Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
Phase: NA
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster, Inc.

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 1 of 83 
MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
CLINICAL INVESTIGATION PROTOCOL 
 
 
 
 
 
 
 
Clinical study for workflow and acute performance 
evaluation of the THERMOCOOL SMARTTOUCH® SF-5D 
system (the THERMOCOOL SMARTTOUCH® SF-5D catheter 
with temperature sensing capabilities and micro electrodes 
and CARTO 3 V 6.0 technology) in treatment of patients with 
Paroxysmal Atrial Fibrillation  
(QDOT MICRO) 
 
 
Sponsor: 
BIOSENSE WEBSTER, INC. 
33 Technology Drive 
Irvine, California 92618  
 
 
Protocol number: 
MQDT-166 
 
Protocol Version Date: 
Version 2.0 – November, 17th, 2017 
 
 
 
 
History of Changes 
 
 
Version Date 
 
Description  
Version 1.0 – May 26, 2016 
 
Original document 
Version 2.0 – November 17th, 2017 
 
Amendment 1 
 
 
 
The THERMOCOOL SMARTTOUCH® SF-5D Catheter (D-1395-05-SI) is for investigational 
device use only and is not commercially available anywhere in the world. ‘(QDot-MICRO)’ is 
an internal Biosense Webster project name and other than as used in the present clinical 
investigation, is not intended for any other external use. The final commercial or trade 
name of the THERMOCOOL SMARTTOUCH® SF-5D catheter may be different. 
 
 

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 2 of 83 
MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
 
Clinical study for workflow and acute performance evaluation of the 
THERMOCOOL SMARTTOUCH® SF-5D system (the THERMOCOOL 
SMARTTOUCH® SF-5D catheter with temperature sensing capabilities 
and micro electrodes and CARTO 3 V 6.0 technology) in treatment of 
patients with Paroxysmal Atrial Fibrillation  
(QDOT MICRO) 
 
 (Protocol # -MQDT-166) 
 
Clinical investigation 
Number 
MQDT-166 
Clinical investigation 
Name 
 QDOT MICRO 
Revision 
Version 2.0  
Date 
17 November 2017 
Sponsor 
Biosense Webster, Inc. 
33 Technology Drive 
Irvine, CA 92618 USA  
Tel +1 800 729 9010 
 
Contacts 
Associate Director Franchise 
Medical Affairs  
Qun Sha, MD, MBA  
Biosense Webster, Inc. 
15715 Arrow Highway  
Irwindale, CA 91706 USA 
Tel: +1 909-274-8044 
qsha@its.jnj.com 
 
Clinical Franchise Manager CSS, US 
Robert Stagg 
Biosense Webster, Inc. 
33 Technology Drive 
Irvine CA 92618 USA USA  
rstagg@its.jnj.com 
 
 
Clinical Franchise Leader CSS, EMEA 
Authorized Legal Representative   
Nathalie Macours 
Biosense Webster, EMEA 
part of the Johnson & Johnson family of companies 

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 3 of 83 
MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
Leonardo Da Vincilaan 15 
1831 Diegem – Belgium 
Tel: +32 2 746 35 27 
Email: nmacours1@its.jnj.com 
 
Whereas, the Clinical Study is sponsored by Biosense 
Webster Inc., Johnson and Johnson Medical NV/SA with 
registered offices at Leonardo Da Vincilaan 15, 1831 
Diegem, Belgium, has been duly appointed by the 
Sponsor to conduct the Clinical Study on its behalf. 
 
 
The sponsor maintains an updated list of principal investigators, sites and institutions 
and Contract Research Organizations (if applicable). The definitive list shall be 
integrated in the study report. 
 

Biosense Webster, Inc. 
CONFIDENTIAL 
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MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
INVESTIGATOR SIGNATURE PAGE 
 
I have read the protocol and agree: 
x 
To conduct this clinical trial in accordance with the design and specific provisions of this 
protocol. 
x 
To await EC-positive opinion for the protocol and informed consent as well as approval from 
the relevant Competent Authorities before initiating enrollment into the clinical trial. 
x 
To ensure that the requirements for obtaining informed consent are met and to obtain 
informed consent from subjects before their enrollment in the clinical trial. 
x 
To adhere to the content of the Investigator Brochure/ Instructions For Use 
x 
To provide copies of the protocol and all pertinent information to all individuals responsible 
to me who assist in the conduct of this study. 
x 
To provide sufficient and accurate financial disclosure and update information if any relevant 
changes occur during the investigation and for 1 year following the completion of the clinical 
trial. 
x 
To collect and record data as required by this protocol and case report forms. 
x 
To maintain the confidentiality of all information received or developed in connection with 
this protocol. 
x 
To conduct this trial in accordance with ISO: 14155-2011 Standards and any other applicable 
local laws and regulations. 
x 
To permit trial-related monitoring, audits, EC review, and regulatory inspection(s) by 
providing direct access to source data/documents. 
x 
To prepare annual, final adverse effect reports as required by this protocol. 
x 
To maintain clinical trial documentation for the period of time required. 
x 
To report all adverse events/incidents within the specified timeframe to Biosense 
Webster. 
x 
To report all serious adverse events/incidents to Sponsor immediately upon awareness of 
event but no later than 72 hours enter them into the EDC system. 
x 
To adhere to the publication policy of Biosense Webster for data collected during this clinical 
trial. 
 
 
Signature of Principal Investigator 
         Date 
 
 
 
Printed Name of Principal Investigator 
 
 
 
 
 
 
 

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 5 of 83 
MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
PROTOCOL SYNOPSIS 
 
Sponsor 
Biosense Webster, Inc. 
33 Technology Drive 
Irvine, California 
United States of America 
92618  
Tel +1 800 729 9010 
 
 
Protocol Title 
Clinical study for workflow and acute performance evaluation of 
the THERMOCOOL SMARTTOUCH® SF-5D system (the 
THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature 
sensing capabilities and micro electrodes and CARTO 3 V 6.0 
technology) in treatment of patients with Paroxysmal Atrial 
Fibrillation  
Abbreviated Title 
QDOT MICRO 
Investigational Devices 
x THERMOCOOL SMARTTOUCH® SF-5D Catheter (D-1395-
05-SI) 
x nMARQ™ Multi-Channel RF Generator (D-1341-07) with 
Software V3.0.1 
Study Purpose  
The purpose of this study is to evaluate the workflow and acute 
performance, during standard electrophysiology mapping and RF 
ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D 
catheter with temperature sensing capabilities and micro 
electrodes used in combination with the CARTO® 3 Navigation 
System with THERMOCOOL SMARTTOUCH® SF-5D-module.  
Study Design 
The QDOT MICRO study is a prospective, multi-center, non-
randomized, interventional clinical study.  
Study Population 
Paroxysmal AF subjects who are scheduled to undergo a clinically-
indicated ablation procedure for management of their paroxysmal 
AF will be the target population for screening. Subjects that are 
consented and meeting all eligibility criteria will undergo ablation 
with the THERMOCOOL SMARTTOUCH® SF-5D system. 
Study Duration & 
Subject Participation 
Approximately 6 months of enrollment, subjects will be followed-
up at 7 days and 3-month post-procedure 
Primary Outcome 
Acute Device Performance 
Acute Device Performance is defined as confirmation of entrance 
block in all targeted PVs after adenosine and/or isoproterenol 
challenge. 
 
 

Biosense Webster, Inc. 
CONFIDENTIAL 
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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
Secondary Outcomes 
x Safety 
o Incidence of early onset (within 7 days of ablation 
procedure) pre-defined primary Adverse Events.  
o Incidence of Serious Adverse Device Effects (SADEs) 
during follow-up period (3 months) 
x Procedural data 
x Rate for touch-up RF application post adenosine 
and/ or isoproterenol challenge 
x Target sites for RF lesion application 
o Target sites 
o Number of RF applications per target 
o Total RF duration per application (sec) 
x Ablation parameters, including but not limited to: 
o Total RF ablation time 
o Temperature (generator files) 
o Contact Force (CARTO® datafiles) 
o Power (generator files) 
o Impedance 
x Total Fluoroscopy time/dose 
x Total procedure time 
x ECG data 
x Investigational device performance (rating with 
survey): 
o Contact and stability of catheter  
o Signal Quality 
o Temperature visualization 
o Ease of use  
Number of Subjects 
Approximately 50 evaluable subjects will be enrolled. 
Number of study sites 
Approximately 5 centers in Europe 
 
 

Biosense Webster, Inc. 
CONFIDENTIAL 
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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
Study Inclusion 
Criteria 
Subjects must meet ALL of the following inclusion criteria to be 
eligible for participation in this clinical investigation: 
1. Age 18 or older 
2. Patients who have signed the Patient Informed Consent 
Form (ICF) 
3. Subjects diagnosed with symptomatic PAF who are 
candidates for catheter ablation  
4. Able and willing to comply with all pre-, post-, and follow-up 
testing and requirements (e.g. Patient not confined by a 
court ruling) 
Study Exclusion 
Criteria 
Subjects who meet ANY of the following exclusion criteria are not 
eligible for enrollment: 
1. Atrial fibrillation secondary to electrolyte imbalance, 
thyroid disease, or reversible or non-cardiac cause. 
2. Previous ablation for atrial fibrillation. 
3. Previously diagnosed with persistent AF. 
4. Documented Left Atrial thrombus  
5. Any carotid stenting or endarterectomy 
6. LA size >50mm  
7. LVEF <40% 
8. Uncontrolled heart failure or NYHA function class III and IV 
9. History of blood clotting or bleeding abnormalities or 
contraindication to anticoagulation (heparin, warfarin, or 
dabigatran) 
10. History of a documented thromboembolic event (including 
TIA) within the past 12 months. 
 
 
 
 

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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
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11. Previous PCI/MI within the past 3 months 
12. Previous cardiac surgery (e.g. CABG) in conjunction with 
valve surgery or any valvular cardiac surgical/percutaneous 
procedure (e.g. ventriculotomy, atriomy, valve repair or 
replacement, presence of a prosthetic valve) within the past 
6 months. 
13. Awaiting cardiac transplantation or other cardiac surgery 
within the next 6 months. 
14.  Unstable angina 
15. Significant pulmonary disease (eg, restrictive pulmonary 
disease, constrictive or chronic obstructive pulmonary 
disease) or any other disease or malfunction of the lungs or 
respiratory system that produces chronic symptoms. 
16. Acute illness, active systemic infection, or sepsis. 
17. Presence of intracardiac thrombus, myxoma, tumor, 
interatrial baffle or patch or other abnormality that 
precludes catheter introduction or manipulation. 
18. Presence of a condition that precludes vascular access. 
19. Presence of implantable cardioverter-defibrillator (ICD) 
20. Significant congenital anomaly or a medical problem that in 
the opinion of the investigator would preclude enrollment in 
this trial. 
21. Currently enrolled in an investigational study evaluating 
another device, biologics, or drug. 
22. Women of child bearing potential whom are pregnant, 
lactating, or planning to become pregnant during the course 
of the clinical investigation (as evidenced by pregnancy test if 
of child bearing potential). 
23. Life expectancy less than 12 months. 
24. Presenting contra-indication for the devices used in the 
study, as indicated in the respective instructions for use. 
 
 
 
 
 
 

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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
 
TABLE OF CONTENT               
1. 
ABBREVIATIONS ......................................................................................................................................................... 14 
2. 
INTRODUCTION .......................................................................................................................................................... 16 
2.1 BACKGROUND .......................................................................................................................... 16 
3. 
INVESTIGATIONAL MEDICAL DEVICES ............................................................................................................... 19 
3.1 GENERAL DEVICE DESCRIPTION .................................................................................................... 19 
3.2 RATIONALE FOR DESIGN ............................................................................................................. 29 
4. 
RISK – BENEFIT ........................................................................................................................................................... 32 
4.1 DESCRIPTION AND ANALYSIS OF RISKS ........................................................................................... 32 
4.2 MINIMIZATION OF RISKS ............................................................................................................. 35 
4.3 POTENTIAL BENEFITS.................................................................................................................. 36 
5. 
CLINICAL INVESTIGATION DESIGN ...................................................................................................................... 36 
6. 
CLINICAL INVESTIGATION OBJECTIVE ............................................................................................................... 36 
7. 
CLINICAL STUDY ENDPOINTS ................................................................................................................................ 37 
7.1 PRIMARY STUDY ENDPOINTS .......................................................................................................... 37 
7.2 SECONDARY STUDY ENDPOINTS ...................................................................................................... 37 
8. 
STUDY POPULATION ................................................................................................................................................. 38 
8.1 SUBJECT IDENTIFICATION ............................................................................................................ 38 
8.2 STUDY INCLUSION CRITERIA ........................................................................................................ 38 
8.3 STUDY EXCLUSION CRITERIA ........................................................................................................ 39 
8.4 SUBJECT DISPOSITION ................................................................................................................ 40 
8.5 EARLY SUBJECT TERMINATION ..................................................................................................... 40 
8.6 SUSPENSION OR PREMATURE TERMINATION OF THE STUDY.................................................................. 41 
8.7 STOPPING RULES ...................................................................................................................... 42 
8.8 CLINICAL INVESTIGATION TIMELINES/DURATION .............................................................................. 43 
9. 
STUDY PROCEDURES ................................................................................................................................................ 43 

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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
9.1 SCREENING/BASELINE ................................................................................................................ 43 
9.2 STUDY ABLATION PROCEDURE ..................................................................................................... 45 
9.3 FOLLOW-UP REQUIREMENTS POST-DISCHARGE ................................................................................. 51 
9.4 MANAGEMENT OF ARRHYTHMIA RECURRENCES AND REPEAT ABLATION PROCEDURES DURING FOLLOW-UP ... 52 
9.5 REQUIRED SCHEDULE FOR SUBJECT TREATMENTS AND EVALUATIONS ...................................................... 52 
10. 
ADVERSE EVENT AND DEVICE DEFICIENCY REPORTING .......................................................................... 52 
10.1 ADVERSE EVENTS (AE) ............................................................................................................. 52 
10.2 REPORTABLE SERIOUS ADVERSE EVENTS (MEDDEV 2.7/3 REV 3) ..................................................... 55 
10.3 PRIMARY ADVERSE EVENTS ....................................................................................................... 57 
10.4 ANTICIPATED ADVERSE EVENTS .................................................................................................. 57 
10.5 ADVERSE DEVICE EFFECT AND SERIOUS ADVERSE DEVICE EFFECTS ....................................................... 57 
10.6 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS (USADE) .......................................................... 58 
10.7 DEVICE DEFICIENCY AND COMPLAINTS ......................................................................................... 58 
10.8 DOCUMENTATION/FOLLOW-UP REPORTING .................................................................................. 59 
11. 
STATISTICAL ANALYSIS METHODS ................................................................................................................... 59 
11.1 SAMPLE SIZE .......................................................................................................................... 59 
11.2 ANALYSIS POPULATION ............................................................................................................ 60 
11.3         STATISTICAL METHODS .......................................................................................................... 60 
11.3.1 ACUTE DEVICE PERFORMANCE .......................................................................................................... 60 
11.3.2 ACUTE SAFETY ............................................................................................................................... 60 
11.3.3 SAFETY ......................................................................................................................................... 60 
11.3.4 PROCEDURAL DATA ........................................................................................................................ 61 
11.3.5 INVESTIGATIONAL DEVICE PERFORMANCE ........................................................................................... 61 
12 
DATA MANAGEMENT ............................................................................................................................................... 61 
12.1 DATA COLLECTION ..................................................................................................................... 61 
12.2 DATA REPORTING ...................................................................................................................... 61 
12.3 MISSING DATA HANDLING ........................................................................................................ 62 
12.4 SOURCE DOCUMENTATION ........................................................................................................ 62 
12.5 DATA VERIFICATION AND REVIEW ............................................................................................... 63 
12.6 FINAL DATA ANALYSIS.............................................................................................................. 63 
12.7 CONFIDENTIALITY AND PROTECTION OF CLINICAL INVESTIGATION DATA ............................................... 63 
13 
QUALITY CONTROL AND QUALITY ASSURANCE ............................................................................................ 64 
13.1 MONITORING OF THE STUDY ...................................................................................................... 64 
13.2 PROTOCOL MODIFICATIONS AND ADHERENCE ................................................................................ 64 
13.3 AUDITS AND INSPECTIONS ......................................................................................................... 65 

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13.4 RESPONSIBILITIES AND RECORD .................................................................................................. 65 
13.5 SUBJECT CONFIDENTIALITY ........................................................................................................ 68 
13.6 ETHICS COMMITTEE ................................................................................................................. 68 
13.7 STUDY DATA REPORTING AND PROCESSING: TRAINING .................................................................... 69 
14 
INVESTIGATION AND MEDICAL DEVICE ACCOUNTABILITY ...................................................................... 69 
14.1 MATERIALS ........................................................................................................................... 69 
14.2 DEVICE ACCOUNTABILITY .......................................................................................................... 70 
14.3 DEVICE RETURNS .................................................................................................................... 70 
14.4 LABELING .............................................................................................................................. 71 
15 
SAFETY COMMITTEE ............................................................................................................................................... 71 
15.1 DATA SAFETY DESIGNEE/COMMITTEE .......................................................................................... 71 
16 
PUBLICATION POLICY ............................................................................................................................................. 71 
17 
REFERENCES ............................................................................................................................................................... 72 
18 
ATTACHMENTS .......................................................................................................................................................... 78 
APPENDIX A: PRIMARY ADVERSE EVENT CLASSIFICATION ................................................................................ 78 
APPENDIX B: FORESEEABLE AND ANTICIPATED ADVERSE EVENTS RELATED TO RF ABLATION ........ 81 
TABLE OF CONTENT OF TABLES 
Table 1 Subject treatment and Follow-up schedule .................................................................................. 9 
Table 2 Required Devices/equipment: .................................................................................................... 28 
Table 3 Primary Adverse Events .............................................................................................................. 37 
Table 4 Ablation parameters for QDOT-MICRO Q-mode ........................................................................ 46 
Table 5 Adverse Event Intensity or Severity Definitions .......................................................................... 53 
Table 6 Adverse Event Outcome Classifications ...................................................................................... 54 
Table 7 Adverse Event Causality Classifications: ..................................................................................... 54 
 TABLE OF CONTENT OF FIGURES 
Figure 1 Overview of the THERMOCOOL SMARTTOUCH® SF-5D Catheter with Bi-directional Tip 
Deflection 
19 

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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
Figure 2 THERMOCOOL SMARTTOUCH® SF-5D tip Section D-1395-06-SI 
20 
Figure 3 THERMOCOOL SMARTTOUCH® SF-5D tip with Thermocouples (6), μElectrodes and angled 
irrigation ports 
21 
Figure 4 Contact Force Sensor – External View 
22 
Figure 5 QDOT MICRO Temperature Control Q-Mode 
24 
Figure 6 THERMOCOOL SMARTTOUCH® SF-5D Dongle with Extension Cable 
25 
Figure 7 Block Diagram of the THERMOCOOL SMARTTOUCH® SF-5D Dongle Processing and Transfer 
Activities 
26 
Figure 8 CARTO 3 v6.0 System QDot-MICRO module Screen Shot 
27 
Figure 9 Connectivity Diagram 
29 
 
 
 
 

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CONFIDENTIAL 
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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
1. ABBREVIATIONS  
AAD 
Antiarrhythmic Drug 
ACT  
Activated Clotting Time 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Atrial Fibrillation  
AFL 
Atrial Flutter 
AT 
Atrial Tachycardia 
BP 
Blood Pressure 
CA 
Competent Authority 
CABG 
Coronary Artery Bypass Grafting 
CE 
Conformité Européen 
CFAE  
Complex Fractionated Atrial Electrogram 
CHF 
Congestive Heart Failure 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT scan 
Computerized Tomography scan 
DD 
Device Deficiency 
EC 
Ethics Committee 
ECG 
ElectroCardioGram 
eCRF 
electronic Case Report Form 
EDC 
Electronic Data Capture 
EF 
Ejection Fraction 
EOS 
End-Of-Study 
EP  
Electrophysiology 
ER 
Emergency Room 
EU 
European Union 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
GastroIntestinal 
 
 

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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
(THERMOCOOL SMARTTOUCH® SF-5D) 
 
 
HCP 
Health Care Provider 
IB 
Investigator Brochure 
ICD 
Implantable Cardioverter-Defibrillator 
ICE 
IntraCardiac Echocardiography 
ICH 
International Conference on Harmonization 
ID 
IDentification 
IFU 
Instructions for Use 
ISO 
International Organization for Standardization 
IV 
IntraVenous 
IVC 
Inferior Vena Cava 
LA 
Left Atrium 
LV 
Left Ventricle 
LVEF 
Left Ventricular Ejection Fraction 
MI 
Myocardial Infarction 
MRI 
Magnetic Resonance Imaging 
PAE 
Primary Adverse Event 
PAF 
Paroxysmal Atrial Fibrillation 
PE 
Primary Endpoint 
PE 
Physical Examination 
PIU 
Patient Interface Unit 
PV 
Pulmonary Vein 
QA 
Quality Assurance 
QoL 
Quality of Life 
RA 
Right Atrium 
RBA 
Risk-Benefit Analysis 
RV 
Right Ventricle 
RF 
RadioFrequency 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SVC 
Superior Vena Cava 
SW 
SoftWare 
TEE 
TransEsophageal Echo 
TIA 
Transient Ischaemic Attack 
TTE 
TransThoracic Echo 
UADE 
Unanticipated Adverse Device Effect 
UAE 
Unanticipated Adverse Event 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
VT 
Ventricular Tachycardia 

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2. INTRODUCTION  
2.1  Background 
 Atrial fibrillation (AF) is the most common sustained arrhythmia in humans.  It affects 
anywhere from 0.4% to 1% of the general population, and increases in prevalence 
with age, from < 1% in young adults to 8% in patients over 80 years of age.1,2  Patients 
with AF report a considerably impaired quality of life (QOL) that is independent of 
disease severity.  Improvement in health-related QOL is directly correlated with 
restoration and maintenance of normal sinus rhythm.  In addition to the impaired 
QOL, AF sufferers have been shown to have an increased risk of stroke, heart failure 
and all-cause mortality.2 
AF is a complex, progressive disease that results in structural and electrical 
remodeling in the heart.3  Progression can be slowed or stopped by electrically 
isolating the pulmonary veins (PVs) from the left atrium (LA).4  According to the 2017 
HRS consensus statement, complete electrical isolation of the pulmonary veins (PVs) 
from the LA is recommended for all AF ablation procedures.5  Radiofrequency (RF) 
catheter ablation has provided excellent results for treating paroxysmal AF (PAF), 
with high rates of elimination of the arrhythmia.6-12   
While ablation with RF catheters has provided good results for treating PAF,7-12  
misplaced, overly forceful or prolonged contact with the RF tip can lead to thermal 
burn injury to non-PV structures.13,14  Because the mechanism of action of RF 
catheters is to induce cell death by temperature increases, the risk of thrombus 
formation and steam pop are of concern.15,16  It is generally accepted that RF ablation 
carries a major complication rate of approximately 4.5%.17  Animal studies have 
demonstrated that, during RF application at high power, saline irrigation maintains a 
low electrode-tissue interface temperature resulting in deeper and larger lesions.18   
However, the first open irrigated-tip catheters introduced for clinical use required 
increasing volumes of saline to be delivered with increasing number of RF 
applications.  Therefore, although irrigation of the RF catheter tip was found to reduce 
temperature at the ablation sites and decrease the associated thrombus formation and 
steam pops,18 there is a risk of volume overload from high volumes of perfused saline.   
Although acute pulmonary vein isolation (PVI) is almost always achieved with RF 
ablation, AF recurrence is common.5  Several studies have correlated inadequate 
electrode-tissue contact with ineffective RF lesion generation.19-23  Higher contact 
force can lead to serious complications such as steam pops, cardiac perforation or 
esophageal injury.21,22,24   
Until recently,25,26 there was no reliable mechanism to provide continuous 
measurement of the direct contact force (CF) between the tip of the RF ablation 
catheter and the endocardial tissue.  In preliminary studies, feedback from the 
addition of a CF sensor to RF ablation catheters showed a high degree of between- and 
within-investigator variability in CF, indicating that even with careful catheter 
manipulation, operators do not have good control over CF.25 Moreover, lower CFs 
were associated with intermittent contact with tissue and were most often applied at 
sites with high rates of reconduction.25,27,28 

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Technology of RF Catheter Ablation 
RF energy utilizes a high frequency (350 kHz to 1 MHz) alternating current to cause 
resistive heating of a narrow rim of tissue that is in direct contact with the electrode 
tip.21  Heating beyond this rim is based on transfer of thermal energy to the 
surrounding tissues, and is the primary mechanism by which RF lesions are formed.22  
Increasing temperature at the electrode-tissue interface increases the lesion size, but 
if the temperature exceeds 80 to 100°C, coagulum on the electrode tip can form and 
lead to an abrupt rise in impedance and a marked decrease in tissue heating.23  The 
temperature of the electrode-tissue interface, therefore, is a limiting factor to 
increasing RF lesion size and depth. The Biosense Webster THERMOCOOL 
SMARTTOUCH® SF family of catheters features two improvements over standard 
irrigated RF catheters.  First, the THERMOCOOL SMARTTOUCH® catheters provide 
real-time measurement of contact force (CF) between the catheter tip and heart wall, 
as well as location information, when used with CARTO® 3 Navigation System.  A 
small spring connects the ablation tip electrode to the catheter shaft with a magnetic 
transmitter and sensors to measure deflection of the spring.  The catheter has a high-
torque shaft with a bi-directional deflectable tip section containing an array of 
electrodes which may be used for recording and stimulation purposes.   
The tip electrode serves to deliver RF energy from the generator to the desired 
ablation site.  Second, the THERMOCOOL SMARTTOUCH® SF catheters incorporate 
“surround flow” technology, which features a 66-hole irrigation pattern.  At the 
proximal end of the catheter, a saline input port with a standard Luer fitting 
terminates from the open lumen.  This saline port serves to permit the injection of 
normal saline to irrigate the tip electrode.  During ablation, heparinized saline is 
passed through the internal lumen of the catheter and through the tip electrode, to 
irrigate and cool the ablation site as well as the electrode tip.  
The addition of a CF sensor at the distal tip of an irrigated RF catheter allows 
measurement of CF in real time during the ablation procedure.  Initial studies in a 
clinical setting have suggested that CF measurement allows identification of the use of 
inappropriately high CF during ablation as well as catheter manipulation,25 and that 
CF measurement during ablation correlates with clinical outcome in AF patients.27   
Subsequent studies with the THERMOCOOL SMARTTOUCH® catheters showed the 
ability to monitor CF in real time to be associated with decreased total procedure time 
and fluoroscopy time,29 and increased acute and long-term procedural success in the 
paroxysmal AF population.29,30  Data have shown the 12-month effectiveness success 
rate was 74%.30  Additionally, sub-analysis showed success rate was consistently 
above 80% when investigators stay within their pre-selected contact force range > 
80% of the time.30   There is ex vivo evidence that a higher contact force may result in 
an increased incidence of serious adverse events.21  Therefore, a catheter with the 
capability to provide real-time electrode-tissue contact force measurements may 
facilitate better control of RF energy application, resulting in an optimal lesion.  
The THERMOCOOL SMARTTOUCH® SF catheter features a porous electrode tip (66 
very small holes) in comparison to the predecessor device, the THERMOCOOL 
SMARTTOUCH® catheter which featured 6 larger holes at the distal electrode tip.  In 
subjects with paroxysmal AF, the THERMOCOOL® catheter with this Surround Flow 

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(SF) technology was as successful as the predecessor THERMOCOOL® catheter in 
achieving PV isolation.   
Both treatment groups received similar amounts of RF energy, but the saline volume 
administered was reduced in the THERMOCOOL® SF group.31 Procedural efficiency 
was also enhanced; time to PV isolation and total RF duration,32,33 as well as saline 
irrigation volume,33,34 were diminished in paroxysmal AF subjects who underwent 
ablation with the THERMOCOOL® SF catheter compared to the THERMOCOOL® 
catheter without SF.  
Commercialization of the THERMOCOOL® SF catheters has been associated with a 
higher complaint rate of cardiac adverse events.  Investigation of this trend revealed 
that the majority of Serious Adverse Events (SAEs) were occurring at centers that 
were not using the catheter according to the instructions for use.  Serious adverse 
events related to atrial esophageal fistula/tamponade/perforation have occurred at 
9% of sites where the product has been distributed.  One and a half percent (1.5%) of 
these centers have reported more than one SAE (2-5 events).  Most sites experiencing 
SAEs were found to be targeting an electrode tip temperature above the safety cut-off 
for THERMOCOOL® SF.   
Catheter tip temperature and electrode impedance are commonly used to monitor 
safe RF delivery.35 While intramural tissue temperature during RF application cannot 
be accurately assessed with conventional irrigated ablation catheter, the placement to 
the tip thermocouples in conventional irrigated catheters has allowed observation of 
temperature increases in the catheter tip as the tissue heats.35 In comparison to 
conventional irrigated-tip catheters with lower numbers of irrigation holes, there is 
no temperature rise at the catheter tip in the porous tip cooling pattern of the 
THERMOCOOL® SF catheters.36 The result is an observed constant temperature 
throughout the RF application even with increasing power levels.36 This has led to 
suggestions that RF applications of the THERMOCOOL® SF catheter with similar 
power settings used with the conventional THERMOCOOL® catheter are associated 
with a higher incidence of complications.37  
 
The THERMOCOOL SMARTTOUCH® SF-5D catheter has been designed to address this 
concern.  Temperature sensing, contact force and micro-electrodes (intended to 
streamline ablation workflow) are features that may potentially enhance the safety of 
the THERMOCOOL SMARTTOUCH® SF catheter.  This study is designed to 
demonstrate the optimal workflow and the acute performance of the THERMOCOOL 
SMARTTOUCH® SF-5D catheter when the instructions for use are followed. 
The addition QMODE algorithm to THERMOCOOL SMARTTOUCH® SF-5D catheter 
temperature regulation introduces temperature controlled ablation to irrigated 
catheters.  Temperature controlled ablation allows RF power to be delivered safely 
without tip char or steam pops.  When using the QMODE algorithm the irrigation rate 
will vary based on temperature to both cool the catheter tip adequately and retain 
temperature sensitivity, ensuring the safety profile. 
 

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3.2         Rationale for Design 
 
3.2.1 Previous Experience with the THERMOCOOL SMARTTOUCH ® 
catheter 
The THERMOCOOL® SMARTTOUCH® Catheter approved in the European Union. By 
displaying precise contact force and direction information, the THERMOCOOL® 
SMARTTOUCH® Catheter provides an important new parameter for the mapping and 
ablation of complex cardiac arrhythmias, such as Atrial Fibrillation (AF). 
 
3.2.2 Previous Experience with the THERMOCOOL SMARTTOUCH® SF 
catheter 
The THERMOCOOL SMARTTOUCH® SF catheter, approved in the European Union, 
features a porous electrode tip (56 small holes) in contrast to the predecessor device, 
which featured 6 larger holes at the distal electrode tip.  In subjects with paroxysmal AF, 
the THERMOCOOL SMARTTOUCH® SF catheter with Surround Flow (SF) technology was 
as successful as the predecessor THERMOCOOL SMARTTOUCH® catheter in achieving PV 
isolation, with delivery of similar amounts of RF energy.   
Moreover, the saline volume administered by the catheter was reduced when compared 
to the SMARTTOUCH® Catheter.31 Procedural efficiency was also enhanced; time to PV 
isolation and total RF duration,32,33 as well as saline irrigation volume,33,34 were 

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diminished in paroxysmal AF subjects who underwent ablation with the THERMOCOOL 
SMARTTOUCH® SF catheter compared to the THERMOCOOL SMARTTOUCH® catheter 
without SF technology.  
3.2.3 Previous Experience with THERMOCOOL SMARTTOUCH® SF-5D 
catheter 
This clinical feasibility study will be the first experience using THERMOCOOL 
SMARTTOUCH SF-5D (D-1395-05-SI) in conjunction with the nMARQ™ Multi-Channel RF 
Generator (D-1341-07; Software V3.0.1). 
 
Bench and animal testing has been performed using the THERMOCOOL SMARTTOUCH 
SF-5D Catheter and the nMARQ™ Multi-channel RF Generator.  Please refer to the 
Investigator’s Brochure for detailed summaries of the test protocols and corresponding 
reports.  A synopsis of the In Vivo animal studies is presented below. 
 
3.2.3.1 Animal studies 
3.2.3.1.1 
Animal Study Thigh Prep Lesion Model 
Animal testing was performed using the catheter and complete system per study 
protocol P-0022114 and test report TR-0022114, Design Verification Test Report 
For Verification of Qdot MICRO-Electrode Catheter with Q-mode Ablation Mode – 
Canine Thigh Preparation Test.  
Purpose 
The purpose of this study was to evaluate the safety and performance of the QDOT 
MICRO-electrode catheter in QMODE ablation mode (Test Catheter) when 
compared with STSF and ST catheters in power control mode (Control catheters) 
using a well-established canine thigh muscle model.    
 
Summary 
The overall incidence of coagulum and steam pop observed with the QDOT MICRO 
catheter in QMODE ablation mode was significantly less compared to the control 
catheters (ST and STSF).  The lesion characteristics were similar between the 
QDOT MICRO catheter and the control catheters.  The overall performance of the 
QDOT MICRO catheter, in the QMODE ablation mode was similar or better 
compared to the control catheters (ST and STSF) in power control ablation mode.  
 
3.2.3.1.2 
Animal Testing: Endocardial Study 

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Animal testing was performed using the catheter and complete system per study 
protocol P-0023068 and test report TR-0023068, Evaluation of Qdot MICRO-
Electrode Catheter with Q-mode Ablation Mode - Beating Heart Animal Study. 
Purpose 
The purpose of this acute study was to evaluate the safety and overall functional 
performance of the QDOT MICRO electrode catheter, in the QMODE ablation mode 
(nMARQ multichannel RF generator), when simulating a clinical pulmonary vein 
isolation (PVI) procedure. The overall safety and functional performance of the 
QDOT MICRO electrode catheter and QMODE ablation mode was compared to the 
control catheter (SmartTouch SF) being used in power control mode (SmartAblate 
generator). 
Summary 
The QMODE Beating Heart study was conducted according to the study protocol 
design and its requirements.  No protocol deviations were noted. 
No char/coagulum was observed on the test catheter (QDOT). The overall 
incidence of steam pop observed with QDOT (5/9 in the LV and 0 in all other 
locations) was lower compared to the control STSF catheter (5/12 in LA, 5/6 in 
LV, 1/7 in RV). Of note, there were zero incidence of steam pop occurred at both 
atrial ablations using the QDOT catheter under the QMODE at the experimental 
settings. 
The QDOT MICRO ablation catheter used in conjunction with the QMODE ablation 
mode was able to: 
x Deliver RF energy at a target site  
x Demonstrate acute isolation of the pulmonary vein. 
x Demonstrate clinically acceptable signal quality which was comparable to 
control. 
x Pace from ring electrodes and microelectrodes during idle-state and during 
ablation. 
x Provide significantly better temperature feedback during ablation than 
control catheter. 
x Function effectively when used in conjunction with ancillary equipment 
like nMARQ multichannel RF generator, QDOT Dongle, CoolFlow pump and 
CARTO 3 mapping system. 
The QDOT MICRO ablation catheter, when used with QMODE ablation mode, was 
able to produce effective electrogram signal attenuation and equivalent (or better) 
lesions as compared with that of STSF in four cardiac chambers. and demonstrate 
signal attenuation. 

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The nMARQ generator was able to successfully modify the irrigation flow rate 
based on QDOT catheter electrode temperature response and power settings to 
maintain temperature limit when used in the QMODE ablation mode. 
                  
4. RISK – BENEFIT  
RF catheter ablation has been used for over 20 years, and the risks and complications 
are well understood.  A summary of risks associated with catheter ablation, including 
analysis of and plans to minimize these risks is provided below: 
4.1 Description and Analysis of Risks 
Risks associated with catheter ablation 
The risk of pulmonary adverse events (e.g., PV stenosis, thrombus and hypertension) 
associated with an AF ablation procedure targeting the pulmonary veins is considered 
small (<4%).10,11,38-42   
Arterial or venous injury, including arterial dissection, thrombosis, occlusion or 
hemorrhage at the catheter insertion sites or at other sites along the vessels can occur 
(risk <1%).43,44 These types of injuries may cause hemorrhage, hematoma or ischemic 
injury to an extremity or major organ. 
Risks associated with RF application 
RF current may cause occlusion of a coronary artery, either by direct thermal damage, 
spasm, or thrombosis. Experience at numerous clinical sites/centers suggests that the 
risk of coronary occlusion is less than 0.5%.43,44 Coronary arterial occlusion could 
produce myocardial infarction, angina or death.   
The application of RF current close to the AV node or HIS bundle could damage or 
destroy the normal AV conduction system, producing complete heart block and 
requiring implantation of a permanent pacemaker. 
A thrombus may form on the ablation electrode during the application of RF current, 
usually indicated by an impedance rise; however, this can also occur in the absence of 
an impedance rise. The thrombus could become dislodged and embolize to produce a 
stroke, myocardial infarction, or other ischemic injury. The risk of an embolus is 
reduced by quickly terminating the application of current after an impedance rise, 
which limits the size of the coagulum on the electrode.  Probably the most important 
aspect of the THERMOCOOL® family of catheters is the absence or very low likelihood 
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Thrombus formation on the endocardium following ablation may produce an arterial 
or pulmonary embolus. This risk may be reduced by the use of aspirin or other 
anticoagulant therapy, at the discretion of the investigator. 
Cardiac perforation may result from catheter manipulation or application of RF 
current. Published risks of cardiac perforation range from <1% to 2.5%.17,30,45-48  This 
may result in cardiac tamponade and may require percutaneous pericardial drainage 
or surgical repair.  In a recent study using the THERMOCOOL SMARTTOUCH® 
Catheter with contact force sensing technology, there were 4 (2.48%, 4/161) reported 
incidents of tamponade.30,45 Additionally, in the SMART-SF study using a new 
investigational catheter with contact force sensing technology the observed incidence 
of tamponade was 1.3% (2/159).  Significant hemodynamic compromise can result in 
neurologic injury or death.  An increased risk of cardiac perforation during ablation 
may be associated with the use of saline-irrigated electrode catheter due to its ability 
to create a larger, deeper lesion.   
This risk is greatest in a thin walled chamber (i.e., right or left atria or right ventricle).  
However, the risk of perforation related to a deep steam pop is reduced if RF energy is 
not delivered perpendicular to the wall at power above 35 or 40 watts.  If the lesion is 
deeper the risk of steam pop is higher above 35-40 watts. 
Peri-esophageal vagal nerve injury or pyloric spasm after left atrial catheter ablation 
of AF can occur when RF energy is applied to the posterior wall of the LA.5 While these 
complications are rare (approximately < 1%), they can potentially compromise the 
clinical outcome severely, requiring surgical treatment.49,50 While there is no 
established method to prevent injury to the vagal nerves, the risk may be reduced by 
using the same techniques used to avoid an atrial esophageal fistula.5 
Injury to a cardiac valve may result from catheter manipulation or the application of 
RF current (risk <1%).43,44   This may produce valvular insufficiency and possibly 
require surgical valve replacement.  
The application of RF energy along the posterior left atrium can result in thermal 
injury to the esophagus and the formation of an atrio-esophageal fistula.  This is a rare 
(0.04%) but severe complication of RF ablation requiring surgical intervention or that 
may result in permanent impairment.17,47 Reducing power at sites in close proximity 
to and/or avoiding sites directly over the esophagus may reduce the risk of thermal 
injury. 
 Injury to the phrenic nerve may occur as a result of RF application in the region of 
right pulmonary veins.  The reported incidence of phrenic nerve injury varies from 
0% to 0.48% when RF energy is used for catheter ablation.51,52 Prior to ablation in the 
region of the right superior pulmonary vein, precautionary measures are 

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recommended to be performed by investigators to evaluate proximity to the phrenic 
nerve, such as pacing maneuvers. 
Risks associated with the general procedure 
Radiation exposure during the fluoroscopic imaging of the catheters may result in an 
increase in the lifetime risk of developing a fatal malignancy (0.1%) or a genetic defect 
in offspring (0.002%).53-55 
A patient could develop an allergic reaction to the local anesthetic, sedatives, x-ray 
dye, heparin, protamine, or other agents administered during the procedure (risk 
<1%).56-60 
Hemorrhage could occur as a result of anticoagulation (risk <0.5%), which may 
require transfusion.43,44  
The percutaneous procedure carries risk of infection, either at the catheter insertion 
site or systemically, including endocarditis and septic emboli (risk <0.5%).43,44 This 
risk can be minimized by using standard aseptic technique and, when indicated, by 
the use of antibiotic agents. 
4.1.1 THERMOCOOL SMARTTOUCH® SF-5D catheter and potential 
procedural risks 
Invasive electrophysiological evaluation and catheter ablation may impart some 
degree of risk to the patient.  The risk of serious complications is generally related to 
the severity of cardiac disease.  The degree of risk of the electrophysiological and 
catheter ablation procedures and the potential benefit of the treatment of persistent 
or recurrent arrhythmia should be determined by a qualified physician.  Cardiac 
catheterization and electrophysiological procedures should be performed by qualified 
and appropriately trained personnel in an electrophysiology laboratory.  The 
laboratory should contain sufficient resuscitative equipment and facilities to manage 
any potential complication.   
Failure to observe any of the contraindications, warnings, and precautions in these 
instructions may result in procedural complications.  Risks include: cardiovascular 
injury or perforation with or without cardiac tamponade, pulmonary embolus, 
tricuspid regurgitation, myocardial infarction, bleeding at the catheter insertion site, 
sepsis, and death.   
Additional contraindications for device use include: hemodynamic instability, 
bacteremia, coagulopathy, prosthetic tricuspid valve, intra-atrial or venous 
thrombosis, and pregnancy. 
4.1.2 nMARQ Multi-Channel RF generator risks 

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Note that the nMARQ™ Multi-Channel RF Generator (D-1341-07) (SW version 2.3.1) 
was CE marked on Oct, 25, 2013.  In order to allow for an interface with the 
THERMOCOOL SMARTTOUCH® SF-5D Catheter, the software was modified to SW 
version 3.0.1.  As a result of the software modification, the nMARQ™ Multi-Channel RF 
Generator will be designated as an investigational device.   Further reference can be 
made to the User manual and addendum, for more information.  Enhanced versions of 
the SW v3.0.1 might be released and used during the course of this study. A protocol 
Amendment will be submitted for approval if any additional significant risks would be 
identified in newly released software versions. 
For SW V3.0.1 there are no anticipated potential direct risks to the subject, the risk is 
mitigated by the temp cutoff setting of the generator.  Further reference can be made 
to the pre-clinical testing reports and Investigator Brochure for more information. 
 
4.2 Minimization of risks 
The risks associated with performing RF catheter ablation using an ablation catheter 
with CF sensing technology, such as the THERMOCOOL SMARTTOUCH® SF-5D 
catheter, is similar to conventional irrigated catheters that do not include this 
technology.  Similarly, the Surround Flow technology found in the THERMOCOOL 
SMARTTOUCH® SF-5D catheter confers a decreased risk of volume overflow 
associated events such as CHF and pulmonary edema in patients with impaired LVEF 
or kidney dysfunction.31, 34   
Data have shown that both the SF and CF technology allow a decrease in overall 
procedure time in experienced users; this in turn decreases fluoroscopy exposure.32  
The criteria for subject selection, methods, personnel, facilities, and training that have 
been specified in this study are intended to minimize the risk to subjects undergoing 
this procedure.  
Subjects will be screened carefully prior to enrollment in the study to ensure 
compliance with the inclusion and exclusion criteria.  The exclusion criteria have been 
developed to exclude subjects with a medical history or condition that increases their 
risk of adverse events (refer to Section 8.3 for the Exclusion Criteria).  All subjects will 
have pre-procedure imaging as described in section 9.1.2.1 to screen for the presence 
of LA thrombus, which is intended to decrease the potential for thromboembolic 
complications.    
Investigators will undergo training on the use of the THERMOCOOL SMARTTOUCH® 
SF-5D Catheter with Contact Force Sensing Capability technology prior to subject 
enrollment.  Investigators skilled in intracardiac mapping and ablation of AF with the 
use of RF ablation catheters containing contact force technology will be selected for 

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participation in the study.  AF ablation procedures will be performed in 
electrophysiology laboratories with the assistance of skilled nurses and technicians.  
Should occlusion of a coronary artery occur for any reason, the physician will attempt 
to restore coronary blood flow through pharmacological, catheter and/or surgical 
intervention as medically indicated. 
Additionally, safety data will be evaluated periodically during enrollment and follow-
up by medical safety officer or designee.  
4.3 Potential benefits 
In patients with PAF, elimination or amelioration of symptoms is a major driving force 
for therapy. The primary clinical benefit of catheter ablation of AF is an improvement 
in quality of life (QoL) resulting from the elimination of arrhythmia-related symptoms 
such as palpitations, fatigue, or effort intolerance.  
The investigational device may allow cardiac ablation procedures to be done with 
greater efficiency, safety, and effectiveness.  This THERMOCOOL SMARTTOUCH® SF-
5D Catheter with Tip/Endocardial Surface Interface Temperature Sensing Capability 
and micro electrodes used in conjunction with CARTO 3 v6.0 QDOT-MICRO Module is 
the first catheter designed with this functionality.  
Further reference can be made to the Risk-Benefit Analysis (RBA) for more 
information. 
5. CLINICAL INVESTIGATION DESIGN  
The Qdot-MICRO study is a prospective, multi-center, non-randomized clinical study to 
evaluate the workflow and acute performance of the THERMOCOOL SMARTTOUCH® SF-
5D system in subjects diagnosed with Paroxysmal Atrial Fibrillation (PAF). 
 
The study population will consist of approximately 50 evaluable subjects with PAF as an 
indication for radiofrequency (RF) ablation. PAF is defined as AF that terminates 
spontaneously or with intervention within 7 days of onset. Episodes may recur with 
variable frequency (ACC guidelines, 2014).67  
 
The study will be conducted at approximately 5 sites in Europe. Follow-up will be 
conducted at 7 days and 3-month post-ablation procedure.  
6. CLINICAL INVESTIGATION OBJECTIVE  
The purpose of this study is to evaluate the workflow and acute performance, during 
standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL 
SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro 
electrodes used in combination with the CARTO® 3 Navigation System with 
THERMOCOOL SMARTTOUCH® SF 5D Module.  

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7. CLINICAL STUDY ENDPOINTS  
7.1 Primary Study Endpoints 
Acute Device Performance 
Acute Device Performance is defined as confirmation of entrance block in all targeted PVs 
after adenosine and/or isoproterenol challenge. 
7.2 Secondary Study Endpoints 
x Safety 
o Incidence of early onset (within 7 days of ablation procedure) primary 
Adverse Events.  
 
Serious Adverse Events occurring within the first week (7 days) following 
an ablation procedure with the THERMOCOOL SMARTTOUCH® SF-5D 
catheter and AE term is one of the adverse events listed, will be considered 
for Primary Event assessment (refer to Appendix A ‘’ Primary Adverse 
Event Classification” for PAE description/criteria) 
                                             Table 3 Primary Adverse Events 
x 
Death 
x 
Atria-Esophageal Fistula* 
x 
Cardiac Tamponade**/Perforation 
x 
Myocardial Infarction 
x 
Stroke/Cerebrovascular Accident 
x 
Thromboembolism 
x 
Transient Ischemic Attack 
x 
Diaphragmatic Paralysis 
x 
Pneumothorax 
x 
Heart Block 
x 
Pulmonary Vein Stenosis 
x 
Pulmonary Edema (Respiratory Insufficiency) 
x 
Vagal Nerve Injury 
x 
Pericarditis 
x 
Major Vascular Access Complication/Bleeding 
*  Pulmonary vein (PV) stenosis and atrio-esophagael fistula that occurs greater than one week (7days) post-procedure shall be 
deemed Primary AEs. ** Hemodynamic compromise or instability is defined as Systolic BP < 80 mmHg 
o Incidence of Serious Adverse Device Effects (SADEs) during follow-up 
period (3 month) 

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x Procedural data 
x Rate for touch-up RF application post adenosine and/ or isoproterenol 
challenge 
x Target sites for RF lesion application 
o Target sites 
o Number of RF applications per target 
o Total RF duration per application (sec) 
x Ablation parameters, including but not limited to: 
o Total RF ablation time 
o Temperature (generator files) 
o Contact Force (CARTO® datafiles) 
o Power (generator files) 
o Impedance 
x Total Fluoroscopy time/dose 
x Total procedure time 
x ECG data 
 
x Investigational device performance (rating with survey): 
o Contact and stability of catheter  
o Signal Quality 
o Temperature visualization 
o Ease of use  
8. STUDY POPULATION  
8.1 Subject identification 
Subjects will be identified sequentially at each site by number only. The subjects will be 
identified by site number and subject number. 
All information and data sent to the sponsor concerning subjects or their participation in 
this clinical investigation will be considered confidential and transmitted anonymously. 
Only authorized sponsor personnel or designee, or local government authorities acting in 
their official capacities will have access to these confidential files. All data used in the 
analysis and reporting of this evaluation will be without identifiable reference to the 
subject. 
The following inclusion and exclusion criteria were selected to ensure the appropriate 
study population is enrolled. 
8.2 Study Inclusion Criteria 
Subjects must meet ALL of the following inclusion criteria to be eligible for participation 
in this clinical investigation: 
1. Age 18 or older 

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2. Patients who have signed the Patient Informed Consent Form (ICF) 
3. Subjects diagnosed with symptomatic documented PAF* who are candidates for 
catheter ablation (*defined as AF that terminates spontaneously or with intervention within 7 
days of onset. Episodes may recur with variable frequency (HRS guidelines, 2017). 
4. Able and willing to comply with all pre-, post-, and follow-up testing and 
requirements (e.g. Patient not confined by a court ruling) 
8.3 Study Exclusion Criteria 
Subjects who meet ANY of the following exclusion criteria are not eligible for enrollment: 
 
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible 
or non-cardiac cause. 
2. Previous ablation for atrial fibrillation. 
3. Previously diagnosed with persistent AF. 
4. Documented Left Atrial thrombus  
5. Any carotid stenting or endarterectomy 
6. LA size >50mm (parasternal long axis view) 
7. LVEF <40% 
8. Uncontrolled heart failure or NYHA function class III and IV 
9. History of blood clotting or bleeding abnormalities or contraindication to 
anticoagulation (heparin, warfarin, or dabigatran) 
10. History of a documented thromboembolic event (including TIA) within the past 12 
months. 
11. Previous PCI/MI within the past 3 months 
12. Previous cardiac surgery (e.g. CABG) or valvular cardiac surgical/percutaneous 
procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a 
prosthetic valve) within the past 6 months. 
13. Awaiting cardiac transplantation or other cardiac surgery within the next 6 
months. 
14. Unstable angina 
15. Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or 
chronic obstructive pulmonary disease) or any other disease or malfunction of the 
lungs or respiratory system that produces chronic symptoms. 
16. Acute illness, active systemic infection, or sepsis. 
17. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or 
other abnormality that precludes catheter introduction or manipulation. 
18. Presence of a condition that precludes vascular access. 
19. Presence of implantable cardioverter-defibrillator (ICD) 
20. Significant congenital anomaly or a medical problem that in the opinion of the 
investigator would preclude enrollment in this trial. 

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21. Currently enrolled in an investigational study evaluating another device, biologics, 
or drug. 
22. Women of child bearing potential whom are pregnant, lactating, or planning to 
become pregnant during the course of the clinical investigation (as evidenced by 
pregnancy test if of child-bearing potential). 
23. Life expectancy less than 12 months. 
24. Presenting contra-indication for the devices used in the study, as indicated in the 
respective instructions for use. 
8.4 Subject Disposition 
The following subject groups are defined: 
x Enrolled subjects: subjects who have signed and dated the Informed Consent Form 
x Excluded subjects: subjects who are enrolled but never undergo the insertion of 
the investigational device. Excluded subjects will not be included in the safety or 
functionality evaluation of the investigational device.  
x Discontinued subjects: subjects who are enrolled and have the investigational 
device inserted but no RF energy is administered by the investigational device. 
Discontinued subjects will remain in the safety cohort. These subjects will be 
followed-up until 7 days post-procedure for safety purpose. 
x Evaluable subjects: subjects who are enrolled and meet the eligibility criteria and 
who undergo ablation with the study catheter.  
x Lost to Follow-up subjects: subjects who are enrolled and evaluable, but contact is 
lost after most recent follow-up visit (despite 3 documented attempts to contact 
the subject). 
x Withdrawn / Early Termination Subjects: subjects who withdraw consent for 
study participation or are withdrawn by the investigator (as described in Section 
8.5) or are terminated from the study prior to completion of all follow-up visits. 
x Completed subjects: subjects who are enrolled and that have not expired, been 
excluded, discontinued, withdrawn, terminated early or lost to follow-up from the 
study, prior to the final study visit. 
8.5 Early Subject Termination 
Every subject should be encouraged to remain in the study until they have completed the 
protocol-required 3-month follow-up period.  If the subject terminates prematurely from 
the study, the reason for termination must be documented by the investigator in the 
source documents and in the appropriate electronic CRF section.  

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Possible reasons for early termination may include but are not limited to the following: 
• 
Withdrawal of consent - Subject decides to withdraw from the study.  This 
decision must be an “independent decision” that is documented in the source 
documentation and in the electronic CRF.   
• 
Lost to follow-up: All subjects should be encouraged to return for protocol 
required office, clinic visit for evaluation during the study follow-up period. If a subject is 
unable to return for an office or clinic visit or unable to be contacted by telephone, 3 
separate telephone calls should be made to obtain subject related safety information. All 
attempts should be documented in the source documents. If the subject does not respond 
to the 3 telephone calls, then the investigator must send a certified letter to the subject. If 
the subject does not respond to the letter, then the subject will be considered “lost to 
follow-up” for the current study visit.  Subject contact must be attempted at each follow-
up time point and if unable to contact the subject after 3 phone calls, the subject should 
once again be sent a certified letter.   
Only after failing to contact the subject at the final follow-up visit will the subject be 
considered lost to follow-up and the study termination/end form will be completed in the 
individual case report form 
• 
Investigator discretion - The investigator may choose to withdraw a subject from 
the study if there are safety concerns. 
• 
Death 
• 
Study Termination - The sponsor can decide to discontinue the study prematurely 
for various reasons. 
8.6 Suspension or premature termination of the study 
The sponsor may either suspend or prematurely terminate the study for significant 
and documented reasons.  
A principal investigator, EC, or regulatory authority may suspend or prematurely 
terminate participation in the study at the study sites for which they are 
responsible. 
If suspicion of an unacceptable risk to subjects arises during the study, or when so 
instructed by the EC or regulatory authorities, the sponsor shall suspend the study 
while the risk is assessed. The sponsor shall terminate the study if an unacceptable 
risk is confirmed. 
The sponsor shall consider terminating or suspending the participation of the 
particular study site or investigator in the study if monitoring or auditing identifies 
serious or repeated deviations on the part of an investigator.  

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If suspension or premature termination occurs, the terminating party shall justify 
its decision in writing and promptly inform the other parties with whom they are in 
direct communication. The principal investigator and sponsor shall keep each other 
informed of any communication received from either the EC or the regulatory 
authority. 
If, for any reason, the sponsor suspends or prematurely terminates the study, the 
sponsor shall inform the responsible regulatory authority as appropriate and 
ensure that the EC is notified, either by the principal investigator or by the sponsor.  
If suspension or premature termination occurs, 
a. the sponsor shall remain responsible for providing resources to fulfill the 
obligation from the Protocol and existing agreements for following up the 
subjects enrolled in the study, and 
b. the principal investigator or authorized designee shall promptly inform the 
enrolled subjects at his/her study site, if appropriate, and 
Note: the method and the timing of this communication will depend on the 
circumstances and the perceived risks 
c. Arrangements will be made for the return of all unused investigational 
medical devices and other material in accordance with the sponsor 
procedures for the study. 
d. The manufacturer or his authorized representative shall notify the 
competent authorities of the Member States concerned of the end of the 
clinical investigation, with a justification in case of early termination. In the 
case of early termination of the clinical investigation on safety grounds this 
notification shall be communicated to all Member States and the 
Commission. 
 
When the sponsor concludes an analysis of the reason(s) for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary 
suspension, the sponsor shall inform the principal investigator, the EC, and, where 
appropriate, the regulatory authority of the rationale and provide them with the 
relevant data supporting this decision. 
Concurrence shall be obtained from the EC and, where appropriate, regulatory 
authorities before the study resumes. 
If subjects have been informed of the suspension, the principal investigator or 
authorized designee shall inform them of the reasons for resumption. 
8.7 Stopping Rules 
The clinical investigation team will review and monitor the clinical safety data on a 
regular basis for any safety or catheter design issues.  Should the team identify any 

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safety issues, the impacted clinical sites, EC’s and CA’s will be immediately notified 
to ensure the safety of their patients and the study may be stopped. 
8.8 Clinical Investigation Timelines/Duration 
Clinical investigation duration is expected to be 9 months (including enrollment 
phase). The enrollment phase is expected to take 6 months following enrollment of 
the first subject. 
9. STUDY PROCEDURES  
9.1 Screening/Baseline 
9.1.1 Informed Consent 
Prior to screening or performing any study related procedures that are solely for the 
purpose of determining eligibility for this study, any potential benefits and risks of the 
study must be explained to the subject directly. Subjects will be informed about all 
aspects of the study that are relevant to the subject's decision to participate 
throughout the study and requested to grant their approval to review their medical 
records, to collect and analyze personal medical information, while maintaining 
confidentiality of the records at all times.   
The informed consent needs to be made up in a native non-technical language that is 
understandable to the subject and needs to be approved by Ethics Committee (EC).  
The subject will be provided ample time to read and understand the informed consent 
form and to consider participation in the study. The informed consent will be 
requested prior to screening and must be personally signed and dated by the subject 
directly prior to performance of any study related activity or procedure. If a subject is 
unable to read or write, informed consent shall be obtained through a supervised oral 
process.  
An independent witness (as applicable) shall be present throughout the process. The 
written informed consent form and any other information shall be read aloud and 
explained to the prospective subject and, whenever possible, subject shall sign and 
personally date the informed consent form. The witness also signs and personally 
dates the informed consent form attesting that the information was accurately 
explained and that informed consent was freely given. The point of enrollment 
corresponds with the time that subjects signs the informed consent. 
The investigator and/or designee must also clearly document the process of obtaining 
informed consent in the subject’s source documents. The voluntary process of 
obtaining informed consent confirms the subject’s willingness to participate in the 
study.  It’s the investigator’s responsibility to ensure that the informed consent 
process is performed in accordance with ICH-GCP and where applicable local and 
federal regulations.  Failure to provide written informed consent renders the subject 
ineligible for the study.  If new information becomes available that can significantly 
affect a subject’s future health and medical care, this information shall be provided to 
the subject(s) affected in written form.  If relevant, all affected subjects shall be asked 

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to confirm their continuing informed consent in writing by dating and signing the 
amended informed consent form. 
9.1.2 Screening/Baseline Visit 
A screening log that is maintained at the clinical site will be used to document all 
patients that were reviewed for potential inclusion into the clinical investigation  
All patients considered for a radiofrequency ablation procedure for paroxysmal Atrial 
Fibrillation should be screened for study eligibility.  The investigator or designated 
member of the research team will evaluate each patient for eligibility for enrollment.   
 
9.1.2.1 Pre-procedure Assessments 
Pre-procedure assessments must be performed within 30 days prior to the index AF 
ablation procedure unless otherwise noted below.  Some assessments (listed below) 
have a shorter window prior to the AF ablation procedure.   
x Transthoracic Echocardiogram (TTE) – Imaging to determine the atrial size 
within 30 days prior to the AF procedure. If the subject has undergone an 
imaging procedure within the 6-months prior to signing an informed consent 
that assessed and documented the left atrial size, the pre-procedure TTE is not 
required. 
x Imaging for detection of LA thrombus – to be performed the day before the 
procedure or the day of the ablation procedure. Subjects meeting either of the 
following 2 criteria must have a pre-procedure TEE to screen for the presence 
of LA thrombus: 
o Subjects with known risk factors such as structural heart disease, 
presence of risk factors for stroke (i.e., CHADS2 score >1), and atrial 
enlargement. 
o Subjects who have been in AF for 48 hours or longer or for an unknown 
duration unless systemic anticoagulation at a therapeutic level has been 
maintained for at least three weeks. 
All other subjects who do not meet the criteria above must either undergo TEE 
or one of the following methods to screen for LA thrombus on the day before or 
the day of the ablation procedure. The imaging method used is at the discretion 
of the investigator based on the patient’s medical history and the investigator’s 
medical judgment: 
o Computed Tomography (CT) 
o Intracardiac Echocardiography (ICE) 
o Magnetic Resonance Imaging (MRI) 
 
x Pregnancy Test – Woman of child-bearing potential only, performed within 1 
week prior to the procedure.  

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x Baseline Medical History 
x Arrhythmias History (including findings from TTM, ECG, Holter monitor, etc.)  
x Baseline Concomitant Cardiac Medications (including anticoagulation 
regimen) 
x Electrocardiogram (12-Lead ECG) 
x Adverse events, if any 
9.2 Study Ablation Procedure 
9.2.1 General Medication Guidelines 
The following medications are recommended/required (as indicated) for subjects 
undergoing a study catheter ablation for AF. 
x Medication Prior to AF Ablation Procedure 
o Uninterrupted systemic anticoagulation therapy is required for at least 3 
weeks prior to the AF ablation procedure.  
x Medication During AF Ablation Procedure 
o Heparin: to achieve an activated clotting time (ACT) of ≥325 seconds 
during the AF ablation procedure. 
o ACT levels should be checked prior to administering RF energy and 
rechecked approximately every 15-30 minutes during the ablation 
procedure to ensure ACT ≥325 seconds. All recordings should be 
documented in the medical records as source documentation. 
o Adenosine: A bolus (I.e. 24mg) to sufficiently confirm PV isolation; rule 
out dormant conduction 
AND/OR 
o Isoproterenol to achieve a ≥ 20 beats per minute increase in heart rate 
to induce AF upon completion of the ablation procedure is 
recommended if pacing maneuvers are not performed (recommended 
dose range is 2-20 mcg/min). 
x Medication Following AF Ablation Procedure 
o Anticoagulation therapy is strongly recommended for 2 months 
following ablation.  Thereafter, subjects should receive anticoagulation 
therapy in accordance with the 2017 HRS.46 Anticoagulation therapy 
will be recorded on the appropriate case report form. 
o Systemic oral anticoagulation is achieved using INR- dose adjusted 
warfarin (INR must be maintained at 2.0-3.0), direct thrombin inhibitor 
or factor Xa inhibitor. 
o Decisions regarding continuation of systemic anticoagulation more than 
2 months post ablation should be based on the patient’s stroke risk 

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The AF ablation procedures for this study should follow the below sequence: 
x Diagnostic catheter placement (discretion of investigator) 
x Electrophysiology study (discretion of investigator) 
x Transseptal puncture 
x Cardioversion if subject is in AF (discretion of investigator) 
x A left atrial anatomical map is required prior to the ablation procedure.  
o An anatomical map is not required of triggers outside of the left atrium 
(e.g., SVC/CS etc.)  
x Introduction of the study catheter and study ablation procedure (see section 
9.2.3.1.2) 
x Post ablation pacing procedure(s) and/or infusion of cardiac medications to 
induce AF (eg, Isoproterenol 2-20 mcg/min) 
9.2.3.1.2 General Introduction of the Study Catheter 
x Detailed Power setting for RF application at LA anatomical locations are 
provided in Section 9.2.3.1.3 
x To minimize the risk of PV stenosis, it is recommended that RF energy 
applications are at least 1 to 2 cm outside the PV ostium to isolate the left and 
right-sided PVs.   
x When ablating near adjacent anatomical structures, take precautions to 
minimize collateral damage to the adjacent structures.   
o When ablating near the esophagus (along the posterior wall of the left 
atrium), take precautions to avoid injuring the esophagus, including 
appropriately reducing RF power and contact force duration (see 
Section 9.2.3.1.6 for required esophageal monitoring instructions) 
o Prior to ablation in the region of the right superior PV, precautionary 
measures are recommended to evaluate proximity to the phrenic nerve, 
such as pacing maneuvers. 
9.2.3.1.3 
  
 
 
 
  
 
 
 
 
 
 
 
  

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x At least one of the following methods MUST be used for esophageal 
localization:  
o Use of an esophageal temperature probe  
o Esophageal visualization with CARTOSOUND® and/or ICE  
o Esophageal visualization using barium swallow 
o Esophageal displacement during RF application 
 
9.2.3.1.7 Ablation Procedures 
The circumferential anatomical approach will be used to isolate all PVs. To minimize 
the risk of PV stenosis, it is recommended that RF energy applications are at least 1 to 
2 cm outside the PV ostium to isolate the left and right-sided PVs.  
Note: confirmation of entrance block in all PVs is required.  
In the event of spontaneous or induced AF and/or atrial flutter, the placement of 
additional RF lesions outside of the PV ostia is at the discretion of the investigator and 
includes the following:  
x Linear lesions between both superior PVs (roof line), the mitral annulus and 
the left inferior PV (mitral isthmus line) or between the LA roof and mitral 
annulus (anterior line)  
x Ablation for any non-PV foci in the LA and/or RA, including isolation of the 
superior vena cava (SVC)  
x Linear lesions in the cavotricuspid isthmus, if the subject has a medical history 
of AFL or AFL is induced spontaneously during the procedure  
If linear lesions are placed, it is recommended that complete conduction block across 
the ablation line be demonstrated by mapping and/or pacing maneuvers.  
9.2.3.1.8 Post-Ablation  
x Verification of entrance block is required for all PVs. 
o A 20-minute waiting period is REQUIRED from the last RF 
application at a PV before verification may be confirmed.  The time 
of the last RF application in a PV and the time of entrance block 
verification MUST be documented in the medical record as source 
documentation. If reconduction is noted, additional RF applications 
should be applied. A second and/or third waiting period will be upon 
investigator’s discretion.  
o Mapping the Ablation lines with the Study catheter’s micro 
electrodes is REQUIRED during the 20-minute waiting period.  If 

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breaks in the RF lines are found additional RF applications should be 
applied.     
 
x To verify entrance block, analyze electrograms in sinus and/or atrial paced 
rhythm to confirm that no PV potentials are present. 
o After a REQUIRED 20-minute waiting period, administer:  
 Adenosine (24mg bolus) to rule out dormant conduction and/or  
 Isoproterenol: to achieve a ≥ 20 beats per minute increase in 
heart rate to induce AF upon completion of the ablation 
procedure (recommended dose range is 2-20 mcg/min). 
x Demonstration of entrance block MUST be confirmed and documented by the 
Lasso® or Pentaray® Circular Mapping Catheter.  
x  The ablation procedure is considered complete when confirmation of entrance 
block in the pulmonary veins is confirmed and documented. 
x Bidirectional block should be confirmed if linear lines are placed (Posterior 
Wall, Roof, Isthmus)  
 
9.2.4 Post Procedure Assessments 
Before hospital discharge: 
x Occurrence of AF or other arrhythmias, if any 
x Concomitant medications (only cardiac related AADs, anticoagulation 
regimen, etc.)  
x Electrocardiogram (12-Lead ECG) 
x Post-procedure Pericarditis Evaluation  
Prior to discharge, all subjects are required to undergo a transthoracic 
echocardiogram (TTE) to assess the pericardium.  In the event significant 
pericardial effusion is identified, subjects should be followed until the 
condition resolves.  
x PV Stenosis Imaging Assessment 
Subjects who exhibit symptoms suggestive of PV stenosis should undergo 
imaging (CT/MRI) to confirm and assess severity, if identified.  In the event 
severe PV stenosis is diagnosed, subjects should be followed until the condition 
resolves or stabilizes.   
x Adverse events, if any 
9.3 Follow-up Requirements post-discharge 
9.3.3 7 days follow-up (telephone or clinic visit) 

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x Occurrence of AF or other arrhythmias, if any 
x Concomitant medications only cardiac related (AADs, anticoagulation 
regimen, etc.) 
x PV Stenosis Imaging Assessment: Subjects who have symptoms suggestive of 
PV stenosis should undergo imaging (CT/MRI) 
x Adverse events, if any 
 
9.3.4 3 Month follow-up (clinic visit) 
x Medical / Hospitalization History  
x Electrocardiogram (12-Lead ECG) 
x Occurrence of AF or other arrhythmias, if any 
x Concomitant medications only cardiac related (AADs, anticoagulation 
regimen, etc.)  
x Adverse events, if any 
x PV Stenosis Imaging Assessment: Subjects who have symptoms suggestive of 
PV stenosis should undergo imaging (CT/MRI) 
x End of Study Follow up (3-Month) 
9.4  Management of Arrhythmia Recurrences and Repeat Ablation 
Procedures during follow-up 
Repeat ablation(s) and management of arrhythmia recurrences during follow-up 
may be managed per investigator discretion.  It’s recommended to perform repeat 
ablations with the THERMOCOOL SMARTTOUCH® SF-5D Catheter utilizing its 
microelectrodes and the Qdot MICRO system. The investigator must verify the 
lesion for gaps and if any, document locations. The follow-up schedule will 
remain based on the initial ablation procedure. 
9.5 Required schedule for subject treatments and evaluations 
Refer to Table 1 for summary of required schedule for subject treatments and 
evaluations. 
10. 
ADVERSE EVENT AND DEVICE DEFICIENCY 
REPORTING  
10.1 
Adverse Events (AE) 
An Adverse Event is 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.  

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NOTE 1: This definition includes events related to the investigational 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. 
As from point of enrollment, at each evaluation and whenever the investigator becomes 
aware of an event, the investigator determines for each enrolled subject whether any 
adverse events (AE) have occurred, and determines their relationship to the 
investigational medical device and procedure as well as the seriousness of the event. 
All adverse events must be recorded in the electronic CRF(s) in a timely manner 
throughout the clinical investigation and shall be reported to the sponsor together with an 
assessment without unjustified delay. 
The date of the adverse event, treatment, resolution, assessment of both seriousness and 
relationship to the investigational device should be provided if available. 
Subjects should be encouraged to report AEs immediately or in response to general, non-
directed questioning (e.g., “How has your health been since the last visit?”). Any time during 
the clinical investigation, the subject may volunteer information that resembles an AE. If it 
is determined that an AE has occurred, the investigator should obtain all the information 
required to complete the AE Form of the electronic CRF. 
All AEs must be followed until resolution or until a stable clinical endpoint is reached. The 
safety officer or designee of this clinical investigation will decide if more follow up 
information is needed in case the event is not resolved or stable at study completion. All 
required treatments and outcomes of the adverse event must be recorded in the electronic 
CRF(s). 
The Sponsor is responsible for the classification of adverse events and ongoing safety 
evaluation of the clinical investigation and shall review the investigator’s assessment of all 
adverse events. The Sponsor will determine and document in writing their seriousness and 
relationship to the investigational device. In case of disagreement between the Sponsor and 
the principal investigator(s), the sponsor shall communicate both opinions to the 
concerned parties. 
10.1.3 
Intensity and Severity 
The following categories of adverse event severity are to be used:  
 
Table 5 Adverse Event Intensity or Severity Definitions 

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Device  
Definitely 
The event is associated with the investigational device beyond reasonable doubt 
as described per MEDDEV 2.7/3 Rev3. 
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 as described per MEDDEV 2.7/3 Rev3. 
Possibly  
The relationship with the use of the investigational device is weak but cannot be 
ruled out completely as described per MEDDEV 2.7/3 Rev3. 
Unlikely  
The relationship with the use of the investigational device seems not relevant 
and/or the event can be reasonably explained by another cause, but additional 
information may be obtained as described per MEDDEV 2.7/3 Rev3. 
Not related 
Relationship to the investigational device can be excluded as described per 
MEDDEV 2.7/3 Rev3. 
 
 
 
 
Study 
Procedure 
Definitely  
The event is associated with the study procedure beyond reasonable doubt as 
described per MEDDEV 2.7/3 Rev3.  
Probable  
The relationship with the study procedure seems relevant and/or the event 
cannot reasonably explained by another cause, but additional information may 
be obtained as described per MEDDEV 2.7/3 Rev3. 
Possibly  
The relationship with the study procedure is weak but cannot be ruled out 
completely as described per MEDDEV 2.7/3 Rev3.  
Unlikely  
The relationship to the study procedure seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be 
obtained as described per MEDDEV 2.7/3 Rev3. 
Not related 
Relationship to the procedure can be excluded as described per MEDDEV 2.7/3 
Rev3. 
 
10.2 
Reportable Serious Adverse Events (MEDDEV 2.7/3 Rev 3) 
The following events are considered reportable events in accordance with 
MEDDEV 2.7/3 Rev 3). 
1. Any Serious Adverse Event that: 
a) led to a death, 
b) led to a serious deterioration in health of the subject, that either resulted in: 
- a life-threatening illness or injury, or 
- a permanent impairment of a body structure or a body function, or 
- in-patient hospitalization or prolongation of existing hospitalization, or 
- in 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 foetal distress, foetal death or a congenital abnormality or birth defect. 

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NOTE 1: Planned hospitalization for pre-existing condition, or a procedure 
required by the Clinical Investigation Plan, without a serious deterioration 
in health, is not considered a serious adverse event. 
2. Any Device Deficiency that might have led to a SAE if: 
a) suitable action had not been taken or 
b) intervention had not been made or 
c) if circumstances had been less fortunate 
3. New findings/updates in relation to already reported events.   
The following clinical events are not considered adverse events for this clinical study: 
x Study Arrhythmia recurrence (Paroxysmal Atrial Fibrillation), independently of 
action taken, by itself is considered a recurrence of disease (pre-existing condition), 
and, therefore, does not meet the definition of an AE.   
x New onset AF/AFL/AT requiring pharmacological or synchronized electrical 
cardioversion during the hospitalization for the index ablation procedure 
x Re-ablation for pre-existing condition itself is not an Adverse Event but any 
procedural complication is considered an Adverse Event and shall be reported 
within the applicable timelines 
 
The investigator must submit to the sponsor (or designee) any SAEs and device deficiencies 
that could have led to a SADE occurring during the clinical investigation within 72 hours 
after being notified of the event and provides additional information, if required by the 
sponsor. The investigator will ensure an appropriate follow-up with the enrolled subjects 
in order to become aware of any serious adverse events in an acceptable timely condition. 
All SAEs need to be followed until the event is resolved (with or without sequelae). The 
safety officer or designee of this clinical investigation will decide if more follow up 
information is needed in case the event is not resolved or stable at study completion. All 
required treatments and outcomes of the SAE must be recorded in the electronic CRF(s). 
The investigator notifies his/her EC of SAEs and device deficiencies that could have led to 
a SADE, occurred at his/her site (and any additional information) as required by Ethics 
Committee or local regulations. 
The sponsor will submit on regular basis (unless otherwise indicated by the Ethics 
Committee or recommended by the Sponsor’s safety officer) to all participating clinical 
investigators an update of all SAEs and all device deficiencies that could have led to a SADE 
occurred at the participating site.  
Event reporting to relevant competent authorities will occur by the sponsor and/or by the 
investigator, depending upon the local requirements and will be done per MEDDEV 2.7/3 
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10.3 
Primary Adverse Events 
The investigator is responsible for reporting, through the electronic data capture system 
(EDC system), all PAEs to the sponsor and/or designee within 72 hours of learning of the 
event. 
Serious Adverse Events occurring within the first week (7 days) following an ablation 
procedure with THERMOCOOL SMARTTOUCH® SF-5D Catheter and AE term is one of the 
adverse events listed, will be considered for Primary Event assessment (Appendix A). 
x 
Death 
x 
Atria-Esophageal Fistula* 
x 
Cardiac Tamponade**/Perforation 
x 
Myocardial Infarction 
x 
Stroke/Cerebrovascular Accident 
x 
Thromboembolism 
x 
Transient Ischemic Attack 
x 
Diaphragmatic Paralysis 
x 
Pneumothorax 
x 
Heart Block 
x 
Pulmonary Vein Stenosis 
x 
Pulmonary Edema (Respiratory Insufficiency) 
x 
Vagal Nerve Injury 
x 
Pericarditis 
x 
Major Vascular Access Complication/Bleeding 
*  Pulmonary vein (PV) stenosis and atrio-esophagael fistula that occurs greater than one week (7days) post-procedure shall be 
deemed Primary AEs. ** Hemodynamic compromise or instability is defined as Systolic BP < 80 mmHg 
10.4 
Anticipated Adverse Events 
An anticipated Adverse Event is an effect which by its nature, incidence, severity or 
outcome has been previously identified in the risk analysis report.  
Anticipated adverse events are described in risks analysis (Refer to Investigators Brochure 
and Instruction for Use). Refer to Appendix B for a comprehensive list of foreseeable and 
anticipated adverse events reported in previous studies of RF ablation. 
10.5 
Adverse Device Effect and Serious Adverse Device Effects 
Adverse Device Effects (ADE’s) are adverse events related to the use of an investigational 
medical device.  
NOTE 1- This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the 
installation, the operation, or any malfunction of the investigational medical device. 

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NOTE 2- This includes any event that is a result of a use error or intentional 
abnormal use of the investigational medical device. 
Serious Adverse Device Effects (SADE’s): adverse device effects that has resulted in any of 
the consequences characteristic of a serious adverse event. 
10.6 
Unanticipated Serious Adverse Device Effects (USADE) 
Unanticipated serious adverse device effect (USADE) is a 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 SADE (ASADE): an effect which by its nature, incidence, severity or 
outcome has been previously identified in the risk analysis report. 
Anticipated adverse device effects are described in risks analysis (Refer to Investigators 
Brochure and Instruction for Use). Refer to Appendix B for a comprehensive list of 
foreseeable and anticipated adverse events reported in previous studies of RF ablation. 
10.7 
Device Deficiency and Complaints 
Inadequacy of an investigational medical device related to its identity, quality, durability, 
reliability, safety or performance. This may include malfunctions, use error, or inadequacy 
in the information supplied by the manufacturer. 
If a device deficiency occurs that could have led to a SADE, the investigator must report the 
event within 72 hours after being notified of the event and provides additional information.  
The sponsor will review all reported device deficiencies and will determine and document 
whether they could have led to a serious adverse device effect (SADE) and report 
accordingly to the regulatory authorities, and ECs. 
Incident reporting of concomitant CE marked devices: 
If a device deficiency of a CE marked device manufactured or distributed by Biosense 
Webster has occurred, the event has to be notified immediately to the sponsor via Biosense 
Webster regular complaints handling process and procedures.  
If this event is considered as an incident according to the definition given in the MEDDEV 
2.12/1 guidelines, the sponsor will notify the incidents to the competent authorities, 
according to the regulatory requirements and company procedures applicable for CE 
marked medical devices. 
A device deficiency related to a medical device not manufactured by Biosense Webster 
should be reported by the investigator to their respective manufacturer as per relevant 
regulation. 

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Complaints related to products manufactured and/or distributed by Biosense Webster, 
used during the procedure related to other devices (other than the study device under 
investigation), are to be reported according to current Biosense Webster procedures and 
other policies as necessary (i.e., institutional policies, EC policies, and local regulations), 
investigators are instructed to return devices in accordance with current company 
procedures and other relevant regulations. 
 Complaints related to non-Biosense Webster, Inc. products must be handled according to 
institutional policies, EC policies, and local regulations. 
10.8 
Documentation/Follow-up reporting 
All AE/SAE must be monitored until they are adequately resolved or explained, including 
submission of follow-up reports to the sponsor or designee as soon as the information 
becomes available. Additional documentation may be requested by the Sponsor or 
designee, including but not limited to, a written subject narrative detailing the clinical 
course of the AE/incident, a copy of any correspondence with the local EC, hospital records, 
death certificate, and an autopsy report, if available. 
10.8.3 
Reporting requirements to sponsor and regulatory/competent 
Authorities 
All Primary AEs, Serious AEs (SAE/SADE, whether or not they are related to the device or 
procedure), Unanticipated Serious Adverse Device Effects (USADE) and study device 
deficiencies must be reported to the Sponsor (Biosense Webster Clinical Operations) or 
designee and entered into the eCRF within 72-hours of awareness by the clinical 
investigation site personnel. 
The sponsor will submit in a timely fashion (unless otherwise indicated by the Ethics 
Committee or regulatory authority) to all participating clinical investigators a safety 
update. Event reporting to relevant competent authorities will occur by the sponsor and/or 
by the investigator, depending upon the local requirements and will be done per MEDDEV 
2.7/3 rev3 guidelines. 
11. 
STATISTICAL ANALYSIS METHODS  
11.1 
Sample Size 
This is a clinical feasibility study for evaluation of workflow and acute performance 
of THERMOCOOL SMARTTOUCH® SF-5D system. This clinical investigation is 
intended to provide preliminary estimates of workflow and acute outcomes.   
Because this study is a feasibility study, there is no statistical power calculation and 
no hypothesis to be generated.  50 evaluable subjects are deemed sufficient to 
characterize the workflow and acute outcomes. 

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Enrollment in the clinical investigation will be approximately 50 evaluable subjects 
with approximately 10 subjects per investigational site, distributed over 
approximately 5 centers in Europe. 
 
11.2 
Analysis Population 
The following analysis populations will be used to complete the analyses of data:  
Safety Population: The Safety population will include all enrolled subjects who 
have the investigational device inserted, regardless if RF energy is delivered.  
Evaluable Population:  The evaluable population will include all enrolled subjects 
who meet the eligibility criteria and who undergo ablation with the study catheter.   
Effectiveness Population: The effectiveness population will include all enrolled 
subjects who have had the investigational device inserted and underwent ablation 
with the study catheter under guidance of the THERMOCOOL SMARTTOUCH® SF-
5D Module. 
      11.3         Statistical Methods 
All data will be summarized by descriptive analyses. No formal statistical inference 
will be made. 
11.3.1 Acute Device Performance 
Acute success is defined as achieving confirmation of entrance block in all targeted 
PVs after adenosine and/ or isoproterenol challenge. The number and percentage 
of subjects who have reached acute success will be summarized. 
11.3.2 Acute Safety 
Acute safety outcome will be reported as the number of primary adverse events and 
the number of subjects experiencing primary adverse events (within 7 days of 
catheter ablation, with exception for PV stenosis and AE fistula (Appendix A)). The 
percentage of subjects experiencing primary adverse events will also be reported.  
 
11.3.3 Safety  
The number and percentage of subjects with early onset (within 7 days of ablation 
procedure with exception for PV stenosis and AE fistula) pre-defined primary 
Adverse Events will be summarized overall and by AE type, seriousness, severity, 
causality, anticipated or not and outcome etc.  The subjects with primary adverse 
events will also be listed. 
The number and percentage of subjects with Serious Adverse Device Effects 
(SADEs) during follow-up period (3 months) will be summarized overall and by 

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AE type, timing (< 7 days, 7-30 days, > 30 days), seriousness, severity, causality, 
anticipated or not and outcome etc. Listing of SADEs will also be provided. 
11.3.4 Procedural Data 
Procedural data will be summarized and listed.  For continuous variables, number 
of subjects with non-missing data, mean, standard deviation, median, 25% 
percentile, 75% percentile, minimum, and maximum will be reported.  For 
categorical variables, the frequency and percentage will be presented for each 
category.  
11.3.5 Investigational device performance  
Investigational device performance (THERMOCOOL SMARTTOUCH® SF-5D 
Catheter (D-1395-05-SI) and nMARQ™ Multi-Channel RF Generator (D-1341-07) 
with Software V. 3.0.1, will be reported by means of survey questions. The scores 
of survey questions will be summarized by presenting the number of subjects with 
non-missing data, mean, standard deviation, median, minimum, and maximum for 
each sub-scale measurement.  Listings of survey answers/scoring will also be 
provided. Workflow questions and interactions with system setup (Dongle (EM-
5050-055F), Interface Cable (D-1357-03-SI), and CARTO 3 v6) might also be 
subjected to investigator feedback. 
12 DATA MANAGEMENT  
The Sponsor or designee will perform all data management activities for this clinical 
investigation. These activities include development and validation of a clinical database, 
into which all clinical investigation data will be entered. The Sponsor or designee will be 
responsible for ensuring overall integrity of the data and database. 
12.1 Data Collection 
Electronic Case Report Forms (eCRF) will be used to collect all subject data during this 
clinical investigation. The eCRF will be developed to capture the information outlined in 
this protocol. Data collected on the eCRFs will be analyzed as defined in the clinical 
investigation protocol. Modification of the eCRF will only be made if deemed necessary by 
the sponsor. All CARTO® 3 v6.0 and Generator data files created during the procedure will 
be downloaded/ extracted and an anonymized copy provided to the sponsor for further 
evaluation. 
12.2 Data Reporting 
The investigator, or a designated individual, is responsible for ensuring that clinical 
investigation data are properly recorded on each subject’s eCRF and related documents. 
The investigator is required to electronically sign the eCRF on the appropriate pages to 
verify that he/she has reviewed and attests to the correctness of the recorded data. 

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Completed eCRF will be monitored by the sponsor personnel, or an appropriately qualified 
and trained designee, at regular intervals throughout the clinical investigation. 
The investigator and institution must permit the inspection of any clinical investigation 
related documentation and eCRF by clinical investigation representatives, responsible 
government agencies, or both. 
All eCRF data should be entered by the designated site personnel in a timely manner after 
the subject visit.  For AE reporting, refer to the Adverse Event Reporting Requirements and 
timelines within this clinical investigation protocol. 
12.3 Missing Data Handling 
Missing questions will be queried for reasons and handled on an individual basis. 
12.4 Source Documentation 
Source documents will serve as the basis for monitoring the eCRF. Source documents may 
include subject’s medical records, hospital charts, clinical charts, the investigator’s subject 
clinical investigation files, admissions and discharge summaries, as well as the results of 
diagnostic tests such as X-rays, laboratory tests, and electrocardiograms. 
If no standard hospital or office document exists to capture information that may be unique 
to this clinical investigation, a worksheet may be developed to record this information, 
which may be signed by the site and serve as the source document for unique clinical 
investigation data. 
Electronic subject records will be considered source documents on the condition that the 
hospital’s database is a validated system. If this is not the case, electronic records will have 
to be printed and added to the subject’s paper file. A print-out of an eCRF cannot be used 
as source documentation. 
 Regulations require that investigators maintain information in the subject’s medical 
records, which corroborate data collected on the eCRF. In order to comply with these 
regulatory requirements, at minimum, the following is a list of information that should be 
maintained on source documentation: 
x Medical history/physical condition of the clinical investigation subject before 
involvement in the clinical investigation sufficient to verify protocol selection 
criteria (if not already present). 
x Dated and signed notes on the day of entry into the clinical investigation including 
the name of the clinical investigation sponsor (Biosense Webster), protocol number, 
clinical site identifier, subject number assigned and a statement that consent was 
obtained. 

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x Dated and signed notes from each clinical investigation visit with reference to the 
eCRF for further information, if appropriate (for specific results of procedures and 
examinations). 
x AEs reported and their resolution, including supporting documents such as 
discharge summaries, EP lab reports, ECGs, laboratory results, etc. 
x Notes regarding protocol-required medication and prescription medications taken 
during the clinical investigation (including start and stop dates). 
x Clinical investigation subject’s condition upon completion of or withdrawal from 
the clinical investigation. 
12.5 Data Verification and Review 
All eCRF will be subjected to automated and manual validation checking for omitted data, 
gross data inconsistencies, and overall data integrity.  The sponsor or designees will 
employ a clinical investigation database on a server, available to site and sponsor 
personnel over an Internet connection. Periodic analysis of data (across cases) will be 
performed in order to examine the expected distributions of data, and to identify outliers 
for possible data entry errors. For first cases at each site, the investigators and/ or 
sponsor may wait for the result of the case analysis before enrolling the next patient in 
this study site. 
12.6 Final Data Analysis 
All exported datasets for analyses will undergo a final data review before final database 
lock. Once all critical data are monitored and locked, the final analyses of clinical 
investigation data will be performed. 
12.7 Confidentiality and Protection of Clinical Investigation 
Data 
During this clinical investigation, all representatives of the Sponsor will comply with all in-
country privacy laws and regulations regarding contact with subjects, their medical record 
information, copying of information, and protection of the subject identities. 
All information and data sent to Biosense Webster concerning subjects or their 
participation in this clinical investigation will be considered confidential.  Only authorized 
Biosense Webster personnel or representatives (including contracted service providers, 
i.e. Core Lab, Clinical Research Associate, CRO, etc.), representatives of the FDA or 
Competent Authorities acting in their official capacities will have access to these 
confidential files upon request (including, but not limited to, laboratory test result reports, 
ECG reports, admissions/discharge summaries for hospital admission occurring during a 
patient’s study participation and autopsy reports for deaths occurring during the clinical 
investigation). Some of the countries to which the study subjects and investigators 
personal data may be transferred may not offer as comprehensive a level of protection of 
personal data as within the European Union but Sponsor will take all reasonable steps to 

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ensure a sufficient level of data protection. All data used in the analysis and reporting of 
this evaluation will exclude identifiable reference to the subject. 
 
13 QUALITY CONTROL AND QUALITY ASSURANCE  
13.1 Monitoring of the study 
The site will undergo periodic monitoring of the clinical investigation, as described in a 
separate monitoring plan and which involves a visit from a Sponsor representative, 
deemed qualified to perform such visit.  Monitoring visits may include, but are not limited 
to, the following: 
x Verification of accuracy of all study logs such as the Subject Log, etc. 
x Verification of proper informed consent for all subjects participating in the clinical 
investigation. 
x Verification of completeness of the Investigator Site File/Regulatory Binder  
x Source verification with the eCRFs  
x Identification and action to resolve any issues or problems with the clinical 
investigation. 
13.2 Protocol Modifications and Adherence 
13.2.1 Protocol Amendment 
All instructions described in this study protocol are to be followed. If an amendment is 
required, it must be made in written form and receive approval from all persons and 
authorities who approved the original protocol. Administrative changes (do not affect 
subject’s benefits/risks ratio) may be inserted with abbreviated approval. All amendments 
will be distributed to all original protocol recipients. 
13.2.2 Prospective Protocol Deviation 
The investigator may prospectively request in writing from the sponsor, or designee, to 
deviate from a specific requirement or requirements stated in the study protocol.  Each 
request must be reviewed and approved by the sponsor prior to allowing the specific 
protocol deviation. 
Such requests will be held to a minimum in order to preserve the integrity of the data  
being collected in the study. 
 
13.2.3 Protocol Deviations/Other Non-compliance issue 

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The study monitors shall verify that the conduct of the study is in compliance with the 
currently approved protocol and applicable regulations, and shall identify any issues of 
non-compliance with regulations or guidelines. 
Issues of non-compliance include but are not limited to protocol deviations, failure to 
obtain proper informed consent, non-conformance to EC requirements, failure to reports 
Adverse Events, product malfunctions and other product issues, non-conformance to GCP. 
A protocol deviation is defined as an instance of failure to follow, intentionally or 
unintentionally, the requirements of the protocol (e.g. missed test or procedure, visit out 
of window, non-adherence to inclusion/exclusion criteria) (even if a prospective protocol 
deviation is granted). Investigators are not allowed to deviate from the protocol.  
Protocol deviations will be monitored closely by the sponsor or designee(s) and shall be 
reported immediately to the EC if the deviation affects subject’s rights, safety and well-
being, or the scientific integrity of the study or according to EC specific requirements. 
Under emergency circumstances, deviations from the protocol to protect the rights, safety 
and well-being of a subject may proceed without prior approval of the sponsor and EC. 
Such deviations shall be documented and reported to the sponsor and the EC as soon as 
possible. 
13.3 Audits and Inspections 
The sponsor and/or designee and/or Regulatory Authorities may contact the participating 
institution to inform the investigator of an upcoming audit/inspection. The investigator 
should immediately notify the sponsor of any Regulatory Authority audits/inspection at 
the study site. The audit/inspection can include the review of documents, facilities, records 
and any other resources deemed by the authorities to be related to study. 
13.4 Responsibilities and Record 
13.4.1 Role of the Sponsor  
As the Sponsor of this clinical investigation, Biosense Webster has the overall 
responsibility for the conduct of the clinical investigation, including assurance that 
the clinical investigation meets the international regulatory requirements and any 
national regulations, as appropriate. The Sponsor will also maintain compliance 
with EU Directive 93/42/EEC, Good Clinical Practice, the International standard ISO 
14155:2011 (Clinical Investigation of Medical Devices for Human Subjects – Good 
clinical practice) and the Declaration of Helsinki (Ethical Principles for Medical 
Research Involving Human Subjects, Brazil, 2013).  

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13.4.2 General Duties 
The sponsor is responsible for providing quality data that satisfy federal regulations 
and informing proper authorities of reportable events and deviations from the 
protocol.   
13.4.3 Sponsor Responsibilities 
x Selection of the study investigators 
x Selection of appropriately qualified and trained individuals, including monitors, to 
conduct the study 
x Development and, if applicable, modifications of protocol and eCRFs 
x Obtain study contracts with investigators/hospitals, CROs and other involved 3rd 
parties 
x Development and/or approval of an adequate informed consent form 
x Ensure that appropriate training/information is provided to the study investigators 
and staff 
x Data and site monitoring 
x Database input, management and maintenance 
x Inform investigator of his/her responsibilities 
x Ensure that all AEs are reported by the study investigators and where appropriate, 
are reported to the other investigators and relevant regulatory authorities 
x Implement insurance coverage prior enrolment of patients 
x Obtain applicable regulatory approval prior to enrollment of subjects 
x Report deviations from the protocol as appropriate. 
x Prepare written required reports and a final clinical study report and provide to ECs 
and regulatory authorities as applicable 
13.4.4 Investigator Responsibilities 
x Obtain EC approval, if applicable 
x Supply the Sponsor with a current curriculum vitae and medical licenses (if 
applicable) for any colleague(s) involved in the study 
x Obtain informed consent form and enroll patients 
x Perform medical procedures 
x Order all tests required by the study protocol 
x Adhere to the study protocol 
x Follow subjects until the end of the study protocol 
x Complete eCRFs on time, completely and accurately 
x Allow the Sponsor direct access to source documents to perform monitoring duties, 
and to perform audits 
x Maintain records and provide reports according to the local legislation/regulations 

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x Share all relevant study-related information with colleagues involved in this study 
x Inform the appropriate entities (e.g., Sponsor, EC in a timely manner regarding the 
occurrence of any AEs and/or device deficiencies. 
13.4.4.1 Investigator Record 
The investigator is responsible for the preparation, review, signature, and maintenance of 
the records cited below. 
x EC approval letter, including approved ICF document, with associated 
correspondence 
x EC membership list 
x Signed Clinical Study Agreement 
x Clinical investigation protocol/Investigational Plan and all amendments, and CRF 
Signed original copy of the Investigator Agreement and CV 
x Correspondence relating to the clinical investigation 
x CV for all Sub-Investigator(s) 
x Investigational site training records 
x All logs including patient ID log, screening log, enrollment log, as applicable 
x Site personnel delegation of authority/responsibility 
x Clinical Monitor/Site Visit sign-in log 
x Reports (e.g., annual reports, final reports from investigator and Sponsor) 
The following records must be maintained for each subject enrolled in the clinical 
investigation: 
x Subject’s case history records including, but not limited to medical history, 
procedure dates, and dates of follow-ups 
x Electronic data, if applicable 
x Source documents (Imaging, ECGs, Pregnancy test, …) 
x Signed informed consents 
x All completed CRFs 
x Supporting documentation of any AE or death 
The investigator must retain copies of procedure reports, procedure nursing notes and the 
results of any interventional procedures that occur while the subject is enrolled in the 
clinical investigation. The sponsor reserves the right to secure data clarification and 
additional medical documentation on subjects enrolled in this clinical investigation. 
13.4.5 Document Retention 
Records and reports will remain on file for a minimum of five (5) years (unless otherwise 
instructed by local requirements) after the completion or termination of this post-approval 
study records and reports may be discarded upon notification by Biosense Webster to the 
clinical investigation site. The principal investigator must contact Biosense Webster prior 

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to destruction of any study-related records or reports to ensure adherence to appropriate 
record retention process. 
All electronic CRFs and all source documents (e.g., informed consent forms, laboratory 
reports, progress notes, medical histories, physical and diagnostic findings, diagnoses, 
procedure dates, and investigational medical device disposition records) that support the 
electronic CRFs must be retained in the files of the responsible investigator for a minimum 
of 5 years or per country specific record retention requirements following notification by 
the sponsor that all investigations have been terminated or completed.  
This documentation must be accessible upon request by the regulatory authorities, the 
sponsor or designee.  
The sponsor must approve archiving or transfer of the documentation for relocation 
purposes off premise, in writing, prior to the actual file transfer. The investigator must 
notify the sponsor, in writing, of transfer location, duration, and the procedure for 
accessing the study documentation. 
If the investigator retires, relocates, or for other reasons withdraws from assuming 
primary responsibility for keeping the study records, custody per written notice (transfer 
of obligation) must be submitted to the sponsor indicating the name and address, of the 
person accepting primary responsibility. The EC must be notified in writing of the name 
and address of the new custodian. Record retention dates must be provided to all parties 
by the sponsor’s corporation. 
13.5 Subject Confidentiality 
Subject confidentiality will be maintained throughout the study in a way that ensures the 
information can always be traced back to the source data. For this purpose, a unique 
subject identification code (ID number and subject name code) will be used that allows 
identification of all data reported for each subject. Data relating to the study might be made 
available to third parties (for example in case of an audit performed by regulatory 
authorities) provided the data are treated confidentially and that the subject’s privacy is 
guaranteed. The privacy of each subject and confidentiality of his/her information shall be 
preserved in reports and when publishing any data. 
13.6 Ethics Committee 
This protocol, informed consent and other applicable study-related documents must be 
reviewed and approved by the appropriate Ethics Committee (EC) and the Competent 
Authorities where the clinical investigation is to be conducted before enrollment of 
subjects. Any additional requirements imposed by the EC or regulatory authority shall be 
followed, if appropriate.  

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The sponsor and the EC must approve in writing any changes to the protocol that affect the 
rights, safety, or welfare of the subjects, or may adversely affect the validity of the clinical 
investigation. 
A signed copy of the EC Approval Form and a signed copy of the EC approval letter 
addressed to the investigator must be submitted to the sponsor certifying clinical 
investigation approval before commencement of subject enrollment. Investigators are 
responsible for submitting and obtaining initial and continuing review (per local 
regulations) of the clinical investigation by their EC. 
13.7 Study Data Reporting and Processing: training 
All Investigators will be required to undergo protocol training prior to starting subject 
enrollment. Investigator experience with AF ablation therapy will be documented. Each 
electrophysiologist must be skilled in intracardiac mapping and ablation of atrial 
fibrillation with the use of the radiofrequency ablation catheters. 
The training of appropriate site personnel will be the responsibility of the sponsor or 
designee. The investigator is responsible for ensuring that his/her staff conduct the study 
according to the protocol and instructions for use accompanying the medical devices. To 
ensure proper device usage, uniform data collection, and protocol compliance, the sponsor 
or designee will present a formal training session to investigators and site personnel. 
Should an investigator miss the formal training session he/she may be trained to the 
protocol and study procedures by the site principal investigator. A sponsor representative 
may be present to support the procedure for the first few cases at each site to ensure that 
the device is being utilized appropriately. 
14 INVESTIGATION AND MEDICAL DEVICE ACCOUNTABILITY  
14.1 Materials 
The Sponsor will keep records of all investigational devices shipped to the site.  
For the THERMOCOOL SMARTTOUCH® SF-5D Catheter, complete manufacturing records 
of every lot of catheter manufactured for human use during this study are maintained at 
Biosense Webster, Inc. Each lot of catheters is released for human use under a Confirmation 
of Conformity from Regulatory Affairs in accordance with MDD 93/42/EEC that will certify 
that the investigational devices conforms to the essential requirements apart from the 
aspects covered by the investigations and that, with regard to these aspects, every 
precaution has been taken to protect the health and safety of the subject. 
After obtaining appropriate approvals (CA/EC), the Sponsor initiate shipments and will 
keep records of all investigational devices shipped to the site. Investigators are responsible 
for appropriate logging of the devices received, verification of packing slip information (i.e., 
lot numbers and quantity shipped), date and identity that each device was used in the 

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study, disposition information regarding return to the Sponsor. The Sponsor will label all 
devices as “exclusively for clinical investigations’;” in a prominent location.  
14.2 Device Accountability 
 The Device Accountability Log shall record the following information for all investigational 
devices: 
x Date of receipt 
x Person in receipt of the devices 
x Quantity received 
x Catalog number  
x Serial/lot numbers 
x Expiry date 
x Date device was used 
x Subject ID on whom device was used 
x Date of return 
x Type of return (i.e., return to Sponsor for adverse event, complaint, etc.) 
x Airway bill number of return shipment 
 
14.3 Device Returns 
All Investigational devices will be labeled as “Exclusively for clinical investigations” and are 
only to be used for subjects enrolled in this clinical investigation.  
All shipped THERMOCOOL SMARTTOUCH® SF-5D catheters (used and unused) will be 
returned to the Sponsor’s attention at the below address. Any suspected malfunctioning 
device or device associated with an adverse event (device related or possibly device 
related) will undergo a thorough complaint analysis and must be properly documented on 
the case report form (CRF).  
All returned devices must be properly decontaminated per hospital policy, product labeling 
and properly labeled with the subject identification number, date of event, identified as a 
defective return, non-defective return, or adverse event.  
Please retain tracking information in the event the package has been lost and requires 
tracking. All investigational devices should be returned to:  
ATTN: Complaints Lab 
Biosense Webster, Inc.  
15715 Arrow Highway 
Irwindale, CA 91706 USA 
 

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14.4 Labeling 
Sample labels are included in the package approved by the Competent Authorities.  All 
labeling clearly identifies the product as investigational.  
15 SAFETY COMMITTEE 
15.1 Data Safety Designee/Committee 
The medical safety officer or designee will review, on regular or urgent basis, all 
applicable adverse events and deaths. This medical safety officer shall advise about 
the appropriateness of continuing or terminating the clinical investigation, based 
upon findings during his review of adverse events and deaths. The overall safety 
profile of the investigational device will be evaluated by the Sponsor at the end of 
the trial. 
16 PUBLICATION POLICY  
Publication of clinical investigation results will be coordinated between Biosense 
Webster, Inc. and the clinical investigation author(s). Authorship will be determined 
prior to development of any manuscript. 
All information concerning the study and investigational medical device, sponsor 
operations, patient application, manufacturing processes, and basic scientific data 
supplied by the sponsor to the investigator and not previously published, are 
considered confidential and remains the sole property of the sponsor. The 
investigator understands that the information developed in this feasibility study 
may be disclosed as required to other investigators or government regulatory 
agencies.  
Any publication or other public presentation of the investigational medical device 
or results from this study require prior review and written approval of the sponsor. 
Draft abstracts, manuscripts, and materials for presentation at scientific meetings 
should be provided to the sponsor at least ninety (90) working days prior to 
abstract or other relevant submission deadlines, unless otherwise agreed. 
 
 
 

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17 REFERENCES 
 
1. Wann, LS, Chair, (2011) 2011 ACCF/AHA/HRS Focused Update on the 
Management of Patients with Atrial Fibrillation (Updating the 2006 Guideline).  J 
Am Coll Cardiol 57:223-242. 
2. Cain ME, (2002) Atrial Fibrillation-Rhythm or Rate Control. New Engl J Med 
347:1822-1823.  
3. Allessie, M. A., Konings, K., Kirchhof, C. J., & Wijffels, M. (1996). Electrophysiologic 
mechanisms of perpetuation of atrial fibrillation. The American Journal of 
Cardiology, 77(3), 10A–23A 
4. Corradi, D., Callegari, S., Maestri, R., Benussi, S., & Alfieri, O. (2008). Structural 
remodeling in atrial fibrillation. Nature Clinical Practice. Cardiovascular Medicine, 
5(12), 782–796.  
5. Calkins H, Chair, Hindricks G, Co-Chair Cappato, R, Co-Chair and Kim YH, Co-Chair. 
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and 
Surgical Ablation of Atrial Fibrillation. Heart Rhythm 2017;14:e275-e443.  
6. Pappone, C., Augello, G., Sala, S., Gugliotta, F., Vicedomini, G., Gulletta, S., … 
Santinelli, V. (2006). A randomized trial of circumferential pulmonary vein 
ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the 
APAF Study. Journal of the American College of Cardiology, 48(11), 2340–2347.  
7. Wilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., … 
THERMOCOOL AF Trial Investigators. (2010). Comparison of antiarrhythmic drug 
therapy and radiofrequency catheter ablation in patients with paroxysmal atrial 
fibrillation: a randomized controlled trial. JAMA, 303(4), 333–340.  
8. Macle, L., Jaïs, P., Weerasooriya, R., Hocini, M., Shah, D. C., Choi, K.-J., … 
Haïssaguerre, M. (2002). Irrigated-tip catheter ablation of pulmonary veins for 
treatment of atrial fibrillation. Journal of Cardiovascular Electrophysiology, 
13(11), 1067–1073. 
9. Haïssaguerre, M., Shah, D. C., Jaïs, P., Hocini, M., Yamane, T., Deisenhofer, I., … 
Clémenty, J. (2000). Electrophysiological breakthroughs from the left atrium to the 
pulmonary veins. Circulation, 102(20), 2463–2465. 
10. Pappone, C., Oreto, G., Rosanio, S., Vicedomini, G., Tocchi, M., Gugliotta, F., … Alfieri, 
O. (2001). Atrial electroanatomic remodeling after circumferential radiofrequency 
pulmonary vein ablation: efficacy of an anatomic approach in a large cohort of 
patients with atrial fibrillation. Circulation, 104(21), 2539–2544. 
11. Oral, H., Knight, B. P., Tada, H., Ozaydin, M., Chugh, A., Hassan, S., … Morady, F. 
(2002). Pulmonary vein isolation for paroxysmal and persistent atrial fibrillation. 
Circulation, 105(9), 1077–1081. 
12. Marrouche, N. F., Dresing, T., Cole, C., Bash, D., Saad, E., Balaban, K., … Natale, A. 
(2002). Circular mapping and ablation of the pulmonary vein for treatment of 
atrial fibrillation: impact of different catheter technologies. Journal of the 
American College of Cardiology, 40(3), 464–474. 

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13. Singh, S. M., d’Avila, A., Doshi, S. K., Brugge, W. R., Bedford, R. A., Mela, T., … Reddy, 
V. Y. (2008). Esophageal injury and temperature monitoring during atrial 
fibrillation ablation. Circulation. Arrhythmia and Electrophysiology, 1(3), 162–
168.  
14. Knopp, H., Halm, U., Lamberts, R., Knigge, I., Zachäus, M., Sommer, P., … Husser, D. 
(2014). Incidental and ablation-induced findings during upper gastrointestinal 
endoscopy in patients after ablation of atrial fibrillation: a retrospective study of 
425 patients. Heart Rhythm: The Official Journal of the Heart Rhythm Society, 
11(4), 574–578.  
15. Koruth, J. S., Dukkipati, S., Gangireddy, S., McCarthy, J., Spencer, D., Weinberg, A. D., 
… Reddy, V. Y. (2013). Occurrence of steam pops during irrigated RF ablation: 
novel insights from microwave radiometry. Journal of Cardiovascular 
Electrophysiology, 24(11), 1271–1277.  
16. Haines, D. E., & Verow, A. F. (1990). Observations on electrode-tissue interface 
temperature and effect on electrical impedance during radiofrequency ablation of 
ventricular myocardium. Circulation, 82(3), 1034–1038. 
17. Cappato, R., Calkins, H., Chen, S.-A., Davies, W., Iesaka, Y., Kalman, J., … Biganzoli, E. 
(2010). Updated worldwide survey on the methods, efficacy, and safety of catheter 
ablation for human atrial fibrillation. Circulation. Arrhythmia and 
Electrophysiology, 3(1), 32–38.  
18. Nakagawa, H., Yamanashi, W. S., Pitha, J. V., Arruda, M., Wang, X., Ohtomo, K., … 
Jackman, W. M. (1995). Comparison of in vivo tissue temperature profile and 
lesion geometry for radiofrequency ablation with a saline-irrigated electrode 
versus temperature control in a canine thigh muscle preparation. Circulation, 
91(8), 2264–2273. 
19. Avitall, B., Mughal, K., Hare, J., Helms, R., & Krum, D. (1997). The effects of 
electrode-tissue contact on radiofrequency lesion generation. Pacing and Clinical 
Electrophysiology: PACE, 20(12 Pt 1), 2899–2910. 
20. Haines, D. E. (1991). Determinants of Lesion Size During Radiofrequency Catheter 
Ablation: The Role of Electrode-Tissue Contact Pressure and Duration of Energy 
Delivery. Journal of Cardiovascular Electrophysiology, 2(6), 509–515.  
21. Yokoyama, K., Nakagawa, H., Shah, D. C., Lambert, H., Leo, G., Aeby, N., … Jackman, 
W. M. (2008). Novel contact force sensor incorporated in irrigated radiofrequency 
ablation catheter predicts lesion size and incidence of steam pop and thrombus. 
Circulation. Arrhythmia and Electrophysiology, 1(5), 354–362.  
22. Thiagalingam, A., D’Avila, A., Foley, L., Guerrero, J. L., Lambert, H., Leo, G., … Reddy, 
V. Y. (2010). Importance of catheter contact force during irrigated radiofrequency 
ablation: evaluation in a porcine ex vivo model using a force-sensing catheter. 
Journal of Cardiovascular Electrophysiology, 21(7), 806–811.  
23. Wittkampf, F. H. M., & Nakagawa, H. (2006). RF catheter ablation: Lessons on 
lesions. Pacing and Clinical Electrophysiology: PACE, 29(11), 1285–1297.  
24. Shah, D., Lambert, H., Langenkamp, A., Vanenkov, Y., Leo, G., Gentil-Baron, P., & 
Walpoth, B. (2011). Catheter tip force required for mechanical perforation of 

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porcine cardiac chambers. Europace: European Pacing, Arrhythmias, and Cardiac 
Electrophysiology: Journal of the Working Groups on Cardiac Pacing, Arrhythmias, 
and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 
13(2), 277–283.  
25. Kuck, K.-H., Reddy, V. Y., Schmidt, B., Natale, A., Neuzil, P., Saoudi, N., … Shah, D. C. 
(2012). A novel radiofrequency ablation catheter using contact force sensing: 
Toccata study. Heart Rhythm: The Official Journal of the Heart Rhythm Society, 
9(1), 18–23.  
26. Ikeda, A., Nakagawa, H., Lambert, H., Shah, D. C., Fonck, E., Yulzari, A., … Jackman, 
W. M. (2014). Relationship between catheter contact force and radiofrequency 
lesion size and incidence of steam pop in the beating canine heart: electrogram 
amplitude, impedance, and electrode temperature are poor predictors of 
electrode-tissue contact force and lesion size. Circulation. Arrhythmia and 
Electrophysiology, 7(6), 1174–1180.  
27. Reddy, V. Y., Shah, D., Kautzner, J., Schmidt, B., Saoudi, N., Herrera, C., … Kuck, K.-H. 
(2012). The relationship between contact force and clinical outcome during 
radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart 
Rhythm: The Official Journal of the Heart Rhythm Society, 9(11), 1789–1795.  
28. Neuzil, P., Reddy, V. Y., Kautzner, J., Petru, J., Wichterle, D., Shah, D., … Kuck, K.-H. 
(2013). Electrical reconnection after pulmonary vein isolation is contingent on 
contact force during initial treatment: results from the EFFICAS I study. 
Circulation. Arrhythmia and Electrophysiology, 6(2), 327–333.  
29. Marijon, E., Fazaa, S., Narayanan, K., Guy-Moyat, B., Bouzeman, A., Providencia, R., 
… Albenque, J.-P. (2014). Real-time contact force sensing for pulmonary vein 
isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year 
results. Journal of Cardiovascular Electrophysiology, 25(2), 130–137.  
30. Natale, A., Reddy, V. Y., Monir, G., Wilber, D. J., Lindsay, B. D., McElderry, H. T., … 
Marchlinski, F. E. (2014). Paroxysmal AF catheter ablation with a contact force 
sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of 
the American College of Cardiology, 64(7), 647–656.  
31. Bertaglia, E., Fassini, G., Anselmino, M., Stabile, G., Grandinetti, G., De Simone, A., … 
Gaita, F. (2013). Comparison of THERMOCOOL® Surround Flow catheter versus 
THERMOCOOL® catheter in achieving persistent electrical isolation of pulmonary 
veins: a pilot study. Journal of Cardiovascular Electrophysiology, 24(3), 269–273.  
32. Sciarra, L., Golia, P., Natalizia, A., De Ruvo, E., Dottori, S., Scarà, A., … Calò, L. (2014). 
Which is the best catheter to perform atrial fibrillation ablation? A comparison 
between standard THERMOCOOL, SmartTouch, and Surround Flow catheters. 
Journal of Interventional Cardiac Electrophysiology: An International Journal of 
Arrhythmias and Pacing, 39(3), 193–200.  
33. Park, C.-I., Lehrmann, H., Keyl, C., Weber, R., Schurr, P., Schiebeling-Römer, J., … 
Jadidi, A. S. (2013). Enhanced efficiency of a novel porous tip irrigated RF ablation 
catheter for pulmonary vein isolation. Journal of Cardiovascular Electrophysiology, 
24(12), 1328–1335.  

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34. Scaglione, M., Blandino, A., Raimondo, C., Caponi, D., Di Donna, P., Toso, E., … Gaita, 
F. (2012). Impact of ablation catheter irrigation design on silent cerebral embolism 
after radiofrequency catheter ablation of atrial fibrillation: results from a pilot 
study. Journal of Cardiovascular Electrophysiology, 23(8), 801–805. 
35. Theis C, Rostock T, Mollnau H, Sonnenschein S, Himmrich E, Kämpfner D, Ocete 
BQ, Bock K, Münzel T, Konrad T.  The Incidence of Audible Steam Pops Is Increased 
and Unpredictable With the ThermoCool® Surround Flow Catheter During Left 
Atrial Catheter Ablation: A Prospective Observational Study. J Cardiovasc 
Electrophysiol. 2015 26:956-962. 
36. Guerra JM, Jorge E, Raga S, Galvez-Monton C, Alonso-Martin C, Rodriguez-Font E, 
Cinca J, Vinolas X: Effects of open-irrigated radiofrequency ablation catheter 
design on lesion formation and complications: In vitro comparison of 6 different 
devices. J Cardiovasc Electrophysiol 2013;24:1157-1162. 
37. Santucci PA, Thomas K, Vasaiwala S, Cytron J, Green A, Winterfield J, Wilber D: 
Initial experience of major complications with a 56 hole irrigated ablation 
catheter. Heart Rhythm 2013;10:32:AB14-03.  
38. Gerstenfeld EP, Guerra P, Sparks PB, Hattori K, Lesh MD, (2001) Clinical Outcome 
After Radiofrequency Catheter Ablation of Focal Atrial Fibrillation Triggers. J 
Cardiovasc Electrophysiol 12:900-908. 
39. Takahasi A, Lesaka Y, Takahasi Y, Takahasi R, Kobayashi K, Takagi K, Kuboyama O, 
Nishimori T, Takei H, Amemiya H, Fujiwara H, Hiraoka M, (2002) Electrical 
Connections Between Pulmonary Veins; Implication for Ostial Ablation of 
Pulmonary Veins in Patients with Paroxysmal Atrial Fibrillation. Circulation 
105:2998-3003. 
40. Yamane T, Shah DC, Jaïs P, Hocini M, Deisenhofer I, Choi K-J, Macle L, Clémenty J, 
Haïssaguerre M, (2002) Electrogram Polarity Reversal as an Additional Indicator 
of Breakthroughs From the Left Atrium to the Pulmonary Veins. J Am Coll Cardiol 
39:1337-1344. 
41. Macle L, Jaïs P, Weerasooriya R, Hocini M, Shah DC, Choi K-J, Scavée C, Raybaud F, 
Clémenty J, Haïssaguerre M, (2002) Irrigated-Tip Catheter Ablation of Pulmonary 
Veins for Treatment of Atrial Fibrillation. J Cardiovasc Electrophysiol 113:1067-
1073. 
42. Deisenhofer I, Schneider MAE, Böhlen-Knauf M, Zrenner B, Ndrepepa G, Schmieder 
S, Weber S, Schreieck J, Weyerbrock S, Schmitt C, (2003) Circumferential Mapping 
and Electric Isolation of Pulmonary Veins in Patients With Atrial Fibrillation. Am J 
Cardiol 91:159-163. 
43. Huang SKS, Wilber DJ (eds): Radiofrequency Catheter Ablation of Cardiac 
Arrhythmias: Basic Concepts and Clinical Applications, 2nd ed. Grouponk, NY: 
Futura Publishing Company, Inc. (2000); Lin AC, Wilber D, Complications 
Associated With Radiofrequency Catheter Ablation. Pages 737-746. 
44. Scheinman MM, Huang S, (2000) The 1998 NASPE Prospective Catheter Ablation 
Registry. PACE 23:1020-1028. 

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 76 of 83 
MQDT-166 
QDOT MICRO Protocol Version 2.0 17-Nov-2017 
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45. NAVISTAR® THERMOCOOL® Catheter Clinical Report IDE #G030236. 
(MASTER_Final_AF_PMA_Results_12Aug08_ThermoCool.pdf) 
46. Packer et al. (2013) Summary of Safety and Effectiveness Data for Cardiac 
CryoAblation Catheter. (CryoAblation SSED Packer 2013.pdf) 
47. Cappato R, Calkins H, Chen SA, et al. (2005) Worldwide survey on the methods, 
efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 
111:1100-1105.  
48. Bunch TJ, Asirvatham SJ, Friedman PA, Monahan KH, Munger TM, Rea RF, Sinak LJ, 
Packer DL. (2005) Outcomes after cardiac perforation during radiofrequency 
ablation of the atrium. J Cardiovasc Electrophysio. 16:1172-11797. 
49. Shah D, Dumonceau JM, Burri H, Sunthorn H, Schroft A, Gentil-Baron P, Yokoyama 
Y, Takahashi A, (2005). Acute pyloric spasm and gastric hypomotility: an 
extracardiac adverse effect of percutaneous radiofrequency ablation for atrial 
fibrillation. J Am Coll Cardiol. Jul 19;46(2):327-30. 
50. Kuwahara T, Takahashi A, Takahashi Y, Kobori A, Miyazaki S, Takei A, Fujino T, 
Okubo K, Takagi K, Fujii A, Takigawa M, Watari Y, Hikita H, Sato A, Aonuma K, 
(2013). Clinical characteristics and management of periesophageal vagal nerve 
injury complicating left atrial ablation of atrial fibrillation: lessons from eleven 
cases. J Cardiovasc Electrophysiol. Aug;24(8):847-51. doi: 10.1111/jce.12130. 
Epub 2013 Mar 29.  
51. Sacher F, Monahan KH, Thomas SP, Davidson N, Adragao P, Sanders P, HociniM, 
Takahashi Y, Rotter M, Rostock T, et al. (2006) Phrenic nerve injury after atrial 
fibrillation catheter ablation: characterization and outcome in a multicenter study. 
J Am Coll Cardiol 47:2498-2503. 
52. Bai R, Patel D, Di BL, Fahmy TS, Kozeluhova M, Prasad S, Schweikert R, Cummings 
J, Saliba W, ndrews-Williams M, et al. (2006) Phrenic nerve injury after catheter 
ablation: should we worry about this complication? J Cardiovasc Electrophysiol 
17:944-948. 
53. Kovoor P, Ricciardello M, Collins L, Uther JB, Ross DL, (1998) Risk to Patients From 
Radiation Associated With Radiofrequency Ablation for Supraventricular 
Tachycardia. Circulation 98:1534-1540. 
54. Nahass GT (1995) Fluoroscopy and the Skin: Implications for Radiofrequency 
Catheter Ablation Am J Cardiol 76:174-176. 
55. Calkins H, Niklason L, Sousa J, el-Atassi R, Langberg J, Morady F, (1991) Radiation 
Exposure During Radiofrequency Catheter Ablation of Accessory Atrioventricular 
Connection, Circulation 84:2376-2382. 
56. Cox B, Durieux ME, Marcus MA, (2003) Toxicity of Local Anaesthetics. Best Pract 
Res Clin Anaesthesiol.17: 111-136. 
57. Mertes PM, Laxenaire MC, (2002) Allergic Reactions Occurring During 
Anaesthesia. Eur J Anaesthesiol. 19:240-262. 
58. Morcos SK, Thomsen HS, Webb JA; Contrast Media Safety Committee of the 
European Society of Urogenital Radiology (2001) Prevention of Generalized 

Biosense Webster, Inc. 
CONFIDENTIAL 
Page 77 of 83 
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QDOT MICRO Protocol Version 2.0 17-Nov-2017 
Protocol #-MQDT-166 
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Reactions to Contrast Media: A Consensus Report and Guidelines. Eur Radiol 
11:1720-1728. 
59. Gruchalla RS, (2003) 10. Drug Allergy. J Allergy Clin Immunol. 111:S548-S559. 
60. Bick RL, Frenkel EP, (1999) Clinical Aspects of Heparin-Induced 
Thrombocytopenia and Thrombosis and Other Side Effects of Heparin Therapy. 
Clin Appl Thromb Hemost. 5:S7-S15.  
61. Ejima K,  Arai K, Suzuki T, et al. (2014) Long-term outcome and preprocedural 
predictors of atrial tachyarrhythmia recurrence following pulmonary vein antrum 
isolation-based catheter ablation in patients with non-paroxysmal atrial 
fibrillation. J Cardiol 64:57-63. Epub 2013 Dec 25. 
62. Oza SR, Hunter TD, Biviano AB, et al. (2014) Acute Safety of an Open-Irrigated 
Ablation Catheter with 56-Hole Porous Tip for Radiofrequency Ablation of 
Paroxysmal Atrial Fibrillation: Analysis from 2 Observational Registry Studies. J 
Cardiovasc Electrophysiol. 25:852-858. Epub 2014 Apr 9.   
63. Kaiser DW, Streur MM, Nagarakanti R, Whalen SP, Ellis CR. (2013) Continuous 
warfarin versus periprocedural dabigatran to reduce stroke and systemic 
embolism in patients undergoing catheter ablation for atrial fibrillation or left 
atrial flutter. J Interv Card Electrophysio. 37:241-247. Epub Apr 28.  
64. Stepanyan G, Badhwar N, Lee RJ, et al. (2014) Safety of new oral anticoagulants for 
patients undergoing atrial fibrillation ablation. J Interv Card Electrophysiol. 40:33-
38. Epub Mar 19.  
65. Khaykin Y, Skanes A, Champagne J, et al. (2009) A Randomized Controlled Trial of 
the Efficacy and Safety of Electroanatomic Circumferential Pulmonary Vein 
Ablation Supplemented by Ablation of Complex Fractionated Atrial Electrograms 
Versus Potential-Guided Pulmonary Vein Antrum Isolation Guided by Intracardiac 
Ultrasound. Circ Arrhythm Electrophysiol 2:481-487.  
66. Di Biase L, Santangeli P, Natale A. (2013) How to ablate long-standing persistent 
atrial fibrillation? Curr Opin Cardiol. 28:26-35. 
67. January CT, Chair, (2014) 2014 AHA/ACC/HRS Guideline for the Management of 
Patients With Atrial Fibrillation: Executive Summary: A Report of the American 
College of Cardiology/American Heart Association Task Force on Practice 
Guidelines and the Heart Rhythm Society. Circulation 130(23):2071-2104.