ArcticLine Feasibility Study
Phase: NA
Conditions: Atrial Fibrillation, Atrial Flutter
Sponsor: Medtronic Cardiac Ablation Solutions

ArcticLine Feasibility Study Clinical Investigation Plan 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title ArcticLine Feasibility Study 
Clinical Investigation Plan Identifier MDT16015 
Study Product Name ArcticLine™ Cardiac Cryoablation Catheter 
Sponsor/Local Sponsor United States 
Medtronic, Inc. 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
1-800-328-2518 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, Ontario, L6Y 0R3 
+1-905-460-3800 
Document Version Version 3.0 18MAR2018 
Lead Principal Investigator Frank Pelosi, MD 
Associate Professor of Medicine 
Director, Electrophysiology Fellowship 
Program 
University of Michigan 
CVC Cardiovascular Medicine 
1500 East Medical Center Drive, CVC #2554 
Ann Arbor, MI 48109-5853 
Telephone: 734-232-0112 
Fax: 734-936-7026 
Email: fpelosi@umich.edu 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it 
is confidential and that it may not be further disclosed by them. 

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 Table of Contents 
 
Table of Contents ......................................................................................................................... 2 
Listing of Tables ........................................................................................................................... 6 
Listing of Figures .......................................................................................................................... 6 
Listing of Appendices .................................................................................................................... 6 
Sponsor Contact Information ......................................................................................................... 7 
1. 
Glossary ............................................................................................................................... 8 
2. 
Synopsis ............................................................................................................................ 10 
3. 
Introduction ....................................................................................................................... 16 
3.1. Background ........................................................................................................................ 16 
3.2. Purpose ............................................................................................................................. 19 
4. 
Objectives and Endpoints ..................................................................................................... 20 
4.1. Objectives .......................................................................................................................... 20 
4.1.1. 
Primary Objective(s) ............................................................................................................ 20 
4.1.2. 
Ancillary Objective #1 ......................................................................................................... 20 
4.1.3. 
Ancillary Objective #2 ......................................................................................................... 21 
4.1.4. 
Ancillary Objective #3 ......................................................................................................... 21 
4.1.5. 
Ancillary Objective #4 ......................................................................................................... 21 
4.1.6. 
Ancillary Objective #5 ......................................................................................................... 21 
4.1.7. 
Ancillary Objective #6 ......................................................................................................... 22 
4.1.8. 
Ancillary Objective #7 ......................................................................................................... 23 
5. 
Study Design ...................................................................................................................... 24 
5.1. Duration ............................................................................................................................. 25 
5.2. Rationale ............................................................................................................................ 25 
5.3. Minimization of Bias ............................................................................................................. 25 
6. 
Product Description ............................................................................................................. 27 
6.1. General .............................................................................................................................. 27 
6.2. ArcticLine Cryoablation Catheter .......................................................................................... 28 
6.3. CryoConsole, including Accessories and Catheter File .............................................................. 28 
6.4. FlexCath Advance Steerable Sheath, 12 Fr .............................................................................. 29 

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6.5. Arctic Front Advance Cryoablation Catheter and Related Devices .............................................. 29 
6.6. Freezor MAX Cryoablation Catheter ....................................................................................... 30 
6.7. Packaging ........................................................................................................................... 31 
6.8. Product Training Requirements ............................................................................................. 31 
6.9. Product Receipt, Tracking and Return ..................................................................................... 32 
6.10. Product Storage .................................................................................................................. 32 
7. 
Selection of Subjects ........................................................................................................... 33 
7.1. Study Population ................................................................................................................. 33 
7.2. Subject Enrollment .............................................................................................................. 33 
7.2.1. 
Staged Subject Enrollment ........................................................................................... 33 
7.3. Inclusion Criteria ................................................................................................................. 33 
7.4. Exclusion Criteria ................................................................................................................. 34 
8. 
Study Procedures ................................................................................................................ 36 
8.1. Schedule of Events .............................................................................................................. 36 
8.2. Subject Consent .................................................................................................................. 37 
8.3. Baseline and Pre-Ablation Procedure ...................................................................................... 39 
8.4. Procedure .......................................................................................................................... 40 
8.4.1. 
High Level Procedure Overview .................................................................................... 40 
8.4.2. 
Esophageal Visualization and Temperature Monitoring .................................................... 41 
8.4.3. 
Peri-Procedural Anticoagulation ................................................................................... 42 
8.4.4. 
Diaphragm Movement ................................................................................................. 42 
8.4.5. 
Pulmonary Vein Cryoablation with Arctic Front Advance Catheter ..................................... 42 
8.4.6. 
Linear Cryoablation with ArcticLine Catheter: Roof and Posterior Wall ............................... 43 
8.4.7. 
Linear Cryoablation with ArcticLine Catheter: Mitral Isthmus ............................................ 44 
8.4.8. 
Linear Cryoablation with ArcticLine Catheter: Cavotricuspid Isthmus ................................ 45 
8.4.9. 
Cardioversion ............................................................................................................ 46 
8.4.10. 
Role of Medtronic Personnel at Study Procedure ............................................................. 46 
8.5. Hospital Discharge .............................................................................................................. 46 
8.6. Medications ........................................................................................................................ 47 
8.6.1. 
Class I and III antiarrhythmic medication use after the 90 day post-procedure blanking period47 
8.7.  Permissible Repeat Cryoablation ........................................................................................... 47 

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8.8. Scheduled Follow-up Visits ................................................................................................... 48 
8.8.1. 
One Week Phone or Office Visit .................................................................................... 49 
8.8.2. 
Three Month Visit ....................................................................................................... 49 
8.8.3. 
Six Month Visit............................................................................................................ 49 
8.8.4. 
Twelve Month Visit ..................................................................................................... 49 
8.8.5. 
Unscheduled Office Visits ............................................................................................ 49 
8.8.6. 
Holter and Patient Activated Ambulatory ECG Monitoring ................................................ 50 
8.8.7. 
12 Lead Electrocardiograms ......................................................................................... 50 
8.9. Assessment of Safety .......................................................................................................... 50 
8.10. Recording Data ................................................................................................................... 50 
8.11. Deviation Handling .............................................................................................................. 51 
8.12. Subject Withdrawal or Discontinuation ................................................................................... 52 
9. 
Risks and Benefits ............................................................................................................... 53 
9.1. Potential Risks .................................................................................................................... 53 
9.2. Potential Benefits ................................................................................................................ 54 
9.3. Risk-Benefit Rationale .......................................................................................................... 54 
10. Adverse Events and Device Deficiencies ................................................................................. 56 
10.1. Definitions/Classifications .................................................................................................... 56 
10.2. Adverse Event and Device Deficiency Definitions ..................................................................... 56 
10.3. Reporting of Adverse Events, including Death ......................................................................... 61 
10.3.1. 
Subject Death ............................................................................................................ 62 
10.3.2. 
Adverse Event Reporting Requirements ......................................................................... 63 
10.4. Reporting of Device Deficiencies ........................................................................................... 67 
10.5. Reporting of Product Complaints ........................................................................................... 68 
11. Clinical Events Committee ................................................................................................... 69 
12. Statistical Design and Methods ............................................................................................. 70 
12.1. Primary Objective ................................................................................................................ 71 
12.2. Ancillary Objective #1 .......................................................................................................... 73 
12.3. Ancillary Objective #2 .......................................................................................................... 74 
12.4. Ancillary Objective #3 .......................................................................................................... 75 
12.5. Ancillary Objective #4 .......................................................................................................... 76 

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12.6. Ancillary Objective #5 .......................................................................................................... 77 
12.7. Ancillary Objective #6 .......................................................................................................... 78 
12.8. Ancillary Objective #7 .......................................................................................................... 80 
13. Ethics ................................................................................................................................ 81 
13.1. Statement(s) of Compliance ................................................................................................. 81 
14. Study Administration .......................................................................................................... 83 
14.1. Monitoring .......................................................................................................................... 83 
14.2. Data Management ............................................................................................................... 83 
14.3. Confidentiality .................................................................................................................... 85 
14.4. Liability .............................................................................................................................. 85 
14.5. CIP Amendments ................................................................................................................ 85 
14.6. Record Retention and Reports ............................................................................................... 86 
14.7. Publication and Use of Information ......................................................................................... 94 
14.8. Suspension or Early Termination ........................................................................................... 96 
14.8.1. 
Early Termination or Suspension ................................................................................... 96 
14.8.2. 
Study-Wide Termination or Suspension ......................................................................... 96 
14.8.3. 
Investigator/Center Termination or Suspension ............................................................. 96 
14.8.4. 
Procedures for Termination or Suspension .................................................................... 97 
14.8.4.1. 
Medtronic-Initiated and Regulatory Authority-Initiated ................................................... 97 
14.8.4.2. 
Investigator-Initiated .................................................................................................. 97 
14.8.4.3. 
IRB/REB/MEC-Initiated ................................................................................................ 97 
15. References ......................................................................................................................... 99 
16. Appendices ....................................................................................................................... 101 
17. Version History ................................................................................................................. 113 

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 Listing of Tables 
 
Table 1: Study Sponsor and Monitoring Contact Information ................................................................ 7 
Table 2: Device Information ..................................................................................................................... 27 
Table 3: Study Procedures and Data Collection by Subject Visit .......................................................... 36 
Table 4:  Required Phrenic Nerve Monitoring.......................................................................................... 42 
Table 5: Follow-up Schedule ................................................................................................................... 48 
Table 6:  Adverse Event and Device Deficiency Definitions .................................................................. 56 
Table 7: Adverse Event Reporting Requirements .................................................................................. 64 
Table 8:  Adverse Event Classification Responsibilities ......................................................................... 66 
Table 9: Device Deficiency Reporting Requirements ............................................................................ 67 
Table 10: Investigator reports applicable for all geographies per Medtronic requirements .............. 88 
Table 11: Additional Investigator reports applicable to the United States .......................................... 89 
Table 12: Sponsor reports for the United States ................................................................................... 91 
Table 13: Sponsor reports for Canada .................................................................................................... 93 
Table 14: Foreseeable adverse events .................................................................................................. 103 
Table 15: Adverse Event Definitions ..................................................................................................... 106 
 
 Listing of Figures 
 
Figure 1:  Study Design Flowchart ........................................................................................................... 24 
 
 Listing of Appendices 
 
Appendix A: CryoConsole Investigational Label .................................................................................. 101 
Appendix B: Instructions For Use ........................................................................................................... 102 
Appendix C: Foreseeable Adverse Events ............................................................................................ 103 
Appendix D: Endpoint-Related Adverse Event Definitions ................................................................. 106 
Appendix E: Draft Data Collection Elements (Case Report Forms) .................................................... 108 
Appendix F: Informed Consent Template ............................................................................................. 109 
Appendix G: IRB/REB/MEC List .............................................................................................................. 110 
Appendix H: Participating Investigators and Institutions .................................................................... 111 
Appendix I: Pre-Clinical Testing ............................................................................................................. 112 

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Medtronic contact information is provided in Table 1. This information is subject to change during 
the course of the clinical study. Periodic updates to study contact information will be sent to the 
centers as needed. 
 
Table 1: Study Sponsor and Monitoring Contact Information 
 
Study sponsors and contacts 
Clinical Study Leader 
Kirsten Rasmussen, Sr. Clinical Research Specialist 
Direct Phone: 763-526-2833 
Direct Fax: 763-367-1727 
Email: kirsten.l.rasmussen@medtronic.com 
Monitoring contacts 
Tina Chen, Principal Clinical Research Monitor 
Direct Phone: 909-753-8042 
Email: tina.chen@medtronic.com 
Sponsor Contact Information 

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Term 
Definition 
AE 
Adverse event 
AF 
Atrial fibrillation 
AAD 
Antiarrhythmic drug 
ACT 
Activated clotting time 
ADE 
Adverse device effect 
AFL 
Atrial flutter 
AHA 
America Heart Association 
AT 
Atrial tachycardia 
C 
Celsius 
CV 
Curriculum vitae 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CIP 
Clinical investigation plan 
CMAP 
Compound Motor Action Potential 
CRF 
Case report form 
CTA 
Clinical trial agreement 
CTI 
Cavotricuspid isthmus 
DD 
Device deficiency 
e.g. 
For example, 
ECG 
Electrocardiogram 
EMG 
Electromyography 
EP 
Electrophysiology 
FD 
Financial disclosure 
FAL 
Foreseeable adverse event list 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
ID 
Identification 
IC 
Informed consent 
IDE 
Investigational device exemption 
IFU 
Instructions For Use 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
1.  Glossary 

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Term 
Definition 
ICMJE 
International Committee of Medical Journal 
Editors 
LAD 
Left atrial diameter 
LVEF 
Left ventricular ejection fraction 
MDD 
Medical Device Directive 
MEC 
Medical ethics committee 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
Mitral isthmus 
NIHSS 
National Institute of Health Stroke Scale 
NOAC 
Novel oral anticoagulant 
NYHA 
New York Heart Association 
N2O 
Nitrous Oxide 
PAF 
Paroxysmal atrial fibrillation 
PV 
Pulmonary vein 
PVI 
Pulmonary vein isolation 
REB 
Research Ethics Board 
RF 
Radiofrequency 
RI 
Right inferior 
RS 
Right superior 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
SAP 
Statistical analysis plan 
TEE 
Transesophageal echocardiogram 
TIA 
Transient ischemic attack 
TTE 
Transthoracic echocardiogram 
US 
United States 
UADE 
Unanticipated adverse device effect 
USADE 
Unanticipated serious adverse device effect 

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Title 
ArcticLine Feasibility Study (“Study”) 
Clinical Study Type 
Feasibility 
Product Name 
ArcticLine Cardiac Cryoablation Catheter (“ArcticLine Catheter”) 
Sponsor 
United States 
Medtronic, Inc. 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
1-800-328-2518 
Local Sponsor 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, Ontario, L6Y 0R3 Canada 
+1-905-460-3800 
Indication under 
investigation 
The proposed indication for the ArcticLine Catheter evaluated in this 
Study is as follows: 
The ArcticLine Cardiac Cryoablation Catheter is indicated for creating 
endocardial linear lesions, subsequent to successful pulmonary vein 
isolation, during cardiac ablation procedures for treatment of patients 
with persistent atrial fibrillation. The ArcticLine Catheter can also be used 
to treat typical atrial flutter. 
Investigation 
Purpose 
Collect preliminary safety and effectiveness data on the ArcticLine 
Catheter 
Product Status 
Component 
Model Number 
Geography 
ArcticLine™ Cardiac 
Cryoablation Catheter 
2AL35 
Canada (investigational) 
US (investigational) 
CryoConsole™, 
including Accessories 
106A3, Models 
10000-008-04 or 
10000-008-08 
Canada (commercial) 
US (commercial) 
ArcticLine™ Catheter 
File 
Not applicable 
Canada (investigational) 
US (investigational) 
FlexCath® Advance 
Steerable Sheath 12 Fr 
4FC12 
Canada (investigational) 
US (investigational) 
Arctic Front Advance® 
Cardiac Cryoablation 
Catheter 
2AF233 
Canada (commercial) 
2AF283 
Canada (commercial) 
2AF234 
US (investigational) 
2AF284 
US (investigational) 
2. Synopsis 

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Component 
Model Number 
Geography 
Freezor® MAX Cardiac 
Cryoablation Catheter 
209F3 
Canada (commercial) 
209F5 
Canada (commercial) 
239F3 
US (investigational) 
239F5 
US (investigational) 
Primary 
Objective(s) 
Estimate the incidence of ArcticLine Catheter-related and ArcticLine 
cryoablation procedure-related serious adverse events (SAEs) with an 
onset date within 7 days post-procedure 
Ancillary 
Objective(s) 
There are seven (7) ancillary objectives for the study, as follows: 
1. Estimate the percentage of patients with acute treatment success of 
the ArcticLine Catheter at the left atrial roof and posterior wall in 
patients with demonstrated entrance block of all pulmonary veins and 
who underwent roof and posterior wall ablation with ArcticLine. 
2. Estimate the percentage of patients with acute treatment success of 
the ArcticLine Catheter at the mitral isthmus in patients who 
underwent mitral isthmus ablation with ArcticLine. 
3. Estimate the percentage of patients with acute treatment success of 
the ArcticLine Catheter at the CTI in patients who underwent CTI 
ablation with ArcticLine. 
4. Characterize chronic treatment success of the ArcticLine Catheter in 
patients with demonstrated entrance block of all pulmonary veins. 
5. Estimate the incidence of ArcticLine Catheter-related and ArcticLine 
cryoablation procedure-related serious adverse events (SAE) through 
the 12 month visit. 
6. Characterize procedural data (e.g. procedure time, fluoroscopy time, 
fluoroscopy dose, number of applications, left atrial dwell time) 
7. Estimate the incidence of adverse events through the 12 month visit 
that meet the following, as defined in the Clinical Investigation Plan: 
• 
Atrioesophageal fistula 
• 
Cardiac perforation/tamponade 
• 
Cerebrovascular accident 
• 
Coronary artery spasm 
• 
Death 
• 
Esophageal injury 
• 
Lung injury (including hemoptysis) 
• 
Major bleeding 
• 
Myocardial infarction 
• 
Pericarditis 
• 
Phrenic nerve injury (ongoing from hospital discharge) 
• 
Pulmonary vein stenosis 
• 
Symptomatic persistent iatrogenic atrial septal defect 

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• 
Transient ischemic attack 
• 
Vagal nerve injury 
• 
Vascular access complications 
Study Design 
The study is a prospective, interventional, multi-center, non-randomized, 
single arm, unblinded clinical study. Adult subjects with history of 
persistent atrial fibrillation (AF), including those with concomitant typical 
atrial flutter (AFL), to undergo ablation of: 
• 
Pulmonary veins (required, unless prior successful pulmonary vein 
isolation confirmed at start of study procedure), 
• 
Left atrial roof and posterior wall (required) 
• 
Mitral isthmus (optional, as determined by investigator), and 
• 
Cavo-tricuspid isthmus (required if subject has a history of AFL or 
AFL is induced during the study procedure, otherwise optional as 
determined by investigator). 
Study subjects from all participating geographies will be followed for 12 
months after the index ArcticLine procedure and will be exited from the 
study at the conclusion of the 12 month follow-up visit. 
Sample Size 
Up to 30 subjects will be treated with the ArcticLine Catheter 
Inclusion/ 
Exclusion Criteria 
Inclusion Criteria 
• 
Documentation of symptomatic persistent AF: 
o Defined as having a continuous episode that is sustained 
beyond 7 days documented via consecutive ECG 
recordings, or 
o Defined as having a continuous episode that is sustained 
beyond 7 days documented by an ECG recording and one 
doctor note indicating the patient had symptoms 
consistent with AF 
• 
Age 18 through 80 years old 
• 
Failure or intolerance of at least one Class I or III antiarrhythmic 
drug 
• 
Subject is able and willing to consent to participate in the study 
and will commit to completion of all follow-up requirements 
Exclusion Criteria 
• 
Longstanding persistent AF, defined as continuous AF greater 
than12 month duration 
• 
Left atrial diameter greater than 5.0 cm 
• 
Active systemic infection 
• 
History of thromboembolic event within the past 6 months or 
evidence of intracardiac thrombus at the time of the procedure 
• 
Prior left atrial ablation attempt, with exception of: 
o Any pulmonary vein isolation attempt to treat AF, or 

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o Successful ablation to treat Wolff-Parkinson White 
syndrome 
• 
History of left atrial tachycardia 
• 
History of cardiac ablation within 90 days of planned clinical study 
procedure 
• 
Planned concomitant ventricular ablation1 
• 
Cryoglobulinemia 
• 
Structural heart disease of clinical significance including: 
o NYHA Class IV Heart Failure 
o Diagnosed with NYHA Class III Heart Failure for more than 
six months at time of the study ablation procedure 
o LVEF less than 35% 
o Any cardiac surgery (e.g. CABG) within 3 months of the 
ablation procedure 
o Any mechanical heart valve, prior aortic or tricuspid valve 
replacement (e.g. valvotomy, valve replacement) or 
tricuspid valve repair 
o Severe mitral valve regurgitation or stenosis 
o Significant congenital anomaly or anatomy unable to 
accommodate device 
• 
Prior surgical maze procedure 
• 
Unstable angina 
• 
Myocardial infarction within 3 months of the ablation procedure 
• 
Presence of primum or secundum atrial septal defect 
• 
Anomalous pulmonary venous return 
• 
Prior surgery for congenital heart disease including atrial septal 
defect repair 
• 
Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 
cm 
• 
Uncontrolled hyperthyroidism 
• 
Thrombocytosis, thrombocytopenia (including history of heparin- 
induced thrombocytopenia) 
• 
Severe comorbidity or poor general physical/mental health that, in 
the opinion of the investigator, will not allow the subject to be a 
good study candidate 
• 
History of blood clotting or bleeding abnormalities 
• 
Contraindication to all anticoagulation (e.g. novel oral 
anticoagulants, heparin or warfarin) 
• 
Pregnant, nursing or planning to become pregnant during study 
duration 
 
 
1 Concomitant ventricular ablation will be allowed in the proposed feasibility clinical study if determined to be in the best 
interest of the subject at the time of the procedure as assessed by the Investigator. However, the ArcticLine Catheter may 
not be used for these purposes. 

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• 
Enrollment in another clinical trial without prior approval from 
Medtronic 
• 
Presence or use of left atrial appendage closure device 
• 
Presence of or planned implantation of a pacemaker, implantable 
cardiac defibrillator, implantable loop recorder or cardiac 
resynchronization device with permanent lead placement 
• 
Pre-existing hemidiaphragmatic paralysis 
• 
Life expectancy less than one year 
• 
Known drug or alcohol dependency 
• 
Existing pulmonary vein stent(s) 
Study Procedures 
and Assessments 
Baseline 
Procedure 
Discharge 
1 week1 
3 month2 
6 month2 
12 month 
Unscheduled 
Repeat Ablation 
after Blanking 
Informed Consent 
X 
Inclusion/Exclusion 
Criteria 
X 
Medical History 
X 
Physical Exam 
X 
AAD & 
Anticoagulation 
Medication Review 
X 
X 
X 
X 
X 
X 
X 
Pregnancy Screen3 
X 
Arrhythmia 
Symptom Review 
X 
X 
X 
X 
X 
X 
NIHSS 
Assessment 
X 
X 
Transthoracic 
Echocardiogram 
(TTE)4 
X 
Transesophageal 
Echocardiogram 
(TEE) 
X 
12 Lead ECG 
X 
X 
X 
X 
X 
X 
Procedure 
Information 
X 
X 
Post-ablation 
endoscopy5 
X 
X 
24h Continuous 
Monitoring with 
Holter 
X 
X 
Patient Activated 
Ambulatory ECG 
Monitor 
Monthly and symptomatic 
episodes 

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Baseline 
Procedure 
Discharge 
1 week1 
3 month2 
6 month2 
12 month 
Unscheduled 
Repeat Ablation 
after Blanking 
Adverse Events 
As they occur 
Device 
Deficiencies 
As they occur 
Study Deviations 
As they occur 
Notes: 
1Phone visit and/or office visit with Nurse Coordinator 
2Multiple modes of data collections may be employed to support the collection of required visit 
data at the 3 and 6 month visits such as: In office patient clinic visit, direct to patient contact 
(i.e. telephone, email, mail contact, etc.), and remote technology transmissions/uploads. 
3Female subjects of child bearing potential only 
4 Only required if data not available from within 6 months prior to consent date 
5Post-ablation endoscopy is required post-ablation, prior to discharge, only if the subject’s 
esophageal temperature drops below 15 degrees C at any time during the study procedure. 
Safety 
Assessments 
Clinical Events Committee: 
An independent committee comprised of electrophysiologists not 
participating in the study will review and adjudicate all adverse events as 
well as all deaths for subjects participating in the study. 
Statistics 
No formal hypotheses for this study: 
• 
Data will be reported as collected and no imputation will be 
performed for missing or incomplete observations. 
• 
Analyses are planned at the following time points: 
o After completion of the first 15 subject index procedures 
and 1 week follow-up visit 
o After completion of all 30 subject index procedures and 1 
week follow-up visit 
o After completion of all subject follow-up visits through 12 
month follow-up visit 

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3.1. 
Background 
Atrial fibrillation (AF) is a common and disabling cardiac arrhythmia with a heterogeneous clinical 
presentation.  The fundamental pathophysiology consists of atrial wavelets propagating in 
different directions, causing disorganized atrial depolarizations without effective atrial contraction, 
with concomitant rapid and irregular ventricular contractions. As published in the 2017 
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical 
Ablation of Atrial Fibrillation, there are several classifications for AF: paroxysmal AF (PAF) is defined 
as AF that terminates spontaneously or with intervention within 7 days of onset; persistent AF is 
defined as continuous AF that is sustained beyond 7 days; and long-standing persistent AF is 
defined as continuous AF of greater than 12-month duration.2 
AF is the most common of the sustained arrhythmias affecting millions of people worldwide. In the 
US, AF affects between 2.7 million and 6.1 million adults3, and that number is expected to double 
over the next 25 years.4 Prolonged AF may lead to electrical, mechanical, and structural changes to 
the left atrium, which may then progress to tachycardia-induced cardiomyopathy, heart failure 
and/or persistent AF. Persistent AF represents approximately 25% of AF cases.5 The prognosis is 
related to the underlying cause of the disease, with idiopathic causes having the best prognosis 
and ischemic cardiomyopathy having a poor prognosis. The mortality rate in patients with AF is 
twice that of patients without AF, and the risk of AF-related stroke is 5-fold compared to the risk in 
patients without AF.6  In comparison to patients with PAF, patients with persistent AF are at a 
 
 
 
 
 
 
 
2 Calkins H, et al., 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and 
Surgical Ablation of Atrial Fibrillation, Heart Rhythm (2017), doi:10.10106/j.hrthm.2017.05.012. 
3 January C, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of 
the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart 
Rhythm Society. J Am Coll Cardiol. 2014. 
4 Go A, et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management 
and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA. 2001; 
285(18): 2370-2375. 
5 Zoni-Berisso M, et al. Epidemiology of atrial fibrillation: European perspective. Clinical Epidemiology. 
2014;6:213-220. doi:10.2147/CLEP.S47385. 
6 Wolf P, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 
1991;22(8):983-988. 
3. Introduction 

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significantly greater risk for cardiac mortality (hazard ratio [HR], 2.37; 95% confidence interval [CI], 
1.19-4.73) and all-cause mortality (HR, 1.89; CI, 1.30-2.74).7 
In the US, approved treatment options for patients with persistent AF are presently limited to 
pharmaceutical therapy and concomitant surgical ablation, which are unsatisfactory for many 
patients with AF.  Per the 2014 AHA/ACC/HRS Guideline for the Management of Patients with 
Atrial Fibrillation, “Antiarrhythmic drug (AAD) efficacy is modest and asymptomatic AF recurrences 
are common”.3 All AADs may result in adverse events requiring therapy discontinuation and, with 
the exceptions of amiodarone and propafenone, increase the likelihood of proarrhythmia.2 Side 
effects for AADs include bradycardia, palpitations, fatigue, dizziness, nausea and vomiting, 
stomach pain, constipation and diarrhea, rash, vision problems, and urinary retention. However, 
there is a growing body of evidence supporting catheter ablation as a reasonable option for 
treating persistent AF patients. In 2017, the HRS/EHRA/ECAS/APHRS/SOLAECE Expert 
Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation continued the Class IIa 
Level B recommendation (as previously published in the 2012 HRS/EHRA/ECAS Expert Consensus 
Statement on Catheter and Surgical Ablation of Atrial Fibrillation8) for catheter and surgical 
ablation of AF for persistent symptomatic AF (refractory or intolerant to at least one Class I or III 
AAD), stating “the benefits of an AF ablation procedure exceed the risks, and that it is reasonable  
to perform AF ablation”.2 In the previously published 2014 AHA/ACC/HRS Guideline for the 
Management of Patients with Atrial Fibrillation, the level of evidence supporting the 
recommendation moved to Class IIa, Level A.2 The current challenge for those who treat this 
patient cohort is the determination of which additional lesions sets can be performed safely with 
the highest efficacy in patients and whether or not the technology used has an impact on the 
results. 
Catheter ablation treatment strategies for AF have evolved over time and currently include 
pulmonary vein isolation (PVI) as a cornerstone of ablation therapy in all types of AF (paroxysmal 
and persistent).9, 10 AF arises primarily from the left side of the heart in the atrium, particularly 
where the pulmonary veins (PVs) join the atrium. The fundamental basis for the AF ablation 
procedure is the elimination of initiating triggers and the creation of myocardial lesions that block 
 
 
7 Ghanbari H, et al. Mortality and cerebrovascular events after radiofrequency catheter ablation of atrial 
fibrillation. Heart Rhythm. 2014;11:1503-1511. 
8 Calkins H, et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial 
Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, 
Definitions, Endpoints, and Research Trial Design. Heart Rhythm 2012;9:632-696. 
9 Raviele, et al. Venice Chart International consensus Document on Atrial Fibrillation: 2011 Update. J Cardiovasc 
Electrophysiol, 2012;23:890-923. 
10 Jais P, et al. Stepwise Catheter Ablation of Chronic Atrial Fibrillation: Importance of Discrete Anatomic Sites for 
Termination. J Cardiovasc Electrophysiol. 2006;17: S28-S36, Suppl. 3. 

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the propagation of AF wave fronts from the triggering source. The muscular sleeves both within 
and near the PVs have been established as a critical source of AF triggers.11 
Over the past decade, there have been many different ablation strategies that have been 
developed and applied to the treatment of persistent AF, including: complex fractionated atrial 
electrograms (CFAE), ganglionated plexi, rotors and linear ablation. One such strategy, the 
stepwise approach was introduced over 10 years ago.8,12 The stepwise strategy assumed that 
better outcomes were obtained when AF was organized and then broke due to additional ablation 
and substrate modification. The strategy was observational in nature and presumed better 
outcomes with a stepwise series of radiofrequency (RF) ablations. However, more recently the 
stepwise strategy has been the topic of reevaluation as outcomes may have been more biased by 
patient cohorts rather than ablation strategy.13 
The largest randomized control trial to-date looking at outcomes of catheter ablation in the 
persistent AF population, STAR AF II14, demonstrated no significant difference in freedom from AF 
or AF/atrial flutter/atrial tachycardia across three study arms (PVI vs. PVI + complex fractionated 
electrograms vs. PVI + lines). It is important to note that one of the trial conclusions was the 
statement that “…reason for the lack of benefit associated with additional ablation in our trial is 
unclear”. The question is open as to whether the use of RF ablation technology in the STAR AF II 
trial had an impact on the ability to achieve transmural and contiguous lesions. While an important 
trial in this space, STAR AF II has not definitively answered the question of whether or not lines are 
effective. Subsequently, Kirchhof and Calkins published a clinical update on catheter ablation in 
patients with persistent atrial fibrillation, stating: “better technology is needed to achieve 
transmural lesions. This has implications not only for the evaluation of linear lesions but also for 
other ablation concepts”. 15 
Medtronic proposes there is a need to investigate the utility of lines using technology (i.e. 
ArcticLine Catheter) capable of creating contiguous, transmural, and durable lesions with fewer 
applications.  ArcticLine is expected to be a safe and effective alternative to the current technology 
 
 
11 Calkins H, et al. HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial 
Fibrillation: Recommendations for personnel, Policy, Procedures and Follow-Up. Europace. 2007;9(6):335-379. 
12 Rostock T, et al. Chronic Atrial Fibrillation Is a Biatrial Arrhythmia Data from Catheter Ablation of Chronic Atrial 
Fibrillation Aiming Arrhythmia Termination Using a Sequential Ablation Approach. Circ Arrhythmia Electrophysiol. 
2008;1:344-353. 
13 Winkle RA. How much ablation to eliminate atrial fibrillation: Is less more or is more more? Heart Rhythm. Epub 
ahead of print. DOI: http://dx.doi.org/10.1016/j.hrthm.2015.06.031 
14Verma A, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med 2015; 372:1812- 
1822. 
15Kirchof and Calkins. Catheter ablation in patients with persistent atrial fibrillation. European Heart J. 
doi:10.1093/eurheartj/ehw260. 

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used to achieve linear ablation (i.e. RF ablation). RF ablation uses a point-by-point approach, 
requiring multiple catheter applications which can leave gaps. We anticipate the safe use of 
ArcticLine in this feasibility study will contribute to planning future clinical evidence activities that 
support the premise that linear ablation can be safe and effective when created with the ArcticLine 
Catheter. 
In regards to patients with a history of cavotricuspid isthmus-dependent flutter, or inducible CTI- 
dependent atrial flutter at the time of the ablation procedure, the 2017 HRS/EHRA/ECAS Expert 
Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation2 published a Class I 
Level B recommendation for ablation, stating it “can be performed safely, easily, and with only a 
slight prolongation in procedure time”. As the clinical evidence is already strong to support the 
success of CTI ablation to treat typical atrial flutter, Medtronic anticipates that the ArcticLine 
Catheter can be used safely to successfully treat typical atrial flutter with the added benefit of 
requiring fewer applications. 
 
3.2. 
Purpose 
The purpose of the study is to collect preliminary safety and effectiveness data on the ArcticLine 
Catheter when used to treat persistent AF and right atrial cavotricuspid isthmus dependent atrial 
flutter (“typical atrial flutter”). These data will be used to guide subsequent product development 
activities for the ArcticLine Catheter, including feedback on device design and input into a future 
pivotal study. 

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4.1. 
Objectives 
 
4.1.1. 
Primary Objective(s) 
Estimate the incidence of ArcticLine Catheter-related and ArcticLine cryoablation procedure- 
related serious adverse events (SAEs) with an onset date within 7 days post-procedure. 
Primary Endpoint 
ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAEs, with an onset date 
within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events 
Committee (CEC), described as follows: 
• 
Atrioesophageal fistula* 
* Includes atrioesophageal fistula with an onset date at any time after the study 
cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter- 
related or ArcticLine cryoablation procedure-related. 
• 
Cardiac perforation/tamponade 
• 
Cerebrovascular accident 
• 
Death 
• 
Esophageal injury 
• 
Major bleeding 
• 
Myocardial infarction 
• 
Pericarditis 
• 
Phrenic nerve injury (ongoing at hospital discharge) 
• 
Transient ischemic attack 
• 
Vagal nerve injury resulting in esophageal dysmotility or gastroparesis 
• 
Vascular access complications 
 
4.1.2. 
Ancillary Objective #1 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the left atrial roof and posterior wall in patients with demonstrated entrance block of all pulmonary 
veins and who underwent roof and posterior wall ablation with ArcticLine. 
4.  Objectives and Endpoints 

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Ancillary Endpoint #1 
Subjects must have confirmed block at the roof line and posterior wall line via periprocedural 
assessment of posterior wall isolation at the completion of the cryoablation procedure to be 
considered an acute treatment success. 
 
4.1.3. 
Ancillary Objective #2 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the mitral isthmus in patients who underwent mitral isthmus ablation with ArcticLine. 
Ancillary Endpoint #2 
Subjects must have confirmed bi-directional conduction block at the mitral isthmus line via 
periprocedural assessment at the completion of the cryoablation procedure to be considered an 
acute treatment success. 
 
4.1.4. 
Ancillary Objective #3 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the CTI in patients who underwent CTI ablation with ArcticLine. 
Ancillary Endpoint #3 
Subjects must have confirmed bi-directional conduction block at the CTI line via periprocedural 
assessment at the completion of the cryoablation procedure to be considered an acute treatment 
success. 
 
4.1.5. 
Ancillary Objective #4 
Characterize chronic treatment success of the ArcticLine Catheter in patients with demonstrated 
entrance block of all pulmonary veins. 
Ancillary Endpoint #4 
AF/AFL/AT episodes of at least 30 seconds duration from the end of the 90 day blanking period 
through the 12 month visit. Per section 8.6.1, the initiation of a new Class I or III antiarrhythmic 
medication or a Class I or III antiarrhythmic medication dose increase after the 90 day blanking 
period will be considered a chronic treatment failure. 
 
4.1.6. 
Ancillary Objective #5 
 
Estimate the incidence of ArcticLine Catheter-related and ArcticLine cryoablation procedure- 
related serious adverse events (SAE) through the 12 month visit. 

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Ancillary Endpoint #5 
ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAEs, as adjudicated by 
the Clinical Events Committee (CEC). 
 
4.1.7. 
Ancillary Objective #6 
Characterize procedural data: 
• 
Total procedure time 
• 
Total ArcticLine Catheter use time 
• 
Left atrial dwell time 
• 
Total fluoroscopy time 
• 
Total fluoroscopy time during ArcticLine Catheter use 
• 
Application duration 
• 
Number of applications 
• 
Fluoroscopy dose 
 
Ancillary Endpoint #6 
• 
Total procedure time is defined as time from first venous access to time of last catheter 
removal. 
• 
Total ArcticLine Catheter use time is defined as cumulative time from each introduction of 
ArcticLine Catheter into the body to its removal. 
• 
Left atrial dwell time is defined as time from transseptal puncture to time of removal of last 
sheath/catheter from the left atrium. 
• 
Total fluoroscopy time is defined as total fluoroscopy time used during the procedure. 
• 
Total fluoroscopy time during ArcticLine Catheter use is defined as the cumulative 
fluoroscopy time from each introduction of ArcticLine Catheter into the body to its 
removal. 
• 
Application duration is defined as total duration in which cryoablation from the ArcticLine 
Catheter is applied to cardiac tissue overall and individually to each target area. 
• 
Number of applications is defined as the total number of times in which the ArcticLine 
Catheter was used to ablate cardiac tissue overall and individually to each target area. 
• 
Total fluoroscopy dose is defined as the amount of radiation deposited into the tissue, 
measured in Gy or mGy units. 

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4.1.8. 
Ancillary Objective #7 
Estimate the incidence of adverse events (AEs) through the 12 month visit. 
 
Ancillary Endpoint #7 
Characterize adverse events through the 12 month visit, described as follows: 
• 
Atrioesophageal fistula 
• 
Cardiac perforation/tamponade 
• 
Cerebrovascular accident 
• 
Coronary artery spasm 
• 
Death 
• 
Esophageal injury 
• 
Lung injury (including hemoptysis) 
• 
Major bleeding 
• 
Myocardial infarction 
• 
Pericarditis 
• 
Phrenic nerve injury (ongoing from hospital discharge) 
• 
Pulmonary vein stenosis 
• 
Symptomatic persistent iatrogenic atrial septal defect 
• 
Transient ischemic attack 
• 
Vagal nerve injury 
• 
Vascular access complications 

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Medtronic is sponsoring the ArcticLine Feasibility Study: a prospective, interventional, multi- 
center, non-randomized, single arm, unblinded clinical study. The goal of the study is to collect 
preliminary safety and effectiveness data on the ArcticLine Catheter. The study design diagram is 
shown in Figure 1. Up to 45 subjects will be enrolled in up to 4 centers in the United States and 
Canada with up to 30 of these subjects treated with the ArcticLine Catheter.  It is anticipated that 
at least 30 ArcticLine Catheters will be used in this study to ensure the sample size is met. The 
maximum number of subjects that may be treated at a single center is 15 subjects (50% of the total 
treated). 
 
Figure 1:  Study Design Flowchart 
 
5.  Study Design 

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5.1. 
Duration 
Subjects from all participating geographies will be followed for 12 months after the index ArcticLine 
ablation procedure and then be exited from the study. Accordingly, the expected total study 
duration is approximately 21 months, representing 9 months of enrollment and 12 months of 
subject follow-up. Subjects who are enrolled and treated with the ArcticLine Catheter will not be 
replaced with newly enrolled subjects upon early study exit. 
 
5.2. 
Rationale 
The study has been designed to collect preliminary safety and effectiveness data of the ArcticLine 
Catheter. Due to the feasibility nature of the study, a comparator arm is not included. There is 
currently no catheter on the market in either Canada or the United States that is capable of 
creating a linear lesion with a single application. 
A traditional feasibility study with a primary safety objective was chosen for the following reasons: 
 
• 
The current standard for creating a linear lesion is to use a point-by-point approach with a 
focal catheter and stitch lesions together. This technique has produced mixed clinical 
evidence regarding effectiveness. This study investigates the safety and performance of a 
catheter specifically designed to make linear lesions. 
• 
Data from the study will be used to guide subsequent product development activities for 
the ArcticLine Catheter, including a potential future pivotal study. 
 
5.3. 
Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of 
bias. Methods incorporated in the study design to minimize potential bias include (but are not 
limited to): 
• 
Subjects will undergo screening to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria prior to enrollment. 
• 
Subject demographics will be collected at baseline to later assess possible characteristics 
that may influence endpoints. 
• 
All investigational center personnel and Medtronic personnel will be trained on their 
respective aspects of the study using standardized training materials. 
• 
All investigational center personnel will be trained on and required to follow the CIP. 
• 
An independent Clinical Events Committee (CEC) will be utilized to review and adjudicate 
reported adverse events and deaths. 
• 
An independent core lab will be utilized to review and adjudicate the arrhythmia component 
of the ancillary objectives. 

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• 
A statistical analysis plan (SAP) will be developed prior to analyzing data. The plan will 
document all pre-specified analyses and analysis methods. 
• 
Monitoring will be conducted to review adherence to the CIP and perform source data 
verification per the Monitoring Plan. 
• 
A maximum of 15 treated subjects will be allowed at a single investigational center to 
ensure an even distribution of total subjects across centers. 
 
In summary, potential sources of bias that may be encountered in this clinical study have been 
considered and minimized by thorough, careful study design. 

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6.1. 
General 
Information on the components included in the study are listed in Table 2 and described below. 
Instructions For Use (IFU) of the devices used in the study are provided in their respective manuals. 
There are no changes to the market-released FlexCath Advance Steerable Sheath (“sheath”), 
CryoConsole, including accessories (with exception of catheter software file), Arctic Front 
Advance Cardiac Cryoablation Catheter, or Freezor MAX Cardiac Cryoablation Catheter devices 
planned at this time. 
Table 2: Device Information 
 
Component 
Required 
Use in 
Study? 
Model 
Number 
Geography 
Manufacturer 
ArcticLine™ 
Cardiac 
Cryoablation 
Catheter 
Yes 
2AL35 
Canada (investigational) 
US (investigational) 
Medtronic CryoCath 
LP 
CryoConsole™, 
including 
Accessories 
Yes 
106A3, 
Models 
10000- 
008-04 or 
10000- 
008-08 
Canada (commercial) 
US (commercial) 
ArcticLine™ 
Catheter File 
Yes 
Not 
applicable 
Canada (investigational) 
US (investigational) 
FlexCath 
Advance® 
Steerable Sheath 
12 Fr 
Yes 
4FC12 
Canada (investigational) 
US (investigational) 
Arctic Front 
Advance® Cardiac 
Cryoablation 
Catheter 
No 
2AF233 
Canada (commercial) 
2AF283 
Canada (commercial) 
2AF234 
US (investigational) 
2AF284 
US (investigational) 
Freezor® MAX 
Cardiac 
Cryoablation 
Catheter 
No 
209F3 
Canada (commercial) 
209F5 
Canada (commercial) 
239F3 
US (investigational) 
239F5 
US (investigational) 
6.  Product Description 

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6.2. 
ArcticLine Cryoablation Catheter 
The ArcticLine Catheter is a sterile, single use, minimally invasive intravascular catheter specifically 
designed for cardiac tissue cryoablation via a linear ablation segment. The ArcticLine Catheter is 
used together with the CryoConsole and related devices. The Catheter is percutaneously 
advanced to the applicable heart chamber from the femoral access via a transseptal sheath in the 
vasculature. The effective length is 107±2.0 cm. Once the catheter reaches the applicable atrium, it 
is positioned and the ablation segment creates a linear lesion at the targeted location. The 
ArcticLine Catheter is not approved for sale in any geography. 
The proposed indication for the ArcticLine Catheter evaluated in this Study is as follows: 
 
The ArcticLine Cardiac Cryoablation Catheter is indicated for creating endocardial linear lesions, 
subsequent to successful pulmonary vein isolation, during cardiac ablation procedures for treatment of 
patients with persistent atrial fibrillation. The ArcticLine Catheter can also be used to treat typical atrial 
flutter. 
Note: Patients enrolled in the study must have persistent atrial fibrillation. For those subjects who 
also have concomitant typical atrial flutter or the investigator determines a prophylactic CTI line is 
warranted, the ArcticLine Catheter will be used to create a CTI line for treatment. Patients with 
stand-alone typical atrial flutter will not be enrolled in the study. 
 
6.3. 
CryoConsole, including Accessories and Catheter File 
The CryoConsole houses the electronics and software for controlling and recording the ablation 
procedure, stores and controls delivery of liquid refrigerant under high pressure through the co- 
axial umbilical to the catheter, recovers the expanded refrigerant vapor from the catheter under 
vacuum, and disposes of the refrigerant through the hospital scavenging system. The hardware 
controls the safety monitoring systems while the software provides the user interface subject 
information, procedure temperature, time set point in automatic mode and procedure data 
information. 
 
The sterile coaxial umbilical delivers the Nitrous Oxide (N2O) gas from the console to the catheter 
and transports refrigerant vapors from the catheter to the console, which is then vented into the 
hospital scavenging system. 

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The sterile electrical umbilical is an electrical extension cable that transports: 
 
• 
Temperature feedback from the catheter to the console 
• 
Leak detection signals from the catheter to the console 
• 
Blood sensor signals from the catheter to the console 
• 
Pressure sensor form the catheter to the console 
The catheter file for each respective cryoablation device resides on the CryoConsole. When a 
catheter is connected to the console, the console searches for the catheter file associated with the 
connected catheter.  The catheter file is read and the parameters from the file are used to 
configure the system accordingly. 
The Arctic Front Advance and Freezor MAX catheter files are readily available on the CryoConsole 
at sites as they are market-released devices. Prior to study start at each site, the ArcticLine 
catheter file will be uploaded from a flash drive by Medtronic personnel to each CryoConsole 
expected to be used in the clinical study. 
 
6.4. 
FlexCath Advance Steerable Sheath, 12 Fr 
The FlexCath Advance Steerable Sheath, 12 Fr (“sheath”) is a percutaneous introducer fitted with a 
hemostasis valve to allow for introduction, withdrawal and swapping of catheters and wires while 
minimizing blood loss. A side-port with three-way stopcock is integrated to allow continuous drip 
infusion, injection through the center lumen, flushing, air or blood aspiration, blood sampling and 
pressure monitoring. The sheath is intended to allow sheath deflection to facilitate catheter 
positioning. It is supplied sterile and packaged together with a dilator. 
The Indications for Use in Canada and the US: The FlexCath Advance Steerable Sheath is intended 
for percutaneous catheter introduction into the vasculature and into the chambers of the heart. 
The sheath deflection facilitates catheter positioning. 
Investigational Note: As the sheath Instructions For Use for both Canada and the US states it can 
accommodate devices up to 10.5Fr, and the ArcticLine Catheter is 11Fr, the sheath will be used 
investigationally for the purposes of the study. 
 
6.5. 
Arctic Front Advance Cryoablation Catheter and Related Devices 
The Arctic Front Advance (“AFA”) Cardiac Cryoablation Catheter is a sterile, single use, minimally 
invasive intravascular balloon catheter specifically designed for tissue cryoablation. The AFA 
Catheter is used together with the CryoConsole and related devices. The AFA Catheter is 
percutaneously advanced to the heart chamber from the femoral access via a transseptal sheath in 

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the vasculature. Once the catheter reaches the left atrium, the balloon is inflated and the cooling 
segment creates circumferential lesions at the antrum of the targeted pulmonary veins. 
Licensed indication in Canada: The Arctic Front Advance Cardiac Cryoablation Catheter is 
indicated for the treatment of patients with atrial fibrillation. 
Approved indication in US: The Arctic Front Advance Cardiac Cryoablation Catheters are indicated 
for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. 
Investigational Note: As the US Arctic Front Advance IFU does not include treatment of persistent atrial 
fibrillation, any use of the device at a US study center will be considered investigational. 
The Achieve and Achieve Advance Mapping Catheter (“Achieve/Achieve Advance mapping 
catheter”) and the Manual Retraction Kit are used in conjunction with the Arctic Front Advance 
catheter as described below. 
The Achieve/Achieve Advance mapping catheter is an intra-cardiac electrophysiology diagnostic 
catheter indicated for multiple electrode electrophysiological mapping of the cardiac structures of 
the heart, i.e., recording or stimulation only. The Achieve/Achieve Advance mapping catheter is 
designed to obtain electrograms in the atrial regions of the heart. 
The Indications for Use in Canada and the US: The Achieve/Achieve Advance mapping catheter is 
indicated for multiple electrode electrophysiological mapping of the cardiac structures of the 
heart, i.e. recording or stimulation only. The Achieve/Achieve Advance mapping catheter is 
designed to obtain electrograms in the atrial regions of the heart. 
The Manual Retraction Kit contains one large syringe, one 3-way stopcock and a coaxial-to-Luer 
adaptor. The kit is used during the rewrap procedure of the Arctic Front Advance catheter if the 
Investigator cannot retract the catheter using the normal catheter retraction cycle. 
 
6.6. 
Freezor MAX Cryoablation Catheter 
The Freezor MAX Cardiac Cryoablation Catheter (“Freezor MAX”) is a sterile, single use, flexible, 
steerable catheter used to ablate cardiac tissue. It is used together with the CryoConsole and 
related devices. The 8mm tip of the focal Freezor MAX reaches cryoablation temperatures when 
refrigerant is injected from the CryoConsole to the tip of the catheter. The catheter tip has an 
integrated thermocouple for temperature reading capability. The catheter is introduced into the 
vasculature by traditional minimally invasive techniques. 
Licensed indication in Canada: The Freezor MAX Cardiac Cryoablation Catheter is intended for use 
in treatment of cardiac arrhythmias. 

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Approved indication in US: The Freezor MAX Cardiac Cryoablation Catheters is indicated for use as 
an adjunctive device in the endocardial treatment of paroxysmal atrial fibrillation in conjunction 
with the Arctic Front Advance Cardiac Cryoablation Catheter for the following uses: gap 
cryoablation to complete electrical isolation of the pulmonary veins, cryoablation of focal trigger 
sites and creation of ablation line between the inferior vena cava and the tricuspid valve. 
Investigational Note: As the US Freezor MAX IFU does not include treatment of persistent atrial 
fibrillation, any use of the device at a US study center will be considered investigational. 
 
6.7. 
Packaging 
In Canada and the US, the ArcticLine Catheter will be labeled as investigational. The sheath will not 
be labeled as investigational, as this device will be considered investigational upon opening and 
introduction into the vasculature per the CIP. The Achieve/Achieve Advance mapping catheter will 
not be labeled as investigational, as these devices will be used on label in the Study. 
In Canada, the AFA and Freezor MAX catheters will not be labeled as investigational, as these 
devices will be used on label in the Study. 
In the US, the AFA and Freezor MAX catheters will not be labeled as investigational, as these 
devices will be considered investigational upon opening and introduction into the vasculature per 
the CIP. 
 
6.8. 
Product Training Requirements 
Only the Principal Investigator at each study center will be permitted to perform the ArcticLine 
Catheter ablation procedure. In addition to the Principal Investigator, sub-investigators who have 
adequate experience with AFA [i.e. 20 independent cases], as deemed by Medtronic, will be 
permitted to perform the PVI portion of the procedure but will not be allowed to handle the 
ArcticLine catheter. Investigators responsible as primary operators for the ArcticLine Catheter 
ablation procedure will be required to undergo product training (to include hands on experience in 
an In Vitro, In Vivo [animal], and human cadaver model) prior to the site’s first subject enrollment. A 
separate training document will overview topics and include details on the format of delivery. 

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6.9. 
Product Receipt, Tracking and Return 
The study will utilize the commercially available sheath, AFA and Freezor MAX with no study driven 
changes to the product or labeling. These devices will not be provided to the centers. Product 
tracking considerations by device type: 
• 
Sheath: Considered investigational in both Canada and the US when opened and 
introduced into the vasculature. 
• 
AFA: Considered investigational in the US when opened and introduced into the 
vasculature; non-investigational in Canada. 
• 
Freezor MAX: Considered investigational in the US when opened and introduced into the 
vasculature; non-investigational in Canada. 
The ArcticLine Catheter Files will be stored on flash drives and uploaded by Medtronic personnel 
(e.g. Field Clinical Engineers) to the CryoConsoles identified at each study site. The flash drives will 
not be handled directly by study site personnel and will remain in the possession of Medtronic 
personnel for the duration of study enrollment. Once a Catheter File is installed on a site’s 
CryoConsole, Medtronic personnel will affix a label denoting the presence of investigational 
software. See Appendix A for the example text of the CryoConsole investigational label. Once 
study enrollment is completed, the ArcticLine Catheter File will be uninstalled from the 
CryoConsole by Medtronic personnel. Medtronic will manage the device accountability for the 
Catheter File and provide each site with a copy of the device disposition log. 
The following products are to be returned to Medtronic by each study site: 
 
• 
All ArcticLine Catheters, including expired catheters or those remaining after conclusion of 
the study 
• 
Any AFA or Freezor MAX catheter with a reportable device deficiency 
• 
Any sheath used in conjunction with an ArcticLine Catheter with a reportable device 
deficiency 
Device disposition logs will be provided to all centers and used for tracking of all investigational 
product throughout the duration of the study, except for the Catheter File device disposition log 
which will be owned by Medtronic as noted above. The logs must be maintained and updated when 
product is disposed of or returned to Medtronic. 
 
6.10. Product Storage 
ArcticLine Catheters are investigational and will be maintained in locked, secure storage with 
access limited only to approved study staff. 

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7.1. 
Study Population 
The study population being studied are patients with documented persistent atrial fibrillation, or 
those with persistent atrial fibrillation and a history of, or inducible, typical atrial flutter, and 
generally good cardiovascular health. 
 
7.2. 
Subject Enrollment 
Patients will be screened to ensure they meet all inclusion criteria and none of the exclusion criteria 
prior to study enrollment, as appropriate. IRB/REB/MEC and Medtronic approval of this CIP and the 
patient Informed Consent Form must be obtained prior to enrolling subjects in the study. 
Enrollment of the subject must occur prior to performing any study procedures. Subjects are 
enrolled at the time the patient Informed Consent Form is signed and dated. 
 
7.2.1. 
Staged Subject Enrollment 
Enrollment of subjects into this study will occur in two stages: 
 
Stage 1: The first stage of enrollment will allow for up to 15 subjects to be enrolled and treated with 
the ArcticLine Catheter. When the first stage of enrollment is complete, Medtronic will temporarily 
halt enrollment of subjects into the study to conduct an interim safety analysis. Additionally, 
Medtronic will assess the data from a concurrent handling animal study using the ArcticLine 
Catheter. 
Stage 2: The second stage of enrollment, beyond the initial 15 subjects, will be conducted if 
supported by the data analysis mentioned above. Required regulatory authority approvals will also 
be obtained as needed for enrollment of the remaining subjects (up to a total of 45 subjects 
enrolled to ensure a total of 30 subjects are treated with the ArcticLine Catheter) to be enrolled 
and treated. 
 
7.3. 
Inclusion Criteria 
• 
Documentation of symptomatic persistent AF: 
o Defined as having a continuous episode that is sustained beyond 7 days 
documented via consecutive ECG recordings, or 
o Defined as having a continuous episode that is sustained beyond 7 days 
documented by an ECG recording and one doctor note indicating the patient had 
symptoms consistent with AF 
• 
Age 18 through 80 years old 
7.  Selection of Subjects 

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• 
Failure or intolerance of at least one Class I or III antiarrhythmic drug 
• 
Subject is able and willing to consent to participate in the study and will commit to 
completion of all follow-up requirements 
 
7.4. 
Exclusion Criteria 
• 
Longstanding persistent AF, defined as continuous AF greater than 12 month duration 
• 
Left atrial diameter greater than 5.0 cm 
• 
Active systemic infection 
• 
History of thromboembolic event within the past 6 months or evidence of intracardiac 
thrombus at the time of the procedure 
• 
Prior left atrial ablation attempt, with exception of: 
o Any pulmonary vein isolation attempt to treat AF, or 
o Successful ablation to treat Wolff-Parkinson White syndrome 
• 
History of left atrial tachycardia 
• 
History of cardiac ablation within 90 days of planned clinical study procedure 
• 
Planned concomitant ventricular ablation16 
• 
Cryoglobulinemia 
• 
Structural heart disease of clinical significance including: 
o NYHA Class IV Heart Failure 
o Diagnosed with NYHA Class III Heart Failure for more than six months at time of the 
study ablation procedure 
o LVEF less than 35% 
o Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure 
o Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g. 
valvotomy, valve replacement), or tricuspid valve repair 
o Severe mitral valve regurgitation or stenosis 
o Significant congenital anomaly or anatomy unable to accommodate device 
• 
Prior surgical maze procedure 
• 
Unstable angina 
• 
Myocardial infarction within 3 months of the ablation procedure 
• 
Presence of primum or secundum atrial septal defect 
• 
Anomalous pulmonary venous return 
• 
Prior surgery for congenital heart disease, including atrial septal defect 
• 
Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm 
 
 
16 Concomitant ventricular ablation will be allowed in the proposed feasibility clinical study if determined to be in the 
best interest of the subject at the time of the procedure as assessed by the Investigator. However, the ArcticLine Catheter 
may not be used for these purposes. 

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• 
Uncontrolled hyperthyroidism 
• 
Thrombocytosis, thrombocytopenia (including history of heparin-induced 
thrombocytopenia) 
• 
Severe comorbidity or poor general physical/mental health that, in the opinion of the 
investigator, will not allow the subject to be a good study candidate 
• 
History of blood clotting or bleeding abnormalities 
• 
Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or warfarin) 
• 
Pregnant, nursing or planning to become pregnant during study duration 
• 
Enrollment in another clinical trial without prior approval from Medtronic 
• 
Presence or use of left atrial appendage closure device 
• 
Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator, 
implantable loop recorder or cardiac resynchronization device with permanent lead 
placement 
• 
Pre-existing hemidiaphragmatic paralysis 
• 
Life expectancy less than one year 
• 
Known drug or alcohol dependency 
• 
Existing pulmonary vein stent(s) 
 
Note: For exclusion criteria that cannot be fully assessed in a subject at the time of baseline, but are 
found to be met during the procedure (e.g. left atrial tachycardia, anatomy unable to accommodate 
the device), the subject will be exited from the study at that time. 

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8.1. 
Schedule of Events 
Data collection requirements are summarized in Table 3, below. 
 
Table 3: Study Procedures and Data Collection by Subject Visit 
 
Baseline 
Procedure 
Discharge 
1 week1 
3 month2 
6 month2 
12 month 
Unscheduled 
Repeat Ablation 
after Blanking 
Informed Consent 
X 
Inclusion/Exclusion Criteria 
X 
Medical History 
X 
Physical Exam 
X 
AAD & Anticoagulation Medication Review 
X 
X 
X 
X 
X 
X 
X 
Pregnancy Screen3 
X 
Arrhythmia Symptom Review 
X 
X 
X 
X 
X 
X 
NIHSS Assessment 
X 
X 
Transthoracic Echocardiogram (TTE)4 
X 
Transesophageal Echocardiogram (TEE) 
X 
12 Lead ECG 
X 
X 
X 
X 
X 
X 
Procedure Information 
X 
X 
Post-ablation endoscopy5 
X 
X 
24 Hr Continuous Monitoring with Holter 
X 
X 
Patient Activated Ambulatory ECG Monitor 
Monthly and symptomatic episodes 
Adverse Events 
As they occur 
Device Deficiencies 
As they occur 
Study Deviations 
As they occur 
Notes: 
1Phone visit and/or office visit with Nurse Coordinator 
2Multiple modes of data collections may be employed to support the collection of required visit data at the 3 and 6 month visits 
such as: In office patient clinic visit, direct to patient contact (i.e. telephone, email, mail contact, etc.), and remote technology 
transmissions/uploads. 
3Female subjects of child bearing potential only 
4 Only required if data not available from within 6 months prior to consent date 
5Post-ablation endoscopy is required post-ablation, prior to discharge, only if the subject’s esophageal temperature drops 
below 15 degrees C at any time during the study procedure. 
8.  Study Procedures 

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8.2. 
Subject Consent 
Patient informed consent (IC) is defined as a legally effective documented confirmation of a 
subject’s (or their legally authorized representative) voluntary agreement to participate in a 
particular clinical study after information has been given to the subject on all aspects of the clinical 
study that are relevant to the subject’s decision to participate. This process includes obtaining a IC 
Form and an Authorization to Use and Disclose Personal Health Information (US only) that has been 
approved by the study center’s IRB/REB/MEC and signed and dated by the subject or their legally 
authorized representative. A subject may only consent after information has been given to the 
subject on all aspects of the clinical investigation that are relevant to the subject’s decision to 
participate. Informed consent may be given by their legally authorized representative only if a 
subject is unable to make the decision to participate in a clinical investigation. In such cases, the 
subject shall also be informed about the clinical investigation within his/her ability to understand. 
Prior to enrolling subjects, the IC Form must have been approved by each center’s IRB/REB/MEC. 
Each site must also use an Authorization to Use and Disclose Personal Health 
Information/Research Authorization (US only) or other privacy language as required by law. The IC 
Form must be controlled (i.e. versioned and/or dated) to ensure it is clear which version(s) were 
approved by the IRB/REB/MEC. Any adaptation of the sample IC Form must be reviewed and 
approved by Medtronic and the IRB/REB/MEC reviewing the application prior to enrolling subjects. 
The Investigator must notify the subject (or their legally-authorized representative) of any 
significant new findings about the study that become available during the study which are pertinent 
to the safety and well-being of the subject. This could impact a subject’s willingness to participate 
in the study. If relevant, approval may be requested from subjects to confirm their continued 
participation. 
Prior to initiation of any study-specific procedures, documented informed consent must be 
obtained from the subject (or their legally authorized representative). Likewise, privacy or health 
information protection regulation may require subjects to sign additional forms to authorize 
centers to submit subject information to the study sponsor. The informed consent process must 
be conducted by the Principal Investigator or an authorized designee, and the IC Form and the 
Authorization to Use and Disclose Personal Health Information/Research Authorization/other 
privacy language (US only) as required by law must be given to the subject (or their legally 
authorized representative) in a language he/she is able to read and understand. The process of 
informed consent must be conducted without using coercion, undue or improper influence on, or 
inducement of the subject to participate by the Investigator or other center personnel. The 
informed consent process shall not waive or appear to waive the subject’s legal rights. The 
language used shall be as non-technical as possible and must be understandable to the subject and 
the impartial witness, where applicable. 

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The subject must have ample time and opportunity to read and understand the IC Form, to inquire 
about details of the study, and to decide whether to participate in the clinical study. All questions 
about the study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the clinical study, the IC Form and the Authorization to 
Use and Disclose Personal Health Information/Research Authorization/other privacy language (US 
only) as required by law must be signed and personally dated by the subject (or their legally 
authorized representative) and either the Investigator or the Investigator’s authorized designee, 
as required by local law. If applicable, witness shall also sign and personally date the consent form 
to attest that the information in the IC Form was accurately explained and clearly understood by 
the subject, and that informed consent was freely given. 
A copy of the IC Form and the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law (US only), signed 
and dated as required by law, must be provided to the subject. 
If consent is obtained the same day the subject begins participating in study-related procedures, it 
must be documented in the subject’s case history that consent was obtained prior to participation 
in any study related procedures. It is best practice for the informed consent process to be 
documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, a witnessed (impartial third party) IC Form will be 
allowed, provided detailed documentation of the process is recorded in the subject’s case history 
and the witness signs and dates the IC Form. 
The original of the signed IC Form and the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language (US only) as required by law must be 
filed in the hospital/clinical chart and/or with the subject’s study documents and should also be 
available for monitoring and auditing. Any Medtronic Field personnel who support the study 
procedure must be able to review the subject’s signed and dated IC Form and verify its 
completeness prior to proceeding with the procedure. In the event the Medtronic Field personnel 
identify an IC Form as being incomplete, the study procedure will not be allowed to occur until the 
consent of the subject can be adequately and appropriately obtained. 

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8.3. 
Baseline and Pre-Ablation Procedure 
The baseline visit can be a standalone visit or can be performed on the same day but prior to the 
cryoablation procedure. The following evaluations will be performed after consent, unless 
previously performed as part of routine clinical evaluations within the specified windows: 
Within 6 months prior to consent date: 
 
• 
Transthoracic echocardiogram (TTE) for the collection of left atrial diameter, left 
ventricular ejection fraction, and mitral valve impairment. A repeat TTE procedure for the 
Study after the consent date is not required if a TTE was performed within 6 months of the 
consent data and all data are available. 
After consent date but prior to procedure: 
 
Note: The time between the consent date and the procedure should not exceed 30 days. If 30 days are 
exceeded, the subject must be re-evaluated against inclusion and exclusion criteria to ensure they still 
qualify for the study. 
• 
Assessment of all factors specified for evaluation under Inclusion Criteria and Exclusion 
Criteria (see Sections  7.3 and 7.4, respectively). 
o Note: After required study testing, if a subject no longer meets the inclusion criteria 
or now meets exclusion criteria, the subject will be exited from the study. 
• 
Demographics 
• 
Medical history 
• 
Physical examination 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
• 
Pregnancy screen (female subjects of child bearing potential only) 
• 
12 lead ECG 
• 
Record rhythm and Class I and III AAD and anticoagulation medications 
• 
National Institute of Health Stroke Scale (NIHSS) Assessment 
• 
The NIHSS will be administered by study site personnel who have been certified to perform 
the NIHSS assessment and are delegated by their respective site to perform such 
assessment. 
• 
Transesophageal Echocardiogram (TEE): 
o TEE will be performed in all subjects within 2 days prior to, including day of, planned 
ablation procedure. 
o Subject will not proceed with the study ablation procedure and will be exited from 
the study if presence of atrial thrombus is identified. 

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8.4. 
Procedure 
The Investigator is to perform the procedure according to the procedural steps in this CIP and the 
applicable Instructions for Use for all devices (except for investigational uses as described in this 
CIP). Current recommendations for anticoagulation are found in the 2017 
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical 
Ablation of Atrial Fibrillation2 and 2014 Focused Update on the Canadian Cardiovascular Society 
Guidelines for the Management of Atrial Fibrillation.17 
 
8.4.1. 
High Level Procedure Overview: 
Appropriate sedation and venous access should be attained per the Investigator’s standard 
practice according to their institution’s pre-established procedures/guidelines at the time of the 
procedure. Investigator may choose compatible guidewires and mapping catheters at their 
discretion. The FlexCath Advance 12Fr sheath must be used for the deployment of the Arctic 
Front Advance and ArcticLine ablation catheters. Deploy diagnostic catheters and perform 
transseptal puncture. 
Perform a baseline voltage map of the left atrium using a 3D mapping system (e.g. NavX, 
Rhythmia). Recommended settings for minimum voltage in this study is 0.2mV. 
Perform baseline mapping of the pulmonary veins to assess for pulmonary vein potentials using a 
circular mapping catheter (e.g. Achieve Advance) to determine if PVI is required. If yes, perform the 
pulmonary vein isolation procedure using Arctic Front Advance Catheter as per Section 8.4.5. 
If PVI ablation is performed, repeat voltage mapping of the left atrium using a 3D mapping system. 
 
If the investigator determines the subject should move forward with ArcticLine ablation, perform 
the following required linear ablations using the ArcticLine Catheter as per Section 8.4.6: 
• 
Left atrial roof line 
• 
Left atrial posterior wall line 
Note: An example where the investigator may choose not to move forward with ArcticLine ablation 
and instead, exit the subject from the study, is when a subject has previously undergone PVI and 
has minimal pulmonary vein reconnection which, in the opinion of the investigator, only requires 
touch-up ablation. 
 
 
 
 
 
 
17 Verma A, et al. 2014 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial 
Fibrillation. Canadian Journal of Cardiology. 30 (2014) 1114-1130. 

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At the investigator’s discretion, perform optional linear ablations at the following anatomic targets 
using the ArcticLine Catheter: 
• 
Mitral isthmus (see Section 8.4.7) 
• 
CTI (see Section 8.4.8) 
At the investigator’s discretion, use pacing maneuvers to determine the immediate effect of the 
ArcticLine ablation(s). Note: Direct Current (DCCV) or pharmacological cardioversion may be 
considered at any point during the procedure when restoration of SR will assist in assessing the 
effectiveness of cryoablations or deemed necessary for the benefit of the patient. 
Repeat ArcticLine ablation(s), as necessary to achieve conduction block, as described in Sections 
8.4.6-8.4.8 . 
Upon completion of a minimum 30-minute wait time from the last ArcticLine ablation for each 
respective anatomy target, perform repeat voltage map of the left atrium using a 3D mapping 
system with the recommended settings. Use of 3-D mapping following the 30-minute waiting 
period should be performed while the subject is in Sinus Rhythm. 
Notes: 
 
• 
Reference ArcticLine Technical Guidance for recommendations on pacing maneuvers and 
3D mapping settings. 
• 
If Investigator is unable to successfully complete a lesion with the ArcticLine Catheter after 
a minimum of four (4) ArcticLine ablation applications, they may cross over to another FDA 
approved catheter. This will be considered an ArcticLine treatment failure. 
• 
Temperatures of –80⁰C are expected with use of the ArcticLine Catheter. 
• 
The ArcticLine Catheter ablation segment should be completely outside of the sheath 
prior to initiating an ablation. Freezing in the sheath may result in occluding the saline drip. 
• 
Methods used to assess for conduction block must be documented and reported. 
• 
Copies of voltage maps from ArcticLine procedures are to be sent to Medtronic. 
 
8.4.2. 
Esophageal Visualization and Temperature Monitoring 
Ensure an esophageal temperature monitor is used for each cryoablation application (Arctic Front 
Advance, if applicable, and ArcticLine). Cease cryoablation if the temperature reaches ≤20°C2. If at 
any time during the study procedure the esophageal temperature reaches <15°C, post-ablation 
endoscopy will be performed prior to the subject’s discharge. If a lesion is observed, it will be 
reported as an adverse event and followed per the site’s standard of care. Use of proton pump 
inhibitors (PPI) is recommended in all ArcticLine Catheter-treated subjects for at least 6 weeks 
post-procedure or longer as per institutional standard of care to reduce the risk of esophageal 
injury. 

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8.4.3. 
Peri-Procedural Anticoagulation 
Heparin should be administered prior to or immediately following transseptal puncture during AF 
ablation procedures and adjusted to achieve and maintain an ACT of 300 to 400 seconds, or per 
standard center guidelines, and checked approximately every 30 minutes. Performance of AF 
ablation in a subject systemically anticoagulated with warfarin or novel oral anticoagulants 
(NOACs) does not alter the need for intravenous heparin to maintain a therapeutic ACT during the 
procedure. Administration of protamine following ablation to reverse heparin should be 
considered. 
 
8.4.4. 
Diaphragm Movement 
Phrenic nerve monitoring, including continuous pacing of the applicable phrenic nerve and 
compound motor action potential (CMAP) recording, must be performed for each anatomic target 
as noted in Table 4. CMAP recording is performed using an electrophysiology (EP) catheter in the 
hepatic vein and/or needle (and/or surface) electromyography (EMG) electrodes on the chest wall. 
Additional methods of phrenic nerve monitoring are recommended. 
 
Table 4:  Required Phrenic Nerve Monitoring 
 
Anatomic Target 
CMAP 
Right Phrenic 
Nerve Pacing 
Left Phrenic 
Nerve Pacing 
Right-sided pulmonary veins (if applicable) 
Optional 
Required 
N/A 
Left-sided pulmonary veins (if applicable) 
Optional 
Optional 
Optional 
Roof 
Optional 
Required 
N/A 
Posterior wall 
Optional 
Required 
N/A 
Mitral isthmus (if applicable) 
Optional 
N/A 
Required 
Cavotricuspid isthmus (if applicable) 
Required 
Required 
N/A 
 
8.4.5. 
Pulmonary Vein Cryoablation with Arctic Front Advance Catheter 
Subjects will be evaluated to determine the need for PVI. If the need is confirmed based on 
intracardiac electrogram recordings, every effort consistent with subject welfare should be made 
to treat all PVs or their anomalous equivalents where electrical activity is noted. 
Subjects in the Study who require pulmonary vein isolation are to be treated as follows: 
 
• 
As stated in Section 8.4, perform a baseline voltage map of the left atrium using a 3D 
mapping system. 
• 
Phrenic nerve monitoring must be done in accordance with Table 4. 
• 
Ablate the pulmonary veins using the Arctic Front Advance Catheter according to the IFU. 
• 
Each pulmonary vein must be assessed for entrance block to demonstrate electrical 
isolation. Optionally, pulmonary vein assessment for exit block may be performed. 
• 
Perform repeat voltage mapping of the left atrium using a 3D mapping system. 

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Notes: 
 
• 
Upon the Investigator’s assessment of procedure completion, Isoproterenol and/or 
adenosine may be used to further assess pulmonary vein isolation. 
• 
Freezor MAX should be used for any gap completion or other FDA approved ablation 
catheter. In the event another catheter is used instead of Freezor MAX for gap completion, 
the subject will be exited from the study. 
 
8.4.6. 
Linear Cryoablation with ArcticLine Catheter: Roof and Posterior Wall 
Once confirmation all pulmonary veins have been isolated and the investigator determines the 
subject should move forward with ArcticLine ablation, perform the following steps: 
Withdraw and remove the Arctic Front Advance catheter through the FlexCath Advance sheath. 
 
Phrenic nerve monitoring must be done in accordance with Table 4. Insert and advance ArcticLine 
Catheter into the left atrium via the FlexCath Advance sheath and position as follows: 
• 
Roof: Position the ArcticLine Catheter between the right and left superior pulmonary veins. 
• 
Posterior wall: Position ArcticLine Catheter between the inferior pulmonary veins. 
Repeat the following steps for both the roof and posterior wall locations: 
• 
Assess the positioning and contact via fluoroscopy, ultrasound imaging, or other 
visualization technique.  Reposition as needed. 
• 
Perform the cryoablation. Cryoapplications of three (3) minutes is recommended for the 
roof and posterior wall targets in the left atrium. 
• 
At the investigators discretion, use pacing maneuvers to determine the immediate effect 
of the ArcticLine ablation(s). 
• 
Note: It is the investigator’s discretion to assess necessity of additional freezes to 
complete the desired ablation line. 
Once the roof line and posterior wall lines are completed, assess the posterior wall for isolation 
using pacing maneuvers and/or 3D mapping. 

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If no further ArcticLine ablation(s) in the left atrium will be performed: 
 
• 
Repeat voltage mapping of the left atrium using a 3D mapping system after a minimum 30- 
minute wait time from the last ArcticLine ablation for each respective anatomy target. 
• 
Use of 3-D mapping following the 30-minute waiting period should be performed while the 
subject is in Sinus Rhythm. 
Notes: 
 
• 
The ArcticLine Catheter ablation segment should be completely outside of the sheath prior 
to initiating the ablation. Freezing in the sheath may result in occluding the saline drip. 
• 
Upon the Investigator’s assessment of procedure completion, Isoproterenol and/or 
adenosine may be used to further assess pulmonary vein conduction. 
• 
Use of another catheter, other than the ArcticLine Catheter, for gap completion of the roof 
and/or posterior wall lines will be considered a treatment failure. 
 
8.4.7. 
Linear Cryoablation with ArcticLine Catheter: Mitral Isthmus 
If the investigator chooses to perform a mitral isthmus line ablation, perform the following steps: 
 
Advance the ArcticLine Catheter to the mitral isthmus by positioning between the mitral annulus 
and either posteriorly to the left inferior pulmonary vein or anteriorly to the left superior pulmonary 
vein. Phrenic nerve monitoring must be done in accordance with Table 4. 
Assess the positioning and contact via fluoroscopy, ultrasound imaging, or other visualization 
technique.  Reposition as needed. 
Perform the cryoablation. Cryoapplications of three (3) minutes is recommended at the mitral 
isthmus. 
• 
Note: It is the investigator’s discretion to assess necessity of additional freezes to 
complete the desired ablation line. 
Assess for bi-directional conduction block across the mitral isthmus, while subject is in sinus 
rhythm, using pacing maneuvers and/or 3D mapping following ArcticLine ablation. 
 
• 
Note: Direct Current (DCCV) or pharmacological cardioversion should be performed prior 
to assessing patient for conduction block. 
If no further ArcticLine ablations in the left atrium will be performed: 
 
• 
Reconfirm bi-directional conduction block at the mitral isthmus following a 30 minute wait 
from the last ArcticLine ablation. 
• 
Repeat voltage mapping of the left atrium using a 3D mapping system after a minimum 30- 
minute wait time for each respective ArcticLine lesion. 

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• 
Use of 3-D mapping following the 30-minute waiting period should be performed while the 
subject is in Sinus Rhythm. 
• 
Local Activation Time (LAT) Mapping to further confirm conduction block following a 30- 
minute wait may be considered. 
Notes: 
 
• 
The ArcticLine Catheter ablation segment should be completely outside of the sheath prior 
to initiating the ablation. Freezing in the sheath may result in occluding the saline drip. 
• 
Upon the Investigator’s assessment of procedure completion, Isoproterenol and/or 
adenosine may be used. 
• 
Use of another catheter, other than the ArcticLine Catheter, for gap completion of the 
mitral isthmus line will be considered a treatment failure. 
 
8.4.8. 
Linear Cryoablation with ArcticLine Catheter: Cavotricuspid Isthmus 
If the investigator chooses to perform a CTI line ablation, perform the following steps: 
 
Advance the ArcticLine Catheter to the CTI by positioning between the inferior vena cava and 
tricuspid annulus. Phrenic nerve monitoring must be done in accordance with Table 4. 
Assess the positioning and contact via fluoroscopy, ultrasound imaging, or other technique. 
Reposition as needed. 
Perform the cryoablation. Cryoapplications of four (4) minutes is recommended at the CTI. 
 
• 
Note: It is the investigator’s discretion to assess necessity of additional freezes to 
complete the desired ablation line. 
Assess the CTI line for bi-directional conduction block using pacing maneuvers and/or 3D mapping 
following a 30-minute wait. 
 
Notes: 
• 
The ArcticLine Catheter ablation segment should be completely outside of the sheath prior 
to initiating the ablation. Freezing in the sheath may result in occluding the saline drip. 
• 
Upon the Investigator’s assessment of procedure completion, Isoproterenol and/or 
adenosine may be used. 
• 
Use of another catheter, other than the ArcticLine Catheter, for gap completion of the 
cavotricuspid isthmus line will be considered a treatment failure. 

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8.4.9. 
Cardioversion 
Direct Current (DCCV) or pharmacological cardioversion may be considered at any point during the 
procedure when restoration of SR will assist in assessing the effectiveness of cryoablations or 
deemed necessary for the benefit of the patient. Electrical or pharmacological cardioversion to 
sinus rhythm must be attempted at the conclusion of the procedure if sinus rhythm was not 
restored. 
 
8.4.10. 
Role of Medtronic Personnel at Study Procedure 
Medtronic personnel will collect procedural data from the CryoConsole post-procedure via data 
download. It is the responsibility of the study center to ensure the subject is identified via subject 
ID number when entered into the system to prevent the distribution of personally identifiable 
information. 
 
8.5. 
Hospital Discharge 
At or shortly before hospital discharge, the following will be performed and collected: 
 
• 
Adverse event assessment 
• 
NIHSS 
o The NIHSS will be administered by study site personnel who have been certified to 
perform the NIHSS assessment and are delegated by their respective site to 
perform such assessment. The discharge NIHSS assessment will be conducted no 
earlier than the day following the procedure and no later than the subject’s 
discharge. If the subject’s discharge NIHSS total score is higher (worse) than the 
baseline NIHSS total score, a formal neurology consult will be initiated by the study 
site team to confirm the presence or absence of stroke or TIA. If the site’s 
neurology team deems it necessary, imaging will be performed. 
• 
Review medications 
• 
12 lead ECG 
• 
Review study requirements with the subject to help ensure compliance with follow-up 
procedures 
Systemic anticoagulation with warfarin or a direct thrombin or Factor Xa inhibitor is recommended 
for at least two months following the AF ablation procedure; however, the anticoagulation 
treatment will be at the Investigator’s discretion according to established guidelines. Decisions 
regarding the continuation of systemic anticoagulation agents more than two months following 
ablation should be based on the subject’s risk factors for stroke and not on the presence of AF. 
Use of proton pump inhibitors (PPI) is recommended in all ArcticLine Catheter-treated subjects for 
at least 6 weeks post-procedure or longer as per institutional standard of care to reduce the risk of 
esophageal injury. 

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8.6. 
Medications 
It is recommended to discontinue the use of Class I and III antiarrhythmic medication by the end of 
the 90 day post-procedure blanking period. 
Information regarding medications prescribed for anticoagulation, proton pump inhibitors, or to 
treat atrial arrhythmias (including adenosine and isoproterenol use during the ablation procedure), 
will be collected from subject enrollment through study exit, including the medication name, dose 
and frequency. 
 
8.6.1. 
Class I and III antiarrhythmic medication use after the 90 day post-procedure 
blanking period 
• 
Subjects may re-initiate, at any point during follow-up, a Class I or III antiarrhythmic 
medication that failed or was not tolerated prior to the ablation procedure at the same or 
lower dose. 
• 
Initiation of a new Class I or III antiarrhythmic medication or a Class I or III antiarrhythmic 
medication dose increase after the 90 day blanking period will be considered a chronic 
treatment failure. 
• 
All medications are permitted in the study except for investigational drugs that may 
confound the study results. 
 
8.7. 
Permissible Repeat Cryoablation 
Repeat ablation, following the same procedure described in Section 8, is allowed one time within 
the 90 day post-procedure blanking period. 
• 
Durability of all lesions, including pulmonary vein and linear lesions, will be assessed for gaps 
prior to re-ablating target locations. 
• 
Ablation of linear lesions, outside of those described in Section 8, will be considered a 
treatment failure. 
• 
Linear ablation using RF in the left or right atria will be considered a treatment failure with 
the exception of subjects who did not undergo CTI ablation with the ArcticLine Catheter in 
their index study procedure. 
• 
Pulmonary vein ablation touch-up using RF will be considered a treatment failure. 
 
Repeat ablation procedures will be documented on an electronic case report form (eCRF). The 
subject’s procedures and follow-up windows will continue based on the index ArcticLine Catheter 
ablation procedure date. 

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8.8. 
Scheduled Follow-up Visits 
After receiving notice of a completed study procedure, Medtronic will provide the target dates and 
windows for each visit to the center. Should a subject miss a visit or the visit fall outside the pre- 
specified window, a study deviation must be reported and the original follow-up schedule 
maintained for subsequent visits. 
Data analyses include follow-up visits, regardless of whether the visit occurs within the window. 
Therefore, a late visit is preferred over a missed visit but must be accompanied by a deviation. 
Follow-up visit windows are listed in Table 5 and are based on days after the index ArcticLine 
Catheter ablation procedure. 
 
Table 5:  Follow-up Schedule 
 
Occurrence/ 
Visit 
Window 
(Calculated days after the ablation 
procedure) 
Window Start 
Window End 
Enrollment/Baseline1 
-30 days 
Day 0 
Index ArcticLine 
Procedure 
Day 0 
Day 0 
1 week phone or office 
7 days 
14 days 
3 month 
91 days 
105 days 
6 month 
165 days 
179 days 
12 month 
365 days 
379 days 
1Note: If the time between the consent date and the procedure exceeds 30 days, 
the subject must be re-evaluated against inclusion and exclusion criteria to 
ensure they still qualify for the study. 
 
Multiple modes of data collections may be employed to support the collection of required visit data 
at the 3 and 6 month visits such as: In office patient clinic visit, direct to patient contact (i.e. 
telephone, email, mail contact, etc.), and remote technology transmissions/uploads. 
The following information is required to be collected at the follow-up visits: 

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8.8.1. 
One Week Phone or Office Visit 
• 
Review medications 
• 
Adverse event assessment 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
 
8.8.2. 
Three Month Visit 
• 
Review medications 
• 
Adverse event assessment 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
• 
12 lead ECG 
• 
Provide the subject with patient activated ambulatory monitoring equipment and provide 
instructions for monthly and symptomatic transmissions 
 
8.8.3. 
Six Month Visit 
• 
Review medications 
• 
Adverse event assessment 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
• 
12 lead ECG 
• 
24-hour continuous monitoring with Holter 
• 
Remind subject of instructions on patient activated ambulatory monitoring equipment for 
monthly and symptomatic transmissions 
 
8.8.4. 
Twelve Month Visit 
• 
Review medications 
• 
Adverse event assessment 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
• 
12 lead ECG 
• 
24-hour continuous monitoring with Holter 
• 
Collect or ensure return of ambulatory monitoring equipment 
 
8.8.5. 
Unscheduled Office Visits 
An unscheduled visit is defined as any unplanned cardiovascular-related office visit or early study 
exit at the study center that occurs between CIP required visits. If the subject exits the study early, 
an unscheduled office visit should occur. The following information is required to be collected at 
unscheduled follow-up visits: 

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• 
Review medications 
• 
Adverse event assessment 
• 
Review symptoms suggestive of recurrent AF/AT/AFL 
• 
12 lead ECG 
 
8.8.6. 
Holter and Patient Activated Ambulatory ECG Monitoring 
Market-released Holters will be distributed by a core lab to centers after activation has occurred. 
All subjects will wear a Holter in conjunction with their 6 and 12 month visits. Holters will be sent to 
the core lab after they have been worn by the subject. The core lab will be responsible for 
adjudication of atrial arrhythmias. The core lab will manage maintenance, calibration and tracking of 
the Holters. 
Market-released Patient Activated Ambulatory ECG Monitors will be distributed by a core lab to 
centers after activation has occurred. All subjects will transmit monthly and symptomatic ECGs 
following their 3 month visit. The monitors will be returned to the core lab at the end of the study. 
The core lab will be responsible for adjudication of atrial arrhythmias. The core lab will manage 
maintenance, calibration and tracking of the monitors. 
 
8.8.7. 
12 Lead Electrocardiograms 
All 12 lead ECGs will be sent to the core lab. The core lab will be responsible for adjudication of 
atrial arrhythmias. Copies of additional source documents may be requested. 
 
8.9. 
Assessment of Safety 
The primary safety objective is based on the Adverse Event data collected. Further information on 
the collection of Adverse Events is discussed in Section 10. 
 
8.10. Recording Data 
The study will collect data using an electronic data management system for clinical studies. 
Centers will enter data onto case report forms (CRFs) within the electronic database. The 
Holter/Patient Ambulatory Monitoring/12-lead ECG core lab will also provide data in the electronic 
database. 
Data reported on the CRFs shall be derived from source documents, which may include 
worksheets, patient medical records and ECG data. These source documents must be maintained 
by the center personnel. Further detail on data management is provided in Section 14.2. 

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8.11. Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the CIP or the 
Clinical Trial Agreement. Prior approval by Medtronic is expected in situations where the 
Investigator anticipates, contemplates, or makes a conscious decision to deviate. If the deviation 
affects subject’s rights, safety and well-being, or the scientific integrity of the study, prior approval 
from IRB/REB/MEC may also be required, depending on local requirement. Prior approval is not 
required when a deviation is necessary to protect the safety, rights or well-being of a subject in an 
emergency or in unforeseen situations beyond the Investigator’s control (e.g. subject failure to 
attend scheduled follow-up visits, inadvertent loss of data due to computer malfunction, inability 
to perform required procedures due to subject illness). Subjects’ failure to submit ambulatory 
monitoring transmissions per the CIP does not require a deviation to be reported. Ambulatory 
monitoring transmission compliance will be tracked by Medtronic personnel and the Core Lab. 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going 
forward. This may also apply for other unforeseen situations (e.g. the subject permanently refuses 
to complete a study required procedure and the data will not contribute to the primary endpoint 
analysis). However, prior approval from Medtronic is required for such situations. 
All study deviations must be reported on the eCRF regardless of whether medically justifiable, pre- 
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an 
emergency. The deviation description must be recorded with an explanation for the deviation. 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the 
life or physical well-being of a subject in an emergency, the deviation must be reported to the 
IRB/REB/MEC as well as Medtronic within five (5) working days. Reporting of all other study 
deviations should comply with IRB/REB/MEC policies and/or local laws and must be reported to 
Medtronic as soon as possible upon the center becoming aware of the deviation. Reporting of 
deviations must comply with IRB/MEC policies, local laws, and/or regulatory agency requirements. 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. CIP amendment, conduct additional training, 
terminate the investigation). Repetitive or serious Investigator compliance issues may result in 
initiation of a corrective action plan with the Investigator and center, and in some cases, 
necessitate suspending enrollment until the problem is resolved or ultimately terminating the 
Investigator's participation in the study. Medtronic will provide center-specific reports to 
Investigators summarizing information on deviations that occurred at the investigational center on 
a periodic basis. 

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8.12. Subject Withdrawal or Discontinuation 
A subject can withdraw from the study at any time. If the subject wishes to exit early from the 
study, the center is required to document the reason for exit on an eCRF and in the subject’s 
medical record. In addition, centers shall follow the regulations set forth by their IRB/REB/MEC. 
It is recommended that Investigators follow the subject until all device and/or procedure-related 
adverse events are recovered / resolved or unresolved with no further actions planned. Following 
completion of the 12 month visit or early study exit, subjects will continue to receive standard 
medical care. All data available through the time of the subject’s exit will be used for analysis. 
Reasons for early study exit include: 
 
• 
Subject lost to follow-up 
• 
Subject did not meet inclusion/exclusion criteria after consent and did not undergo an 
ablation procedure 
• 
ArcticLine Catheter was not used during the subject’s ablation procedure 
• 
Subject did not provide consent or data use protection authorization 
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic 
location) 
• 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion 
criteria not met, failure of subject to maintain adequate study compliance) 
• 
The sponsor decides the study will be closed or a particular center will be closed. 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two 
attempts and the method of attempt (e.g., one letter and one phone record or two letters) to 
contact the subject must be recorded. 
An unscheduled office visit should be attempted if the subject exits the study outside of a 
scheduled follow-up visit. Subjects treated with the ArcticLine Catheter who exit from the study 
should continue to be followed by an electrophysiologist for follow-up of any potential adverse 
events at the recommended interval of 12 months from the index ArcticLine Catheter ablation 
procedure. 
For subjects who have not undergone treatment with the ArcticLine Catheter, a new subject may 
be enrolled to achieve the target sample size of N=30 treated subjects in the Study. 

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9.1. 
Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a 
product, from the business analysis phase through development, market release, and post-market 
surveillance. The ArcticLine Catheter has been examined and tested via modeling, bench, and pre- 
clinical animal testing and the residual risks associated with the ArcticLine Catheter have been 
found to be acceptable. These residual risks have been mitigated to the fullest extent possible 
through design, manufacturing, labeling and training. The potential benefits related to the use of 
the ArcticLine Catheter have been determined to outweigh any potential risks. 
There are potential risks and side effects associated with ablation procedures. The Investigator 
shall describe risks in further detail when asked by the subject. The ArcticLine Catheter has not 
been approved for use in any geography. Therefore, the risks must be continuously monitored, 
assessed and documented by the Investigator. Possible additional risks for participating in the 
study include the following (although others are possible) and are further defined in Appendix C: 
• 
Access site complications (e.g. 
bruising, ecchymosis) 
• 
Anemia 
• 
Arrhythmia (e.g. atrial flutter, 
bradycardia, heart block, tachycardia) 
• 
Back pain 
• 
Bleeding, possibly requiring 
transfusion 
• 
Bronchitis 
• 
Cardiac tamponade 
• 
Cardiopulmonary arrest 
• 
Catheter entrapment in cardiac 
structures requiring intervention 
• 
Cerebral vascular accident 
• 
Chest discomfort/pain/pressure 
• 
Cold feeling 
• 
Coronary artery spasm 
• 
Cough 
• 
Death 
• 
Diarrhea 
• 
Dizziness 
• 
Embolism 
• 
Esophageal damage (including 
atrioesophageal fistula) 
• 
Fatigue 
• 
Fever 
• 
Headache 
• 
Hemoptysis 
• 
Hypotension/hypertension 
• 
Infection (e.g. pericarditis, sepsis) 
• 
Lightheadedness 
• 
Myocardial infarction 
• 
Nausea/vomiting 
• 
Perforation 
• 
Pericardial effusion 
• 
Phrenic nerve injury 
• 
Pleural effusion 
• 
Pneumonia 
• 
Pneumothorax 
• 
Pseudoaneurysm 
• 
Pulmonary edema 
• 
Pulmonary vein stenosis 
9.  Risks and Benefits 

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• 
Shortness of breath 
• 
Sore throat 
• 
Transient ischemic attack 
• 
Vagal nerve injury (e.g. gastroparesis) 
• 
Valve damage with potential 
regurgitation 
• 
Vasovagal reaction 
• 
Visual changes 
 
9.2. 
Potential Benefits 
The ArcticLine Catheter, designed to create linear cardiac lesions which interrupt errant electrical 
signals, may reduce or eliminate persistent atrial fibrillation in subjects with confirmed pulmonary 
vein isolation; however, some subjects may not receive this benefit. Using ArcticLine to create 
linear lesions may result in shorter procedure times, and contain fewer gaps, than lines created 
with traditional point-by-point technology resulting in the possibility of less fluoroscopy and 
anesthesia exposure to subjects. Additionally, the ArcticLine Catheter may be an improved 
technology over RF ablation in creating lesions that are not only continuous but transmural and 
durable. 
Clinical benefit has not been demonstrated as this study is the first human use of the ArcticLine 
Catheter. The information gained from the study could result in improved management of atrial 
fibrillation. 
 
9.3. 
Risk-Benefit Rationale 
The cohort of subjects for inclusion in the study is symptomatic as a result of their persistent atrial 
fibrillation and the failure of Class I or III antiarrhythmic drug therapy. Alternatives to creation of 
linear lesions with the ArcticLine Catheter in this cohort includes pulmonary vein isolation alone or 
point-by-point linear ablation using RF technology. Investigation into the former with AFA is 
currently ongoing; the latter has not proven efficacy in this population, possibly due to the lack of 
durable transmural lesions15 and/or understanding of the underlying substrate18. 
Cryoablation therapy offers the opportunity to reduce the episodes of atrial fibrillation and 
therefore reduce the subject’s risk of stroke and symptoms. The use of the ArcticLine Catheter, a 
technology that can create a linear lesion with fewer applications, may reduce the potential for 
gaps through creation of a contiguous line. This may prevent recurrence of atrial fibrillation and 
typical atrial flutter as well as onset of new atrial tachycardia/atrial flutter. 
 
 
 
 
 
 
18 Zakeri, et al. The burden of proof: The current state of atrial fibrillation prevention and treatment trials. Heart 
Rhythm. 2017;14:763-782. 

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Increases in possible risks from the use of the ArcticLine Catheter when used in conjunction with 
the Arctic Front Advance Catheter include longer procedure times, more exposure to radiation 
through increased use of fluoroscopy, and increased left atrial dwell time. 
Results of this feasibility study are expected to be used to guide subsequent product development 
activities for the ArcticLine Catheter, including an eventual pivotal study; the goal of which is to 
confirm meaningful therapeutic benefit of the ArcticLine Catheter to create linear lesions. After 
careful review of the risks and benefits, the benefits are found to outweigh the risks and justify this 
investigation of the ArcticLine Catheter in this underserved population. 

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10.1. Definitions/Classifications 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects. Reporting and analysis of safety data are mandated by 
regulatory authorities worldwide. Medtronic has established procedures in conformity with 
worldwide regulatory requirements to ensure appropriate reporting of safety information. The 
study is conducted in accordance with these procedures and regulations. 
Since the safety reporting requirements and classification systems vary for each regulatory 
agency, requirements from all participating geographies are taken into account for the collection 
and reporting of safety information. 
 
10.2. Adverse Event and Device Deficiency Definitions 
Table 6:  Adverse Event and Device Deficiency Definitions 
 
General 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is 
restricted to events related to investigational medical 
devices. 
(ISO 14155:2011, 3.2) 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical 
device 
NOTE 1: This definition includes adverse events resulting 
from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from an 
error use or from intentional misuse of the investigational 
medical device. (ISO 14155:2011, 3.1) 
10. Adverse Events and Device Deficiencies 

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Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors 
and inadequate labeling (ISO 14155:2011, 3.15) 
Relatedness 
Procedure related 
An Adverse Event directly related to any portion of the 
procedure. 
System related 
An Adverse Event that results from the presence or 
performance (intended or otherwise) of the system (including 
the ArcticLine Catheter, CryoConsole, Arctic Front Advance, 
Freezor MAX, FlexCath Advance Sheath, Achieve Mapping 
Catheter, Manual Retraction Kit) 
Cardiovascular related 
An Adverse Event relating to the heart and the blood vessels 
or the circulation. 
Not Related 
Relationship to the device or procedures can be excluded 
when: 
▪ 
The event is not a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
▪ 
The event has no temporal relationship with the use 
of the device or the procedures; 
▪ 
The serious event does not follow a known response 
pattern to the medical device (if the response 
pattern is previously known) and is biologically 
implausible; 
▪ 
The discontinuation of medical device application or 
the reduction of the level of activation/exposure – 
when clinically feasible – and reintroduction of its use 
(or increase of the level of activation/exposure) do 
not impact the serious event; 
▪ 
The event involves a body-site or an organ not 
expected to be affected by the device or procedure; 
▪ 
The serious event can be attributed to another cause 
(e.g., an underlying or concurrent illness/clinical 
condition, an effect of another device, drug, 
treatment, or other risk factors); 
▪ 
The event does not depend on a false result given by 
the device used for diagnosis (when applicable); 
▪ 
Harms to the subject are not clearly due to use error; 

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▪ 
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 
event. 
Unlikely 
The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained by 
another cause, but additional information may be obtained. 
Possible 
The relationship with the use of the investigational device is 
weak but cannot be ruled out completely. Alternative causes 
are also possible (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or 
treatment). Cases were relatedness cannot be assessed or 
no information has been obtained should also be classified as 
possible. 
Probable 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably 
explained by another cause, but additional information may 
be obtained. 
Causal Relationship 
The event is associated with the device or study 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 device 
use/application or procedures; 
▪ 
The event involves a body-site or organ that the 
device or procedures are applied to or the device or 
procedures have an effect on; 
▪ 
The serious event follows a known response pattern 
to the medical device (if the response pattern is 
previously known); 
▪ 
The discontinuation of medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure) impact on the serious event 
(when clinically feasible); 
▪ 
Other possible causes (e.g., an underlying or 
concurrent illness/clinical condition or/and an effect 
of another device, drug, or treatment) have been 
adequately ruled out; 
▪ 
Harm to the subject is due to error in use; 

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▪ 
The event depends on a false result given by the 
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. 
Seriousness 
Serious Adverse Event (SAE) 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, 
that either resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, or 
3) in-patient or prolonged hospitalization (>24 hours), 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) led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
NOTE 1: Planned hospitalization for a pre-existing condition, 
or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event. 
(ISO 14155:2011, 3.37) 
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
(ISO 14155:2011, 3.36) 
Unanticipated Adverse Device Effect 
(UADE) 
Any serious adverse effect on health or safety or any life- 
threatening problem or death caused by, or associated with, 
an (investigational) device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of 
incidence in the CIP or applicable (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. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse 
Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current 
version of the risk analysis report. 
NOTE: Anticipated serious adverse device effect (ASADE) is 
an effect which by its nature, incidence, severity or outcome 
has been identified in the risk analysis report. (ISO 
14155:2011 3.42) 

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Other 
Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that is 
expected to occur in all subjects for a projected duration 
according to the Investigator’s opinion, including, but not 
limited to those provided below. These are not reportable 
AEs unless they occur after or last longer than the timeframe 
specified. If any other events below are classified as serious 
they must be reported as an adverse event. 
Event Description 
Timeframe 
(hours) from 
the Surgical 
Procedure 
Anesthesia related nausea / vomiting 
24 
Low-grade fever (<100°F or 37.8°C) 
48 
Mild to moderate bruising / ecchymosis in 
groin area / groin pain 
168 
Sleep problems (insomnia) 
72 
Back pain related to laying on table 
72 

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10.3. Reporting of Adverse Events, including Death 
For the purposes of the study, all Adverse Events will be collected starting at the time of signing the 
IC Form through the duration of the subject’s participation in the study. 
 
Reporting of these events to Medtronic will occur on an AE eCRF, including a description of AE, 
date of onset of AE, date of awareness of center, treatment, resolution, assessment of both the 
seriousness and the relatedness to the investigational device. Each AE must be recorded on a 
separate AE eCRF.  Exceptions include: 
• 
Documented pre-existing conditions are not considered AEs unless the nature or severity 
of the condition has worsened. Additionally, arrhythmia episodes that are not new or 
worsening conditions and for which no action is taken are not reportable as AEs. 
• 
Unavoidable Adverse Events, listed in Table 6: Adverse Event and Device Deficiency 
Definitions need not be reported unless the adverse event worsens or is present outside 
the stated timeframe after the ablation procedure. 
• 
Cardioversions (DC or Drug) for recurrent symptomatic atrial fibrillation and other atrial 
arrhythmias are not considered serious adverse events. 
Where the definition indicates “device”, it refers to any device used in the study. This might be the 
catheter, or any other component of the system under investigation, or any market-released 
component of the system. 
For any changes in status of a previously reported adverse event (i.e. change in actions taken, 
change in outcome, change in relatedness), an update to the original AE must be provided. All 
adverse events must be followed until the adverse event has been resolved, the subject exits the 
study or until study closure, whichever occurs first. 
At the time of study exit, all collected AEs with an outcome of “not recovered/not resolved”, 
“recovering/resolving” or “unknown” must be reviewed and updates provided as applicable. 
All reported adverse events will be reviewed by a Medtronic representative. AEs will be classified 
according to the definitions provided. 
Upon receipt of adverse events at Medtronic, a Medtronic representative will review the adverse 
event for completeness and accuracy and when necessary will request clarification and/or 
additional information from the Investigator. Medtronic will utilize MedDRA, the Medical Dictionary 
for Regulatory Activities, to assign a MedDRA term for each adverse event based on the 
information provided by the Investigator. 
Regulatory reporting of AEs that could have led to a SADE will be completed according to local 
regulatory requirements. Refer to Table 7 for a list of required Investigator and Medtronic reporting 

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requirements and timeframes. It is the responsibility of the Investigator to abide by any additional 
AE reporting requirements stipulated by the IRB/MEC responsible for oversight of the study. 
For a list of Foreseeable Adverse Event List (FAL), refer to Appendix C. This is a list of adverse 
events related to the ArcticLine Catheter or procedure that may be experienced by subjects. This 
list may help to assess if an adverse event is unexpected in nature. Additionally, refer to Appendix 
D, for expanded definitions on a subset of adverse events as they relate to endpoint assessment. 
For emergency contact regarding a SAE, contact a clinical study representative immediately (refer 
to the study sponsor per the sponsor contact information). 
Adverse Events and Deaths will be classified according to the standard definitions as outlined in 
Table 8. 
 
10.3.1. 
Subject Death 
All subject deaths must be reported by the Investigator to Medtronic on an adverse event eCRF (AE 
with outcome of fatal) as soon as possible after the Investigator first learns of the death. There 
should be one AE with the outcome of fatal. 
A copy of the death certificate, if available, and allowed by state/local law, should be sent to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary 
report and all relevant hospital records should be sent to the Medtronic clinical study team, if 
available. If an autopsy is conducted, the autopsy report should also be sent to the Medtronic 
clinical study team if available and allowed by state/local law. When the death occurs at a remote 
center, it is the investigative center’s responsibility to attempt retrieval of information about the 
death. In summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death 
• 
Relatedness to device and/or procedure 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and/or allowed by state/local law) 

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Sufficient information will be required in order to properly classify the subject’s death. The 
Investigator shall classify each subject death per the following definitions: 
• 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the 
heart. 
• 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss 
of consciousness within one hour of the onset of acute symptoms; preexisting heart 
disease may have been known to be present, but the time and mode of death are 
unexpected. If time of onset cannot be determined, SCD will alternatively be defined as any 
unexpected cardiac death occurring out of the hospital or in the emergency room as dead 
on arrival. 
• 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, 
including all cardiac deaths of hospitalized subjects on inotropic support. 
• 
Non-cardiac Death: A death not classified as a cardiac death. 
• 
Unknown Classification: Unknown death classification is intended for use only when there is 
insufficient or inadequate information to classify the death. 
 
The CEC will review deaths and provide a final adjudication of the primary cause of death and 
cardiac classification. Regulatory reporting of Subject Deaths will be completed according to local 
regulatory requirements. 
 
10.3.2. 
Adverse Event Reporting Requirements 
Regulatory reporting of AEs will be completed according to local regulatory requirements. Refer to 
Table 7 for a list of required investigator reporting requirements and timeframes, and of required 
Medtronic reporting requirements and timeframes. 
The investigator is required to report all SAEs to Medtronic immediately, and to the IRB/EC per 
local requirements. It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study. 
Additionally, Medtronic is required to report these events to the local regulatory authority based 
on their requirements. 
For AEs that require immediate reporting, initial reporting may be done by contacting the study 
sponsor per the sponsor contact information provided in this document. 

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Table 7: Adverse Event Reporting Requirements 
 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
All geographies: Immediately after the investigator first learns of the event or 
new information in relation with an already reported event. 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
Authorities 
All geographies: Submit per local reporting requirement. 
Sponsor submit to: 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
Authorities 
US: Submit no later than 7 calendar days after sponsor awareness 
All geographies: Submit per local reporting requirement. 
Serious Adverse Device Effects (SADEs) 
Investigator submit to: 
Medtronic 
All geographies: Submit as soon as possible after the Investigator first learns of the 
event, and per local requirements 
Canada: SADEs on the patient, the user or any other person must be reported to the 
Regulator and to the Sponsor within 72 hours after it comes to the attention of the 
qualified investigator. 
IRB/REB/MEC 
All geographies:  Submit per local reporting requirement. 
Regulatory 
authorities 
All geographies: Submit as soon as possible after the Investigator first learns of the 
event, and per local requirements 
Sponsor submit to: 
IRB/REB/MEC 
All geographies:  Submit per local reporting requirement. 
Regulatory 
authorities 
Canada: All SADEs on the patient, the user or any other person: these must be 
reported by Medtronic within 10 days from the date the first person becomes aware. 
Preliminary and final reporting to the Canadian Ministry of Health (Health Canada) of 
events occurring inside (always) or outside Canada (in case of corrective actions) 
that is related to a failure of the device or a deterioration in its effectiveness, or any 
inadequacy in its labeling or its directions for use and has led to the death or a 
serious deterioration in the state of health of a patient, user or other person or could 
do so were it to recur. Report a) within 10 days after awareness, if incident has led to 
death or a serious deterioration in the state of health of a patient, user or other 
person b) within 30 days, if incident has not led to death or a serious deterioration in 
the state of health of a patient, user or other person, but could do so were it to recur 
c) as soon as possible, if incident occurred outside of Canada and is related to a 
corrective action. (Medical Devices Regulation Mandatory Problem Reporting 59(1), 
59(2), 60 (1)) 
US:  Submit no later than 7 calendar days after sponsor awareness. 
Unanticipated Adverse Device Effects (UADEs) and Unanticipated Serious Adverse Device Effects 
(USADEs) 
Investigator submit to: 
Medtronic 
US: Submit as soon as possible, but no later than within 10 working days after the 
Investigator first learns of the event. (21 CFR 812.150(a)(1)) 

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Canada: USADEs on the patient, the user or any other person must be reported to 
the Regulator and to the Sponsor within 72 hours after it comes to the attention of 
the qualified investigator. 
IRB/REB/MEC 
US: Submit as soon as possible, but no later than within 10 working days after the 
Investigator first learns of the event. (21 CFR 812.150(a)(1)) 
All geographies: Submit per local reporting requirement. 
Sponsor submit to 
Investigator 
All geographies: Notification as soon as possible and not later than 10 working days 
after the sponsor first learns of the effect. (21 CFR 812.150(b)(1)) 
IRB/REB/MEC 
All geographies: Notification as soon as possible and not later than 10 working days 
after the sponsor first learns of the effect. (21 CFR 812.150(b)(1)) 
Regulatory 
authorities 
US: Notification as soon as possible to FDA, but not later than 10 working days after 
the sponsor first learns of the effect. (21 CFR 812.150(b)(1)) 
Canada: All USADEs on the patient, the user or any other person; these must be 
reported by Medtronic within 10 days from the first person at Medtronic that 
becomes aware. Preliminary and final reporting to the Canadian Ministry of Health 
(Health Canada) of events occurring inside (always) or outside Canada (in case of 
corrective actions) that is related to a failure of the device or a deterioration in its 
effectiveness, or any inadequacy in its labeling or its directions for use and has led to 
the death or a serious deterioration in the state of health of a patient, user or other 
person or could do so were it to recur. Report a) within 10 days after awareness, if 
incident has led to death or a serious deterioration in the state of health of a patient, 
user or other person b) within 30 days, if incident has not led to death or a serious 
deterioration in the state of health of a patient, user or other person, but could do so 
were it to recur c) as soon as possible, if incident occurred outside of Canada and is 
related to a corrective action. (Canada Medical Devices Regulations, SOR/98-282; 
Mandatory Problem Reporting 59(1), 59(2), 60 (1)) 
Adverse Device Effects 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the Investigator first learns of the 
effect. 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
authorities 
All geographies: Submit per local reporting requirement. 
Sponsor submit to: 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
authorities 
All geographies: Submit per local reporting requirement. 
All other reportable Adverse Events 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the Investigator first learns of the 
event. 
Regulatory 
authorities 
All geographies: Submit per local reporting requirement. 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Sponsor submit to: 

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Regulatory 
authorities 
US: After every five subjects reach the one (1) week follow-up visit, submit a report 
summarizing all SAEs, and ArcticLine procedure related and/or ArcticLine Catheter 
related AEs. 
All other geographies: Submit per local reporting requirement. 
 
 
Table 8:  Adverse Event Classification Responsibilities 
 
What is classified? Who classifies? Classification Parameters 
Relatedness 
Investigator 
Procedure related, System related, Cardiovascular 
related 
Sponsor 
Procedure related, System related 
Seriousness 
Investigator 
SAE 
Sponsor 
SAE, UADE/USADE, Device Deficiency with SADE 
potential 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided 
by Investigator 
Death 
Classification 
Investigator 
Sudden Cardiac, Non-Sudden Cardiac, Non-Cardiac, 
Unknown 

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10.4. Reporting of Device Deficiencies 
Device deficiency (DD) information will be collected throughout the study and are to be reported to 
Medtronic, as per Table 9: Device Deficiency Reporting Requirements. A Medtronic representative 
will review the device deficiency for completeness and accuracy and when necessary will request 
clarification and/or additional information from the Investigator. Note that device deficiencies that 
result in an adverse device effect (ADE) to the subject should be captured as an Adverse Event 
only. 
Device deficiencies that did not lead to an AE, but could have led to a Serious Adverse Device Effect 
(SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting. For device deficiencies that 
require immediate reporting, initial reporting may be done by contacting the study sponsor per the 
sponsor contact information. 
 
Table 9: Device Deficiency Reporting Requirements 
 
Device Deficiencies and SADE Potential 
Investigator submit to: 
Medtronic 
All geographies: Report, without unjustified delay, all device deficiencies that could 
have led to a serious adverse device effect 
Regulatory 
authorities 
All geographies:  Submit per local reporting requirement. 
IRB/REB/MEC 
All geographies:  Submit per local reporting requirement. 
Sponsor submit to: 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
authorities 
Canada:  Any Device Deficiency that: 
• 
has resulted in any of the consequences characteristic of an SAE on the 
patient, the user or any other person; These must be reported by Medtronic 
within 10 days from the date Medtronic becomes aware. 
or 
• 
could do so were it to reoccur. These must be reported by Medtronic within 
30 days from the date Medtronic becomes aware. 
Preliminary and final reporting to the Canadian Ministry of Health (Health Canada) of 
events occurring inside (always) or outside Canada (in case of corrective actions) 
that is related to a failure of the device or a deterioration in its effectiveness, or any 
inadequacy in its labeling or its directions for use and has led to the death or a 
serious deterioration in the state of health of a patient, user or other person or could 
do so were it to recur. Report a) within 10 days after awareness, if incident has led to 
death or a serious deterioration in the state of health of a patient, user or other 
person b) within 30 days, if incident has not led to death or a serious deterioration in 
the state of health of a patient, user or other person, but could do so were it to recur 
c) as soon as possible, if incident occurred outside of Canada and is related to a 
corrective action. (Canada Medical Devices Regulations, SOR/98-282; Mandatory 
Problem Reporting 59(1), 59(2), 60 (1)). 

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All geographies: Submit per local reporting requirement. 
All Other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the Investigator first learns of the 
event. 
IRB/REB/MEC 
All geographies: Submit per local reporting requirement. 
Regulatory 
authorities 
All geographies: Submit per local reporting requirement. 
 
 
10.5. Reporting of Product Complaints 
In geographies where devices are market-released, product complaint reporting is applicable. This 
includes when an AE is related to a market-released device during the study. The reporting of 
product complaints is not part of the Study and should be done in addition to the Adverse Event 
reporting requirements. Refer to local regulations for reporting requirements. 
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related 
to the identity, quality, durability, reliability, safety, effectiveness or performance of a medical 
device that has been placed on the market. 
It is the responsibility of the Investigator to report all product complaint(s) associated with a 
market-released medical device distributed by Medtronic, regardless whether they are related to 
intended use, misuse or abuse of the product. Reporting must be performed immediately and via 
the regular channels for market-released products. 
Medtronic will notify the regulatory authorities (e.g. FDA, Health Canada) as applicable for the 
following incidents immediately upon learning of them: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as 
well as any inadequacy in the labeling or instructions for use which led or might have led to 
the death or serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
A serious deterioration in the state of heath includes: 
o Life-threatening illness or injury 
o Permanent impairment of a body function or permanent damage to a body 
structure 
o A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 

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An independent Clinical Events Committee (CEC) will review and adjudicate all adverse events as 
well as all deaths for subjects participating in the study. 
The CEC will consist of a minimum of three (3) non-Medtronic employed physicians that are not 
participating Investigators for the study, including a CEC chairperson. Medtronic personnel may 
facilitate and participate in a CEC meeting but will be non-voting members. 
For adverse events and deaths reviewed by the CEC, Medtronic will provide the CEC with the 
Investigator’s description and classification. The CEC is responsible for reviewing the 
Investigator’s assessment and supportive documentation (when available), reviewing applicable 
definitions, and determining final classifications for all adjudication parameters. Additionally, the 
CEC will provide an adjudication of the death classification for all reported deaths including primary 
cause of death and cardiac classification. 
If the CEC disagrees with the Investigator’s classification of the event, the rationale will be 
provided to the Investigator. If the Investigator agrees with the CEC’s adjudication, the eCRF 
documenting the event will be updated accordingly. 
If the Investigator does not agree with the CEC’s adjudication classification, both determinations 
will be provided within the final report; however, the CEC’s adjudication will be used for data 
analysis. The disagreement will also be included in reporting to IRB/REB/MECs and regulatory 
authorities, if required. 
11. Clinical Events Committee 

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A separate Statistical Analysis Plan (SAP) will be developed to further describe statistical methods, 
pre-specified data handling rules, and pre-specified analyses that will be included in study reports. 
Any deviation from the pre-specified statistical analyses will be noted in the study report. 
Additional exploratory analyses of the data may be conducted as deemed appropriate. 
 
As this is a feasibility study, analysis of accruing data will be allowed. Analyses are planned at the 
following time points (though only select objectives may be analyzed at the first 2 analyses): 
• 
After completion of the first 15 subject index procedures and 1 week follow-up visit 
• 
After completion of all 30 subject index procedures and 1 week follow-up visit 
• 
After completion of all subject follow-up visits through 12 month follow-up visit 
12. Statistical Design and Methods 

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12.1. Primary Objective 
Estimate the incidence of ArcticLine Catheter-related and ArcticLine cryoablation procedure- 
related serious adverse events (SAEs) with an onset date within 7 days post-procedure. 
Endpoint Definition 
 
ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAEs, with an onset date 
within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events 
Committee (CEC), described as follows: 
• 
Atrioesophageal fistula* 
* Includes atrioesophageal fistula with an onset date at any time after the study 
cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter- 
related or ArcticLine cryoablation procedure-related. 
• 
Cardiac perforation/tamponade 
• 
Cerebrovascular accident 
• 
Death 
• 
Esophageal injury 
• 
Major bleeding 
• 
Myocardial infarction 
• 
Pericarditis 
• 
Phrenic nerve injury (ongoing at hospital discharge) 
• 
Transient ischemic attack 
• 
Vagal nerve injury resulting in esophageal dysmotility or gastroparesis 
• 
Vascular access complications 
 
Sample Size 
 
The sample size of 30 treated subjects for this study was chosen with the goal to collect 
preliminary safety and effectiveness data on the ArcticLine Catheter’s use in both the left and right 
atrium. Assuming there are 30 ArcticLine cryoablation procedures in the study and the SAE rate is 
3.3% (1/30 subjects: the rate of cryoablation procedure events in the STOP AF pivotal trial [PMA 
#P100010] was 3.1%), the exact 95% confidence interval will have a width of 17%. 
 
Analysis Methods 
 
The percentage of catheter related and cryoablation procedure related SAEs will be calculated as 
the number of procedures with at least one SAE meeting the endpoint definition divided by the 
number of cryoablation procedures. Each procedure will count, so subjects with repeat 

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cryoablations will contribute more than once to the denominator. Exact methods will be used to 
construct a 95% confidence interval for the percentage of procedures with an SAE. 
Determination of Patients for Analysis 
 
All ArcticLine cryoablation procedures will be included. An ArcticLine cryoablation procedure is 
considered to have occurred once the ArcticLine Catheter is introduced into the vasculature. 

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12.2. Ancillary Objective #1 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the left atrial roof and posterior wall in patients with demonstrated entrance block of all pulmonary 
veins and who underwent roof and posterior wall ablation with ArcticLine. 
Endpoint Definition 
 
Subjects must have confirmed block at the roof line and posterior wall line (“roof/wall”) via 
periprocedural assessment of posterior wall isolation at the completion of the cryoablation 
procedure to be considered an acute treatment success. 
Analysis Methods 
 
The percentage of acute roof/wall treatment successes will be calculated as the number of 
roof/wall procedures achieving success divided by the number of index ArcticLine cryoablation 
procedures where the roof/wall was attempted. Exact methods will be used to construct a 95% 
confidence interval for the percentage. 
Determination of Patients for Analysis 
 
All subjects undergoing an ArcticLine cryoablation procedure of the roof/wall will be included. An 
ArcticLine cryoablation procedure of the roof/wall is considered to have occurred once an 
ArcticLine cryoapplication at the roof and/or wall begins. Only the first ArcticLine cryoablation 
procedure of the roof/wall per subject will be included. 

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12.3. Ancillary Objective #2 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the mitral isthmus in patients who underwent mitral isthmus ablation with ArcticLine. 
Endpoint Definition 
 
Subjects must have confirmed bi-directional conduction block at the mitral isthmus line via 
periprocedural assessment at the completion of the cryoablation procedure to be considered an 
acute treatment success. 
Analysis Methods 
 
The percentage of acute mitral isthmus line treatment successes will be calculated as the number 
of mitral isthmus line procedures achieving success divided by the number of index ArcticLine 
cryoablation procedures where the mitral isthmus line was attempted. Exact methods will be used 
to construct a 95% confidence interval for the percentage. 
Determination of Patients for Analysis 
 
All subjects undergoing an ArcticLine cryoablation procedure of the mitral isthmus will be included. 
An ArcticLine cryoablation procedure of the mitral isthmus is considered to have occurred once an 
ArcticLine cryoapplication at the mitral isthmus begins. Only the first ArcticLine cryoablation 
procedure of the mitral isthmus per subject will be included. 

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12.4. Ancillary Objective #3 
Estimate the percentage of patients with acute treatment success of the ArcticLine Catheter at 
the CTI in patients who underwent CTI ablation with ArcticLine. 
Endpoint Definition 
 
Subjects must have confirmed bi-directional conduction block at the CTI line via periprocedural 
assessment at the completion of the cryoablation procedure to be considered an acute treatment 
success. 
Analysis Methods 
 
The percentage of acute CTI line treatment successes will be calculated as the number of CTI line 
procedures achieving success divided by the number of index ArcticLine cryoablation procedures 
where the CTI line was attempted. Exact methods will be used to construct a 95% confidence 
interval for the percentage. 
Determination of Patients for Analysis 
 
All subjects undergoing an ArcticLine cryoablation procedure of the CTI will be included. An 
ArcticLine cryoablation procedure of the CTI is considered to have occurred once an ArcticLine 
cryoapplication at the CTI begins. Only the first ArcticLine cryoablation procedure of the CTI per 
subject will be included. 

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12.5. Ancillary Objective #4 
Characterize chronic treatment success of the ArcticLine Catheter in patients with demonstrated 
entrance block of all pulmonary veins. 
Endpoint Definition 
 
AF/AFL/AT episodes of at least 30 seconds duration from the end of the 90 day blanking period 
through the 12 month visit. Per section 8.6.1, the initiation of a new Class I or III antiarrhythmic 
medication or a Class I or III antiarrhythmic medication dose increase after the blanking period will 
be considered a chronic treatment failure. 
Analysis Methods 
 
Standard statistics will be used to summarize the percentage of patients without AF/AFL/AT and 
cumulative time spent in AF/AFL/AT as collected from the 6 month and 12 month Holter data. 
Determination of Patients for Analysis 
 
• 
All subjects undergoing an ArcticLine cryoablation procedure and who meet the following 
criteria will be included in the analysis: 
• 
Confirmed acute entrance block of all pulmonary veins 
• 
Confirmed acute posterior wall isolation (i.e. roof line and posterior wall line conduction 
block) 
• 
Confirmed acute bi-directional conduction block at the mitral isthmus, if applicable 
• 
Available 6 month and 12 month Holter data 
• 
Note: An ArcticLine cryoablation procedure is considered to have occurred once the 
ArcticLine Catheter is introduced into the vasculature. 
• 
Note: For subjects who did not receive CTI ablation with ArcticLine Catheter, documented 
occurrence and treatment of typical right-sided cavotricuspid isthmus dependent atrial 
flutter during follow-up will not contribute to this endpoint. 

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12.6. Ancillary Objective #5 
Estimate the incidence of ArcticLine Catheter-related and ArcticLine cryoablation procedure- 
related serious adverse events (SAE) through the 12 month visit. 
Endpoint Definition 
 
ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAEs, as adjudicated by 
the Clinical Events Committee (CEC). 
Analysis Methods 
 
Kaplan-Meier methods will be used to estimate event percentages separately for each of the 
events listed above. Time 0 will be the time of the index ablation and subjects without an event will 
be censored at their last documented time in the study (e.g., follow-up, exit, death). Though 
Kaplan-Meier methods will be used, only point estimates for the rates at 12 months (not graphs) 
will be reported. 
Determination of Patients for Analysis 
 
All subjects undergoing an ArcticLine cryoablation procedure will be included. An ArcticLine 
cryoablation procedure is considered to have occurred once the ArcticLine Catheter is introduced 
into the vasculature. 

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12.7. Ancillary Objective #6 
Characterize procedural data: 
• 
Total procedure time 
• 
Total ArcticLine Catheter use time 
• 
Left atrial dwell time 
• 
Total fluoroscopy time 
• 
Total fluoroscopy time during ArcticLine Catheter use 
• 
Application duration 
• 
Number of applications 
• 
Fluoroscopy dose 
Endpoint Definition 
 
• 
Total procedure time is defined as time from first venous access to time of last catheter 
removal. 
• 
Total ArcticLine Catheter use time is defined as cumulative time from each introduction of 
ArcticLine Catheter into the body to its removal. 
• 
Left atrial dwell time is defined as time from transseptal puncture to time of removal of last 
sheath/catheter from the left atrium. 
• 
Total fluoroscopy time is defined as total fluoroscopy time used during the procedure. 
• 
Total fluoroscopy time during ArcticLine Catheter use is defined as the cumulative 
fluoroscopy time from each introduction of ArcticLine Catheter into the body to its 
removal. 
• 
Application duration is defined as total duration in which cryoablation from the ArcticLine 
Catheter is applied to cardiac tissue overall and individually to each target area. 
• 
Number of applications is defined as the total number of times in which the ArcticLine 
Catheter was used to ablate cardiac tissue overall and individually to each target area. 
• 
Total fluoroscopy dose is defined as the amount of radiation deposited into the tissue, 
measured in Gy or mGy units. 
Analysis Methods 
 
Standard statistics (e.g., mean, standard deviation) will be used to summarize each variable. Data 
from index cryoablations and repeat cryoablations will be reported separately. 

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Determination of Patients for Analysis 
 
All subjects undergoing a cryoablation procedure will be included. A cryoablation procedure is 
considered to have occurred once the skin is punctured. 

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12.8. Ancillary Objective #7 
Estimate the incidence of adverse events (AEs) through the 12 month visit. 
 
Endpoint Definition 
 
Characterize adverse events through the 12 month visit, described as follows: 
 
• 
Atrioesophageal fistula 
• 
Cardiac perforation/tamponade 
• 
Cerebrovascular accident 
• 
Coronary artery spasm 
• 
Death 
• 
Esophageal injury 
• 
Lung injury (including hemoptysis) 
• 
Major bleeding 
• 
Myocardial infarction 
• 
Pericarditis 
• 
Phrenic nerve injury (ongoing from hospital discharge) 
• 
Pulmonary vein stenosis 
• 
Symptomatic persistent iatrogenic atrial septal defect 
• 
Transient ischemic attack 
• 
Vagal nerve injury 
• 
Vascular access complications 
Analysis Methods 
 
Kaplan-Meier methods will be used to estimate event percentages. Time 0 will be the time of the 
index ablation and subjects without an event will be censored at their last documented time in the 
study (e.g., follow-up, exit, death). Though Kaplan-Meier methods will be used, only point 
estimates for the percentages at 12 months (not graphs) will be reported. 
Determination of Patients for Analysis 
 
All subjects undergoing an ArcticLine cryoablation procedure will be included. A cryoablation 
procedure is considered to have occurred once the skin is punctured. 

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13.1.    Statement(s) of Compliance 
The study will be conducted in compliance with international ethical and scientific quality 
standards, known as good clinical practice (GCP). GCP includes review and approval by an 
independent IRB/REB/MEC before initiating a study, continuing review of an ongoing study by an 
IRB/REB/MEC, and obtaining and documenting the freely given informed consent of a subject 
before initiating the study. 
The study will be conducted according to federal, national and local laws, regulations, standards, 
and requirements of the countries/geographies where the study is being conducted. For all 
geographies, the principles of the Declaration of Helsinki have been implemented through the 
patient informed consent (IC) process, IRB/REB/MEC approval, study training, clinical trial 
registration, preclinical testing, risk-benefit assessment and publication policy. 
All geographies will follow and comply with: 
 
• 
Principles of Declaration of Helsinki (including privacy and data protection laws), or the laws 
and regulations of each participating country, whichever affords greater protection for the 
study subjects 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) 
• 
The procedures described within this CIP 
• 
Local IRB/REB/MEC requirements 
All participating geographies will make study data available to the regulatory body such as FDA or 
Health Canada if the regulatory body deems an onsite inspection necessary. The regulatory body 
will be able to inspect records at clinical centers around the world to resolve any uncertainties 
about whether the study was conducted in accordance with good clinical practice. 
In addition to the regulatory requirements outlined above, the study will be conducted in 
compliance with relevant local laws. These include but are not limited to: 
• 
In Canada, the Medical Devices Regulations, 1998 (SOR/98-282), 59(1), 59(2), 60(1), and the 
Canadian Regulatory Guidelines for Mandatory Medical Device Problem Reporting for 
Medical Devices, 2011. 
• 
Declaration of Helsinki 2013 
• 
In the United States and Canada, US FDA 21 CFR Parts 
o 50: Protection of Human Subjects 
o 56: Institutional Review Boards 
o 812: Investigational Device Exemptions 
13. Ethics 

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The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and 
Drug Administration Amendments Act (FDAAA) and Declaration of Helsinki on 
http://clinicaltrials.gov (PL 110-85, Section 810(a)). 
Approval of the Clinical Investigation Plan (CIP) is required from the following groups prior to any 
study procedures at a study center: 
• 
Health Canada or FDA 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
An independent IRB/REB/MEC 

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14.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study. Trained 
Medtronic personnel or delegates appointed by Medtronic may perform study monitoring at the 
study center to ensure that the study is conducted in accordance with the CIP, the Clinical Trial 
Agreement, and applicable regulatory and local requirements. Medtronic, or delegates, must 
therefore be allowed access to the subjects’ case histories (clinic and hospital records, and other 
source data/documentation) upon request as per the IC Form, Research Authorization (where 
applicable) and Clinical Trial Agreement. The Principal Investigator should also be available during 
monitoring visits. 
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring 
visits and any suspected inconsistency in data that requires investigation. Regulatory documents 
may be reviewed at each study center. Monitoring for the study may include, but not limited to, site 
qualification visits, site initiation visits, interim monitoring visits, and closeout visits, will be done in 
accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess center study progress, the Investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/REB/MEC approval 
and review of the study, maintenance of records and reports, and review of source documents 
against subject eCRFs. Monitors review center regulatory and study compliance by identifying 
findings of non-compliance and communicating those findings along with recommendations for 
preventative/corrective actions to center personnel. Monitors may work with study personnel to 
determine appropriate corrective action recommendations and to identify trends within the study 
or at a center. 
 
14.2. Data Management 
Data will be collected using an electronic data management system for clinical studies. eCRF data 
will be stored in a secure, password-protected database which will be backed up nightly. Data will 
be reviewed using programmed and manual data checks. Data queries will be made available to 
centers for resolution. 
Data collected by Holters, Patient Activated Ambulatory Monitors and ECGs will be managed and 
over-read by a core lab. Final classification of recurrent AF/AT/AFL will be stored in the study 
database. 
14. Study Administration 

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Study management reports may be generated to assess data quality and study progress. At the 
end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
All records and other information about subjects participating in the study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form, unless it’s impossible to make it anonymous, for instance, where 
the subject’s name cannot be removed from the data carrier, such as fluoroscopy images. In the 
case that de-identifying is impossible or involves a disproportionate effort, files containing 
personal data of subjects shall only be made accessible to authorized persons (secured role-based 
access). 
Procedures in the CIP require source documentation. Source documentation will be maintained at 
the center. Source documents, which may include worksheets, subject medical records, console 
files, must be created and maintained by the investigational center team. 
The data reported on the eCRFs shall be derived from source documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing. The eCRF may be 
considered source for the following data collection elements: 
• 
Database generated subject reference ID 
• 
Esophageal temperature 
• 
Investigator assessment of adverse event or death relatedness and severity 
• 
Date center became aware of the adverse event, device deficiency or death 
• 
Reason for study deviation 
• 
If Arctic Front Advance and Achieve/Achieve Advance is used, time of isolation of the 
cryoablation catheter 
• 
Investigator’s assessment of conduction block 
When copies or print-outs of the source documents are made, center personnel must ensure that 
all copies or printouts of the original source documents are certified copies. 
The sponsor or a regulatory authority may audit or inspect the study center to evaluate the 
conduct of the study. The clinical Investigator(s)/institution(s) shall allow study related monitoring, 
audits, IRB/REB/MEC review and regulatory inspection by providing direct access to source 
data/documents. 

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14.3. Confidentiality 
All records and other information about subjects participating in the study will be treated as 
confidential. 
 
14.4. Liability 
If used, warranty information is provided in the product packaging for the AFA, Freezor MAX and 
sheath devices. 
Canada: Medtronic of Canada is a wholly owned subsidiary of Medtronic, Inc., which as the parent 
company of such entity maintains appropriate general liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable local law and custom 
concerning specific insurance coverage. If required, a General Liability insurance 
statement/certificate will be provided to the REB/MEC. 
US: Medtronic Inc. maintains appropriate clinical study liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable law and custom concerning 
specific insurance coverage. If required, a Clinical Trial Insurance statement/certificate will be 
provided to the IRB. 
The study is conducted in multiple countries; therefore, reimbursement and indemnification will be 
addressed on a country specific basis in the study documents and center Clinical Trial Agreements. 
 
14.5. CIP Amendments 
Approval of subsequent revisions to the CIP is required at each study center from the following 
groups prior to implementation of the revised CIP at the center: 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent IRB/REB/MEC 
 
If a CIP amendment occurs, center personnel will need to be re-trained as necessary, and will need 
to submit any changes to their IRB/REB/MEC as required by the committee. 

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14.6. Record Retention and Reports 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in stored in secured file cabinets at 
Medtronic during the course of this study. After closure of the study Medtronic will archive records 
and reports indefinitely. 
Investigator Records 
The Investigator is responsible for the preparation and retention of the records cited below. All the 
below records, except for case history records and eCRFs, should be kept in the Investigator Site 
File (i.e., the study binder provided to the Investigator) or Subject Study Binder. CRFs must be 
maintained and signed electronically within the electronic data capture system during the study. 
The following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after the date on which the investigation is 
terminated or the date that the records are no longer required for purposes of supporting a pre- 
market approval application: 
• 
All correspondence between the IRB/REB/MEC, sponsor, monitor, local regulatory 
agencies and the Investigator that pertains to the investigation, including required reports 
• 
Subject’s case history records, including: 
• 
IC Form signed and dated by subject 
• 
Observations of adverse events and device deficiencies 
• 
Medical history 
• 
Procedure and follow-up data 
• 
Documentation of the dates and rationale for any deviation from the CIP 
• 
Reports of adverse events 
• 
Subject screening logs (if used) 
• 
List of investigation centers 
• 
Financial disclosure of Investigators 
• 
Device Disposition Logs 
• 
All approved versions of the CIP, IC, and Investigator’s Brochure/Report of Prior 
Investigations 
• 
Signed and dated Clinical Trial Agreement and Investigator Statement 
• 
Current curriculum vitae of Investigators 
• 
Documentation of delegated tasks 
• 
IRB/REB/MEC approval documentation. Written information that the Investigator or other 
study staff, when member of the IRB/REB/MEC, did not participate in the approval process. 

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Approval documentation must include the IRB/REB/MEC composition, where required per 
local law. 
• 
Regulatory authority notification, correspondence and approval, where required per local 
law 
• 
Study training records for center staff 
• 
Insurance certificates (where requested by the IRB/REB/MEC) 
• 
Any other records that FDA and local regulatory agencies require to be maintained 
• 
Final Study Report including the statistical analysis 
 
Investigator Reports 
The Investigator is responsible for the preparation (review and signature) and submission to the 
sponsor of all case report forms, adverse events, device deficiencies, deaths, and any deviations 
from the clinical investigation plan. If any action is taken by an IRB/EC with respect to this clinical 
study, copies of all pertinent documentation must be forwarded to Medtronic in a timely manner. 
Reports are subject to inspection and to the retention requirements as described above for 
investigator records. 
The investigator shall prepare and submit in a complete, accurate and timely manner the reports 
listed in this section. 

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Table 10: Investigator reports applicable for all geographies per Medtronic requirements 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of 
IRB/EC approval 
Sponsor and 
Relevant 
authorities 
The Investigator must report a withdrawal of 
approval by the reviewing IRB/EC of the 
Investigator’s part of the investigation within 5 
working days. 
Study deviations Sponsor and 
IRB/EC 
Any deviation from the clinical investigation plan 
shall be recorded together with the explanation of 
the deviation.  Notice of deviations from the CIP 
to protect the life or physical wellbeing of a 
subject in an emergency shall be given as soon as 
possible, but no later than 5 working days after 
the emergency occurred. Except in such 
emergency, prior approval is required for changes 
in the plan or deviations. 
Final report 
Sponsor, 
IRBs/ECs, and 
Relevant 
Authorities 
This report must be submitted within 3 months of 
study completion or termination. 
Refer to Section 10 for adverse event, complaint, and device deficiency reporting. 

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Table 11: Additional Investigator reports applicable to the United States 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of 
IRB/EC approval Sponsor 
The Investigator must report a withdrawal of 
approval by the reviewing IRB/EC of the 
Investigator’s part of the investigation within 5 
working days.  (21 CRF 812.150 (a)(2)). 
Progress report 
Sponsor and 
IRB/EC 
The Investigator must submit this report to the 
sponsor and IRB at regular intervals, but in no 
event less than yearly. (21 CFR 812.150 (a)(3)). 
Study deviations Sponsor and 
IRB/EC 
Notice of deviations from the clinical investigation 
plan to protect the life or physical wellbeing of a 
subject in an emergency shall be given as soon as 
possible, but no later than 5 working days after 
the emergency occurred. Except in such 
emergency, prior approval is required for changes 
in the plan or deviations. If the deviation may 
affect the scientific soundness of the plan or the 
rights, safety and welfare of the subjects, the 
deviation must be approved by Medtronic, the 
IRB/EC, and the FDA/applicable regulatory 
authorities. If the deviation does not affect these 
issues then only Medtronic must approve it. (21 
CFR 812.150(a)(4)) 
Failure to obtain 
Informed 
Consent Form 
prior to 
investigational 
device use 
Sponsor and 
IRBs/ECs 
If an Investigator uses a device without obtaining 
a signed Informed Consent Form, the Investigator 
shall report such use within 5 working days after 
device use.  (21 CFR 812.150(a)(5)) 
Final report 
Sponsor, 
IRBs/ECs, and 
Relevant 
Authorities 
This report must be submitted within 3 months of 
study completion or termination of the 
investigation or the Investigator’s part of the 
investigation.  (21 CFR 812.150(a)(6)) 

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Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records: 
• 
All correspondence which pertains to the investigation 
• 
Signed Investigator Trial Agreements, financialdisclosureofInvestigators,andcurrent 
signedanddated(Europeonly)curriculum vitae of Principal Investigator and key 
members of the investigator center team (as required by local law), and Delegated 
Tasks List 
• 
All approved versions of the ICF, and other information provided to the subjects 
and advertisements, including translations. 
• 
All approved versions of the Clinical Investigation Plan and study related reports, 
Investigator’s Brochure/Report of Prior Investigation Summary 
• 
All case report forms and supporting documentation submitted by investigator, 
samples of Informed Consent Forms, and other information provided to the subjects 
• 
Copies of all IRB/EC approval letters and relevant IRB/EC correspondence and 
IRB/EC voting list/roster/letter of assurance 
• 
Names of the institutions in which the clinical investigation will be  conducted 
• 
Regulatory authorities correspondence, notification and approval, as required by national 
legislation 
• 
Insurance certificates 
• 
Names/contact addresses of monitors 
• 
Monitoring visit reports and follow-up letters 
• 
Forms for reporting any adverse events and adverse device effects 
• 
Statistical analyses and underlying supporting data. 
• 
Final report of the clinical investigation 
• 
Study training records for center personnel and Medtronic personnel involved in the 
study 
• 
Any other records that local regulatory agencies require to be maintained 
 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in 
the table below. In addition to the reports listed below, Medtronic shall, upon request of reviewing 
IRB/EC, regulatory agency or FDA, provide accurate, complete and current information about any 
aspect of the investigation. Safety data reporting requirements are listed in the adverse event 
section. 

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Table 12: Sponsor reports for the United States 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of 
IRB/EC approval 
Investigators, 
IRB/EC, 
FDA, and 
relevant 
authorities 
Notification within five working days. (21 CFR 
812.150(b)(2)) 
Withdrawal of 
FDA approval 
Investigators, 
IRB/EC, and 
relevant 
authorities 
Notification within 5 working days. (21 CFR 
812.150(b)(3)) 
Investigator List FDA 
Submit at 6-month intervals, a current list of the 
names and addresses of all Investigators 
participating in the investigation. (21 CFR 
812.150(b)(4)) 
Progress Reports IRB/EC and 
FDA 
Progress reports will be submitted at least 
annually.  (21 CFR 812.150(b)(5), 812.36(f) 
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
IRB/EC, 
relevant 
authorities, 
and 
FDA 
Notification within 30 working days and will 
include the reasons for any request that an 
Investigator return, repair, or otherwise dispose 
of any devices.  (21 CFR 812.150(b)(6)) 
Failure to obtain 
Informed 
Consent Form 
FDA 
Investigator’s report will be submitted to FDA 
within five working days of notification. (21 CFR 
812.150(b)(8)) 
Final report 
Investigators, 
IRB/EC, 
Regulatory 
authorities 
upon request, 
and FDA 
Medtronic will notify FDA within 30 working days 
of the completion or termination of the 
investigation. A final report will be submitted to 
the FDA, investigators, and IRBs within 6 months 
after completion or termination of this study. (21 
CFR 812.150(b)(7)) 

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Report 
Submit to 
Description/Constraints 
Study deviation 
Investigators 
Ensure that all deviations from the clinical 
investigation plan are reviewed with the 
appropriate clinical investigator(s), are reported 
on the case report forms and the final report of 
the clinical investigation. 
Site specific study deviations will be submitted to 
investigators periodically. 
Other 
IRB/EC, and 
FDA 
Accurate, complete, and current information 
about any aspect of the investigation. (21 CFR 
812.150(b)(10)) 

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Table 13: Sponsor reports for Canada 
 
Report 
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical 
investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities, 
and 
Head of the 
Institution 
Provide prompt notification of termination or 
suspension and reason(s). 
Recall and device 
disposition 
Investigators, 
Ethics 
Committee 
Notification within 30 working days and will 
include the reasons for any request that an 
investigator return, repair, or otherwise dispose 
of any devices. 
Study deviation 
Investigators 
Ensure that all deviations from the Clinical 
Investigation Plan are reviewed with the 
appropriate clinical investigator(s), are reported 
on the case report forms and the final report of 
the clinical investigation. 
Site specific study deviations will be submitted to 
investigators periodically. 

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14.7. Publication and Use of Information 
Publications from the study will be handled according to Medtronic Global Standard Operating 
Procedures and as indicated in the Clinical Trial Agreement. 
Publication Committee 
 
Medtronic may form the ArcticLine Feasibility Study Publication Committee from the study 
Investigators. Medtronic personnel may serve as members of the committee. This committee will 
manage study publications with the goal of publishing findings from the data. The Publication 
Committee will develop the final Publication Plan as a separate document. 
The Publication Committee’s role is to: 1) manage elements addressed in the publication plan as 
outlined in this section, 2) develop the final Publication Plan under separate cover, 3) execute the 
Publication Plan, 4) oversee the publication of primary and ancillary study results, 5) review and 
prioritize publication proposals, 6) provide input on publication content, and 7) determine 
authorship. In addition, the committee will apply and reinforce the authorship guidelines set forth 
in the Publication Plan. 
Membership in the Publication Committee does not guarantee authorship. The committee will 
meet as needed. 
Management of Primary and Ancillary Publications 
 
The Publication Committee reviews, prioritizes, and manages all publications including primary and 
ancillary publications.  Primary publications are those that address analyses of the primary 
objective and ancillary objectives as specified in the CIP. An ancillary publication is any publication 
that does not address the study objectives identified in the CIP.  They include publications 
proposed and developed by other Medtronic departments or entities, clinicians participating in this 
clinical study, and clinicians not participating in this clinical study. The committee will work with 
Medtronic to ensure that requests do not present conflicts with other proposals, are not 
duplicative, and to determine which ancillary publication proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the 
end of the study or with individual center data. Requests for publications on study objectives 
utilizing subset data (e.g., regional) will be evaluated for scientific validity and the ability of 
Medtronic to provide resources. 
Criteria for Determining Authorship 
 
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 

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www.icmje.org). Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all the conditions below: 
 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related 
to the accuracy or integrity of any part of the work are appropriately investigated and 
resolved 
Decisions regarding authorship and contributorship will be made by the committee. The selected 
authors will be responsible for drafting the publication. All selected authors must fulfill the 
authorship conditions stated above to be listed as authors, and all contributors who fulfill the 
conditions must be listed as authors. 
All Investigators not listed as co-authors will be acknowledged as the “Medtronic ArcticLine 
Feasibility Study Investigators” and will be individually listed according to the guidelines of the 
applicable scientific journal when possible and affiliation. Any other contributors will be 
acknowledged by name with their specific contribution indicated. 
Transparency 
 
Transparency of study results will be maintained by the following means: 
 
• 
a final report, describing the results of all objectives and analysis, will be distributed to all 
Investigators and IRB/REB/MECs of participating countries when required by local law 
• 
registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated 
• 
submitting for publication the primary study results after the study ends 
• 
disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to 
the policies set forth by the corresponding journals and conferences 
• 
making an individual center’s study data accessible to the corresponding Investigator after 
the completion of the study, if requested. 

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14.8. Suspension or Early Termination 
 
14.8.1. 
Early Termination or Suspension 
Early termination is the closure of a clinical study that occurs prior to meeting defined endpoints. 
This is possible for the whole study or a single center. Suspension is a temporary postponement of 
study activities related to enrollment. This is possible for the whole study or a single center. If 
suspension is lifted, the Investigator shall assess whether to continue the clinical study at their 
center. 
 
14.8.2. 
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not 
limited to: 
• 
Adverse events associated with the system or product under investigation which might 
endanger the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or regulatory body (where the study is operating under regulatory 
body authority) 
• 
Technical issues during the manufacturing process 
 
14.8.3. 
Investigator/Center Termination or Suspension 
Possible reasons for clinical Investigator or center termination or suspension include but are not 
limited to: 
• 
Failure to obtain IRB/REB/MEC annual renewal of the study 
• 
Persistent non-compliance to the CIP (e.g. failure to adhere to inclusion/exclusion criteria, 
failure to follow subjects per visit schedule) 
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the Clinical Trial Agreement (e.g. failure to 
submit data in a timely manner, failure to resolve data queries and monitoring findings in a 
timely manner) 
• 
IRB/REB/MEC suspension of the center 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 
• 
Investigator request (e.g. no longer able to support the study) 

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14.8.4. 
Procedures for Termination or Suspension 
 
14.8.4.1. 
Medtronic-Initiated and Regulatory Authority-Initiated 
• 
Medtronic will promptly inform the clinical Investigators of the termination or suspension 
and the reasons and inform the regulatory authority(ies) where required. 
• 
In the case of study termination or suspension for reasons other than a temporary 
IRB/REB/MEC approval lapse, the Investigator will promptly inform the IRB/REB/MEC. 
• 
In the case of study termination, the Investigator must inform the subjects and may inform 
the personal physician of the subjects to ensure appropriate care and follow-up is provided. 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is 
lifted by Medtronic. 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare. 
 
14.8.4.2. 
Investigator-Initiated 
• 
The Investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension. 
• 
The Investigator will promptly inform the institution (where required per regulatory 
requirements). 
• 
The Investigator will promptly inform the IRB/REB/MEC. 
• 
The Investigator will promptly inform the regulatory authorities (where required per 
regulatory requirements). 
• 
The Investigator will promptly inform the subjects and/or the personal physician of the 
subjects to ensure appropriate care and follow-up is provided. 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare. 
 
14.8.4.3. 
IRB/REB/MEC-Initiated 
• 
The Investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days. 
• 
Subject enrollment must stop until the suspension is lifted. 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/REB/MEC 
policy or its determination if an overriding safety concern or ethical issue is involved. 
• 
The Investigator will inform his/her institution (where required per local requirements). 
• 
The Investigator will promptly inform the subjects (or legally-authorized designees as 
allowed by local law) and/or the personal physician of the subjects, with the rationale for the 
study termination or suspension. 

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• 
The Investigator will promptly inform the regulatory authorities (where required per 
regulatory requirements). 

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• 
Calkins H, et al. HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical 
Ablation of Atrial Fibrillation: Recommendations for Personnel, Policy, Procedures and 
Follow-Up. Europace. 2007;9(6):335-379. 
• 
Calkins H, et al., 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and 
Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural 
Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial 
Design. Heart Rhythm 2012;9:632-696. 
• 
Calkins H, et al., 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement 
on Catheter and Surgical Ablation of Atrial Fibrillation, Heart Rhythm (2017), 
doi:10.10106/j.hrthm.2017.05.012. 
• 
Ghanbari H, et al. Mortality and cerebrovascular events after radiofrequency catheter 
ablation of atrial fibrillation. Heart Rhythm. 2014;11:1503-1511. 
• 
Go A, et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for 
Rhythm Management and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial 
Fibrillation (ATRIA) Study. JAMA. 2001; 285(18): 2370-2375. 
• 
Jais P, et al. Stepwise Catheter Ablation of Chronic Atrial Fibrillation: Importance of 
Discrete Anatomic Sites for Termination. J Cardiovasc Electrophysiol. 2006;17: S28-S36, 
Suppl. 3. 
• 
January C, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial 
fibrillation: a report of the American College of Cardiology/American Heart Association 
Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014. 
• 
Kirchof and Calkins. Catheter ablation in patients with persistent atrial fibrillation. European 
Heart J. doi:10.1093/eurheartj/ehw260. 
• 
Raviele, et al. Venice Chart International Consensus Document on Atrial Fibrillation: 2011 
Update.  J Cardiovasc Electrophysiol, 2012;23:890-923. 
• 
Rostock T, et al. Chronic Atrial Fibrillation Is a Biatrial Arrhythmia Data from Catheter 
Ablation of Chronic Atrial Fibrillation Aiming Arrhythmia Termination Using a Sequential 
Ablation Approach. Circ Arrhythmia Electrophysiol. 2008;1:344-353. 
• 
Verma A, et al. 2014 Focused Update of the Canadian Cardiovascular Society Guidelines for 
the Management of Atrial Fibrillation. Canadian Journal of Cardiology. 2014;30:1114-1130. 
• 
Verma A, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J 
Med 2015; 372:1812-1822. 
• 
Winkle RA. How much ablation to eliminate atrial fibrillation: Is less more or is more more? 
Heart Rhythm. Epub ahead of print. DOI: http://dx.doi.org/10.1016/j.hrthm.2015.06.031 
• 
Wolf P, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham 
Study. Stroke. 1991;22(8):983-988. 
15. References 

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• 
Zakeri et al. The burden of proof: The current state of atrial fibrillation prevention and 
treatment trials. Heart Rhythm. 2017;14:763-782. 
• 
Zoni-Berisso M, et al. Epidemiology of atrial fibrillation: European perspective. Clinical 
Epidemiology. 2014;6:213-220. doi:10.2147/CLEP.S47385. 

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Appendix A: CryoConsole Investigational Label 
CryoConsoles used in the study will have investigational software installed, a Catheter File, to allow 
for use of the ArcticLine Catheter. These CryoConsoles will have a console label affixed to the 
exterior that denotes the presence of investigational software. As the study will be conducted in 
both Canada and US, the label will be in both French and English and consist of the following 
language: 
CAUTION / ATTENTION 
CryoConsole 106A3 
This CryoConsole is used for: ArcticLine Feasibility Study 
Cette CryoConsole est utilisée pour l’étude clinique: ArcticLine Feasibility Study 
 
One (1) Investigational ArcticLine Catheter File (software) installed. 
(in addition to other, commercially available, software) 
Un (1) fichier de recherche “ArcticLine Catheter File” (logiciel) installé. 
(en plus d’autres logiciels commerciaux) 
 
ArcticLine Catheter File: 
Exclusively for clinical investigations / Exclusivement pour l’investigation clinique 
To be used by qualified investigators only / Réservé uniquement à l’usage de chercheurs qual 
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. 
CAUTION: Investigational Device. Limited by Federal Law (USA) to investigational use. 
 
For questions, contact the Investigator: 
En cas de questions, contacter le chercheur: 
 
 
 
See ArcticLine Instructions for Use for more details. 
Voir les Instructions d’utilisation du cathéter ArcticLine pour plus d’information. 
 
Medtronic CryoCath LP 
9000 Autoroute Transcanadienne 
Pointe-Claire, Quebec, H9R 5Z8 
Canada 
16. Appendices 

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Appendix B: Instructions For Use 
Always reference the current version of the Instructions For Use document as provided by 
Medtronic under separate cover. 

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Appendix C: Foreseeable Adverse Events 
The information provided in this section pertains to foreseeable adverse events that may be 
observed in study subjects and may collectively assist in identifying those events for a given device 
or therapy that are unexpected in nature. 
 
The cryoablation procedure involves surgery, therefore, standard adverse events associated with 
a surgical procedure may be experienced (e.g. anesthesia complications, injury, infections, 
bleeding, exacerbation of pre-existing conditions, healing complications). The focus of this section 
is to specifically address in more detail, those events that are foreseeable due to the use, 
performance, and/or presence of the ArcticLine Catheter under investigation. 
 
Treatment required for procedure and/or cryoablation system related adverse events that are 
experienced may include medication or other surgical and medical remedies. The adverse events 
associated with the use of the ArcticLine Catheter include but are not limited to those in Table 14. 
 
Table 14 pertains to the foreseeable/anticipated adverse events that may be observed in the study 
and may assist in identifying those adverse events that are unexpected in nature. 
 
Table 14: Foreseeable adverse events 
 
Adverse Event/Risk 
Definition 
Access site complications (e.g. 
bruising, ecchymosis) 
Complications at catheter insertion site in the groin 
Anemia 
Deficiency of red blood cells or of hemoglobin in the blood 
resulting in weariness 
Arrhythmia (e.g. atrial flutter, 
bradycardia, heart block, 
tachycardia) 
Disruption of normal heart rate or rhythm 
Back pain 
Pain felt in the lower or upper back 
Bleeding, possibly requiring 
transfusion 
Loss of blood, including loss resulting in transfusion 
Bronchitis 
Inflammation of the lining of bronchial tubes that carry air to 
and from the lungs 
Cardiac tamponade 
Pressure on the heart as a result of fluid collecting in the sac 
surrounding the heart 
Cardiopulmonary arrest 
Cessation of blood circulation and/or respiration due to 
dysfunction of the heart and/or lungs 
Catheter entrapment in cardiac 
structures requiring intervention 
Tangling of the catheter in the heart which requires invasive 
intervention, including surgical repair 
Cerebral vascular accident 
Blockage of blood flow, or rupture of an artery, to the brain 
which causes sudden death of brain cells 

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Adverse Event/Risk 
Definition 
Chest discomfort/pain/pressure 
Includes a range of feeling from sharp stabbing to dull ache 
in the chest 
Cold feeling 
Having a low or inadequate temperature 
Coronary artery spasm 
Temporary constriction of a coronary artery, including ECG 
evidence reflecting ST segment abnormally high above 
baseline 
Cough 
Rapid expulsion of air from the lungs 
Death 
Complication or deterioration of health ultimately leading to 
a patient’s death 
Diarrhea 
Feces discharged from the bowels frequently and in a liquid 
form 
Dizziness 
Feeling faint, woozy, weak or unsteady 
Embolism 
Introduction of air, formation and dislodgement of a blood 
clot (thrombus) or dislodgement of cholesterol/plaque 
within the blood vessel, which travels downstream into small 
vessels, blocking blood flow and causing temporary or 
permanent damage to organs distal to blockage. Emboli are 
known to cause myocardial infarction, transient ischemic 
attack, stroke/cardiovascular accident, blurred vision, visual 
changes, paralysis, paresis, or kidney damage, peripheral 
ischemia and may ultimately lead to incapacitation or death. 
Symptomatic and non-symptomatic. 
Esophageal damage (including 
atrioesophageal fistula) 
Damage to the esophagus, including ulcer and 
atrioesophageal fistula (an abnormal passageway between 
the heart and esophagus) 
Fatigue 
Extreme tiredness 
Fever 
Abnormally high body temperature 
Headache 
Pain in the head 
Hemoptysis 
Coughing up blood or blood-stained mucus 
Hypotension/hypertension 
Low/high blood pressure 
Infection (e.g. sepsis) 
Invasion and multiplication of microorganisms (e.g. bacteria, 
virus) not normally present within the body 
Lightheadedness 
Feeling faint, woozy, weak or unsteady 
Myocardial infarction 
Blockage of blood flow to the heart muscle (i.e. heart attack) 
Nausea/vomiting 
• 
Nausea: sensation of unease and discomfort in the 
upper stomach with an urge to vomit 
• 
Vomiting: forceful expulsion of stomach contents 
through the mouth and/or nose 
Perforation 
Unintended puncture through the wall of a blood vessel or 
cardiac tissue 
Pericardial effusion 
Fluid collecting in the sac that surrounds the heart 
Pericarditis 
Inflammation of the sac-like tissue that surrounds the heart 

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Adverse Event/Risk 
Definition 
Phrenic nerve injury 
Damage to the nerve that controls breathing; may cause 
hiccups, involuntary spasm of the diaphragm and 
respiratory organs, or paralyze the diaphragm 
Pleural effusion 
Collection of extra fluid around the lungs 
Pneumonia 
Lung infection that inflames air sacs in one or both lungs 
Pneumothorax 
Collapsed lung 
Pseudoaneurysm 
Collection of blood in the tissue surrounding the catheter 
insertion site due to ongoing leaking of blood from a blood 
vessel 
Pulmonary edema 
Excess fluid in the lungs 
Pulmonary vein stenosis 
Blockage in the blood vessels takes blood from the lungs to 
the heart 
Shortness of breath 
Difficulty breathing 
Sore throat 
Pain in throat 
Transient ischemic attack 
New focal neurological deficit with rapid symptom 
resolution (usually 1 to 2 hours), no more than 24 hours 
Vagal nerve injury (e.g. 
gastroparesis) 
Injury to the vagal nerve resulting in esophageal dysmotility 
or gastroparesis, including: 
• 
Delayed gastric emptying 
• 
Difficulty swallowing/narrowing of the esophagus 
• 
Digestive discomfort/pain in the abdomen 
Valve damage with potential 
regurgitation 
Damage to heart valve (e.g. tricuspid, mitral), including 
backward flow of blood through the valve 
Vasovagal reaction 
Reflex of the involuntary nervous system that causes the 
heart to slow down and blood pressure drops; may result in 
fainting 
Visual changes 
Changes to vision, including blurred vision and bilateral 
visual disturbance 

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Appendix D: Endpoint-Related Adverse Event Definitions 
Table 15 describes definitions for a subset of endpoint-related adverse events that may be 
observed in the study. 
 
Table 15: Adverse Event Definitions 
 
Adverse Event 
Definition 
Atrioesophageal Fistula 
Connection between the atrium and the lumen of the esophagus. 
Evidence supporting this diagnosis includes documentation of 
esophageal erosion combined with evidence of a fistulous connection 
to the atrium such as air emboli, an embolic event, or direct 
observation at the time of surgical repair. 
Cardiac tamponade/ 
perforation 
Development of a significant pericardial effusion during or within 30 
days of undergoing the study 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. 
Cerebrovascular 
accident/stroke 
Rapid onset of a focal or global neurological deficit with at least one of 
the following: change in level of consciousness, hemiplegia, 
hemiparesis, 
numbness or sensory loss affecting one side of the body, dysphasia or 
aphasia, hemianopia, amaurosis fugax, or other neurological signs or 
symptoms consistent with stroke. Confirmed by neurology 
assessment and/or radiographic confirmation. 
Esophageal injury 
Injury to the lumen of the esophagus that does not result in an 
atrioesophageal fistula. Confirmed by endoscopic examination. 
Hemoptysis 
Expectoration of blood or blood-tinged sputum from the lungs or 
tracheobronchial tree. 
Lung Injury 
Presence of any of the following: bronchial lesion, hemoptysis, 
constriction, pulmonary hemorrhage, bronchia fistula 
Major bleeding 
Bleeding that requires and/or is treated with transfusion or results in a 
20% or greater fall in hematocrit. 
Myocardial infarction 
Presence of any one of the following criteria: 
1) detection of ECG changes indicative of new ischemia (new 
ST-T changes or new LBBB), which persist for more than one 
hour; 
2) development of new pathological Q waves on an ECG; 
3) imaging evidence of new loss of viable myocardium or new 
regional wall motion abnormality. 
Pericarditis 
Pericardial effusion that leads to pericarditis with 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. 

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Adverse Event 
Definition 
Phrenic nerve injury 
Absent phrenic nerve function as assessed by diaphragmatic 
fluoroscopy/sniff test that is ongoing from hospital discharge. 
Phrenic nerve injury is considered permanent when it is documented 
to be present 12 months or longer following ablation. 
Pulmonary vein 
stenosis 
Reduction of the diameter of a PV or PV branch. PV stenosis can be 
categorized as mild <50%, moderate 50%–70%, and severe ≥70% 
reduction in the diameter of the PV or PV branch. 
Symptomatic 
persistent iatrogenic 
atrial septal defect 
New atrial septal defect found by new on-set pulmonary hypertension 
(symptomatic) and assessed via ultrasound Doppler imaging. 
Transient ischemic 
attack 
New focal neurological deficit with rapid symptom resolution (usually 
1 to 2 hours), no more than 24 hours. Confirmed by neurology 
assessment and/or radiographic confirmation. 
Vagal nerve injury 
Injury to the vagal nerve that results in esophageal dysmotility or 
gastroparesis (i.e. delayed gastric emptying). 
Vascular access site 
complication 
Development of a hematoma (excluding minor hematomas not 
requiring surgical treatment), AV fistula or pseudoaneurysm that 
requires intervention, prolongs the hospital stay, or requires hospital 
admission. 

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Appendix E: Draft Data Collection Elements (Case Report Forms) 
Draft CRFs for the study will be provided under separate cover. Final CRFs will be provided to 
centers via the electronic data management system after the center has fulfilled all requirements 
for database access. 

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Appendix F: Informed Consent Template 
The Informed Consent Template will be distributed under separate cover. 

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Appendix G: IRB/REB/MEC List 
A final IRB/REB/MEC list has not been finalized prior to development of the Clinical Investigator 
Plan and will be distributed under separate cover. 

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Appendix H: Participating Investigators and Institutions 
A final list of participating Investigators and institutions has not been finalized prior to 
development of the Clinical Investigation Plan and will be distributed under separate cover. 

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Appendix I: Pre-Clinical Testing 
A summary of results from pre-clinical testing with the ArcticLine Catheter is provided in the 
Report of Prior Investigations Summary under separate cover. 

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Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not Applicable, New Document 
Mandi Rupp, Principal Clinical Research 
Specialist 
Jeff Cerkvenik, Senior Principal 
Statistician 
Kirsten Rasmussen, Clinical Research 
Specialist 
Craig Dull, Principal Field Clinical Engineer 
2.0 
• 
Sponsor Contact Information 
Section: Updated monitoring 
contact phone number 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 1: Added National 
Institute of Health (NIHSS) 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 2: Updated definition of 
symptomatic persistent AF; added 
NIHSS and post-ablation 
endoscopy to study procedures 
and assessments table; added 
notes regarding post-ablation 
endoscopy and 3 and 6 month 
visits to study procedures and 
assessments table; edited 
statistics section to indicate that 
the first interim analysis is planned 
after 15 subjects 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 4.1.1: Updated to clarify 
that AE fistula that presents at any 
time after the study procedure will 
be included in the endpoint 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
17. Version History 

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2.0 
• 
Section 4.1.5: Updated to clarify 
how antiarrhythmic medication 
use will impact the endpoint 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 5.1: Edited to clarify that 
subjects enrolled and treated with 
ArcticLine will not be replaced with 
newly enrolled subjects upon early 
study exit 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 5.3: Removed statement 
that all centers and geographies 
will use the same version of the 
CIP 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 6.4: Updated description 
of FlexCath Advance Steerable 
Sheath 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 6.8: Added further detail 
to product training requirements 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 7.2.1: Added to describe 
staged subject enrollment 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 7.3: Updated definition of 
symptomatic persistent 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 

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2.0 
• 
Section 8: Added NIHSS and post- 
ablation endoscopy to Table 3; 
Added notes regarding post- 
ablation endoscopy and 3 and 6 
month visits to Table 3; Removed 
“office” from follow-up visit 
references throughout 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.3: Updated baseline 
assessment to include a review of 
arrhythmic symptoms and the 
NIHSS assessment 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.4.1: Added detail 
regarding the use of FlexCath 
Advance Steerable Sheath; 
Included a note that the ablation 
segment of the ArcticLine 
Catheter should be completely 
outside of the sheath prior to 
initiating the ablation 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.4.2: Added requirement 
for post-ablation endoscopy 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.4.5: Added reference to 
phrenic nerve pacing 
requirements (Table 4); Included 
clarification on gap completion 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.4.6: Included a note that 
the ablation segment of the 
ArcticLine Catheter should be 
completely outside of the sheath 
prior to initiating the ablation; 
Added reference to phrenic nerve 
pacing requirements (Table 4); 
Included clarification on gap 
completion 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 

Medtronic Confidential 
056-F275, v3.0 Clinical Investigation Plan Template 
This document is electronically controlled 
ArcticLine Feasibility Study Clinical Investigation Plan 
Version 3.0   18MAR2018 
Page 116 of 118 
 
 
 
2.0 
• 
Section 8.4.7: Included a note that 
the ablation segment of the 
ArcticLine Catheter should be 
completely outside of the sheath 
prior to initiating the ablation; 
Added reference to phrenic nerve 
pacing requirements (Table 4); 
Included clarification on gap 
completion 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.4.8: Included a note that 
the ablation segment of the 
ArcticLine Catheter should be 
completely outside of the sheath 
prior to initiating the ablation; 
Added reference to phrenic nerve 
pacing requirements (Table 4); 
Included clarification on gap 
completion 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.5: Added discharge 
NIHSS assessment 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.6.1: Updated to clarify 
how antiarrhythmic medication 
use will impact the endpoint 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 8.8: Added a paragraph 
regarding data collection methods 
for the 3 and 6 month visits 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 9.1: Updated risks 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 

Medtronic Confidential 
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This document is electronically controlled 
ArcticLine Feasibility Study Clinical Investigation Plan 
Version 3.0   18MAR2018 
Page 117 of 118 
 
 
 
2.0 
• 
Section 10.3.1: Death information 
update to be its own section 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 10.3.2: AE Reporting 
Requirements made into a 
separate section with content 
added to clarify reporting 
requirements; Table 7 revised to 
include enhanced reporting 
requirements in the US. 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 12: Edited interim 
analyses to indicate that the first 
interim analysis is planned after 15 
subjects 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 12.1: Updated primary 
endpoint definition to clarify that 
AE fistula that presents at any 
time after the study procedure will 
be included in the endpoint 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Section 12.5: Added statement to 
clarify how use of antiarrhythmic 
medications will impact the 
endpoint; Updated determination 
of patients for analysis by adding 6 
month Holter data and removing 
the entrainment maneuver 
requirement for CTI dependent 
flutter recurrence. 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Appendix C, Foreseeable Adverse 
Events updated 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 

Medtronic Confidential 
056-F275, v3.0 Clinical Investigation Plan Template 
This document is electronically controlled 
ArcticLine Feasibility Study Clinical Investigation Plan 
Version 3.0   18MAR2018 
Page 118 of 118 
 
 
 
2.0 
• 
Table 15, Endpoint Definitions 
updated 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
2.0 
• 
Grammatical and formatting 
updates throughout 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
Mandi Rupp, Principal Clinical Affairs 
Specialist 
3.0 
• 
Section 1.0: Added Compound 
Motor Action Potential (CMAP), 
Electromyography (EMG) and 
Electrophysiology (EP) 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
3.0 
• 
Section 8.4.4: Added CMAP as a 
requirement for phrenic nerve 
monitoring 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
3.0 
• 
Table 4, Added CMAP 
requirements, updated title to 
“Required Phrenic Nerve 
Monitoring” 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
3.0 
• 
Sections 8.4.5, 8.4.6 and 8.4.7: 
Updated phrenic nerve pacing to 
phrenic nerve monitoring to be 
inclusive of pacing and CMAP 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer 
3.0 
• 
Section 8.4.8: Added statement 
that phrenic nerve monitoring 
must be performed in accordance 
with Table 4 
Kirsten Rasmussen, Senior Clinical 
Research Specialist 
Chris Anderson, Senior Statistician 
Craig Dull, Principal Field Clinical Engineer