’s last known mailing address or local 
equivalent methods, where possible). These contact attempts must be documented in 
the subject’s medical record or study file and in the “End of Study” Electronic Case 
Report Forms (eCRFs).  
• Should the subject continue to be unreachable, he or she will be considered lost to 
follow-up from the study. 
9.4. Subject Status and Classification 
9.4.1. Consent Ineligible (Screening Failures) 
A subject who has given written informed consent but is found not to meet eligibility criteria 
before undergoing the index procedure and before having the study device inserted in the body, 
will be classified as “Consent Ineligible”.  
Subjects determined to be Consent Ineligible do not count towards the enrollment ceiling and 
will not be used for analysis of the endpoints. The original signed and dated ICF must be 
maintained in the center’s subject file. A subject identification number (ID) will be assigned 
in the Electronic Data Capture (EDC) system.  
For consent ineligible subjects, at the minimum the following forms must be completed: 
• Enrollment eCRFs; 
• Adverse Event eCRFs for any reportable event (as defined in section 17) that occurs 
after signing the ICF, up to the point of subject withdrawal; 
• Protocol deviation eCRF, if applicable; 
• End of Study eCRF. 
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9.4.2. Intent 
A subject who has given written informed consent, meets eligibility criteria, but does not have 
any study devices inserted into the body will be classified as “INTENT”. This includes subjects 
that had been prepared for the procedure (e.g. medication administered) and/or who had non-
study devices inserted into the body. Subjects that are enrolled in the study but do not undergo 
ablation procedure within 90 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 towards 
the enrollment ceiling and will not be used for analysis of the endpoints. The original signed 
ICF must be maintained in the center’s subject 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 eCRFs; 
• Adverse Event eCRFs for any reportable event (as defined in section 17) that occurs 
after signing the ICF, up to the point of subject withdrawal; 
• Protocol deviation eCRF, if applicable; 
• End of Study eCRF. 
9.4.3. Attempt 
A subject who has given written informed consent, and has any study device inserted into the 
body but does not receive any Cryoablation application will be classified as “ATTEMPT.” 
Attempts subjects will count towards the overall enrollment ceiling of 400 subjects and will be 
used for analysis of the endpoints as per section 11.2.1. The original signed ICF must be 
maintained in the center’s subject file. A subject ID will be assigned in the EDC system. These 
subjects won’t be allowed to be re-enrolled in the study. 
Attempt subjects will be followed up to 30 days after index procedure, for safety purposes. All 
applicable case report forms in the EDC system will be completed. The original signed 
Informed Consent and any relevant documentation must be maintained in the center’s subject 
file.  
For attempt subjects, at the minimum the following forms must be completed:  
• Enrollment and Baseline eCRFs; 
• Index Procedure eCRFs; 
• 30 days Safety follow-up Phone Call; 
• Adverse Event eCRFs or Device Deficiency eCRF for any reportable event (as defined 
in section 17) that occurs after signing the ICF, up to the point of subject withdrawal; 
• Protocol deviation eCRF, if applicable; 
• End of study eCRF. 
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9.4.4. Treatment 
Any subject who has given written informed consent and has the specified study device 
inserted into the body and received at least one Cryoablation application will be classified as 
“TREATMENT”. These subjects are followed in accordance with the Data Collection 
Schedule (Table 10.1-1) and included in all study analyses. A subject ID will be assigned in 
the EDC system. For TREATMENT subjects, all applicable eCRFs per the protocol will be 
completed. Treatment subjects do count towards the overall 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 subject file. Treatments will be further classified into the 
following subgroups: 
• PVI-only: Subjects receiving treatment for PVI only or PVI and CTI. 
• PVI plus additional ablations (PVI+): Subjects receiving treatment for PVI (or PVI 
and CTI), plus additional ablations at other anatomical location(s) in the right or left 
atrium intended to treat AF, AT or atypical AFL.   
PVI-only subjects are included in all study analyses, with additional primary endpoint analyses 
being performed for PVI+ subjects as well as combined PVI-only and PVI+ subjects, as 
described in Section 11.2.1. 
9.5. End-of-Study Definition  
The clinical study is considered completed when subjects are no longer being examined or the 
last subject’s last study visit has occurred. The subject’s end of study is defined as completion 
of the last visit or procedure as shown in the Data Collection Schedule (Table 10.1-1) in the 
study. 
10. Study Methods 
10.1. Data Collection 
The data collection schedule is shown in Table 10.1-1. Data collection will take place at the 
following time points: 
• Informed Consent and Enrollment clinic visit 
• Baseline clinic visit, can be the same day as enrollment visit, however the Informed 
Consent must be signed and dated prior to conducting any study related activities (up 
to 90 days before Index Procedure); 
• Index (Ablation) procedure (day 0); 
• Pre-discharge visit must be done before hospital discharge (required); 
• 3 months follow-up visit (recommended in-clinic follow-up visit if done as per SOC, 
at a minimum a telephone contact follow-up is required.) This telephone contact 
follow-up would only be required if in-clinic follow-up was not done. 
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• 6 months follow-up visit (optional, this can be either a in-clinic follow-up visit or a 
telephone contact follow-up as per SOC.); 
• 12 months in-clinic follow-up visit (required); 
• An additional follow-up visit is any subject visit triggered by subject symptoms, 
clinical events or per SOC that is not already defined as one of the study visits at the 
investigational site.
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Table 10.1-1: Data Collection Schedule 
 
 
Procedure/Assessment 
Enrollment
Baseline2 
Index 
(ablation) 
Procedure 
Day 0 
Prehospital 
Discharge 
Post-
Procedure 
before 
discharge 
Month 3 
Follow-Up 
(91±14 days) 
Clinic visit / 
Telephone 
Month 6 
Follow-Up 
(180±30 days) 
Clinic visit / 
Telephone 
Month 12  
Follow-Up 
(365±40 days) 
Clinic visit 
Additional 
Follow-Up 
  
Repeat 
(additional) 
ablation 
procedure 
30-Days 
Safety 
Telephone 
Follow-Up 
(for attempt 
subjects 
only) 
Informed consent process, including 
informed consent signature date1 
X 
 
 
 
 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
LVEF, LA diameter and LA volume 
SOC3 
 
 
 
 
 
 
 
 
Physical assessment 
X 
 
X 
SOC 
SOC 
X 
SOC 
 
 
LA assessment5 imaging and thrombus 
assessment 
SOC4 
 
 
 
 
 
 
 
Quality of Life (AFEQT and EQ-5D-5L) 
X 
 
 
 
 
X 
 
 
 
Procedural Data 
 
X 
 
 
 
 
 
X9 
 
3D Mapping information 
 
SOC 
 
 
 
 
 
 
 
12-Lead ECG 
X6 
X 
SOC 
SOC 
SOC 
X 
SOC 
X 
 
Documentation of intervention for 
AF/AF/AT (if any) 
 
 
X 
X 
X 
X 
X 
X 
 
Documentation of new AF/AFL/AT (if 
any) 
 
X 
X 
X 
X 
X 
X 
X 
 
Documentation of Medications 
X 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
 
Protocol deviations 
X 
Adverse events assessment 
X8 
 
 
 
X = required; SOC – reporting required if done per standard of care;  
 
 
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1  Informed Consent must be signed and dated prior to conducting any study related activities (up to 90 days before Index Procedure). 
2  Baseline visit can be the same day as enrollment visit, however the ICF must be signed before any study-related activities. 
3  Per investigator’s method. It is recommended to have the assessment within 180 days prior to enrollment.  
4  Assessment of left atrium anatomy, pulmonary veins anatomy and rule-out presence of thrombus is strongly recommended and to be performed according to site’s SOC practice - 
Assessments can be performed using CT, Magnetic Resonance Imaging (MRI), pulmonary venogram, Intracardiac Echo (ICE), Trans-Esophageal Echocardiography (TEE) or 
other. 
5  It is recommended to have the LA assessment performed within 180 days prior to enrollment. 
6  Most recent rhythm via 12-lead ECG. 
7  Data will be required if there is any New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation medication regimen. 
8  Adverse event assessment will be performed as from enrollment until study completion. 
9   Procedural data required for this visit is minimum, refer to protocol section 10.11 for details.    
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10.2. Study Candidate Screening 
Investigators are responsible for screening all subjects and selecting those subjects who are 
appropriate for study inclusion, as per eligibility criteria (see section 8). 
The subjects selected for participation should be from the investigator’s general patient 
population. The investigator is expected to follow hospitals SOC testing to diagnose and screen 
subjects for inclusion in the study. 
Prior to having any study related activities performed, subjects must give written informed 
consent to the study, as per section 10.3 and section 18. 
10.3. Informed Consent and Enrollment  
Subjects who provide written informed consent are considered enrolled in the study. As soon 
as informed consent is obtained, subject’s eligibility criteria can be determined. A qualified 
center representative will review the consent with a potential subject. The subject should be 
given ample time to consider participation and ask questions if necessary. All questions from 
the subject should be addressed prior to the subject signing the ICF. An approved ICF shall be 
signed and dated by the subject. After the subject signs the ICF, a signed copy must be provided 
to the subject and the original is to be filed in the electronic or paper medical records. No study-
specific data collection of any procedure should be conducted prior to consent. 
 
The index procedure must be performed within 90 days post ICF signature. 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 intent subject cannot be re-enrolled as re-enrollment is not 
allowed in this study. The site will ensure that originally signed ICF and documentation of the 
ICF signature process are filed in subjects’ files and that the subject’s participation into the 
study is documented per hospital process (e.g.in the medical file). Original signed ICFs and 
the ICF process documentation will be made available for review at Monitoring Visits. 
For additional information regarding the informed consent process, refer to section 18. 
10.4. Baseline Visit 
The following assessments must be performed during the baseline visit. Baseline visit can be 
the same day as enrollment visit, however the ICF must be signed and dated prior to conducting 
any study related activities (up to 90 days before Index Procedure). These assessments shall be 
recorded on the respective eCRF.   
• Visit date; 
• Documentation of ICF signature date; 
• Eligibility criteria check; 
• Demographics – including age at time of consent, gender; 
• Medical history – including, but not limited to: 
o Underlying Cardiovascular disease (if any) and history of cardiac events; 
o Arrhythmia history; 
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o Non-cardiac comorbidities; 
o Prior surgical interventions and/or cardiac procedures. 
• LVEF, left atrial diameter, left atrial volume (if available), as per investigator's method. 
It is recommended to have the assessment within 180 days prior to enrollment; 
• Physical Assessment – including height, weight, resting heart rate, systolic and 
diastolic blood pressure; 
• Quality of Life assessment through AFEQT and EQ-5D-5L questionnaires; 
• Most recent rhythm via 12-lead ECG; 
• Medications: Current Anti-Arrhythmic Drugs and Anticoagulation medication 
regimen; 
• Protocol deviations, if applicable. 
 
The assessment of LA anatomy* and the screening for potential LA thrombi prior to the 
procedure is strongly recommended to be performed according to the site’s SOC practice, 
however it is recommended to follow the indications from the HRS/JCS consensus statement 
for AF ablation (1,14).  
This includes : 
• For check out presence of left atrial thrombus** and cardiac examination: The gold 
standard per JCS for diagnosis is TEE observation prior ablation. 
• Alternatively Cardiac MRI, spiral CT scan, ICE or pulmonary venogram, to assess PV 
anatomy and PV dimension may be used.  
 
*It is recommended to perform the LA anatomy assessment within 180 days prior to enrollment. 
 
** If a thrombus is observed prior to ablation, the subject no longer meets eligibility criteria and shall not have 
the ablation procedure performed: the subject will then be withdrawn from the study, classified as Consent 
Ineligible and no further follow-up is required.  
10.4.1. Medications 
10.4.1.1. Anti-Arrhythmic Drugs 
Information on all AAD medications will be collected on the eCRF starting from baseline visit. 
During the entire course of the study, details on changes will be specified on the eCRF. Post-
index procedure AADs are allowed per investigator’s discretion during the blanking period (90 
days post-index procedure). According to HRS/JCS consensus guidelines (1,14), it is 
recommended to stop the administration of AAD for any AT after blanking period. If the 
investigator determines that the subject must be prescribed an increased dosage of AAD or a 
new AAD for treatment of any AT after the blanking period, the subject will be considered a 
Primary Effectiveness Failure. 
AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for 
control of AF/AFL/AT recurrence.   
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Treatment with Class II/IV medications for conditions other than control of atrial arrhythmia 
recurrence is also permitted and will be documented. Every effort should be made to keep those 
drugs at a stable dose over the entire course of the study. 
10.4.1.2. Anticoagulation 
The use of anticoagulation up to the procedure (including up to transseptal puncture) is per 
SOC of the investigator. Information on anticoagulation therapy, pre and post index procedure 
will be collected in the eCRF. 
It is recommended that heparin is administered prior to or immediately following transseptal 
puncture during ablation procedure and adjusted to achieve and maintain an ACT of at least 
300 seconds. The ACT levels should be checked at a 15-30 minutes interval during the duration 
of the procedure. 
10.5. Index (ablation) Procedure (Day 0) 
10.5.1. General Info 
All subjects must meet the eligibility criteria prior to Index (ablation) Procedure. If subject is 
found not meeting eligibility criteria, it will be withdrawn from the study.  
The study-related ablation procedure must be performed by study-delegated investigators 
trained in electrophysiology (EP). Any reportable safety events that occur must be reported on 
the Adverse Event eCRF. The index ablation procedure must be performed within 90 days of 
a subject’s enrollment into the study. 
10.5.1.1. Esophagus Management 
Information on esophagus management, if any, will be collected in the eCRF (e.g. temperature 
monitoring, esophageal deviation). It is highly recommended to perform temperature 
monitoring.  
10.5.1.2. Phrenic Nerve Activity Monitoring 
During ablation, phrenic nerve activity monitoring will be performed according to the SOC at 
the site. In case of phrenic nerve injury at the procedure, the subject status and potential 
resolution of the adverse event will be monitored during the course of the study. 
10.5.1.3. Pulmonary Vein Isolation  
The goal of the ablation procedure is electrical isolation of all pulmonary veins or anatomical 
equivalents. Electrical isolation of the veins must be demonstrated at minimum with evidence 
of entrance block in all of the pulmonary veins using the Cryo Mapping Catheter (Other 
techniques of additional assessment are per investigator’s discretion or as per SOC).  
If the subject is in AF prior to the ablation, it will be up to the investigator’s discretion whether 
to cardiovert or proceed with the procedure with the subject in AF. Electrocardiographic 
documentation of the subject’s rhythm prior to ablation will be collected. 
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10.5.1.4. 3D mapping 
Three-dimensional (3D) mapping may be used during the procedure. If 3D mapping is 
performed, a commercially available device will be used, and the information should be 
collected on the eCRF including: mapping catheter, 3D mapping system, mapping times etc.  
In case a post PVI map is collected, information on lesion and/or presence of conduction gaps 
should be collected for each PV. Potential gaps or poor lesion extension will be collected 
including localization information: vein and anatomical location. 
10.5.1.5. Cryoablation System Preparation  
All devices must be prepared as described in the IFU / Tenpubunsyo. 
The console will create a record for each ablation attempted, including (but not limited to) 
ablation duration and cryoballoon temperature. Esophagus temperature and DMS activity data 
will also be collected if esophageal probe and DMS are connected.  
In order to accurately capture information relevant to the study, the following information must 
be entered into the Console at each index procedure: 
Prior to ablation: 
• 
On the subject information screen, enter the subject’s identification (subject ID is 
provided by the EDC system when enrolling the subject) and the operating physician’s 
name. 
• 
If the physician decides to use DMS it should be connected to the subject 
during right PV ablations (for data acquisition). The DMS is an adjunctive 
sensor designed to monitor a phrenic nerve pacing response. SOC methods for 
evaluating phrenic nerve function and determining when intervention is 
needed (e.g. palpation, ICE) should always be applied during right pulmonary 
vein ablations. The DMS is not intended as a substitute for such SOC methods.     
• 
In case the DMS is used, the steps reported in the IFU/Tenpubunsyo will be 
followed.  
 
10.5.2. Cryoablation procedure steps 
Preparation activities should be performed as follows: 
1. Assessment of presenting rhythm by 12-lead ECG. 
2. Baseline the fluoroscopy exposure time (Time 0).  
3. Place additional diagnostic catheters, for example in the coronary sinus or for pacing 
the phrenic nerve, at the discretion of the physician. 
4. Per institutional protocol, complete transseptal access (single or double).  
5. Prepare the Cryo Steerable Sheath. Insert the sheath over the guidewire and advance 
the sheath across the atrial septum. 
6. Prepare the Cryoablation Catheter and the Cryo Mapping Catheter. Insert the Cryo 
Mapping Catheter into the Cryoablation Catheter. Insert the Cryoablation Catheter into 
the Cryo Steerable sheath and advance it into the left atrium. 
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7. Baseline the LA dwell time. 
Following the step-wise approach for the ablation procedure is recommended: 
8. Navigating and positioning of the balloon 
a. Advance the Cryo Mapping Catheter and Cryoablation Catheter under 
fluoroscopic guidance to the proximity of the target PV 
b. Inflate the balloon while remaining outside of the target PV 
c. Occlude targeted vein by advancing the balloon as necessary but remain outside 
of the tubular portion of the vein.  
d. Verify balloon position of the PV occlusion. Verification may be performed 
with fluoroscopy and/or contrast injection or other technique (per investigator’s 
discretion). 
e. If the selected vessel is a right PV, start phrenic nerve pacing prior to starting 
the cryoablation. 
9. Cryo Ablation of all target PVs 
a. Perform cryo ablation. A minimum ablation time of TTI + 120sec is highly 
recommended, where possible. If no PV potential is visible, a minimum 
ablation time of 180sec is highly recommended.  
b. During each ablation application: annotate the anatomical location of ablation, 
the time-to-isolation* (as observed on the PolarMap EGMs and representing 
the time point when electrical activity disappears) and the ablation duration. 
* TTI is required to be captured through the console, when available. 
c. Wait for the thawing phase to be completed prior to manipulating the 
Cryoablation Catheter.  
d. As needed, perform additional cryoablation in the same PV, adjusting the 
position of the Cryoablation Catheter, if necessary. 
10. Confirmation of isolation of the PV at minimum by entrance block using the Cryo 
Mapping Catheter (Other techniques of additional assessment are per investigator’s 
discretion) is required for all pulmonary veins or their anatomical equivalent. 
Note: If at any time during the ablation procedure, the investigator is unable to continue the 
ablation with the designated study catheter (for the PV isolation), the investigator may 
complete the case with a device determined best for the subject. The case will represent an 
acute procedural failure (per protocol definition), regardless of PVI achievement with other 
catheters. The point at which failure was determined as well as the rationale (including a device 
deficiency or adverse event, if any) must be documented in the EDC system. A protocol 
deviation will be documented in the EDC system.  
10.5.2.1. Cryoablation-specific recommendations 
Investigators may deliver one or more cryo applications per each pulmonary vein (or their 
anatomical equivalent) in order to achieve PVI.   
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In order to preserve subject’s safety, it is recommended to adhere to the following indications: 
• Terminate ablation if, in case of temperature monitoring, esophagus temperature falls 
below 20°C. Do not start a 2nd ablation until esophagus temperature returns to baseline 
levels. 
• Terminate ablation if an impairment of diaphragmatic movement is detected by the 
operating investigator during ablation. Do not start a 2nd ablation until phrenic nerve 
activity returns to baseline levels. 
• Do not apply more than 2 consecutive ablations in the same PV location if applicable*  
• Do not apply more than 4 total ablations in a single PV* 
* Ablations inferior to 60 seconds in duration are not considered in the total ablation count. Multiple 
ablations superior to these recommended numbers are reasonable in case of segmental ablations of large 
common trunk. 
10.5.3. Additional ablation(s) 
The Cryoablation System cannot be used for the ablation of other arrhythmia(s)/additional 
line(s) or applications outside the PVs. For this purpose another commercially available 
ablation system will be used. If additional ablations are required, BSC recommends performing 
the PVI first and at minimum by entrance block testing. 
 
Additional ablations outside PVs could be done: 
• In the right atrium  per physician’s discretion (including but not limited to CTI lines 
for treatment of atrial flutter).  
• In the left atrium: 
- 
Roof line ablations are accepted if those are part of SOC during PVI ablation 
procedures.  
- 
To complete any unsuccessful PV isolation that may occur. 
- 
To treat any emergent arrhythmia (spontaneous or induced) that would require 
treatment for patient welfare. Ablations in the left atrium with another 
commercially available catheter to complete any unsuccessful PV isolation that 
may occur or to treat any emergent arrhythmia (spontaneous or induced) that 
would require treatment for patient welfare. 
 
Additional ablations outside PVI cannot be done: 
• In the left atrium: 
- 
Posterior wall and any other ablations are not accepted under this protocol.  
- 
Any advance planned ablations outside PV, if not triggered by an emergent 
arrhythmia (spontaneous or induced). 
• Any scheduled ventricular ablations. 
 
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.  
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10.5.4. Index Procedure Data Collection 
The following data related to the procedure will be collected: 
• Date of procedure 
• Identification of study devices for the following:  
o Cryoablation Catheter  
o Cryo Mapping Catheter  
o Cryo Steerable Sheath  
o Console  
o Related accessories 
• Identification of non-study devices (if applicable):  
o Any additional sheaths/introducers used during the procedure including 
manufacturer, model and type 
o Any additional catheter(s) used during the procedure including manufacturer, 
model, and type (e.g. Coronary Sinus (CS) catheter) 
o Mapping system, if used (manufacturer, model and software version)  
• Presenting rhythm at the beginning of the procedure (by means of a 12-lead ECG) 
• Method of delivering sedation or anesthesia for the procedure 
• Method of transseptal access to left atrium: single or double  
• Method of evaluating phrenic nerve function and determining when intervention is 
needed 
 
Specific to the PVI ablation the following information will be collected (including, but not 
limited to): 
• Per each ablation application: 
o Acute Time-to-Isolation (if available) 
o Minimum balloon temperature 
o Time to thaw  
o Duration of each cryo application 
o DMS and Esophageal temperature, if available 
o Reason, if any, for premature interruption of the ablation  
• For each pulmonary vein or anatomical equivalent: 
o PV isolation success, at minimum by entrance block using the Cryo Mapping 
Catheter (Other techniques of additional assessment are per investigator’s 
discretion) documented through EGMs printed from recording system and/or in 
medical file.  
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• Any other ablation performed during the index procedure (before, during or after PVI)   
 
At the end of the procedure, the following information will be collected:  
• Total procedure time, defined as time elapsed from time first access sheath insertion 
into the subject until the last catheter removed; 
• Total Fluoroscopy time measured from baseline fluoroscopy time (Time 0);  
• Total cryoablation time (duration of all cryo applications); 
• Duration of LA dwell time, defined as time from the Cryoablation Catheter introduced 
in the LA (exiting the sheath) to the last time of Cryoablation Catheter exiting the LA; 
• Rhythm at end of case (documented by means of a post-ablation EGM/12-lead ECG); 
• Cardioversion(s) performed during the procedure, if any; 
• Assessment of reportable adverse events including resolution of ongoing events, if 
applicable/ device deficiencies; 
• Assessment of phrenic nerve palsy (method per investigator’s discretion, eg. through 
fluoroscopy of diaphragm movement);* 
• Protocol deviations, if applicable. 
 
*Subjects may be intubated or not breathing spontaneously at the conclusion of the procedure, 
which may impair appropriate assessment of phrenic nerve functionality. Therefore, at the 
discretion of the investigator, it is recommended that pacing of the phrenic nerve to be 
performed using an intracardiac catheter during the required post-ablation fluoroscopy to 
observe diaphragm movement and assess for phrenic nerve palsy. If abnormality is detected 
during post-ablation testing, it is recommended to follow-up according to standard of care for 
phrenic nerve palsy. Additionally, a similar pre-ablation assessment of the subject for phrenic 
nerve palsy is encouraged as a baseline comparator 
 
The ablation data report collected through the console will be saved and exported to external 
media, as provided by the sponsor.  
10.6. Pre-Discharge  
The pre-discharge follow-up visit must be completed before the subject is discharged from the 
hospital.  
Data collection during the Pre-Discharge visit will be recorded on the respective eCRF. 
Data collection includes: 
• Date of visit; 
• Physical assessment including at minimum resting heart rate, weight, systolic and 
diastolic blood pressure; 
• Rhythm at time of visit (by means of a 12-lead ECG) if available; 
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• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices or from a 10-second 12-lead 
ECG); 
• Any of the following interventions for AF, or new onset of AFL or ATs;  
o Repeat procedure 
o Electrical and/or pharmacological cardioversion for AF/AFL/AT 
• New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation 
medication regimen; 
• Protocol deviations, if applicable; 
• Reportable Adverse Events, including resolution of ongoing events, if applicable. 
o In cases of phrenic nerve palsy at the index procedure, the subject should be 
assessed to evaluate if the event resolved (method per investigator’s 
discretion). 
10.7. Month 3 Follow-up (91 ± 14 days)  
The Month 3 follow-up must be completed between 77 and 105 days post-index procedure.  
Month 3 follow-up visit: recommended in-clinic follow-up visit if done as per SOC at a 
minimum a telephone contact follow-up is required. This telephone contact follow-up would 
only be required if in-clinic follow-up was not done. Due to the range for the visit completion 
and the endpoint requirement for medication, AAD medication changes made during the 
Month 3 Follow-up visit will be counted as being made within the blanking period. 
Data collection during the Month 3 follow-up visit will be recorded on the respective eCRF. 
Data collection includes: 
• Date of visit/telephone; 
• Physical assessment including at minimum resting heart rate, weight, systolic and 
diastolic blood pressure (not required for telephone); 
• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices or from a 10-second 12-lead 
ECG); 
• Any of the following interventions for AF, or new onset of AFL or ATs;  
o Repeat procedure 
o Electrical and/or pharmacological cardioversion for AF/AFL/AT 
• New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation 
medication regimen; 
• Protocol deviations, if any; 
• Reportable Adverse Events, including resolution of ongoing events, if applicable. 
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o In cases of a pre-existing and unresolved phrenic nerve palsy the subject should 
be assessed to evaluate if the event resolved (method per investigator’s 
discretion). 
10.8. Month 6 Follow-up (180 ± 30 days) 
Month 6 follow-up visit is optional, this can be either a in-clinic follow-up visit or a telephone 
contact follow-up as per SOC. 
If any SOC clinical visit is completed either in clinic or telephone call between 150 and 210 
days post-index procedure, it will qualify as a Month 6 follow-up.  
Data collection during the Month 6 follow-up visit will be recorded on the respective eCRF. 
Data collection includes  
• Date of visit/telephone; 
• Physical assessment including at minimum resting heart rate, weight, systolic and 
diastolic blood pressure (not required for telephone); 
• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices or from a 10-second 12-lead 
ECG); 
• Any of the following interventions for AF, or new onset of AFL or ATs;  
o Repeat procedure 
o Electrical and/or pharmacological cardioversion for AF/AFL/AT 
• New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation 
medication regimen; 
• Protocol deviations, if any; 
• Reportable Adverse Events, including resolution of ongoing events, if applicable. 
o In cases of a pre-existing and unresolved phrenic nerve palsy the subject should 
be assessed to evaluate if the event resolved (method per investigator’s 
discretion). 
10.9. Month 12 Follow-up Visit (365 ± 40 days) 
The Month 12 follow-up must be completed between 325 and 405 days post-index procedure, 
in-clinc visit is required. 
Data collection during the Month 12 follow-up visit will be recorded on the respective eCRF. 
Data collection includes  
• Date of visit; 
• Physical assessment including at minimum resting heart rate, weight, systolic and 
diastolic blood pressure; 
• Quality of Life assessment through AFEQT and EQ-5D-5L questionnaires; 
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• Rhythm at time of visit (by means of a 12-lead ECG); 
• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices or from a 10-second 12-lead 
ECG); 
• Any of the following interventions for AF, or new onset of AFL or ATs;  
o Repeat procedure 
o Electrical and/or pharmacological cardioversion for AF/AFL/AT 
• New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation 
medication regimen; 
• Protocol deviations, if any; 
• Reportable Adverse Events, including resolution of ongoing events, if applicable.  
o In cases of a pre-existing and unresolved phrenic nerve palsy the subject should 
be assessed to evaluate if the event resolved (method per investigator’s 
discretion). 
10.10. Additional Visits 
An additional follow-up visit is any subject visit triggered by subject symptoms that is not 
already defined as one of the study visits at the investigational site. 
Data collection during the additional follow-up visit will be recorded on the respective eCRF. 
Data collection should include: 
• Date of visit; 
• Physical assessment including at minimum resting heart rate, weight, systolic and 
diastolic blood pressure; 
• Any documented recurrent AF episode(s), or new onset of AFL or AT events (≥ 30 
seconds in duration from any clinical recording devices or from a 10-second 12-lead 
ECG); 
• Any of the following interventions for AF, or new onset of AFL or ATs;  
o Repeat procedure 
o Electrical and/or pharmacological cardioversion for AF/AFL/AT 
• New, discontinued or changes to current Anti-Arrhythmic Drugs and Anticoagulation 
medication regimen; 
• Protocol deviations, if any; 
• Reportable Adverse Events, including resolution of ongoing events, if applicable.  
o In cases of a pre-existing and unresolved phrenic nerve palsy the subject should 
be assessed to evaluate if the event resolved (method per investigator’s 
discretion). 
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10.11. Repeat ablation procedure 
It is known that during the first 90 days post-index procedure (blanking period), subjects can 
suffer from recurrences of AF or onset of new AT. Within the blanking period, more than one 
repeat ablation procedure, using a commercially available ablation system, is allowed.  
A repeat ablation procedure performed after blanking period will count as a failure for the 
primary effectiveness endpoint. During the repeat ablation procedure, the anatomical location 
of potential ablation gaps in the pulmonary veins will be assessed. 
In case a repeat ablation procedure occurs during the 12 month follow-up period, the data of 
this procedure will be entered in the ‘Additional Procedure’ eCRF. In case this ablation 
procedure is performed to treat a supraventricular arrhythmia, including AF, AFL or AT, 
following detailed information about this repeat ablation procedure will be collected:  
• Was the ablation procedure performed in the LA?; 
• Was this repeat ablation procedure performed using BSC cryoablation?; 
• For repeat ablation procedures performed in the LA: was this repeat ablation procedure 
performed to treat AF/AFL/AT? If no, specify the arrhythmia type; 
• Rhythm at the beginning (12-lead ECG) and the end of the repeat procedure (documented 
by means of a post-ablation EGM/12-lead ECG); 
• Reportable Adverse Events, including resolution of ongoing events, if applicable, and/or 
Device Deficiencies;  
o In cases of a pre-existing and unresolved phrenic nerve palsy the subject should be 
assessed to evaluate if the event resolved (method per investigator’s discretion); 
• Protocol deviations, if applicable. 
10.12. Study Completion 
All TREATMENT subjects will be followed for 12 months after the index (ablation) 
procedure. Data collection will continue up to the point of the Month 12 close out follow-up 
visit. The End of Study eCRF will have to be completed at study completion. 
10.13. 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. monsoons, typhoons, earthquakes, snow storms, floods etc.) 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 that is not IRB/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/AFL/AT. Any 
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clinical recording devices as long as the requirements listed in this protocol are fulfilled (e.g. 
24-hour Holter monitoring, home monitoring systems or implanted devices) can be used to 
detect any recurrence of AF/AFL/AT.  
10.14. Source Documents 
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 10.14-1. 
Table 10.14-1: Source Documentation Requirements 
Requirement 
Disposition 
Informed Consent documentation process 
Retain at Center 
Medical history documents pertaining to eligibility criteria 
Retain at Center 
Documentation of demographics data 
Retain at Center 
Physical assessment 
Retain at Center 
Medication regimen and Changes 
Retain at Center 
Medical history 
Retain at Center 
Quality of Life Instruments (AFEQT and EQ-5D-5L) 
Retain at Center 
Documentation of isolation confirmation for each Pulmonary Vein 
Retain at Center 
Printed and signed PDF Console Export Case Data 
Retain in subject binder 
12-Lead ECGs data including ongoing rhythm 
Retain at Center 
Signed Technical Source Form 
Retain in subject binder 
Imaging, per SOC at the site 
Retain at Center 
Documentation of  new AF/AFL/AT AND Intervention for 
AF/AFL/AT 
Retain at Center 
Adverse Events 
Retain at Center 
In the event of a subject death (if requested): 
• 
Death narrative 
• 
Relevant medical records 
• 
Death Certificate 
• 
Autopsy report 
Submit one copy to BSC, 
Retain one copy at center 
11. Statistical Considerations 
Statistical considerations for the primary and secondary endpoints are described in the 
following sections.  Note that no formal hypothesis tests are planned for the endpoints.   
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with a POLARxTM FIT device, as well as subgroups of subjects who did have additional 
ablations beyond PVI. These subgroups include, but are not limited to:  
• Subjects undergoing CTI 
• Subjects undergoing CTI and other RA ablations 
• Subjects undergoing LA ablations beyond just PVI.  
11.2.2. Control of Systematic Error/Bias 
Selection of subjects will be made from the investigator’s population. All subjects that have 
signed the ICF will be enrolled in the study. 
11.2.3. Number of Subjects per Investigative Site 
To avoid any center effect and bias, individual centers will not be allowed to enroll more than 
20 subjects meeting enrollment criteria, unless Boston Scientific gives written approval to do 
so. Enrollment of an amount of study subjects in excess of such approved number of 20 total 
subjects must first be approved by sponsor, notified/submitted to Institution’s IRB/EC, as 
applicable, and requires an amendment of exhibit A of the clinical study agreement. 
11.3 Data Analyses 
11.3.1. Interim Analyses  
No formal interim analyses are planned for the purpose of stopping the study early for declaring 
effectiveness or for futility. Analysis of each endpoint will be performed when all applicable 
data for that endpoint has been collected. Analyses of acute data (procedural safety and acute 
procedural success) may be performed and used for publication purposes after completion of 
study enrollment, index procedure, 7 day and 3 month follow-up of all subjects.  
11.3.2. Subgroup Analyses 
Additional ancillary analyses on specific subgroup of subjects, may be presented. 
These analyses will include but not limited to the following: 
• Age (< 60 versus ≥ 60 years); 
• Gender (Male versus Female); 
• Monitoring (Subjects with data from continuous ECG recording systems (eg. ILR, PM, 
ICD, CRT) versus those without). 
11.3.3. Justification of Pooling 
Center-to-center heterogeneity will be assessed for the primary endpoints by performing a 
random effects logistic regression analysis. Centers with less than five enrollments will be 
combined to form “supercenters”. Small centers will be combined until the newly created 
supercenter has five enrollments, and then a new supercenter will be created. Centers will be 
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deemed to be heterogeneous if the variance of the random center effect is found to significantly 
differ from zero. A significance level of 15% will be used for this test. 
11.3.4. Multivariable Analyses 
For each primary endpoint, univariate analyses of the following covariates will be performed, 
and any found to be significantly associated with the outcome at the 0.15 alpha level will be 
included as covariates in a multivariate regression model.  
 
The analysis will be done for the entire study cohort as well as for the following treatment 
cohorts: 
• PVI-only subjects 
• PVI+ subjects  
• Subjects treated with the POLARxTM FIT device 
 
Backward selection with 0.15 alpha level stay criterion will be used to determine the final 
multivariate model.  The list of baseline covariates includes, but is not necessarily limited to: 
• Subject demographics (e.g. age, gender) 
• Subject baseline characteristics (e.g. LVEF and LA diameter) 
• Procedural techniques (e.g., esophageal temperature monitoring,) 
 
Additional multivariable analyses will be performed to assess on the effect of cryo dosing 
parameters on acute (e.g. procedure duration, dwell time, acute success, acute adverse events, 
and other procedural outcomes)  and chronic parameters e.g. (freedom from effectiveness 
failure). Analyses will be performed on a per-subject and per-vein basis. Cryo dosing 
parameters to be assessed for use in the per-subject model may include, but not be limited to:  
• Total number of applications > 60s 
• Total application duration. 
 
Cryo dosing parameters to be assessed for use in the per -vein model may include, but not be 
limited to:  
• Total number of applications > 60s 
• Total application duration. 
• Occlusion score 
• TTI driven applications (yes or no) 
• TTI. 
11.3.5. Additional Analyses 
Additional analyses include, but are not limited to:  
• Procedure times: LA dwell time*, total ablation time, number of cryo applications per 
vein, time to thaw, total fluoroscopy time and total procedure time;  
• Time-To-Isolation per ablation application, if available; 
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• Freedom from recurrence of individual types of AF, or new AFLs or ATs between Days 
91 and 12-month follow-up; 
• Analysis of additional ablation techniques performed as there is foreseen CTI and roof 
line ablation performed with other catheters outside PVI; 
• Analysis of different anaesthesia techniques (General anaesthesia with or without 
intubation versus sedation); 
• Freedom from AF recurrence in subjects with anatomical variants of PV such as, but 
not limited to, common ostia, additional pulmonary vein or early branching; 
• Freedom from primary effectiveness failure evaluated in subgroups of subjects 
(termination of AAD versus continuation of AAD after blanking period); 
• For subjects undergoing 3D mapping with the Boston Scientific Rhythmia Mapping 
System and performing a post-procedural map, map information will be collected to 
determine lesion locations; 
• The percentage of subjects that undergo repeat ablation during the course of the clinical 
follow-up; 
• More than one repeat procedure during the blanking period (within 90 days post-index 
procedure):  
• Changes in the quality of life measures (AFEQT and EQ-5D-5L) between baseline and 
12 months follow up.  
• The percentage of subjects experiencing device-related adverse events; 
• Propensity adjusted comparison of procedural and therapy success between POLAR 
ICE (NCT04250714) and POLAR SMART. 
* LA dwell time is defined as time from the Cryoablation Catheter introduced in the LA to the last time of 
Cryoablation Catheter exiting the LA. 
11.3.6. 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, recommended within 10 
business days.  
The clinical database will reside on a production server hosted by Medidata 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 
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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 electronic case report 
forms (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. 
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. 
The data reported on the eCRFs shall be derived from source documents and shall be consistent 
with these source documents. Any discrepancies shall be explained in writing. Any change or 
correction made to the clinical data will be dated, initialed, and explained, if necessary, and 
shall not obscure the original entry. A written audit trail shall be maintained which will be 
made available for review by BSC or its representative. Refer to the eCRF Completion 
Guidelines when completing the eCRF. 
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 
The Technical Source Form (TSF) is the approved document to capture protocol required data 
elements that are not duplicated in any other source documents. This form requires review and 
approval by the investigator and is to be used by the study sites as a source document. 
Collection and completion of all information on the Technical Source Form is the 
responsibility of the appropriately delegated site personnel.  
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At the conclusion of the procedure, the completed technical source form must be signed (and 
initialed as needed) by the following people: 
• the Delegated Site Personnel completing the form; 
• the Delegated Investigator conducting and/or supervising the case. 
12.4. Quality of Life (QOL) 
Clinical trials increasingly recognize the value of including patient reported outcome measures 
in their design. To understand the impact of AF ablation procedures on patient’s quality of life, 
the quality of life instruments used for the trial will be the EQ-5D-5L for a generic 
questionnaire and the AFEQT for disease specific. Subjects will be asked to complete the 
questionnaires at the Baseline visit and 12-month follow-up. 
The EQ-5D-5L, generic quality of life measure, will be used to assess health utilities. It is a 
descriptive system of health-related quality of life states consisting of five dimensions 
(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can 
take one of five responses. The responses record five levels of severity (no problems/slight 
problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D 
dimension. 
The AF Effect on Quality of Life (AFEQT) was developed to evaluate disease-specific quality 
of life for patients with AF. The 20-item questionnaire is subdivided into three domains: 
symptoms, daily activities, and treatment concerns with responses provided on a seven-point 
Likert scale. 
13. 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 IRB/EC 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 study. 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 EDC. Sites may also be 
required to report deviations to the IRB/EC, per local guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including IRB/EC notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
The sponsor will not approve protocol waivers.  
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14. Compliance 
14.1. 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 ISO 14155: Clinical Investigation of Medical 
Devices for Human Subjects - Good Clinical Practice, relevant parts of the ICH Guidelines for 
GCP, ethical principles that have their origins in the Declaration of Helsinki, and applicable 
individual country laws and regulations.  
The study shall not begin until the required approval/favorable opinion from the IRB/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 IRB/EC or regulatory authority shall be followed, if appropriate.  
14.2. 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 IRB/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.   
• 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 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. 
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• Report to sponsor, per the protocol requirements, all reportable events. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE and potential/USADE or UADE, if required by applicable laws 
or regulations or this protocol or by the IRB/EC, and supply BSC with any additional 
requested information related to the safety reporting of a particular event. 
• 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 IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this protocol 
and local IRB/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 Informed Consent Form 
(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). 
• 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. 
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14.2.1. Delegation of Responsibility 
When specific tasks are delegated by the Principal Investigator, including but not limited to 
conducting the informed consent process, the Principal Investigator is responsible for 
providing appropriate training, ensuring delegates 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 Principal Investigator is accountable for regulatory violations 
resulting from failure to adequately supervise the conduct of the clinical study.  
14.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC for the clinical investigation before recruiting subjects and implementing all 
subsequent amendments, if required. 
A copy of the written IRB/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. 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 IRB/EC before the 
changes are implemented to the study. All changes to the ICF will be IRB/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 IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by applicable local/country laws or regulations or IRB/EC requirements. Copies of 
the study reports and the IRB/EC continuance of approval must be provided to the sponsor.  
14.4. Sponsor Responsibilities 
All information and data sent to 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 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.  
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14.4.1. 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 cryoablation 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. 
At the request of the investigator and while under investigator supervision as allowed by local 
regulations, BSC personnel may operate equipment during cryoablation 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 
Console during the preparation and execution of the mapping and ablation procedure; 
• Clarifying device behavior, operation or diagnostic output as requested by the investigator 
or other health care personnel; 
• Interaction with Boston Scientific noninvasive equipment (Console and applicable 
accessories) and interpretation of information contained therein to support the collection 
of required information by the delegated site staff; 
• Print out reports/export data directly from the console and provide original printouts or 
electronic data reports to clinical site as source documentation; 
• 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. 
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 protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following: 
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject  
• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 
• Participate in Subject Consent process 
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14.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC for 
subjects in the study will be obtained. 
15. 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. 
16. Potential Risks and Benefits 
16.1. Instructions for Use (IFU)/ Tenpubunsyo 
Refer to the IFU/ Tenpubunsyo for an overview of anticipated adverse (device) effects, and 
risks associated to the commercial device(s).   
16.2. Risks associated with Participation in the Clinical Study 
There are no specific tests outside SOC for PVI Cryo catheter ablation of AF required by this 
clinical study protocol. Therefore, there is no foreseen increased risk to subjects for 
participating in the study. 
In addition to SOC, the protocol requires the completion of quality of life questionnaires. 
16.3. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
using the devices in accordance with their applicable IFU/Tenpubunsyo performing procedures 
in 
the 
appropriate 
hospital 
environment, 
following 
recommended 
standard 
practices/guidelines, adherence to subject selection criteria, close monitoring of the subject's 
physiologic status during procedures and/or follow-ups and by promptly supplying BSC with 
all pertinent information required by this protocol. 
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16.4. Anticipated Benefits 
Subjects may not receive any direct benefit from participating in this study as compared to the 
current SOC received for treatment of AF.  
The collected data will help to collect safety and performance data for Japan and South Korea 
specifically and collect information on the efficacy of the Cryoablation System if used in 
today’s SOC. The data will help indirectly to improve and optimize current practice. 
16.5. Risk to Benefit Rationale, if applicable 
Risk management activities, including Hazard Analyses (HA) and Failure Mode Effects 
Analyses (FMEA), have been performed on the Cryoablation System, steerable sheath and 
extension cable to identify and analyze known and foreseeable hazards (in both normal and 
fault conditions) and reasonably foreseeable sequences or combinations of events that could 
result from using this product and the risks associated with each hazard.  Mitigations have been 
implemented in the design, processes, and/or labeling and directions for use of the product to 
reduce the residual risk of each hazard as necessary and practicable. The HA has been reviewed 
and approved and the remaining risks are acceptable when weighed against the intended 
benefits to the subject. 
17. Safety Reporting 
17.1. 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 Serious Adverse Events, including all events leading to death; 
• All Thromboembolic Events; 
• All Study Procedure Related AEs (index and repeat procedure); 
• All Study Device-Related Adverse Events; 
• All Study Related Device Deficiencies; 
• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
previously not defined in the IFU; 
• All BSC Commercialized Device-Related Adverse 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. 
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 
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as an AE, but should only be reflected as an outcome of one (1) specific SAE (see Table 17.2-1 
for AE definitions). 
Death should not be recorded as an SAE but should only be reflected as an outcome of one (1) 
specific SAE (see Table 17.2-1 for Safety definitions). 
If the subject experiences a new arrhythmia between index procedure and end of study, and 
the investigator considers this adverse event to be procedure related, it needs to be reported. 
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 
the problem as compared to the subject’s baseline which cannot be attributed to the 
expected progression of the disease or condition;  
• 
A recurrence of an arrhytmia should be reported on the “AF recurrence” eCRF and 
should not be recorded as an adverse event, unless it meets seriousness criteria as per 
table 17.2-1; 
• 
Pre-planned hospitalizations at time of enrollment or for a pre-existing condition;  
• 
If an additional ablation procedure is required, this additional ablation procedure should 
not be considered as an Adverse Event, unless associated with subject worsening 
condition or a new diagnosis. If the investigator considers this event to be related to 
any procedure, the event needs to be reported. In this case, the additional ablation 
procedure should be reported in the Adverse Event eCRF as corrective action of the 
specific Procedure Related Adverse Event reported for the worsening condition or new 
diagnosis. 
Refer to IFU/ Tenpubunsyo for the known risks associated with the commercial device(s). 
17.2. Definitions and Classification 
Adverse event definitions are provided in Table 17.2-1. Administrative edits were made on the 
safety definitions from applicable regulations and guidance including (but not limited to) 21 
CFR Part 812, ISO 14155 and EU MDR 2017/745/MDCG 2020-10/1 Guidance on Safety 
Reporting in Clinical Investigations for clarification purposes. 
 
Table 17.2-1: 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 17.2-1: 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 IFU/Tenpubunsyo, 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) foetal distress, foetal 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 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. 
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Table 17.2-1: Safety Definitions 
Term 
Definition 
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. 
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) 
• 
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) 
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 criteria. 
17.3. Relationship to Study Device(s) 
The investigator must assess the relationship of the reportable AE to the study device, and/or 
study procedure. See criteria in Table 17.3-1. 
 
 
 
 
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Table 17.3-1: 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. 
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; 
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- 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. 
17.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 17.4-1: 
Investigator Reporting Requirements 
. Adverse events and device deficiencies must always be reported through the eCRF system. 
In the event that an alternative method of reporting is necessary (i.e. the eCRF system is 
unavailable), report the adverse event or device deficiency to Boston Scientific by sending the 
Event Notification Form via email to the following email address: 
POLARSMART.Safety@BSCI.COM 
 
Table 17.4-1: 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 1 business day of first becoming 
aware of the event.  
• 
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  
Complete AE eCRF page 
with all available new and 
updated information.  
• 
Within 10 calendar days after becoming 
aware of the event or as per local/regional 
regulations.  
• 
All death events must be reported within 
3 calendar days 
• 
Reporting required through the end of the 
study  
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
When documentation is available 
• 
Upon request of sponsor 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
• 
Within 3 calendar days of first becoming 
aware of the event or as per local/regional 
regulations. 
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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) 
• 
Reporting required through the end of the 
study 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
When documentation is available 
• 
Upon request of sponsor 
Device Deficiencies 
(including but not limited to 
malfunctions, use errors, and 
inadequacy in information 
supplied by the manufacturer, 
including labelling) 
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. 
Complete DD eCRF with 
all available new and 
updated information.  
• 
Within 3 calendar days of first becoming 
aware of the event.  
• 
Reporting required through the end of the 
study 
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.  
• 
Adverse Device Effects (or other key 
events of interest, e.g., Heart Failure): In 
a timely manner but not later than 30 
business days after becoming aware of the 
information  
• 
Adverse Events: In a timely manner but 
recommend within 30 business days after 
becoming aware of the information  
• 
Reporting required through the end of 
study 
• 
Upon request of sponsor 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
17.5. 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 will be documented and reported to BSC (as per table 17.4-1). If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning the 
device(s) will be provided upon request. If it is not possible to return the device, the investigator 
should document why the device was not returned and the final disposition of the device. 
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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17.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators, IRBs/ECs and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory authorities 
of UADEs and SAEs as required by local/regional regulations. 
17.7. 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 IRB/EC must 
be notified of any deaths in accordance with that site’s IRB/EC policies and procedures.  
Upon request of sponsor, 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 study devices, clinical study, procedure, or subject 
condition; 
• Whether or not the death was witnessed; 
• Whether the subject 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, upon request from sponsor:  
If the subject expired in the hospital:  
• 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 applicable, the Boston Scientific catheters should be returned promptly to Boston 
Scientific CRM/EP for analysis. 
 
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If the subject 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). 
18. Informed Consent 
Subject participation in this clinical study is voluntary. Informed Consent is required from each 
subject. 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 and/or Regulatory authority, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO), and approved by the site’s IRB/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 IRB/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 IRB/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.  
The ICF shall always be signed and personally dated by the subject 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 signs, the subject shall be asked to provide informed consent for continued 
participation as soon as his/her medical condition or age 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.  
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Failure to obtain subject consent will be reported by BSC to the applicable regulatory authority 
according to their requirements (e.g., the principles of the Declaration of Helsinki, local 
applicable regulation 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. IRB/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 IRB/EC. The new version of the ICF must be approved by the 
IRB/EC. Acceptance by Boston Scientific is required if changes to the revised ICF are 
requested by the site’s IRB/EC. The IRB/EC will determine the subject population to be re-
consented. 
19. Committees 
19.1. 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 Electrophysiology and 
with the necessary therapeutic and subject matter expertise to evaluate and classify the events 
into the categories outlined above. 
19.2. Steering Committee 
A Steering Committee composed of the sponsor's Clinical Management and the study 
Coordinating Principal Investigator(s) have been convened. Responsibilities may include 
oversight of the overall conduct of the study with regard 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. As appropriate, the Steering Committee may be 
invited to participate as POLAR SMART Investigators.  
19.3. Other Committee 
Other committee may be added at the discretion of sponsor, the scope and the procedures to 
be followed will be defined in a separate document.  
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20. Suspension or Termination 
20.1 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 IRBs/ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of study termination. 
20.1.1 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 by the IRB/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. 
20.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or associated IRB/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 IRBs/ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of these occurrences. 
20.3 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 sites by Boston Scientific. The 
IRB/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 IRB/EC terminates participation in the study, participating investigators, 
associated IRBs/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. 
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The Principal Investigator or his/her designee must return all study-related documents and 
devices (Sponsor Equipment), if supplied by Boston Scientific, unless this action would 
jeopardize the rights, safety, or welfare of the subjects. 
20.4 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 6 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 devices and testing equipment (Sponsor 
Equipment), as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the subjects. The IRB/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. 
21. Study Registration and Results 
21.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 
21.2. 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, IRB/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. 
21.3. 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. 
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• BSC involvement in the publication preparation and the BSC Publication Policy should be 
discussed with the Coordinating Principal Investigator(s) and/or Executive/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/).  
22. Bibliography 
1. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/ SOLAECE expert 
consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary: 
executive summary. Europace. 2018 Jan 1;20(1):157-208. 
2. Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomstrom-Lundqvist, C., 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). European Heart Journal. 2020; 42: 
373-498. 
3. Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, American Heart 
Association Council on Epidemiology, Prevention Statistics Committee, and Stroke Statistics 
Subcommittee, et al. Heart Disease and Stroke Statistics—2019 update: a report from the American 
Heart Association. Circulation 2019 Mar 5; 139: e56-e528 
4. Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, 
McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. 
Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation 
2014 Feb 14; 129 (8): 837-847. 
5. Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence 
and prevalence of atrial fibrillation in the US adult population. Am J Cardiol 2013 Oct 15;112:1142-
1147. 
6. Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, 
Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, 
from 2000 to 2060. Eur Heart J 2013 Sep; 34: 2746-2751. 
7. Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial fibrillation: epidemiology, pathophysiology, 
and clinical outcomes. Circ Res 2017 Apr 28; 120: 1501-1517. 
8. Camm, A. J., Lip, G. YH., De Caterina, R., Savelieva, I., Atar, D., Hohnloser, S. H., Gerhard 
Hindricks, G., Kirchhof, P and ESC Committee for Practice Guidelines (CPG). 2012 focused update of 
the ESC Guidelines for the management of atrial fibrillation. An update of the 2010 ESC Guidelines 
for the management of atrial fibrillation. Developed with the special contribution of the European 
Heart Rhythm Association. Eur Heart J 2012 Nov; 33(21): 2719-2747. 
9. Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, 
Poole JE, Rosenberg Y, Lee KL, Packer DL and CABANA Investigators. Effect of Catheter Ablation 
vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA 
Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. 
10. de Vos CB, Pisters R, Nieuwlaat R, Prins MH, Tieleman RG, Coelen RJ, et al. Progression from 
paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll 
Cardiol 2010 Feb 23; 55(8): 725 – 731. 
11. Son, M. K., Lim, N-Y. and Park, H-Y. Trend of Prevalence of Atrial Fibrillation and use of Oral 
Anticoagulation Therapy in Patients With Atrial Fibrillation in South Korea (2002–2013). J Epidemiol. 
2018 Feb 5; 28(2): 81-87. 
12. Poole JE, Bahnson TD, Monahan KH, Johnson G, Rostami H, Silverstein AP, Al-Khalidi HR, 
Rosenberg Y, Mark DB, Lee KL, Packer DL, CABANA Investigators and ECG Rhythm Core Lab. 
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Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the 
CABANA Trial. J Am Coll Cardiol. 2020 Jun 30; 75(25): 3105-3118. 
13. Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg 
YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev 
A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli 
GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL and CABANA Investigators. 
Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and 
Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. 
JAMA. 2019 Apr 2; 321(13): 1261-1274. 
14. Nogami, A., Kurita. T., Abe, H., Ando. K., Ishikawa., T., Imai. K., et al. JCS/JHRS 2019 Guideline on 
Non-Pharmacotherapy of Cardiac Arrhythmia. Circulation Journal. 2021; 85: 1104 – 1244. 
15. Mark DB, Anstrom KJ, Sheng S, et al. Effect of Catheter Ablation vs Medical Therapy on Quality of 
Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial [published 
correction appears in JAMA. 2019 Jun 18; 321(23):2370]. JAMA. 2019;321(13):1275-1285.  
16. Cheung, C. C., Nattel, S. and Andrade, J. G. Management of Atrial Fibrillation in 2021: An Updated 
Comparison of the Current CCS/CHRS, ESC, and AHA/ACC/HRS Guidelines. Can J Cardiol. 2021 
Oct; 37(10): 1607-1618. 
17. Packer D, Kowal R, Wheelan K, Irwin J, et al. Cryoballoon Ablation of Pulmonary Veins for 
paroxysmal Atrial Fibrillation. JACC.2013;61:1713-23. 
18. Kuck KH, Brugada J, Fu¨ rnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn 
K, Pocock SJ, Albeneque JP, Tondo C, for the FIRE AND ICE Investigators. Cryoballoon or 
radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med 2016;374:2235–2245. 
19. Okumura K, Matsumoto K, Kobayashi Y, Nogami A, Hokanson RB, Kueffer F, CRYO-Japan PMS 
Study Investigators. Safety and efficacy of cryoballoon ablation for paroxysmal atrial fibrillation in 
Japan: Results from the Japanese prospective post-market surveillance study. Circ J 2016; 80: 1744 – 
1749. 
20. Tilz RR, Meyer-Saraei R, Eitel C, Fink T, Sciacca V, Lopez LD, Kirstein B, Schlüter M, Vogler J, 
Kuck KH and Heeger CH. Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein 
Isolation - The Prospective ICE-AGE-X Study. Circ J. 2021 Jul 21;85(8):1296-1304.  
21. Creta A, Kanthasamy V, Schilling RJ, Rosengarten J, Khan F, Honarbakhsh S, Earley MJ, Hunter RJ, 
and Finlay M. First experience of POLARx™ versus Arctic Front Advance™: An early technology 
comparison. J Cardiovasc Electrophysiol. 2021 Apr; 32(4): 925-930. 
22. Kochi AN, Moltrasio M, Tundo F, Riva S, Ascione C, Dessanai MA, Pizzamiglio F, Vettor G, Cellucci 
S, Gasperetti A, Tondo C, Fassini G. Cryoballoon atrial fibrillation ablation: Single-center safety and 
efficacy data using a novel cryoballoon technology compared to a historical balloon platform. J 
Cardiovasc Electrophysiol. 2021 Mar; 32(3): 588-594. 
23. Yap SC, Anic A, Breskovic T, Haas A, Bhagwandien RE, Jurisic Z, Szili-Torok T and Luik A. 
Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon 
technologies for pulmonary vein isolation: Insights from an initial multicenter experience. J Cardiovasc 
Electrophysiol. 2021 Mar; 32(3): 580-587.  
23. Abbreviations and Definitions 
23.1. Abbreviations 
Abbreviations are shown in Table 23.1-1Table 23.1-1. 
Table 23.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
AAD 
Anti-Arrhythmic Drugs 
ACT 
Activated Clotting Time 
ADE 
Adverse Device Effect 
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Table 23.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
AF-CB4 
Fourth Generation of Arctic Front Cryoballoon 
AFEQT 
Atrial Fibrillation Effect on Quality of Life Survey 
AFL 
Atrial Flutter 
AT 
Atrial Tachycardia 
CABG 
Coronary artery bypass grafting 
CRT 
Cardiac Resynchronization Therapy 
CS 
Coronary Sinus 
CTI 
Cavotricuspid Isthmus 
CVA 
Cerebrovascular Accident 
DD 
Device Deficiency 
DMS 
Diaphragm Movement Sensor 
DVT 
Deep Vein Thrombosis 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EP 
Electrophysiology 
ESC 
European Society of Cardiology 
HCP 
Health Care Personnel 
ICB 
Inter Connection Box 
ICE 
Intracardiac Echo 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
JCS 
Japan Circulation Society 
JHRS 
Japan Heart Rhythm Society 
LA 
Left Atrium 
LAAO 
Left Atrial Appendage Occulsion 
MI 
Myocardial Infarction 
MRI 
Magnetic Resonance Imaging 
N2O 
Nitrogen Dioxides 
PCI 
Percutaneous Coronary Intervention 
PM 
Pacemaker 
PMCF 
Post Market Clinical Follow-up 
PTCA 
Percutaneous transluminal coronary angioplasty 
PV 
Pulmonary Vein 
PVI 
Pulmonary Vein Isolation 
RA 
Right Atrium 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
TEE 
Trans-esophageal echocardiography 
TIA 
Transient Ischemic Attack 
TSF 
Technical Source Form 
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Table 23.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
TTE 
Trans-Thoracic echocardiography 
TTI 
Time-to-isolation 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
23.2. Definitions 
Terms are defined in Table 23.2-1: Definition.  
Table 23.2-1: Definition 
Term 
Definition 
Activated Coagulation/Clotting 
Time 
ACT is a test that is used to monitor the effectiveness of high dose 
heparin therapy. 
Arterial-Venous Fistula 
Abnormal communication between an artery and a vein. 
Atrioesophageal Fistula 
A connection between the atrium and the lumen of the esophagus. 
Attempt Subject 
Any subject that signs the consent form, and has any study device 
inserted into the body but does not receive any Cryoablation 
application.  
AV block 
A conduction disturbance that results in the partial inability of an 
electrical impulse generated in the atria to reach the ventricles. 
Blanking Period 
90-day period between ablation procedure and the initiation of the 
Effectiveness Evaluation Period during which up to one additional 
ablation procedure can be performed and subjects can be prescribed 
antiarrhythmic drugs as determined necessary by the investigator. 
Cardiac tamponade/perforation 
 
The development of a significant pericardial effusion during or within 
30 days of undergoing an AF ablation procedure. A significant 
pericardial effusion is one that results in hemodynamic compromise, 
requires elective or urgent pericardiocentesis, or results in a 1-cm or 
more pericardial effusion as documented by echocardiography.  
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 has given written informed consent 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 90 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 
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Table 23.2-1: Definition 
Term 
Definition 
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 
Occlusion Grade 
Score 4 = excellent (full retention of contrast medium without visible 
outflow)  
Score 3 = moderate (incomplete occlusion with slight leakage of 
contrast medium)  
Score 2= poor  (presence of sustained and massive leakage of contrast 
medium) 
Score 1 = very poor (immediate rapid outflow from the PV). 
Paroxysmal Atrial Fibrillation 
Recurrent symptomatic Atrial Fibrillation that terminates 
spontaneously or with intervention within seven days of onset. 
Pericardial Effusion 
A collection of fluid or blood in the pericardial space around the heart 
or in pleural space around the lungs. 
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. 
Pneumothorax 
Collapse of the lung due to an abrupt change in the intrapleural 
pressure within the chest cavity. 
Primary Effectiveness Failure 
A TREATMENT subject with  
• 
Acute procedure failure 
• 
Documented atrial fibrillation, or new onset of atrial flutter or 
atrial tachycardia event (≥ 30 seconds in duration from an event 
monitor or Holter, or from a 10 second 12-lead ECG) between 
Days 91 and 12-month post index procedure 
• 
Any of the following interventions for atrial fibrillation, or new 
onset of atrial flutter or atrial tachycardia between Days 91 and 
12-month post index procedure: 
o 
Repeat AF procedure 
o 
Electrical and/or pharmacological cardioversion for 
AF/AFL/AT 
o 
Prescribed a higher dose of any AAD documented at 
baseline or a new AAD not documented at baseline 
Procedural Success 
Pulmonary vein isolation achieved with the Boston Scientific 
cryoablation system as demonstrated by entrance block at the 
minimum. 
Prolonged Hospitalization 
Hospitalization ≥72 hours after the study procedure for reasons other 
than anticoagulation 
Pseudoaneurysm 
A dilation of an artery with disruption of one or more layers of its 
walls. 
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Table 23.2-1: Definition 
Term 
Definition 
Pulmonary Edema/Heart Failure 
Ineffective pumping of the heart leading to an accumulation of fluid in 
the lungs. Typical symptoms include shortness of breath with exertion, 
difficulty breathing when lying flat and leg or ankle swelling. 
Pulmonary Vein Stenosis 
(Significant) 
Pulmonary vein stenosis is defined as a reduction of the diameter of a 
PV or PV branch. For the primary safety endpoint of this study, 
significant pulmonary vein stenosis is defined as symptomatic and 
requiring intervention. 
Source Data 
 
 
Ref: ISO 14155 
All information in original records, certified copies of original records 
of clinical findings, observations, or other activities in a clinical 
investigation, necessary for the reconstruction and evaluation of the 
clinical investigation. This includes source data initially recorded in an 
electronic format.  
Source Document 
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. 
Stroke/Cerebrovascular accident 
(CVA) 
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 one side of the body, 
dysphasia or aphasia, hemianopia, amaurosis fugax, or other 
neurological signs or symptoms consistent with stroke. 
Duration of a focal or global neurological deficit ≥24 hours; OR <24 
hours if therapeutic intervention(s) were performed (e.g., thrombolytic 
therapy or intracranial angioplasty); OR available neuroimaging 
documents a new hemorrhage or infarct; OR the neurological deficit 
results in death. 
No other readily identifiable non-stroke cause for the clinical 
presentation (e.g., brain tumor, trauma, infection, hypoglycemia, 
peripheral lesion, pharmacological influences). 
Confirmation of the diagnosis by at least one of the following: 
neurology or neurosurgical specialist; neuroimaging procedure (MRI 
or CT scan or cerebral angiography); lumbar puncture (i.e., spinal fluid 
analysis diagnostic of intracranial hemorrhage). 
Symptomatic AF 
Required symptom(s) of AF that were experienced by the subject, 
made them seek medical attention, and were concurrent with a 
documented episode by ECG, event monitoring and/or Holter monitor. 
Symptoms may have included palpitations, irregular pulse (i.e. rapid, 
racing, pounding, fluttering, bradycardic), dizziness, weakness, chest 
discomfort, and breathlessness. 
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 
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Table 23.2-1: Definition 
Term 
Definition 
Treatment Subject 
Any subject that signs the consent form, and has the specified study 
devices inserted into the body and undergoes protocol specific 
treatment (cryoablation) for the intended disease. 
Vagal Nerve Injury/Gastroparesis  
Vagal nerve injury is defined as injury to the vagal nerve that results in 
esophageal dysmotility or gastroparesis.  Vagal nerve injury is 
considered to be a major complication if it prolongs hospitalization, 
requires hospitalization, or results in ongoing symptoms for more than 
30 days following an ablation procedure 
Vascular access complications 
Development of a hematoma, an AV fistula, or a pseudoaneurysm. A 
major vascular complication is defined as one that requires 
intervention, such as surgical repair or transfusion, prolongs the 
hospital stay, or requires hospital admission. 
24. Appendices 
24.1. Quality of Life Instruments 
Clinical trials increasingly recognize the value of including patient reported outcome measures 
in their design. To understand the impact of atrial fibrillation ablation procedures on subject’s 
quality of life, the quality of life instruments used for this study will be the EQ-5D-5L for a 
generic questionnaire and the AFEQT for disease specific. Subjects will be asked to complete 
the questionnaires at the Enrollment visit and 12- month close out follow-up. 
The EQ-5D, generic quality of life measure, will be used to assess health utilities. It is a 
descriptive system of health-related quality of life states consisting of five dimensions 
(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can 
take one of five responses. The responses record five levels of severity (no problems/slight 
problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D 
dimension. 
The Atrial Fibrillation Effect on Quality of Life Survey (AFEQT) was developed to evaluate 
disease specific quality of life for patients with atrial fibrillation. The 20-item questionnaire is 
subdivided into three domains: symptoms, daily activities, and treatment concerns with 
responses provided on a seven-point Likert scale. 
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