Evaluation of the VISITAG SURPOINT™ Module With External Processing Unit (EPU) When Used With the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Biosense Webster, Inc.

 
Biosense Webster, Inc 
 
 
CONFIDENTIAL 
 
 
 
Evaluation of the VISITAG SURPOINT™ Module with 
External Processing Unit (EPU) when used with the 
THERMOCOOL SMARTTOUCH® SF and the 
THERMOCOOL SMARTTOUCH® Catheters for 
Pulmonary Vein Isolation (PVI)  
(SURPOINT COA) 
 
 
Clinical Study Protocol 
 
Protocol# BWI_2017_06 
 
 
Version 4.0 
March 8, 2019 
 
 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 2 of 91 
Table of Contents 
 Introduction .......................................................................................................................... 17 
1.1 
Background .................................................................................................................... 17 
1.2 
Rationale......................................................................................................................... 18 
1.3 
Risk Analysis.................................................................................................................. 20 
1.3.1 
Description and Analysis of Risks .......................................................................... 20 
1.3.2 
Minimization of Risks............................................................................................. 22 
1.3.3 
Precautions .............................................................................................................. 23 
1.4 
Device Description ......................................................................................................... 24 
1.4.1 
THERMOCOOL SMARTTOUCH® SF catheter .................................................. 24 
1.4.2 
THERMOCOOL SMARTTOUCH® catheter ....................................................... 25 
1.5 
Approved Catheters ........................................................................................................ 27 
1.6 
Supply of Approved Catheter ......................................................................................... 27 
1.7 
VISITAG SURPOINT™ Module (Tag Index) .............................................................. 27 
1.8 
VISITAG SURPOINT™ EPU Description ................................................................... 29 
1.8.1 
VISITAG SURPOINT™ EPU indication for Use .................................................. 29 
1.8.2 
Principles of Operation ........................................................................................... 29 
 
Study Objective .................................................................................................................... 30 
 
Study Design ........................................................................................................................ 30 
3.1 
Subject Selection ............................................................................................................ 30 
3.1.1 
Inclusion Criteria .................................................................................................... 30 
3.1.2 
Exclusion Criteria ................................................................................................... 31 
3.2 
Subject Disposition ........................................................................................................ 32 
3.3 
Subject Withdrawal/Early Termination ......................................................................... 32 
3.4 
Subjects Lost to Follow up ............................................................................................. 33 
 
Study Endpoints ................................................................................................................... 33 
4.1 
Primary Endpoints .......................................................................................................... 33 
4.1.1 
Primary Effectiveness Endpoint ............................................................................. 33 
4.1.2 
Primary Safety Endpoint ......................................................................................... 34 
4.2 
Secondary Endpoints ...................................................................................................... 34 
4.2.1 
Secondary Effectiveness Endpoints ........................................................................ 34 
4.2.2 
Secondary Safety Endpoints ................................................................................... 35 
4.3 
Additional Endpoints...................................................................................................... 35 
4.4 
Health Economic Data ................................................................................................... 36 
 
Treatment Description ......................................................................................................... 36 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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5.1 
Patient Screening ............................................................................................................ 38 
5.2 
Informed Consent ........................................................................................................... 38 
5.3 
Pre-Procedure Assessments............................................................................................ 39 
5.4 
General AF Procedure Guidelines.................................................................................. 39 
5.5 
Esophageal Monitoring .................................................................................................. 40 
5.6 
Recommended RF Power: .............................................................................................. 40 
5.7 
Contact Force (CF) Settings ........................................................................................... 41 
5.8 
VISITAG™ Settings ...................................................................................................... 41 
5.9 
VISITAG SURPOINT™ Tag Index Targets ................................................................. 42 
5.10 
Ablation Procedure ..................................................................................................... 42 
5.11 
Post Ablation .............................................................................................................. 43 
5.12 
Post Procedure Assessments ....................................................................................... 43 
5.13 
Standard Tests and Procedures ................................................................................... 47 
5.14 
Study Medications ...................................................................................................... 49 
5.14.1 
Anticoagulation Medications .............................................................................. 49 
5.15 
Antiarrhythmic Drug (AAD) Management ................................................................ 49 
5.15.1 
Definitions ........................................................................................................... 49 
5.16 
Heart Rhythm Monitoring .......................................................................................... 50 
5.17 
Study Equipment ........................................................................................................ 51 
5.17.1 
Required Catheters and Equipment ..................................................................... 51 
5.17.2 
Recommendation for Irrigation Pump Setting and RF Power Delivery ............. 52 
5.17.3 
Investigator Training ........................................................................................... 53 
5.18 
Repeat AF Ablation Procedures ................................................................................. 54 
5.19 
Core Laboratory .......................................................................................................... 54 
 
Adverse Events .................................................................................................................... 55 
6.1 
Adverse Event Recording............................................................................................... 55 
6.2 
Classification .................................................................................................................. 55 
6.2.1 
Primary Adverse Event ........................................................................................... 55 
6.3 
Serious AEs .................................................................................................................... 59 
6.4 
Non-Serious AEs (NSAEs) ............................................................................................ 59 
6.5 
Anticipated AEs ............................................................................................................. 59 
6.6 
Unanticipated Serious Adverse Device Effect ............................................................... 63 
6.7 
Clinical Investigation Device Failure/Malfunction/Deficiency ..................................... 63 
6.8 
Reporting Requirements ................................................................................................. 63 
6.9 
Intensity or Severity ....................................................................................................... 63 

SURPOINT COA 
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Biosense Webster, Inc 
 
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CONFIDENTIAL 
Page 4 of 91 
6.10 
Outcome...................................................................................................................... 64 
6.11 
Causality ..................................................................................................................... 64 
6.12 
Documentation............................................................................................................ 65 
6.13 
Clinical Events Committee (CEC) ............................................................................. 65 
 
Statistical Analysis Methods ................................................................................................ 66 
7.1 
Study Design .................................................................................................................. 66 
7.2 
Treatment Assignment ................................................................................................... 66 
7.3 
Randomization and Blinding Procedures ....................................................................... 66 
7.4 
Interval Windows ........................................................................................................... 66 
7.5 
Primary and Secondary Endpoint(s) and Associated Hypotheses ................................. 67 
7.5.1 
Primary Endpoints and Associated Hypotheses ..................................................... 67 
7.5.2 
Secondary Endpoints .............................................................................................. 68 
7.5.3 
Additional Endpoints .............................................................................................. 69 
7.5.4 
Health Economic Data ............................................................................................ 69 
7.6 
Level of Significance ..................................................................................................... 69 
7.7 
Analysis Sets .................................................................................................................. 70 
7.8 
Sample Size Justification ............................................................................................... 70 
7.9 
Statistical Analysis Methods .......................................................................................... 70 
7.9.1 
General Conventions ............................................................................................... 70 
7.9.2 
Subject Disposition ................................................................................................. 71 
7.9.3 
Demography and Baseline Characteristics ............................................................. 71 
7.9.4 
Analysis of Primary Endpoints ............................................................................... 71 
7.9.5 
Additional Analysis for Primary Effectiveness Endpoint ....................................... 73 
7.9.6 
Analysis of Secondary Endpoints ........................................................................... 73 
7.9.7 
Analysis of Additional Endpoints ........................................................................... 73 
7.9.8 
Analysis of Health Economic Data ......................................................................... 74 
7.10 
Data Monitoring Committee ....................................................................................... 74 
 
Administrative Responsibilities ........................................................................................... 74 
8.1 
Ethics Review ................................................................................................................. 74 
8.2 
Patient Informed Consent ............................................................................................... 74 
8.3 
Confidentiality ................................................................................................................ 74 
8.4 
Data Management .......................................................................................................... 74 
8.4.1 
Case Report Forms (CRFs) ..................................................................................... 74 
8.4.2 
Data Reporting ........................................................................................................ 74 
8.4.3 
Data Review ............................................................................................................ 75 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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8.5 
Records and Reports....................................................................................................... 75 
8.5.1 
Records ................................................................................................................... 75 
8.5.2 
Record Retention .................................................................................................... 76 
8.5.3 
Procedural Data ....................................................................................................... 76 
8.5.4 
Investigator’s Final Report ..................................................................................... 76 
8.5.5 
Interim Post-Approval Study Status Report ........................................................... 76 
8.6 
Labeling .......................................................................................................................... 77 
8.7 
Deviations from Protocol and Good Clinical Practice ................................................... 77 
 
Study Management .............................................................................................................. 77 
9.1 
Study Timelines.............................................................................................................. 77 
9.2 
Investigator Responsibilities .......................................................................................... 77 
9.3 
Sponsor Responsibilities ................................................................................................ 78 
9.4 
Training .......................................................................................................................... 79 
9.4.1 
Research Team ........................................................................................................ 79 
9.5 
Sponsor Contact Information ......................................................................................... 80 
9.6 
Initiation of the Investigation ......................................................................................... 80 
9.7 
Monitoring the Study ..................................................................................................... 80 
9.8 
Termination of the Study................................................................................................ 80 
9.9 
Device Log ..................................................................................................................... 81 
9.9.1 
Device Log .............................................................................................................. 81 
9.10 
Electronic Case Report Forms .................................................................................... 81 
9.11 
Source Documentation ............................................................................................... 82 
9.12 
Subject Confidentiality/Record .................................................................................. 82 
9.13 
Data Management ....................................................................................................... 82 
 References ............................................................................................................................ 82 
APPENDIX A: STUDY DEFINITIONS...................................................................................... 88 
 
 
 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 6 of 91 
Protocol Agreement Form 
 
Study Title: Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit 
(EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL 
SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) 
(SURPOINT COA) 
I have read this protocol and agree to conduct this clinical investigation in accordance with the 
design and specific provisions outlined herein. I understand the protocol, and I understand I am 
solely responsible to ensure the investigation is conducted in accordance with Good Clinical 
Practices (GCP), applicable country regulations the Declaration of Helsinki, the signed clinical 
study contract with Sponsor and with the protocol outlined herein. I will conduct this study as 
outlined therein and will make reasonable effort to complete the study within the time period 
designated by the Sponsor.    
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to 
me who will assist in the conduct of this study. I will discuss this material with them to ensure they 
are fully informed regarding the device and the conduct of the study.  
 
I will fulfill the requirements of my Institutional Review Board (IRB)/Ethics Committee (EC), or 
other oversight committee, to ensure complete and continual oversight of this clinical 
investigation. I will use an Informed Consent Document approved by the Sponsor and my 
reviewing IRB/EC (where required).  
 
I agree to report all information or data in accordance with the protocol and, in particular, I agree 
to report any serious adverse events, device related adverse events, or procedure related adverse 
events as defined in this protocol to the Sponsor, and comply with all adverse event reporting 
requirements of my reviewing IRB/EC. I agree to permit the Sponsor, its authorized 
representatives, my reviewing IRB/EC, and any regulatory authority/body access to all records 
relating to the clinical investigation. 
 
The below signature confirms I have read and understood this protocol and its associated 
amendments or attachments, and will accept respective revisions or amendments provided by the 
Sponsor. 
 
 
 
 
____________________________   _____________________________  _______________ 
 Principal Investigator  
   
Signature 
 
 
   
Date 
 Name (PRINT) 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 8 of 91 
Two hundred eighty (280) enrolled subjects will be treated using 
the STSF catheter with EPU and 50 subjects will be treated with 
ST catheter. It is estimated that the attrition rate is no more than 
10-15% which means about 30 subjects may be accounted for 
excluded subjects before receiving treatment. 
Study Population 
Subjects undergoing electrophysiology mapping and RF ablation 
with THERMOCOOL SMARTTOUCH® SF (STSF) and 
THERMOCOOL SMARTTOUCH® (ST) catheters for treatment 
of Antiarrhythmic Drug Refractory symptomatic paroxysmal AF 
Geographic areas to be 
included 
Geographic involvement will include the US. 
Study Duration 
~24 months (including 12 months enrollment and 12 months 
follow up from LPI) 
Start Date:  3Q18 
End Date:3Q20 
Procedure(s) Description 
Pulmonary Vein Isolation (PVI) 
VISITAG™ parameters 
• 2-3mm stability range 
• 3-5 sec stability time  
• Force Over Time (FOT) 25%,  
• 3gr force 
• Respiratory Gating Mandatory (unless using Jet Ventilation)  
• Tag size – 3mm 
• Maximum Inter tag distance 6mm 
 
VISITAG SURPOINT™ Module Tag Index Target Values:  
• Anterior, Ridge, Roof segments - target value: 550 
• Posterior and inferior segments - target value: 380 
Note: All Tag Index target values, especially the posterior wall, 
are in the absence of safety concerns (i.e. no temperature rise 
from esophageal probe, pain during conscious sedation, steam 
pop, etc).  In the absence of safety concerns, achieveing target 
Tag Index values will be the endpoint of RF energy application. 
If for safety reasons the ablation needs to be stopped prior to 
reaching the Tag Index target value, please do so and document 
accordingly with associated VISITAG ™ location number. 
Ablation Parameters: 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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Increases in power and force from previous workflow to hit 
a specific Tag Index target with a shorter procedure time is 
not recommended. 
• RF power range: 15-45 Watts (Investigator discretion) 
• Contact Force Target range: 5-25 gram (recommended) 
• RF Time: defined based on above mentioned VISITAG 
SURPOINT™ Module and Tag Index targets 
• Flow rate:  
o STSF Catheter 
▪ 8 ml/min for STSF for power ≤ 30W 
▪ 15 ml/min for STSF for power > 30W 
o ST Catheter 
▪ 17 ml/min for STSF for power ≤ 30W 
▪ 30 ml/min for STSF for power > 30W 
Primary Objective 
The primary objective of this clinical investigation is to 
demonstrate the safety and 12-month effectiveness of Tag Index-
guided ablation using the VISITAG SURPOINT™ Module 
with 
External 
Processing 
Unit 
when 
used 
with 
the 
THERMOCOOL 
SMARTTOUCH® 
SF 
(STSF) 
and 
THERMOCOOL 
SMARTTOUCH® 
(ST) 
catheters 
for 
pulmonary vein isolation (PVI) in the treatment of subjects with 
drug refractory symptomatic paroxysmal atrial fibrillation.  
Specifically: 
 
• 
To demonstrate the safety based on the proportion of 
subjects with early-onset (within 7 days of ablation 
procedure) primary adverse events  
• 
To demonstrate the 12-month effectiveness based on the 
proportion of subject with freedom from documented atrial 
arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) 
or atrial flutter (AFL) episodes during the effectiveness 
evaluation period (Day 91-365)  
Secondary Objectives 
The major secondary objectives of this study are:  
• 
to evaluate the incidence of (serious) adverse events during 
and after procedure up to 3 months following procedure.  
• 
Acute Procedural Success as defined by:  
o The % of subjects with ipsilateral PVI (entrance block) at 
the end of the procedure, and  
o The % of subjects with ipsilateral PV isolation (entrance 
block) after first encirclement, after waiting period and 
adenosine challenge   

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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• 
Procedural efficiency gain with the use of VISITAG 
SURPOINT™ Module with External Processing Unit  
Exploratory Objectives 
N/A 
Primary Endpoints & Follow-
up Intervals 
Acute Safety:  
o Incidence of early onset primary adverse events (PAE) 
related to the device or procedure. Occurrence of Primary 
AEs within 7 days of an ablation procedure. (refer to Table 
6-1 for a comprehensive definition list of primary adverse 
events) 
12-Month Effectiveness: 
Freedom from documented (Symptomatic and 
asymptomatic) atrial fibrillation, atrial flutter and atrial 
tachycardia (AF/AFL/AT) (hereinafter collectively referred 
to as “atrial tachyarrhythmias") recurrence (episodes ≥ 30 
secs on TTM or continuously recorded on the standard 12-
leads ECG or 24 Hour Holter monitoring) during the 
evaluation period (Day 91-365) 
Secondary Endpoints & 
Follow-up Intervals 
Secondary Safety Endpoints:  
o 12-Month PAE Rate: Cumulative incidence of primary 
adverse events occurring within seven (7) days 
following an AF ablation procedure using study 
catheters with EPU and any late onset atrio-esophageal 
fistula or PV stenosis through 12 months 
o Incidence of Unanticipated Adverse Device Effects 
(UADEs) 
o Incidence of Serious Adverse Events (SAEs) within 7 days 
(early onset), >7 to 30 days (peri-procedural) and >30 days 
(late onset) of initial ablation 
o Incidence of bleeding complication: a) major bleeding, b) 
clinically relevant non-major, and c) minor bleeding as 
defined in the 2017 HRS/EHRA/ECAS/APHRS 
/SOLAECE Consensus Statement 
Secondary Effectiveness Endpoints:  
o Acute Procedural success:  
o % of subjects with ipsilateral PVI (entrance block) at the 
end of the procedure  
o % of subjects with ipsilateral PVI (entrance block) after 
first encirclement (evaluated prior to the 30-minute 
waiting period and adenosine challenge)  

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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o % of subjects with ipsilateral PVI (entrance block) after 
first encirclement without acute reconnection, after 
waiting period and adenosine challenge   
o % of touch-up (ablation of acute reconnection) among 
all targeted veins  
o Anatomical location of acute PV reconnection after first 
encirclement 
o Repeat Ablation Procedures:  
o Incidence (%) of repeat ablation procedures with 
VISITAG SURPOINT™ module during 12-months 
period post-procedure   
o % PVs re-isolated among all of the targeted PVs at 
repeat procedure  
o % repeat ablation procedures requiring new linear 
lesions and/or identifying new foci outside of initially 
isolated area among the repeat ablation procedures 
Additional Endpoints: 
• 
Procedural data 
o total procedure time, PVI time, RF application time, 
mapping time 
o fluoroscopy time/dose 
o location of RF applications, number of RF applications 
o RF ablation parameters per application  
o VISITAG SURPOINT™ values (Tag Index) per 
segment 
o VISITAG™ parameters will be collected in the 
CARTO® 3 system during the ablation procedures for 
generation of LA ablation maps 
• 
HEMA 
o Incidence of hospitalizations post-index ablation 
procedure 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to be 
eligible for participation in this study:  
1. Symptomatic paroxysmal AF who had at least one AF 
episode electrocardiographically documented within one 
(1) year prior to enrollment. Documentation may include 
electrocardiogram (ECG); Transtelephonic monitoring 
(TTM), Holter monitor or telemetry strip 

SURPOINT COA 
Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 12 of 91 
2. Failed at least one antiarrhythmic drug (AAD) (Class I or 
III) as evidenced by recurrent symptomatic AF, or 
intolerable to the AAD 
3. Age 18 years or older 
4. Signed Patient Informed Consent Form (ICF) 
5. Able and willing to comply with all pre-, post-, and follow-
up testing and requirements 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria are not 
eligible for enrollment. 
1. Previous surgical or catheter ablation for atrial 
fibrillation 
2. Previous cardiac surgery (including CABG) within the 
past 6 months (180 days) 
3. Valvular cardiac surgical/percutaneous procedure (i.e., 
ventriculotomy, atriotomy, and valve repair or 
replacement and presence of a prosthetic valve) 
4. Any carotid stenting or endarterectomy 
5. Documented LA thrombus on imaging 
6. LA size > 50 mm on imaging  
7. LVEF < 40% 
8. Contraindication 
to 
anticoagulation 
(heparin 
or 
warfarin) 
9. History of blood clotting or bleeding abnormalities 
10. PCI/MI within the past 2 months (60 days) 
11. Documented thromboembolic event (including TIA) 
within the past 12 months (365 days) 
12. Rheumatic Heart Disease 
13. Uncontrolled heart failure or NYHA function class III or 
IV 
14. Severe mitral regurgitation (Regurgitant volume ≥ 60 
mL/beat, Regurgitant fraction ≥ 50%, and/or Effective 
regurgitant orifice area ≥ 0.40cm2) 
15. Awaiting cardiac transplantation or other cardiac surgery 
within the next 12 months (365 days) 
16. Unstable angina 
17. Acute illness or active systemic infection or sepsis 
18. AF secondary to electrolyte imbalance, thyroid disease, 
or reversible or non-cardiac cause.  

SURPOINT COA 
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Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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19. Presence of implanted ICD/CRT-D. 
20. Significant 
pulmonary 
disease, 
(e.g., 
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. 
21. Gastroesophageal Reflux Disease (GERD; active 
requiring significant intervention not including OTC 
medication) 
22. Significant congenital anomaly or medical problem that 
in the opinion of the investigator would preclude 
enrollment in this study. 
23. Women who are pregnant (as evidenced by pregnancy 
test if pre-menopausal) 
24. Concurrent enrollment in an investigational study 
evaluating another device, biologic, or drug. 
25. Presence of intracardiac thrombus, myxoma, tumor, 
interatrial baffle or patch or other abnormality that 
precludes vascular access, or manipulation of the 
catheter. 
26. Life expectancy less than 12 months 
Statistical Analysis and Power 
Calculation 
The Final analyses for primary safety and effectiveness 
endpoints will apply Bayesian methods and use a beta-
binomial model. Under the assumption of 65% success rate for 
effectiveness and 8% rate for primary safety, with 330 
subjects, assuming a 10-15% attrition rate, we will have more 
than 90% power for declaring success for each of the primary  
endpoints controlling the type-I error at 5%. 
Interim Analysis 
Two interim analyses are planned to evaluate declaration of 
early success.  
Determination if DMC/CEC 
required 
CEC will be convened to adjudicate the primary safety endpoint. 
No DMC is required. The product will be commercially available. 
Time and Events Schedule 
• Baseline 
o Demographics 
o Medical History 
o Quality of Life Assessment (SF-12) 
o AAD Medication History 
o Arrhythmia History 

SURPOINT COA 
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Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
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o Device Interrogation (if applicable) 
• Ablation Procedure 
o Ablation procedure strategy (AF, AFL, & AT) will 
utilize Investigator’s Standard of Care 
Data Collection:  
o EPU and Catheter Information (Serial #, Lot #) 
o Target sites for RF lesion application 
▪ Target Sites 
▪ Number of RF Applications per target 
▪ total RF duration per application (sec) 
▪ Fluoroscopy time/dose 
▪ Procedure Times 
o Total procedure time 
o Total mapping time 
o Total RF time 
o Time to PVI 
▪ Fluid delivered 
o From the Study Catheter 
o From IV (if applicable) 
o CARTO and modified RF Generator download for 
offline analysis   
▪ Segmentation of LA ablation maps based on chosen 
CARTO tags 
▪ Full Case backup [including complete VISITAG 
export] and CARTO Case recording 
▪ RF Ablation parameters per application: Power, 
Impedance, Flow Rate, Temperature, and Time 
▪ Contact force measurements and RF ablation 
parameters  
▪ VISITAG SURPOINT™ value per application 
▪ Localized ECG Electrodes measurements for 
offline analysis 
o Acute Success (entrance and exit block PVI) 
o Adverse Events 
• Discharge 

SURPOINT COA 
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Biosense Webster, Inc 
 
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o Recurrence of arrhythmia prior to discharge 
o Device Interrogation (if applicable) 
o HEMA Billing information 
o Adverse Events 
• Follow-up Assessments Post Ablation* 
o 7 Day phone Call 
o 1-month 
o 3-month 
o 6-month 
o 12-month  
Data to be collected during the study visits will include:  
• Adverse Events (since last visit) 
• Medication update/changes 
• Quality of Life Assessment (SF-12) 
• Billing Information for all hospitalizations, ER visits and 
outpatient visits for economic analyses 
• Recurrence of Study Arrhythmia (each patient will be 
provided a TTM event monitor and Holter monitor) 
o Repeat ablation procedures/subject during the follow-up 
period, repeat ablation procedure will be at the 
discretion of the investigator     
o Throughout the 12-month effectiveness follow-up 
period, arrhythmia status will be assessed by symptom-
initiated event monitoring.   
▪ Device Interrogation (if applicable) 
▪ All symptomatic cardiac episodes will be 
documented   
*based on the initial ablation procedure 
QUALIFICATION AND 
ACTIVATION OF 
OPERATORS 
• ST or STSF experience – ≥20 cases 
• Experience with VISITAG™ – ≥20 cases 
• All operators– require training as specified in physician 
training plan 
• Retrospectively provide 5 PAF cases with segmented (9 
regions) VISITAG™ with standard workflow 
 

SURPOINT COA 
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Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 16 of 91 
List of Abbreviations 
AAD 
Antiarrhythmic drug 
ICF 
Informed consent form 
ACC 
American College of Cardiology 
 
 
ACT 
Activated clotting time 
IEC 
Independent Ethics Committee  
AE 
Adverse event 
IFU 
Instructions for use 
AF 
Atrial fibrillation 
IRB 
Institutional Review Board 
AFL 
AHA 
Atrial flutter 
American Heart Association 
ITT 
Intent-to-treat 
HIPAA 
Health Insurance Portability and 
Accountability Act 
ANOVA 
Analysis of variance 
AT 
Atrial tachycardia 
LA 
Left atrium 
AV 
Atrioventricular 
MI 
Myocardial infarction 
BP 
Blood pressure 
MRI 
Magnetic resonance imaging 
CABG 
Coronary Artery Bypass Grafting 
MV 
Mitral valve 
CEC 
Clinical Events Committee 
 
 
CHF 
Congestive heart failure 
PAF 
Paroxysmal atrial fibrillation 
CF 
Contact force 
PCI 
Percutaneous coronary intervention 
CFAE 
CHADS 
Complex fractionated atrial electrogram 
Congestive heart failure, High blood 
pressure, Age 75+, Diabetes, previous Stroke 
or transient ischemic attack 
PIU 
Patient Interface Unit 
PP 
Per protocol 
 
 
PV 
Pulmonary vein 
CPVI 
CRF 
Complete pulmonary vein isolation 
Case Report Form 
PVI 
Pulmonary vein isolation 
 
QOL 
 
Quality of life 
CRT-D 
Cardiac Resynchronization Therapy 
Defibrillator 
CS 
Coronary sinus 
RA 
Right atrium 
CT 
Computed tomography 
RF 
Radiofrequency 
CTI 
Cavotricuspid isthmus 
SADE 
Serious adverse device effect 
CVA 
Cerebrovascular accident 
SAE 
Serious adverse event 
ECAS 
European Cardiac Arrhythmia Society 
SAP 
Statistical analysis plan 
EPU 
External processing unit 
SF 
Surround Flow 
ESC 
European Society of Cardiology 
SVC 
Superior vena cava 
FDA 
Food Drug Administration 
TIA 
Transient ischemic attack 
GCP 
Good Clinical Practice 
TEE 
Transesophageal echocardiogram 
ECG 
Electrocardiogram 
TTE 
Transthoracic echocardiogram 
EHRA 
European Heart Rhythm Association 
TTM 
Transtelephonic monitoring 
HRS 
Heart Rhythm Society 
UADE 
Unanticipated adverse device effect 
ICD 
Implantable cardioverter defibrillator 
USADE 
Unanticipated serious adverse device effect 
ICE 
Intracardiac echocardiography 
VT 
Ventricular tachycardia  
 
 
 
 

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Evaluation of the VISITAG SURPOINT™ Module with External 
Processing Unit (EPU) when used with the THERMOCOOL 
SMARTTOUCH® SF and THERMOCOOL SMARTTOUCH® Catheters 
for pulmonary vein isolation (PVI) 
(SURPOINT COA) 
 INTRODUCTION 
1.1 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.1-4 AF is a complex, 
progressive disease that results in structural and electrical remodeling in the heart.  
Radiofrequency (RF) catheter ablation has provided excellent results for treating many 
types of supraventricular arrhythmias.1,5 Its utility in treating paroxysmal AF has already 
been established; studies have shown high rates of elimination of the arrhythmia.Error! 
Reference source not found.,Error! Reference source not found. In a randomized clinical trial comparing 
catheter ablation to AAD therapy, RF ablation with the NAVISTAR® THERMOCOOL® 
catheter was associated with elimination of symptomatic atrial arrhythmias in 70% of 
patients, and elimination of any atrial arrhythmia irrespective of symptoms in 63% of 
patients at 1 year.Error! Reference source not found.  
The 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Consensus Statement states that 
electrical isolation of the pulmonary veins (PVs) from the left atrium is “the cornerstone 
for most AF ablation procedures.”4 Additional ablation sites will be allowed at the 
discretion of the investigator but will be limited to certain parameters. All linear lesions 
will require confirmation of block by mapping or pacing maneuvers and prophylactic 
ablation of empirical sites is not recommended.  
The Biosense Webster THERMOCOOL SMARTTOUCH® SF and THERMOCOOL 
SMARTTOUCH® catheters feature improvements over standard irrigated RF catheters. 
They 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 uni-directional or 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 current from the RF generator to the desired ablation site.The 
THERMOCOOL SMARTTOUCH® SF catheter incorporates “surround flow” technology. A 
temperature sensor is embedded in the 3.5 mm tip dome electrode, which features a 56-
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 normal 
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.  

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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.6 However, the first catheters that were introduced did not provide the same 
irrigation flow for any orientation of the catheter, and required increasing volumes of saline 
to be delivered with increasing number of RF applications. The THERMOCOOL 
SMARTTOUCH® SF catheter features a porous electrode tip (56 very 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® catheter with Surround Flow (SF) 
technology was as successful as the predecessor THERMOCOOL® catheter in achieving 
PV isolation, even though both treatment groups received similar amounts of RF energy. 
Moreover, the saline volume administered was reduced7 due to the tip design. Procedural 
efficiency was also enhanced; time to PV isolation and total RF duration,8,9 as well as saline 
irrigation volume,9,10 were diminished in paroxysmal AF subjects who underwent ablation 
with the THERMOCOOL® SF catheter compared to the THERMOCOOL® catheter 
without SF.  
There have been several studies showing that there is a correlation between electrode-tissue 
contact and RF lesion generation.11-13 Until recently, there has been no reliable mechanism 
to provide a measurement of the direct CF between the tip of the RF ablation catheter and 
the endocardial tissue. 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 manipulation14, and 
that CF measurement during ablation correlates with clinical outcome in AF patients.15 
Subsequent studies with the THERMOCOOL SMARTTOUCH® catheters showed the 
ability to know CF in real time to be associated with decreased procedure time and 
fluoroscopy time,16 and increased acute and long-term procedural success in the 
paroxysmal AF population.16,17 There is ex vivo evidence that a higher contact force may 
result in an increased incidence of serious adverse events.18 Therefore, a catheter with the 
capability to provide real-time electrode-tissue contact force may have the potential to 
better control RF energy application resulting in a more optimal lesion and reducing the 
incidence of serious injury to the patient.  
1.2 Rationale 
The theoretical benefits of catheters with CF sensing technology include feedback to the 
user of adequate degree of tissue contact to prevent inappropriate RF power application. 
The data from carefully controled studies have shown when investigators stay within their 
pre-selected contact force range > 80% of the time the 12-month effectiveness success rate 
is consistently above 80%.  Additional benefits of confirmed tissue contact may include 
efficient creation of 3-D anatomical maps with the CARTO® 3 Navigation System(s), and 
may translate to a reduction in mapping, fluoroscopy, and procedure times. Catheters with 
THERMOCOOL SMARTTOUCH® technology have been used safely in the paroxysmal 
AF population.16,17 
While irrigation of the RF catheter tip has been found to effectively reduce temperature at 
ablation sites and associated adverse events (e.g., thrombus, steam pop),6 there is a risk of 
volume overload from high volumes of perfused saline. The “surround flow” technology 

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of the THERMOCOOL SMARTTOUCH® SF catheters allow a reduction in 
intraprocedural saline perfusion7,9,10 as well as in procedure time.8,9 
Real world reports utilizing CF ablation strategies have produced variable results for 12-
month outcomes.19,20 PV reconnection is common and believed to be the result of catheter 
instability, tissue edema, and a reversible non-transmural injury.  These studies 
demonstrated a need for better tools to facilitate ablation strategy in a way that allows the 
operator to reproduce consistent success with a personalized PVI strategy. 
The VISITAG SURPOINT™ Tag Index is a novel lesion quality marker that utilizes 
contact force, time, and power.  The formula (a weighted Force-Power-Time Integral) was 
developed as a marker of ablation outcome and has been evaluated extensively in animal 
studies.21,22   
After commercialization of the VISITAG SURPOINT™, early retrospective analysis 
examined the hypothesis that a minimum Tag Index value was necessary to avoid 
reconnection after PVI.25 Early results demonstrated a relationship between a minimum 
Tag Index value and acute PV reconnection.  No acute PV reconnections were seen when 
the calculated minimum Tag Index value was 380 for posterior/inferior segments and 550 
for anterior/roof segments.25 This study established that different Tag Index values were 
required for the variety of tissue thickness that are found between different anatomical 
regions in the left atrium.  In a retrospective analysis of the SMART-SF study data, lower 
Tag Index average values were also used to achieve a successful radiofrequency ablation 
at the posterior anatomical location compared with other locations while the average 
contact force applied at each PV anatomical segment was not significantly different.26 
A study comparing acute success of Tag Index to another lesion quality tool, the Force 
Time Integral (FTI), 26,27 investigators again demonstrated the requirement for a minimum 
Tag Index value to have a successful RF application.  In this study patients returned for an 
electrophysiology procedure 2 month after a PVI procedure to examine the success of the 
PVI.  It was observed that a low Tag Index value within an ablation segment was 
independently predictive of PV reconnection.  No reconnections were seen when the 
minimum Tag Index values per segment were ≥370 for posterior/inferior segments and 
≥480 for anterior/roof segments.29 
In this study both lesion quality assessment tools analyzed, demonstrated good acute 
success, however, the VISITAG SURPOINT™ Tag index is believed to be superior to 
FTI.29 As a marker of lesion quality FTI has two significant limitations; 1) it does not 
include the role of power delivery in lesion creation and 2) it relies on simple multiplication 
of contact force and application time.29 The relationship between contact force and time is 
dynamic, with both making differing contributions to lesion formation. Using FTI ignores 
the contribution of power to lesion formation.  With a fixed FTI (300gs) an increase in 
power application from 20W to 35W results in an almost three-fold increase in lesion 
volume. This introduces an unnecessary element of risk when applying RF to the thin tissue 
on the posterior wall.      
Two recent prospective publications, including 12-month effectiveness outcomes, the 
success of tailored Tag Index values was demonstrated.  Hussein et al, compared Tag Index 
value guided ablation to CF-guided propensity-matched controls. When targeting Tag 
Index values of 550 anterior/roof and 400 posterior/inferior segments, they demonstrated; 

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a) better procedural outcomes, with both a much higher rate of first-pass isolation (97% vs 
84%) and lower incidence of acute PV reconnection (6% VS 13%), b) the AI group 
experienced significantly improved freedom from AT at 12 months (83% vs 63%), and c) 
Tag Index-guided ablation was associated with a significantly higher impedance drop (13.7 
Ω vs 8.8 Ω), suggesting creation of better quality lesions.   They concluded that the Tag 
Index value guided ablation may provide a more tailored approach to LA ablation, 
balancing ablation effectiveness with avoidance of unnecessarily excessive ablation in 
thin-walled, higher-risk regions.28 
Recently, Taghji et al in a large single center study (n=130), demonstrated that a PVI 
ablation strategy using inter-lesion distance ≤6 mm and Tag Index values ≥400 at posterior 
wall and ≥550 at anterior wall resulted in improved acute and 12-month effectiveness 
success.  Acute success was found to be 98% first-pass PVI and 98% adenosine-proof 
isolation.  At 12 months, the single-procedure freedom from AF/AT/AFL was 91.3% in a 
subset (104/130) of the patients who were off antiarrhythmic drug therapy.  Single-
procedure freedom from both AF/AT/AFL and off antiarrhythmic drug therapy was 
73.1%.29 
Efficiency gains using the Tag index values (anterior=550; posterior=400) have also been 
observed.  De Potter et al, reported the PVI success rate after first encirclement was 96%.  
This was associated with acute procedural efficiency when compare to the SMART-AF 
study (94.6 min. vs 222.7 min.).  The authors concluded that using Tag Index target values 
increased the predictability of procedures. The efficiency gains observed, did not 
compromise safety or long-term effectiveness.30 
To further delineate the utility of using tag index values and inter lesion distance (≤6mm) 
for PVI during AF ablation procedures, Phlips et al58 designed the single center “Close” 
study to provide comparative data to conventional contact force guided PVI.  In the 100-
patient study (CLOSE group – 50 VISITAG SURPOINT and CONV-AF group – 50 
conventional CF), the authors demonstrated superiority in effectiveness and efficiency 
while maintaining an acceptable safety profile.  Ablation procedure time was significantly 
shorter for the CLOSE group when compare to CONV-CF group (149±33 min vs. 192±42 
min.; p<0.0001).  No complications were observed in the CLOSE group, one tamponade 
was reported in the CONV-CF group.  Kaplan-Meier analysis also demonstrated 12-
months effectiveness superiority (freedom from atrial tachyarrhythmias) when the CLOSE 
group was compared to the CONV-CF group (94% vs. 80%; p=0.039).  With the limitations 
inherent in a single center study, this study provides additional evidence for the uniform 
application of RF energy at different anatomical location within the left atrium when a 
physician adds the tag index to his standard technique for PVI the cornerstone of successful 
AF ablation therapy. 58  
1.3 Risk Analysis 
RF catheter ablation has been used for over 15 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: 
1.3.1 
Description and Analysis of Risks  
Risks associated with catheter ablation 

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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%).31-35  
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%).36,37 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 centers suggests that the risk of coronary 
occlusion is less than 0.5%.36,37 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, thrombus may also occur in the absence 
of an impedance rise. Thrombus may become dislodged and embolize to produce a stroke, 
myocardial infarction, or other ischemic injuries. Risk of embolus is reduced by quickly 
terminating the application of current after an impedance rise, which limits the size of the 
coagulum on the electrode. An important feature of the THERMOCOOL® family of 
catheters is the absence or very low likelihood of thrombus formation during RF. 
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. Published 
risks of cardiac perforation range from <1% to 2.5%.36,37,54,56 This potentially life-
threatening injury may result in cardiac tamponade and may require percutaneous 
pericardial drainage or surgical repair. In the SMART-AF study using the THERMOCOOL 
SMARTTOUCH® Catheter with contact force sensing technology, there were 4 (2.48%, 
4/161) reported incidents of tamponade.51 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. 
Injury to a cardiac valve may result from catheter manipulation or the application of RF 
current (risk <1%).36,37 This may produce valvular insufficiency and possibly require 
surgical valve replacement.  

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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.38 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 the right 
pulmonary veins. The reported incidence of phrenic nerve injury varies from 0% to 0.48% 
when RF energy is used for catheter ablation.39,40 Prior to ablation in the region of the right 
superior pulmonary vein, precautionary measures such as pacing maneuvers are 
recommended to evaluate proximity to the phrenic nerve. 
Periesophageal 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.4 While these 
complications are rare (approximately < 1%), they can potentially compromise the clinical 
outcome severely, requiring surgical treatment.52,53 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.4 
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%).41-43 
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%).44-48 
Hemorrhage could occur as a result of anticoagulation (risk <0.5%), which may require 
transfusion.36,37  
The percutaneous procedure carries risk of infection, either at the catheter insertion site or 
systemically, including endocarditis and septic emboli (risk <0.5%).36,37 This risk can be 
minimized by using standard aseptic technique and, when indicated, by the use of antibiotic 
agents. 
Risks associated with the VISITAG SURPOINT™ module 
The use of the VISITAG SURPOINT™ module carries the risk that a physician may 
misread the Tag index value information or the CARTO EPU may give incorrect 
information (false high tag index values or false low tag value).  The outcome of these risks 
are similar to the risks associated with RF application and have been addressed in Risks 
associated with RF application above. 
1.3.2 
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 and 
THERMOCOOL SMARTTOUCH® catheters, are similar to conventional irrigated catheters 
that do not include this technology. Similarly, the Surround Flow technology found in the 
THERMOCOOL SMARTTOUCH® SF catheter confers a decreased risk of volume 
overflow associated events such as CHF and pulmonary edema in patients with impaired 

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LVEF for kidney dysfunction.7,10 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.8  
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 prior to treatment 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 3.1.2 Exclusion Criteria). All subjects will have pre-procedure imaging as 
described in Section 5.3 to exclude subject that may have LA thrombus, which is intended 
to decrease the potential for thromboembolic complications.   
Investigators will undergo training (refer to Sections 5.17.3) on the use of the 
THERMOCOOL SMARTTOUCH® SF Catheter THERMOCOOL SMARTTOUCH® 
catheter with Contact Force Sensing Capability technology prior to subject enrollment and 
the VISITAG SURPOINT™ Module.  
Investigators experienced in intracardiac mapping and ablation of AF with the use of RF 
ablation catheters containing contact force technology will be selected for participation in 
the study. AF ablation procedures will be performed in equipped electrophysiology 
laboratories with the assistance of nurses and technicians trained in electrophysiology and, 
as applicable, in the requirement of this protocol.  
The VISITAG SURPOINT™ module is not intended to replace the current practice of 
clinical judgment for safe RF application including monitoring changes in power, contact 
force, catheter stability and lesion contiguity. 
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, adverse event data will be evaluated periodically during enrollment and 
follow-up by the Sponsor’s Medical Safety Officer and an unbiased physician review 
committee functioning as a Clinical Events Committee (CEC) for this study. 
1.3.3 
Precautions 
Invasive electrophysiological evaluation and catheter ablation may impart some degree of 
risk to the subject. 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 versus the potential benefit of the treatment of a paroxysmal 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 most potential complications. 
Failure to observe the contraindications, warnings, and precautions in these instructions 
and the IFU may result in procedural complications. Immediate risks from ablation 
treatment may include: cardiovascular injury or perforation with or without cardiac 

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tamponade, pulmonary embolus, tricuspid regurgitation, myocardial infarction, bleeding at 
the catheter insertion site, sepsis, and death.  
Contraindications for catheter ablation of arrhythmia include: existing hemodynamic 
instability, bacteremia, coagulopathy, prosthetic tricuspid valve, intra-atrial or venous 
thrombosis, and pregnancy. 
1.4 Device Description 
The Biosense Webster THERMOCOOL SMARTTOUCH® family of catheters are 
steerable, multi-electrode, luminal catheters with a deflectable tip designed to facilitate 
electrophysiological mapping of the heart and to transmit RF current to the catheter tip 
dome electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring 
electrodes. For ablation, the catheter is used in conjunction with an RF generator and a 
dispersive pad (indifferent electrode). The catheter has force sensing technology that 
provides a real-time measurement of contact force between the catheter tip and the heart 
wall.  
1.4.1 
THERMOCOOL SMARTTOUCH® SF catheter 
The catheter has a high-torque shaft, with either a uni-directional or bi-directional braided 
deflectable tip section, containing an array of ring electrodes. The high-torque shaft allows 
the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip 
at the desired site. All ring electrodes are manufactured from platinum-iridium. The tip 
dome electrode is manufactured from palladium-platinum and serves to deliver RF current 
from the RF generator to the desired ablation site. The catheter incorporates a temperature 
sensor that is embedded in the 3.5 mm tip dome electrode. The 3.5 mm tip dome features 
a 56-hole irrigation pattern as shown below in Figure 1-1. 
Figure 1-1 Catheter Tip 
 
 
 
  
1.4.1.1 
Bi-directional Catheter Description (D-1348-XX-S) 
The catheter has a high-torque shaft with a bi-directional deflectable tip section containing 
an array of electrodes which includes a 3.5 mm tip dome. All of the electrodes may be used 
for recording and stimulation purposes. The tip electrode serves to deliver RF current from 
56-hole pattern 

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the RF generator to the desired ablation site. The tip electrode and ring electrodes are made 
from a noble metal. The catheter incorporates a thermocouple temperature sensor that is 
embedded in the 3.5 mm tip electrode. A Rocker Lever is used to deflect the tip. The high 
torque shaft also allows the plane of the curved tip to be rotated to facilitate accurate 
positioning of the catheter tip at the desired site. Additionally, a variety of curve types are 
available in symmetric or asymmetric combinations, providing two 180° opposed, single 
planed curves. Currently, the available curves for the Biosense Webster THERMOCOOL 
SMARTTOUCH® SF Bi-Directional Navigation Catheter include the following: DF, FF, 
and FJ. 
1.4.1.2 
Uni-directional Catheter Description (D-1347-XX-S) 
The catheter has a high-torque shaft with a Uni-Directional deflectable tip section 
containing an array of electrodes which includes a 3.5 mm tip dome. All of the electrodes 
may be used for recording and stimulation purposes. The tip electrode serves to deliver RF 
current from the RF generator to the desired ablation site. The tip electrode and ring 
electrodes are made from a noble metal. The catheter incorporates a thermocouple 
temperature sensor that is embedded in the 3.5 mm tip electrode. Tip deflection is 
controlled at the proximal end by a handpiece in which a piston slides; a thumbknob on the 
piston controls piston travel. When the thumbknob is pushed forward, the tip is deflected 
(curved). When the thumbknob is pulled back, the tip straightens. The high torque shaft 
also allows the plane of the curved tip to be rotated to facilitate accurate positioning of the 
catheter tip at the desired site. 
 
1.4.2 
THERMOCOOL SMARTTOUCH® catheter 
 
1.4.2.1 
Bi-directional Catheter Description (D-1327-0X-S) 
The bi-directional catheter has a high-torque shaft with a bi-directional deflectable tip 
section containing an array of electrodes, which includes a 3.5 mm tip dome.  All of the 
electrodes may be used for recording and stimulation purposes.  The tip electrode serves 

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to deliver RF current from the RF generator to the desired ablation site.  The tip 
electrode and ring electrodes are made from platinum-iridium.  The catheter 
incorporates a thermocouple temperature sensor that is embedded in the 3.5 mm tip 
electrode.  A rocker lever is used to deflect a tip with an asymmetrical DF curve, 
providing two 180° opposed, single planed curves.  The high-torque shaft also allows 
the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter 
tip at the desired site.   
1.4.2.2 
Uni-directional Catheter Description (D-1336-0X-S) 
The unidirectional catheter has a high-torque shaft with a uni-directional deflectable tip 
section containing an array of electrodes, which includes a 3.5 mm tip dome. All of the 
electrodes may be used for recording and stimulation purposes. The tip electrode serves 
to deliver RF current from the RF generator to the desired ablation site. The tip 
electrode and ring electrodes are made from platinum-iridium. The catheter 
incorporates a thermocouple temperature sensor that is embedded in the 3.5mm tip 
electrode. Tip deflection is controlled at the proximal end by a hand piece in which a 
piston slides; a thumb knob on the piston controls piston travel. When the thumb knob 
is pushed forward, the tip is deflected (curved). When the thumb knob is pulled back, 
the tip straightens. The high-torque shaft also allows the plane of the curved tip to be 
rotated to facilitate accurate positioning of the catheter tip at the desired site. 
 
At the proximal end of the STSF/ST catheters, 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 normal saline is passed 
through the internal lumen of the catheter and and through the irrigated, tip electrode. A 
compatible irrigation pump is used to control the saline irrigation.The catheter connects to 
the CARTO 3 Navigation System through an interface box called the Patient Interface Unit 
(PIU).  The catheter interfaces with standard recording equipment and a compatible RF 
generator via accessory extension cables with the appropriate connectors.   
 
The THERMOCOOL SMARTTOUCH family of catheters feature a location sensor embedded 
in the tip section that transmits location information to the CARTO 3 Navigation System.  
An appropriate reference device is required for location reference position purposes.  A 
sensor in the tip section transmits contact force information that is displayed on the 
CARTO 3 Navigation System.  For use in mapping procedures, for information on 
appropriate reference devices, and for further description of the operation of the CARTO 
3 Navigation System, refer to the CARTO 3 Navigation System User Manual. 
For further information on the irrigation pump (COOLFLOW® Irrigation Pump, 
SMARTABLATE™ Irrigation Pump) RF Generator (Stockert 70, SMARTABLATE™ 
RF Generator), and required cables, refer to the respective Instructions for Use and/or User 
Manual. 
Refer to Section 5.17 (Study Equipment) for details on additional equipment required for 
this study.  
 

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1.5 Approved Catheters 
The THERMOCOOL SMARTTOUCH® Diagnostic /Ablation Deflectable Tip Catheters 
with Contact Force Sensing Capability (D-1327-0X-S and D-1336-0X-S) and the 
THERMOCOOL SMARTTOUCH® SF Diagnostic /Ablation Deflectable Tip Catheters 
with Contact Force Sensing Capability (D-1347-XX-S and D-1348-XX-S) are the only 
approved catheters to be used in this study.  
For the remainder of this protocol, “STSF” will refer to the THERMOCOOL 
SMARTTOUCH® SF Diagnostic/Ablation Deflectable Tip Catheters with Contact Force 
Sensing Capability and “ST” will refer to the THERMOCOOL SMARTTOUCH ®Diagnostic/ 
Ablation Deflectable Tip Catheters with Contact Force Sensing Capability 
Instructions for Use (IFU)  
A copy of the IFU for the THERMOCOOL SMARTTOUCH® SF and The THERMOCOOL 
SMARTTOUCH® catheters and interface cable is included in each product package. 
1.6 Supply of Approved Catheter 
The THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® 
Catheters have been approved for the treatment of drug refractory PAF.  Catheters used in 
this study can be taken from commercial stock.  
1.7 VISITAG SURPOINT™ Module (Tag Index) 
The VISITAG SURPOINT™ module is a lesion quality marker that utilizes contact 
force, time, and power to calculates Tag Index values that are displayed on the CARTO 3 
system screen.  The formula (a weighted Force-Power-Time Integral) was developed as a 
marker of ablation outcome and has been evaluated extensively in animal studies.21,22   
 
Tag Index is based on the hypothesis that there is an Index that represents a dimension (e.g. 
depth, diameter) of a single lesion generated on the cardiac tissue.  Tag Index is calculated 
via integration of the ablation parameters used during the cardiac ablation. 
 
The general mathematical model for the integration of the ablation parameters is: 
 
( )
( )
c
b
T
a
dt
t
P
t
AE
k
t
Index




=
0
)
(
 
 
 
 
It is hypothesized that the ablation volume (i.e., formula in parenthesis) correlates with the 
applied radiofrequency (RF) Power (P) and Application Time (t), which represents the 
amount of thermal flux created to produce a cardiac lesion during ablation.  Ablation 
Efficiency (AE) reflects the amount of RF Power (P) that is transferred to the cardiac tissue.  
The Exponent coefficient (c) (outside the parenthesis) is anticipated to provide a single 
dimension of the lesion volume. 
 
AE: Ablation Efficiency  
P: RF Power 
t: Application Time 
k, a, b, c: user defined coefficients  
where 

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By giving a different weight to the power, force, and time parameters the calculated Tag 
Index value results in a single index number that is cumulative over the time of the RF 
application. The Tag Index value is not intended to indicate the effectiveness of RF energy 
application and is not intended to replace current practice of clinical judgment.  It is 
intended to provide the operator with a reproducible RF application strategy, that is more 
uniform at specified anatomical location of the LA.   
 
During an RF application, the CARTO 3 system displays the contact force dash board and 
the ablation bar (refer to figure 1-2 below).  The Ablation Bar displays the cumulative Tag 
Index value next to the clinically accepted endpoints for RF applications (e.g. time, 
temperature, power changes, impedance changes and CF). The Tag Index values are 
calculated in the EPU and communicated to the CARTO Screen for display.   
Figure 1-2: CARTO GUI with Contact Force dash board and CARTO Ablation Bar 
 
 
 
 

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1.8 
VISITAG SURPOINT™ EPU Description 
The EPU is an external hardware designed to perform Tag Index calculations.  The EPU 
receives ablation data (power, contact force, and duration) from the CARTO® 3 System, 
computes the Tag Index values, and then returns the computed results for display in the 
CARTO® 3 System.  A picture of the EPU is provided in Figure 1. 
 
Figure 1-3: VISITAG SURPOINT™ EPU with Attached Docking Plate 
  
 
1.8.1 
VISITAG SURPOINT™ EPU indication for Use 
The VISITAG SURPOINT™ EPU is intended to perform Tag Index calculations 
combining parameters of power, contact force, and duration during electrophysiology 
procedures. The EPU is intended for use with the CARTO® 3 System (software version 
6.0.60 or higher) with the CARTO VISITAG™ Module and the VISITAG SURPOINT™ 
Module installed. 
Equivalent Tag index values do not represent equivalentRF lesion size. The clinical utility 
of Tag Index value has not been evaluated. For information on the application of RF 
energy, refer to the instructions for use for the ablation catheter. 
The VISITAG SURPOINT™ EPU is intended for use with a compatible contact force 
sensing catheter including the THERMOCOOL SMARTTOUCH® or THERMOCOOL 
SMARTTOUCH® SF Catheter. 
1.8.2 
Principles of Operation 
The EPU is an external processing unit connected to the CARTO® 3 System Workstation 
through a USB cable.  The EPU receives ablation data from the CARTO® 3 System 
Workstation, namely data streams of ablation power, contact force, and duration.  The EPU 
operates automatically whenever the CARTO® 3 System Workstation is on, provided that 

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the VISITAG SURPOINT™ Module has been installed and activated. During an AF 
ablation procedure conducted with the VISITAG SURPOINT™ Module, data 
automatically flows to and from the EPU.  Upon request from the VISITAG SURPOINT™ 
Module, the EPU will calculate the Tag Index value according to a pre-installed Tag Index 
formula.  The calculated results are sent back to the CARTO® 3 System Workstation to be 
displayed for the user. 
 STUDY OBJECTIVE 
The purpose of this study is to assess the safety and 12-month effectiveness of Tag Index-guided 
ablation using the THERMOCOOL SMARTTOUCH® SF (STSF) and the THERMOCOOL 
SMARTTOUCH® (ST) Catheters with VISITAG SURPOINT™ Module with External 
Processing Unit(EPU) for pulmonary vein isolation in the treatment of drug refractory 
symptomatic paroxysmal atrial fibrillation. 
 STUDY DESIGN 
The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical 
evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST 
catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic 
drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled 
subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated 
with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will 
be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated 
with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be 
compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed 
consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria 
will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. 
After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90).  
After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects 
having AF recurrence and/or receiving therapeutic interventions during the evaluation period will 
be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes).  
All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of 
Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month 
follow up visit.  
3.1 Subject Selection  
3.1.1 
Inclusion Criteria 
Candidates for this study must meet ALL of the following criteria: 
1. 
Symptomatic paroxysmal AF who had at least one AF episode 
electrocardiographically documented within one (1) year prior to enrollment. 
Documentation may include electrocardiogram (ECG); Transtelephonic 
monitoring (TTM), Holter monitor or telemetry strip.  

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2. 
Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by 
recurrent symptomatic AF, or intolerable to the AAD.  
3. 
Age 18 years or older. 
4. 
Signed Patient Informed Consent Form (ICF). 
5. 
Able and willing to comply with all pre-, post-, and follow-up testing and 
requirements. 
3.1.2 
Exclusion Criteria 
Candidates for this study will be EXCLUDED from the study if ANY of the following 
conditions apply: 
1. 
Previous surgical or catheter ablation for atrial fibrillation 
2. 
Previous cardiac surgery (including CABG) within the past 6 months (180 days) 
3. 
Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, 
and valve repair or replacement and presence of a prosthetic valve) 
4. 
Any carotid stenting or endarterectomy 
5. 
Documented LA thrombus on imaging 
6. 
LA size > 50 mm on imaging 
7. 
LVEF < 40% 
8. 
Contraindication to anticoagulation (heparin or warfarin) 
9. 
History of blood clotting or bleeding abnormalities 
10. 
PCI/MI within the past 2 months (60 days) 
11. 
Documented thromboembolic event (including TIA) within the past 12 months 
(365 days) 
12. 
Rheumatic Heart Disease 
13. 
Uncontrolled heart failure or NYHA function class III or IV 
14. 
Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction 
≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2) 
15. 
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 
(365 days) 
16. 
Unstable angina 
17. 
Acute illness or active systemic infection or sepsis 
18. 
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac 
cause.  
19. 
Presence of implanted ICD/CRT-D. 
20. 
Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or 

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chronic obstructive pulmonary disease) or any other disease or malfunction of the 
lungs or respiratory system that produces chronic symptoms. 
21. 
Gastroesophageal Reflux Disease (GERD; active requiring significant intervention 
not including OTC medication) 
22. 
Significant congenital anomaly or medical problem that in the opinion of the 
investigator would preclude enrollment in this study. 
23. 
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 
24. 
Concurrent enrollment in an investigational study evaluating another device, 
biologic, or drug. 
25. 
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or 
other abnormality that precludes vascular access, or manipulation of the catheter. 
26. 
Life expectancy less than 12 months 
3.2 Subject Disposition 
• Enrolled Subjects: subjects who sign the informed consent. 
• Excluded Subjects: subjects who do not have the STSF/ST catheter inserted or 
have the STSF/ST catheter inserted but do not undergo ablation with VISITAG 
SURPOINT™ Module. Subjects who have the STSF/ST catheter inserted but do 
not undergo ablation with VISITAG SURPOINT™ Module will be followed for 
12-months. 
• Lost to Follow-up Subjects: subjects who are enrolled and have STSF/ST catheter 
inserted and undergo ablation with VISITAG SURPOINT™ Module, but contact 
is lost after most recent follow-up visit (despite 3 documented attempts). 
• Withdrawn / Early Termination Subjects: subjects who withdraw consent for 
study participation or are withdrawn by the investigator or are terminated from the 
study prior to completion of all follow-up visits. 
• Completed Subjects: enrolled subjects who completed the 12-month follow-up 
visit. 
3.3 Subject Withdrawal/Early Termination  
Subjects may withdraw from the clinical investigation at any time. The decision for the 
subject to withdraw informed consent must be made independently of influence by the 
investigator or site personnel. The subject’s decision will be documented in the source and 
eCRF. The investigator may also choose to withdraw a subject from the study if there are 
safety concerns. If a subject withdraws from the study, the date and reason for withdrawal 
will be recorded on the appropriate electronic case report form (eCRF).   
All data will be collected (as available) until the subject is withdrawn. If the subject is 
withdrawn due to an adverse event (AE) or serious adverse event (SAE), the investigator 
should follow the subject until the AE/SAE has resolved or is considered stable. 

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3.4 Subjects Lost to Follow up  
Subjects should be encouraged to return for protocol required, clinic visits 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 requesting the subject’s continuation in the study or confirming 
the subject’s desire to terminate from the study. 
If the subject does not respond to the phone telephone calls or letter, then the subject will 
be considered “lost to follow-up.”  
 STUDY ENDPOINTS 
4.1 Primary Endpoints 
4.1.1 
Primary Effectiveness Endpoint  
The primary effectiveness endpoint is defined as the freedom from documented 
(Symptomatic and asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia 
(AF/AFL/AT) (hereinafter collectively referred to as “atrial tachyarrhythmias") recurrence 
(episodes ≥ 30 secs on TTM or continuously recorded on the standard 12-leads ECG or 24 
Hour Holter monitoring) during the evaluation period (Day 91-365) and freedom from the 
following failure modes:  
• Acute procedural failure, including: 
o Failure to confirm entrance block in all pulmonary veins post-procedure,  
• Repeat ablation failure, including:  
o > 1 repeat ablation procedures during the 3-Month Blanking Period (Day 0-
90) after the index ablation procedure. 
o Any repeat ablation procedure during the Evaluation Period. 
• DC cardioversion for AF/AFL/AT following the 3-month blanking period  
• Surgical treatment for AF/AFL/AT after the index ablation procedure. 
• AAD failure: Taking a new AAD, a previously failed AAD at a greater than the 
highest ineffective historical dose or starting an AAD for AF during the evaluation 
period (refer to section 5.14 for details). 
In summary, effectiveness success is defined as freedom from atrial tachyarrhthmia during 
the Evaluation Period, off or on a previously failed AAD, and not exceeding 1 repeat 
ablation procedures for an atrial tachyarrhthmia during the 3-Month Blanking Period. 
This study is designed to compare the primary effectiveness of the VISITAG 
SURPOINT™ Module with EPU to a pre-determined performance goal of 50%, which is 
indicated as the minimum acceptable success rate at 12 months for a paroxysmal AF 
population in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE consensus statement.   

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4.1.2 
Primary Safety Endpoint  
The primary safety endpoint is the incidence of any primary adverse event occurring within 
7 days following an AF ablation procedure (including the initial and repeat procedures) 
using the STSF/ST catheter with the EPU per protocol, except atrio-esophageal fistula and 
PV stenosis, which may also be considered as primary adverse events if occurring greater 
than seven (7) days post the ablation procedure 49,50. 
Primary adverse events include the following conditions (refer to Table 6-1 Primary 
Adverse Events for detailed instructions for defining these adverse events): 
 
• Death 
• Atrio-esophageal fistula 
• Cardiac Tamponade*+/Perforation+ 
• Myocardial infarction (MI) 
• Stroke / Cerebrovascular accident (CVA) †, †† 
• Thromboembolism 
• Transient Ischemic Attack  
• Diaphragmatic paralysis 
• Pneumothorax 
• Heart block 
• PV stenosis 
• Pulmonary edema (Respiratory 
Insuffciency)  
• Vagal Nerve Injury 
• Pericarditis 
• Major vascular access complication 
/ bleeding 
* Hemodynamic compromise or instability is defined as Systolic BP < 80 mm Hg. 
+ Cardiac Tamponade/Perforation occurring within 30 days of the AF ablation process will be considered 
Primary AEs 
†  Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal 
evidence based upon neuroimaging studies. 
†† Modified Rankin score assessments should be made by certified individuals.  
 
4.2 Secondary Endpoints 
4.2.1 
Secondary Effectiveness Endpoints 
• Acute Procedural Success 
o % of subjects with ipsilateral PVI (entrance block) at the end of the procedure  
o % of subjects with ipsilateral PV isolation (entrance block) after first encirclement 
(evaluated prior to the 30-minute waiting period and adenosine challenge)  
o % of touch-up (ablation of acute reconnection) among all targeted veins  
o Anatomical location of acute PV reconnection after first encirclement 
• Repeat ablation procedures during 12-month period post-procedure 
o Incidence (%) of repeat ablation procedures  
o % PVs re-isolated among all of the targeted PVs at repeat procedure  
o % repeat ablation procedures requiring new linear lesions and/or identifying new 
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• 12-Month Single Procedure Success  
o The 12-month single procedure success is defined as freedom from documented 
AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a 
single ablation procedure and off AADs. Any repeat ablation procedure or AAD 
therapy will be deemed effectiveness failure for this analysis. 
4.2.2 
Secondary Safety Endpoints  
• 12-Month PAE Rate: Cumulative incidence of primary adverse events occurring 
within seven (7) days following an AF ablation procedure using study catheters 
with EPU and any late onset atrio-esophageal fistula or PV stenosis through 12 
months 
• Incidence of Unanticipated Adverse Device Effects (UADEs) 
• Incidence of Serious Adverse Events (SAEs) within 7 days (early onset), >7 to 30 
days (peri-procedural) and >30 days (late onset) of initial ablation  
• Incidence of bleeding complication (ISTH definitions): a) major, b) clinically 
relevant non-major and c) minor bleeding  
Refer to section 6.3 for the definition of Serious Adverse Event.  Refer to Appendix A: 
Study Definitions for the ISTH beeding complications definitions.  
4.3 Additional Endpoints 
No formal statistical hypothesis and inferential statistics will be formulated and 
performed for the additional endpoints. 
• Procedural Data: 
o Total procedure time, PVI time, RF application time, mapping time and 
RF application time per lesion  
o Total Fluoroscopy Time/dose 
o Fluid delivered from the study catheter  
o Location of RF applications, number of RF applications 
o Repeat Ablation Rate 
o RF Ablation parameters per application (e.g. temperature, power, 
impedance, CF etc.) 
o Device(s) utilized (per ablation) 
o VISITAG™ Settings 
o CF range 
o Power range 
o Tag Index Assessment per anatomical region 

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NOTE: Tag Index data (Force, Power, and Time) will be collected in the CARTO® 
3 System during the ablation procedures. The data will be processed to generate the 
Tag Index. 
• Quality of Life:  
o Quality of Life (QOL) status will be evaluated by assessing SF-12 
4.4 Health Economic Data 
The cost and frequency of health care utilization during hospitalization for the study index 
ablation procedure, as well as any additional hospitalizations during the study period will 
be collected. Because this data does not support the safety and effectiveness of the 
STSF/ST Catheter and the VISITAG SURPOINT™ module, it will not be provided to the 
Food and Drug Administration (FDA) as part of the IDE reporting.   
The hospitalization health care data to be collected may include, but is not limited to: copies 
of the subject’s hospital bills (UB04) and/or itemized hospital bills.  Subject’s admission 
date, discharge date, procedure date, ICD-10 and procedure code, Diagnosis Related Group 
(DRG) assignment and total cost for the hospitalization will be extracted from the forms. 
In addition, the sponsor will also collect health economic data associated with follow up 
care, including any repeat ablation procedure for treating arrhythmia, any inpatient or 
outpatient visit (including ER admissions) to address post-procedural complications or any 
procedure related condition and any inpatient or outpatient visit (including ER admissions) 
related to arrhythmia and cardiovascular conditions.   
 TREATMENT DESCRIPTION 
The Sponsor’s intention is for the enrolled subject population to be as representative as possible 
of the well-defined study population. Investigators will be encouraged to consecutively evaluate 
all paroxysmal AF candidates for ablation for participation in the study, and to offer enrollment to 
all who meet preliminary eligibility criteria. Screening log will be maintained at the research sites. 
Sponsor will attempt to include a diversified group of research sites engaging a variety of academic 
and private institutions geographically located throughout the US. To ensure generalizability of 
results and minimize the influence of any single site, no more than approximately 15% of the total 
enrollment will be allowed at a single site. Prior to enrollment, a few sites will be selected to only 
enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll 
subjects who will be treated with the STSF catheter. 
Potential clinical sites and investigators will be screened on the following criteria: 
• Experience and qualifications- Electrophysiologists with Catheter ablation 
experience, Previous clinical research study experience, performance and 
reporting,  
• Previous experience with hosting and responding to FDA inspections and 
sponsor audits and their outcomes if applicable 
• Study specific: THERMOCOOL SMARTTOUCH® and THERMOCOOL 
SMARTTOUCH® SF catheter use and past experience, VISITAG module 
experience  

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• Patient population: number of patients with Paroxysmal atrial fibrillation, 
monthly PAF ablation volume.  
• Time and resources to commit to the study- Number of ongoing PAF trails, 
Number of other studies being conducted, number of dedicated study 
coordinators, number of operators (EPs performing catheter ablation at a site), 
number of research managers. 
• Previous experience with the site enrollment, if any 
• Assess if potential Investigators are disqualified, debarred or restricted from 
performing research by regulatory bodies and/or health authorities. 
• Assess financial conflict of interest assessment for investigators and sites 
• Certifications and training- GCP, HIPAA, Safe harbor, use of human subjects 
for research 
• IRB processes: 
o Is the site using a central or local IRB? 
o Average turnaround time for full IRB approval? 
• Facilities: Esophageal temperature monitoring, equipped to handle emergency 
situation 
• Geographic location: to ensure generalizability 
Historically, women have been underrepresented in or excluded from many clinical studies, 
leading to lack of information for women and their physicians regarding the risks and benefits of 
many medical treatments and diagnostic procedures. It is the Sponsor’s intent to apply the 
principles from FDA’s guidance titled Evaluation of Sex-Specific Data in Medical Device Clinical 
Studies in this clinical trial to ensure adequate representation of women and minorities. The 
Sponsor will take reasonable steps to ensure adequate representation of women and racial or ethnic 
minorities in this clinical trial: 
In order to reflect the gender ratio of the intended population, Sponsor plans to enroll 
approximately 70% males and 30% females in the study. The gender ratio (male: female = 7:3) 
undergoing ablation procedures in the AF population is estimated based on previous studies.5757 In 
order to ensure that an appropriate gender ratio is maintained at our sites the sponsor may choose 
to do the following: 
• Target investigational sites where recruitment of needed populations can be more easily 
facilitated (e.g., women’s clinics).  
• Alternative communication strategies for study recruitment to reach women through social 
media ads, study related flyers and brochures may be done.  
• The sites will maintain screening logs that can be evaluated to ensure appropriate 
enrollment of women.  
• The investigational sites will be encouraged to increase recruitment by communicating the 
study information with primary care and family practitioners. 
• The subjects may be provided compensation to cover transportation costs and child care 
costs.  

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• The investigational sites will be encouraged to consider flexibility in follow-up visit 
scheduling to match subjects' schedules, which may include evenings and weekends, as 
long as the visits fall within visit window. 
• The sponsor will ensure collection, analysis and reporting of gender demographics in 
interim post-approval study status reports and clinical study reports.  
5.1 Patient Screening 
All patients considered for RF ablation procedure for drug refractory recurrent 
symptomatic PAF should be evaluated by the investigator or designated member of the 
research team for study eligibility per the protocol inclusion and exclusion criteria. 
Subjects are enrolled upon signing the informed consent form. No subject may undergo 
any protocol required tests or examinations falling outside the standard of care without first 
signing the Informed Consent form for this clinical investigation.  
5.2 Informed Consent 
Signing of an approved Informed Consent form (ICF) or Patient Information/Informed 
Consent form (PI/ICF) by the study candidate documents the patient’s acceptance and 
enrollment in the study. Prior to signing, the investigator or authorized member of the 
research team should discuss the background, potential risks and benefits, and expectations 
of the study with the candidate. The candidate should have any questions answered to his 
or her satisfaction, and should have access to an investigator for technical or medical 
questions as requested. Sufficient time must be given for this process. The subject or legal 
representative must sign the consent form prior to conducting any study-specific exams or 
tests that fall outside of the standard of care. The consent form used must have prior 
approval from a duly-constituted Institutional Review Board, Regional Ethics Board, or 
Ethics Committee. Failure to obtain informed consent renders the subject ineligible for 
participation in the study. 
The informed consent will include an authorization for use and disclosure of the subject’s 
protected health information, in accordance with the Health Insurance Portability and 
Accountability Act (HIPAA) or as required per local regulations. Subject confidentiality 
will be maintained throughout the clinical trial in a way that assures that individual subject 
data can be tracked back to the source data. For this purpose, a unique subject identification 
code will be used that allows identification of all data reported for each subject. Data 
relating to the trial may be made available to third parties, provided the data are treated as 
confidential and that the subject’s privacy is guaranteed. 
The informed consent will also request authorization for release of billing information 
specific to the subject’s participation in the study. Specifically, the subject’s UB04 (an 
itemized bill for the study procedure), the explanation of benefits (EOB) and any other 
hospitalizations or ER visits that occur during the study will be requested for each 
procedure and/or hospitalization. 

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5.3 Pre-Procedure Assessments 
Pre-procedure assessments should be performed within 30 days prior to the index AF 
ablation procedure unless otherwise noted. Some assessments (listed below) have a shorter 
window prior to the AF ablation procedure.  
• Transthoracic Echocardiogram (TTE) – Imaging to determine the atrial size prior 
to the AF procedure. If the subject has undergone an imaging procedure within the 
last 6-months where the atrial size (parasternal long axis view) was assessed and 
documented, the pre-procedure imaging assessment is not required. 
• Imaging for detection of LA thrombus – performed day before procedure or within 
48 hours of ablation procedure. The following are allowable imaging modalities: 
o TEE 
o CT/MRI 
o Intracardiac Echocardography (ICE) 
• Pregnancy Test – Pre-menopausal women only, performed within 24 hours prior to 
the procedure. 
• New York Heart Association (NYHA) Classification 
• Electrocardiogram (12-Lead ECG) 
• Baseline medical history 
• Arrhythmias history (including findings from TTM, ECG, Holter monitor, etc.)  
• Concomitant cardiac medications (including anticoagulation regimen and failed 
AADs) 
• Baseline Quality of Life (QOL) assessment; SF-12 Health Survey   
5.4 General AF Procedure Guidelines 
The AF ablation procedures for this study should follow the sequence below: 
• Diagnostic catheter placement 
• Electrophysiology study (discretion of investigator) 
• Transseptal puncture 
• Cardioversion if subject is in AF (discretion of investigator) 
• A left atrial anatomical map is required prior to an ablation procedure in the LA.  
o An anatomical map is not required of triggers outside of the left atrium e.g. 
SVC/CS etc.  
• 
CARTO® Respiratory Gating Mandatory (unless using Jet Ventilation) 
• Introduction of the STSF/ST Catheter 
o Minimize the amount of power, contact force and time when ablating the 
posterior wall.  

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o To minimize the risk of PV stenosis, it is recommended that RF energy 
applications are at least 1 to 2 cm outside the PV ostia to isolate the left and 
right-sided PVs.  
o Use caution when ablating near the esophagus (along the posterior wall 
of the left atrium), including but not limited to appropriately reducing RF 
power 
o For ablation in the region of the right superior PV, precautionary 
measures such as pacing maneuvers are recommended to evaluate 
proximity to the phrenic nerve.  
• Post ablation pacing procedure(s) and/or infusion of cardiac medications to induce 
AF/reconnection (e.g., Adenosine, Isoproterenol 2-20 mcg/min) 
5.5 Esophageal Monitoring 
REQUIRED: An appropriate strategy to minimize risk of esophageal injury MUST be 
used to ensure the physician has accurate information about the location of the esophagus 
relative to intended sites of ablation. The method used to localize the esophagus will be 
collected in the CRFs. 
At least one of the following methods MUST be used for esophageal localization: 
• Use of an esophageal temperature probe, 
• Esophageal visualization with CARTOSOUND® and/or ICE, 
• Esophageal visualization using barium swallow. 
Power reduction data and clinical practice associated with posterior wall RF applications 
will be collected in the CRFs and CARTO® data files for analysis. 
NOTE 1: The recommendations provided are based on data obtained from animal and 
clinical studies. Use clinical judgment when using this catheter paying careful attention to 
impedance drop, electrogram reduction, time of RF application, and with consideration of 
individual subject conditions when selecting settings.  
NOTE 2: Power and contact force should both be reduced when creating RF lesions on 
the posterior wall of the left atrium. 
NOTE 3: Reduce Power when high contact forces are observed during creation of RF 
lesions in the left atrium. For CF ≥ 20g power should be ≤ 35 watts. 
5.6 Recommended RF Power:  
• A RF power range of 15-45 Watts (W) is recommended for atrial ablation.7-10 
• Do not rely on the catheter tip temperature response to guide ablation. If the 
temperature increases rapidly, stop RF application immediately. 
• At anatomical locations other than the LA posterior wall or CS:  
o Maximum power should not exceed 45 W, and 

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o Duration of ablation should not exceed 60 seconds of continuous ablation at 
a given location. 
• RF energy delivery can be interrupted at any time when there is a safety concern 
(e.g., esophageal temperature rise, pain during conscious sedation, and steam pop).  
• LA posterior wall close to the esophagus: 
o Start ablation at < 25 W. 
o Move/drag the catheter to a new location if clinically effective ablation is 
not achieved within 20 seconds, as denoted by EGM reduction and/or 
impedance drop. 
o Power can be increased if clinically effective ablation isn’t achieved within 
20 seconds, as demonstrated by absence of EGM reduction and/or 
impedance drop). Maximum power used SHOULD NOT exceed 35 W.  
o RF energy delivery can be interrupted at any time when there is a safety 
concern (e.g., esophageal temperature rise, pain during conscious sedation, 
and steam pop). 
• Ablation within the CS: 
o If ablation is required in the CS, power may not exceed 35 W. 
o Duration of ablation is limited to 20 seconds per location in the CS. 
• Power reduction data and clinical practice associated with posterior wall RF 
applications will be collected in the CRFs and CARTO® data files for analysis. 
5.7 Contact Force (CF) Settings  
Operators should select individualized CF target ranges based on their case experience and 
the prior results from the THERMOCOOL SMARTTOUCH® SF catheter IDE trial.24  
• Contact Force settings: 
o Contact Force Target range: 5-25 gram (recommended) 
o Minimum CF of 3-5 grams 
• Risk of cardiac tamponade and perforation may correlate with higher CF (≥ 40 g) 
used during RF ablation. 
o  For CF ≥ 20g, power should be ≤ 35 watts. 
• Contact force data and individual procedure working ranges will be collected for 
each RF application during a study ablation procedure for offline analysis. 
5.8 VISITAG™ Settings 
• Stability Settings: 
o Range: 2-3 mm 
o Time: 3-5 seconds 

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• Filter (FOT) Settings: 
o If an FOT filter is desired, the percentage of time of the chosen gram force 
should be 25%. 
• Tag size – 3mm 
• Maximum Inter tag distance 6mm 
5.9 VISITAG SURPOINT™ Tag Index Targets  
VISITAG SURPOINT™ Module Tag Index target values for specified anatomical 
locations: 
•  Anterior, Ridge, Roof segments - target value: 550 
• Posterior and inferior segments - target value: 380 
NOTE 1: All Tag Index target values, especially the posterior wall, are in the absence of safety 
concerns (i.e. no temperature rise from esophageal probe, pain during conscious sedation or steam 
pop, etc).  In the absence of safety concerns, achieveing target Tag Index values will be the endpoint 
of RF energy application.  
NOTE 2: If for safety reasons the ablation needs to be stopped prior to reaching the Tag Index 
target value, please do so and document accordingly with associated VISITAG™ location number. 
NOTE 3: Increases in power and force from previous workflow to hit a specific Tag Index target 
with a shorter procedure time is not recommended 
5.10 Ablation Procedure 
The ablation procedure includes PVI, ablation of non-PV triggers and substrate 
modification. Study procedure requirements are outlined below: 
• PVI of all PV’s are required (acute success) 
• Linear ablation lines are only required to treat documented macro-reentry atrial 
tachycardia’s and limited to the following targets only: 
o LA roof line 
o MV isthmus line 
o LA floor line 
o CTI  
• A right atrial CTI linear ablation is REQUIRED in cases with documented typical 
atrial flutter either prior to or during the procedure. 
• Ablation of spontaneous non-PV triggers 
• CFAE ablation (left atrial, right atrial and CS) is not recommended 
• Ablation of non-PV triggers induced by adenosine or isoproterenol 

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NOTE 4: Tag Index target values for non-PV targets are not provided. The operator should 
follow the catheter IFU, use clinical judgment and their standard of care while ablating 
non-PV targets. 
Prophylactic ablation of empirical sites is not allowed. 
All linear lesions require confirmation of bidirectional conduction block by pacing 
and/or mapping maneuvers. 
5.11 Post Ablation 
• Verification of entrance block is required for all PVs. 
o A 30-minute waiting period is REQUIRED from the last RF application 
at a PV before verification may be confirmed. If reconduction is noted, 
additional RF applications should be applied and a second 30-minute waiting 
period will be required to recheck for entrance block. If reconduction is still 
noted, additional RF applications may be applied but a third 30-minute 
waiting period is not required prior to recheck for entrance block. 
• To verify entrance block, analyze electrograms in sinus and/or atrial paced rhythm 
to confirm that no PV potentials are present. 
o Administration of adenosine or isoproterenol after a 30-minute waiting 
period is REQUIRED to rule out dormant conduction.  
• Demonstration of entrance block MUST be confirmed and documented by the 
LASSO® Circular Mapping Catheter or PENTARAY® NAV Catheter.  
• Linear ablation lines may only be performed to treat documented macro-reentry 
atrial tachycardia’s (LA roof line, MV isthmus line, LA floor line, CTI. 
o Bidirectional block must be confirmed and documented 
• The ablation procedure is considered complete when confirmation of block is 
confirmed and documented. 
• In addition to the data collected on the CRFs, a CARTO® backup file identified 
with the subject’s study number will be made for each case and sent to the sponsor 
as part of the data collection. 
5.12 Post Procedure Assessments 
• Before hospital discharge: 
o Occurrence of arrhythmias, if any 
o Electrocardiogram (12-Lead ECG) 
o Transthoracic Echocardiogram (TTE), if necessary. Subjects who develop 
symptoms suggestive of pericardial effusion and/or pericarditis should 
undergo a transthoracic echocardiogram (TTE) to assess the pericardium, 
before hospital discharge. In the event significant pericardial effusion is 
identified, subjects should be followed until the condition resolves. 

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o Cardiac-related concomitant medications (such as AADs, anticoagulation 
regimen, etc.)  
o Adverse events, if any 
o Collect Subject Hospitalization Billing information (including UB04 and 
EOB)  
• Follow-up measurements at 7-9 Days (telephone)  
o Medical History – any change from previous 
o Occurrence of arrhythmias, if any 
o Cardiac-related 
concomitant 
medications 
(such 
as 
AADs, 
anticoagulation regimen, etc.)  
o Adverse events, if any 
▪ Subjects who have symptoms suggestive of PV stenosis should undergo 
imaging (CT/MRI) 
o Health Economic Data for hospitalizations, ER visits and outpatient 
visits, if any 
▪ At all visits, health economic data to be collected may include, but is 
not limited to: hospitalization charge (UB04), repeat ablation procedure 
and/or procedures resulting from the ablation procedure, outpatient 
visits, and ER visits 
• Follow-up measurements at 1-Month (+/-7days): 
o Medical history- any change from previous 
o Physical Exam including standardized neurological assessment and 
cardiovascular/ pulmonary examination.  
o Occurrence of arrhythmias, if any 
o Electrocardiogram (12-Lead ECG) 
o Concomitant medications only cardiac related (AADs, anticoagulation 
regimen, etc.)  
o TTM Monitor (refer to section 5.16 for transmission schedules) 
o Adverse events, if any 
▪ Subjects who have symptoms suggestive of PV Stenosis should undergo 
imaging (CT/MRI) 
o Health Economic Data for hospitalizations, ER visits and outpatient 
visits, if any 
▪ At each follow-up visit, health economic data to be collected may 
include, but is not limited to: hospitalization charge (UB04), repeat 
ablation procedure and/or procedures resulting from the ablation 
procedure, outpatient visits, and ER visits 

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• Follow-up measurements at, 3-Month (+/- 7 days), 6 (+/-14 days), 12-Month 
(+/- 28 days) and Unscheduled Clinic Visits: 
o Medical History – any change from previousOccurrence of arrhythmias, if 
any 
o Occurrence of arrhythmias, if any 
o Electrocardiogram (12-Lead ECG) 
o QOL Assessments (SF-12 Health Survey) (Only collected at 3, 6 and 12 
months visit) 
o TTM Monitor (refer to section 5.16 for transmission schedules) 
o 24 hour Holter monitoring (12-month visit) 
o Concomitant medications only cardiac related (AADs, anticoagulation 
regimen, etc.)  
o Adverse events, if any 
▪ Subjects who have symptoms suggestive of PV Stenosis should undergo 
imaging (CT/MRI) 
o Health Economic Data for hospitalizations, ER visits and outpatient 
visits, if any 
▪ At each follow-up visit, health economic data to be collected may 
include, but is not limited to: hospitalization charge (UB04), repeat 
ablation procedure and/or procedures resulting from the ablation 
procedure, outpatient visits, and ER visits 
o End of Study Report – Subject completion/discontinuation form (12-Month 
or last completed visit) 
Note: For follow-up visit schedules defined in this protocol, 1 month = 30 
days, 1 week =7 days.   
 
 
 
 
 
 
 
 
 
 
 

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5.13 Standard Tests and Procedures 
The required schedule for subject treatments and evaluations is summarized in Table 5-1.  
Table 5-1 
Schedule of Treatments and Evaluations 
 
Pre-Procedure 
 
 
Phone 
Call 
Follow-Up Visits 
 
 
Screening / 
Baseline 
Ablation 
Procedure1 Discharge 
7-9 
Days 
1 Month 
+/- 1 wks  
3 Month 
+/- 1 wks  
6 Month 
+/- 2 wks  
12 
Month  
+/- 4 wks  
Unsched
uled Visit 
Visit no. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Informed consent1 
X 
 
 
 
 
 
 
 
 
 
Inclusion & exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical history  
X 
 
 
 
X10 
X10 
X10 
X10 
X10 
X10 
Physical Exam 
 
 
 
 
 
X 
 
 
 
 
Arrhythmias 
X 
[history] 
 
 
X 
X 
X 
X 
X 
X 
X 
ECG 
 
X 
 
X 
 
X 
X 
X 
X 
X 
NYHA 
 
X 
 
 
 
 
 
 
 
 
QOL assessment2 
 
X 
 
 
 
 
X 
X 
X 
 
Pregnancy test3 
 
X 
 
 
 
 
 
 
 
 
LA thrombus 
Imaging4 
 
 
X4 
 
 
 
 
 
 
 
TTE5,13 
 
X5 
 
X13 
 
 
 
 
 
 
Ablation assessments 
 
 
X 
 
 
 
 
 
 
 
Device deficiency 
 
 
X 
 
 
 
 
 
 
 
Concomitant 
medications6 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Health Economic 
Data Collection7 
 
 
 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
Adverse events8,9  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Pre-Procedure 
 
 
Phone 
Call 
Follow-Up Visits 
 
 
Screening / 
Baseline 
Ablation 
Procedure1 Discharge 
7-9 
Days 
1 Month 
+/- 1 wks  
3 Month 
+/- 1 wks  
6 Month 
+/- 2 wks  
12 
Month  
+/- 4 wks  
Unsched
uled Visit 
Visit no. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
TTM monitoring11 
 
 
 
 
 
X11 
X11 
X11 
X11 
 
24 Hour Holter 
 
 
 
 
 
 
 
 
X 
 
PV stenosis imaging 
assessment12 
 
 
 
 
X12 
X12 
X12 
X12 
X12 
X12 
Subject Completion/ 
discontinuation form 
 
 
 
 
 
 
 
 
X14 
 
 
1 Initial ablation procedure should be done within 30 days of consent. 
2 Quality of life tools (SF-12 Health Survey) 
3 Pregnancy test must be done on pre-menopausal women only, within 24 
hours of the procedure. 
4 Section 5.3 of the protocol should be followed when determining if a 
subject should undergo imaging for the presence of LA Thrombus.  
5 Imaging TTE to determine the atrial size (if the subject has 
undergone an imaging procedure within the last 6-months where 
the atrial size was assessed, the pre-procedure imaging assessment 
is not required) 
6 Concomitant medications: only cardiac related (anti-arrhythmia drugs, 
anticoagulation regimen, etc.) 
7 Health Economic Data for hospitalizations (UB04), ER visits and 
outpatient visits, if any  
 
8 AEs collected once consent has been signed  
9 If AE results in Hospitalization health economic data collection is 
required  
10 Collected to confirm no changes in medical history since last visit 
11 TTM: all symptomatic cardiac episodes should be recorded and 
transmitted at the time the event occurs. Asymptomatic transmissions 
should be recorded as scheduled (weekly: months 2-5 and monthly: 
months 6, 7, 8, 9, 10, 11, 12) and transmitted to the Core Lab. Refer to 
section 5.16. 
12 PV imaging (CT/MRI) for subjects who have symptoms suggestive of 
PV stenosis 
13  Subjects who develop symptoms suggestive of pericardial effusion 
and/or pericarditis should undergo a transthoracic echocardiogram 
(TTE) to assess the pericardium  
14 12-month visit or last completed visit 
 

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5.14  Study Medications 
The following medications are recommended/required (as indicated) for subjects 
undergoing a Study procedure ablation for AF. 
5.14.1 Anticoagulation Medications 
• Medication Prior to AF Ablation Procedure 
o Subject should be placed on systemic anticoagulation therapy for at least 3 weeks 
prior to the AF ablation procedure.  
• Medication During AF Ablation Procedure 
o Heparin: to achieve an activated clotting time (ACT) of ≥ 325 seconds during the 
AF ablation procedure in the left atrium. 
o ACT levels MUST be checked prior to administering RF energy and rechecked 
every 15-30 minutes during the ablation procedure in the left atrium to ensure ACT 
≥ 325 seconds. All recordings must be documented in the medical records as source 
documentation. 
o Adenosine: 12 mg to 24 mg  bolus to confirm PV isolation; rule out dormant 
conduction  
o Isoproterenol: recommended if pacing maneuvers are not performed, to achieve a 
≥ 20 beats per minute increase in heart rate to induce AF upon completion of the 
ablation procedure is (recommended dose range is 2-20 mcg/min). 
• Medication Following AF Ablation Procedure 
o It is recommended that physicians follow the relevant recommendations from the 
2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on 
Catheter and Surgical Ablation of AF.4 All anticoagulation therapy will be recorded 
on the appropriate case report form. 
o All subjects MUST be maintained on systemic oral anticoagulation therapy for 2 
months post-procedure. Reinitiate oral anticoagulation therapy within 3-5 hours 
post procedure. 
o Systemic oral anticoagulation is achieved using INR- dose adjusted warfarin (INR 
should be maintained between 2.0 and 3.0, inclusive), direct thrombin inhibitor, or 
factor Xa inhibitor. 
o At 2 months post-procedure, decision regarding continuation of systemic anti-
coagulation agents is based on the subject risk for thromo-embolism. Systemic oral 
anticoagulation is strongly encouraged to be continued beyond 2 months post 
ablation in subjects with CHADS2 score > 1.  
5.15 Antiarrhythmic Drug (AAD) Management 
5.15.1 
Definitions 
• Antiarrhythmic drugs (AADs)  

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o The study protocol will classify and analyze the following: 
o Class I drugs (e.g., flecainide, propafenone, disopyramide, etc.) 
o Class III drugs (e.g., amiodarone, dronedarone, dofetilide, etc.) 
• Previously Failed AAD 
Any AAD that a subject has ever taken for the treatment of his/her AF, prior to 
enrollment, is considered a “previously failed AAD” if it meets both of the following 
conditions: 
o prior to enrollment, the AAD was ineffective in controlling the subject’s AF 
or produced intolerable side effects leading to its discontinuation; 
o the AAD is administered for AF 
• New AAD  
ANY AAD that was never taken for the treatment of AF prior to enrollment is 
considered a “new AAD” if the drug is administered to treat an “atrial 
tachyarrhythmia” post-enrollment. 
5.16 Heart Rhythm Monitoring 
ECG, Transtelephonic monitors (TTM) and 24 Hour Holter Monitoring will be used to 
monitor the subjects’ heart rhythm post-treatment.  
Electrocardiogram (12-lead ECG): 
ECG device will be provided to each site. Sites will be instructed to record and transmit 
for every subject per the schedule of treatment and evaluations summarized in Table 5-1. 
 
Transtelephonic Monitors (TTM): 
Transtelephonic monitors (TTM) will be provided to each subject at the 1-month follow-
up visit for scheduled transmissions of heart rhythm status.  Subjects will be instructed to 
transmit all emergent symptomatic cardiac events and follow a detailed schedule if the 
subject remains asymptomatic post ablation during the last 2 months of the blanking period 
and the Evaluation Period (Day 91-365).   
The TTM transmission schedule: 
• Each subject will be provided with a TTM device at the 1-month visit.  
• Subjects will complete a test transmission upon receipt of the TTM device to 
demonstrate a working understanding of the device.  
• The TTM schedule will include 2 months of TTMs during the blanking period. At 
the 1-month office visit or during discharge, subjects will be provided a TTM for 
event monitoring during the follow-up period. The first transmission will be at the 
1- month office visit. TTM schedule will be every week for months 2, 3, 4 and 5 . 
After the weekly transmissions, subjects will be asked to record and transmit a 
minimum of 1 transmission (60 seconds) per month until the effectiveness 

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assessment period is completed (12 months post index procedure). In addition, 
subjects will also be asked to transmit any symptom-triggered episode that occurs 
during the 12-month follow-up period. 
Months (post-procedure) 
TTM schedule (asymptomatic) 
Month 2, 3, 4, 5 
1 per week 
Month 6, 7, 8, 9, 10, 11, 12 
1 per month 
 
• All symptomatic cardiac episodes should be recorded and transmitted soon after the 
event occurs. A core lab will be used to evaluate and assess the TTM tracings. 
 
Holter Monitoring: 
• A 24 Hour Holter will be used at the 12 month follow-up visit to monitor the 
subjects’ heart rhythm. A core lab will be utilized to evaluate and assess the 
24-hour Holter recordings.   
5.17 Study Equipment 
5.17.1 
Required Catheters and Equipment 
The following devices are required for the AF ablation procedure during this study: 

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 ADVERSE EVENTS  
6.1 Adverse Event Recording  
An Adverse Event is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) occurring during a 
clinical study, whether or not related to the study device or ablation procedure.  
Adverse events will be collected from signing of informed consent throughout study 
follow-up, at each evaluation and whenever the physician becomes aware of an event. 
Investigators will determine, at each encounter, whether any adverse events (AE) have 
occurred, and judge their seriousness and relationship to the study device and procedure.  
All adverse events, regardless of classification, seriousness, intensity, outcome, or 
causality, must be recorded in the electronic CRF(s) in a timely manner throughout the 
study. Onset date of the event, its treatment, current status (resolved, stabilized, or 
ongoing), and assessment of its seriousness and relationship to the device should be 
provided when available. All AEs will be monitored until they are resolved or stabilized 
(no further changes anticipated).  
AF recurrence by itself is considered a recurrence of disease (pre-existing condition), and, 
therefore, does not meet the definition of an AE. Recurrence of pre-existing AFL/AT is 
also considered recurrence of disease, and not an AE.  
The following additional clinical events will not be considered adverse events for this 
clinical study: 
• Minor pericarditis attributable to the ablation procedure defined as pleuritic chest 
discomfort with or without pericardial rub and ECG changes. 
• A trace / trivial / minor pericardial effusion that is asymptomatic, requires no 
medical intervention, and does not extend hospitalization will not be considered an 
adverse event. 
• AF/AFL/AT recurrence requiring pharmacological or synchronized electrical 
cardioversion during the hospitalization for the index ablation procedure, or 
throughout the duration of the study. 
• Reablation for AF or pre-existing AFL/AT. 
6.2 Classification 
Any of the following events are to be reported to the sponsor immediately. The Sponsor 
may request additional information after the initial notification. 
6.2.1 
Primary Adverse Event 
A Primary AE is one of the following events occurring within seven (7) days following an 
AF ablation procedure with the STSF/ST catheter and VISITAG SURPOINT™ module 
with EPU, except atrio-esophageal fistula and PV stenosis, which may also be considered 
as primary adverse events if occurring greater than seven (7) days post the ablation 
procedure 49,50.  

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6.3 Serious AEs  
A serious adverse event (SAE) is any event that meets one or more of the following 
criteria: 
• Lead to a death 
• Lead to a serious deterioration in the health of a subject that: 
o Resulted in a life-threatening illness or injury 
o Resulted in a permanent impairment of a body structure or a body 
function; 
o Required in-patient hospitalization or prolongation of existing 
hospitalization* 
o Resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function 
• Lead to fetal distress, fetal death or a congenital abnormality or birth defect. 
“Hospitalization” means the event necessitated an admission to a health care facility 
e.g., with at least an overnight stay. Emergency room visits that do not result in 
admission to the hospital should be evaluated for one of the other serious outcomes. 
*Planned hospitalization for a condition present prior to the participant’s enrollment in 
the study will not meet the definition of an SAE, but should nevertheless be included in 
routine study reporting.  
6.4 Non-Serious AEs (NSAEs) 
A non-serious AE is any event that results in minimal transient impairment of a body 
function or damage to a body structure, and does not require any intervention listed 
under the criteria for “Serious Adverse Event.” Nonserious adverse events require 
routine reporting via EDC. 
6.5 Anticipated AEs 
An anticipated AE is one that has been reported in previous studies of RF ablation and 
can be anticipated in this current study as per the risk analysis. Table 6-2 provides a 
comprehensive list of anticipated AEs. 
 
Table 6-2 Anticipated Adverse Events 

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6.6 Unanticipated Serious Adverse Device Effect 
A (serious) adverse device effect (ADE/SADE) is any (serious) adverse effect on 
subjects’ health, safety, rights, welfare, and life-threatening problems including death, 
which is caused by, or associated with the study device. Accordingly, relationship to 
device or study is crucial assessment by investigators. An unanticipated adverse device 
effect (UADE) or unanticipated serious adverse device effect (USADE) is any ADE or 
SADE that has not been previously identified in nature, severity, or degree of incidence 
in the study plan or risk analysis report. 
6.7 Clinical Investigation Device Failure/Malfunction/Deficiency 
A device has failed if it does not perform according to the instructions for use or fails to 
meet the expectations of the device and/or investigator (i.e., related to appearance of the 
device, performance, durability, safety, effectiveness, quality, reliability, labeling, etc.). 
If a device failure is detected or suspected, it should be documented on the appropriate 
CRF and the device must be promptly returned according to the Sponsor’s 
instructions. If the device failure is associated with an AE, both the device failure and 
AE must be reported to the Sponsor immediately upon awareness (refer to section 6.8). 
6.8 Reporting Requirements 
All serious AEs, UADE/SADE/USADE, and Study device 
failure/malfunction/deficiency, whether or not they are related to the device or 
procedure, must be reported by eCRF to the Sponsor (Biosense Webster Clinical 
Operations). Investigators/sites are expected to report any Primary AEs, Serious AEs, 
UADE/SADE/USADE, and Study device failure/malfunction/deficiency immediately 
upon their awareness of the event as soon as possible but no longer than 72 hours* 
from when the study site becomes aware of SAEs and UADEs. For all other non-
serious Adverse Events, the Study Site has 2 weeks from when the study site becomes  
aware to inform the Johnson and Johnson Study Sponsor. Failure to report any event 
requiring expedited reporting within this interval will be classified as a protocol 
deviation.  
6.9 Intensity or Severity 
Intensity (or severity) of AEs is defined as follows:  

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 STATISTICAL ANALYSIS METHODS 
7.1 Study Design 
The SURPOINT COA study is a prospective, multicenter, non-randomized clinical evaluation of 
the VISITAG SURPOINT™ Module with EPU when used with the STSF and ST catheters in 
treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A 
maximum of 330 subjects  will be enrolled at up to 45 sites. Two hundred eighty (280) subjects 
will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST 
catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will 
be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated 
with the STSF catheter. Two interim analyses are planned to take place after all subjects who are 
treated using STSF catheter with EPU have completed their 3-month and 6-month follow-up visits 
for the evaluation of early success. The planned interim analysis will be based on data collected 
only in the subjects who are treated using STSF catheter with EPU. The final analysis of the 
primary effectiveness and safety endpoints will be based on all subjects’s full 12-month follow-up 
data. Effectiveness and safety endpoints defined in association with the primary study objectives 
will be compared to the predetermined performance goals.   
Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with 
the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects 
will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter 
the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic 
interventions during the evaluation period will be considered effectiveness failures.  
All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of 
Treatments and Evaluations in protocol). Subjects complete the SURPOINT COA study after the 
12-month follow up visit.  
7.2 Treatment Assignment 
This is a single-arm study. The only treatment assigned is the THERMOCOOL 
SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheters using 
VISITAG SURPOINT™ Module with External Processing Unit (EPU). 
7.3 Randomization and Blinding Procedures 
This study is a non-randomized single-arm study.  An independent group will perform the Bayesian 
interim analyses. The sponsor is not blinded to individual or aggregated data.  
7.4 Interval Windows 
The required schedule for subject treatments and evaluations is summarized in Table 5-1 of the 
study protocol.  

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7.5 Primary and Secondary Endpoint(s) and Associated Hypotheses 
7.5.1 
Primary Endpoints and Associated Hypotheses  
7.5.1.1 
Primary Effectiveness Endpoint  
The primary effectiveness endpoint of this study is the effectiveness success rate at Month 12, 
defined as the proportion of subjects who are freedom from documented (symptomatic and 
asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia (AF/AFL/AT) (hereinafter 
collectively referred to as “atrial tachyarrhythmias") recurrence (episodes ≥ 30 secs on TTM or 
continuously recorded on the standard 12-leads ECG or holter) during the evaluation period (Day 
91-365) and freedom from the following failure modes:  
• Acute procedural failure, including: 
o Failure to confirm entrance block in all pulmonary veins at the end of 
procedure 
• Repeat ablation failure, including:  
o > 1 repeat ablation procedures during the 3-Month Blanking Period (Day 0-
90) after the index ablation procedure. 
o Any repeat ablation procedure during the evaluation period. 
• DC cardioversion for AF/AFL/AT following the 3-month blanking period  
• Surgical treatment for AF/AFL/AT after the index ablation procedure. 
• AAD failure: Taking a new AAD for AF, a previously failed AAD at a greater than 
the highest ineffective historical dose during the evaluation period. 
This study is designed to compare the primary effectiveness of the VISITAG SURPOINT™ 
Module with EPU to a pre-determined performance goal of 50%, which is indicated as the 
minimum acceptable success rate at 12 months for a paroxysmal AF population in the 2017 
HRS/EHRA/ECAS/APHRS/SOLAECE consensus statement.   
The hypotheses to be tested for this evaluation are: 
𝐻0: 𝑝≤0.50         vs.         𝐻𝐴: 𝑝> 0.50,     
where 𝑝 is the effectiveness success rate. 
7.5.1.2 
Primary Safety Endpoint  
The primary safety endpoint is the proportion of subjects with any primary adverse event (PAE) 
occurring within 7 days following the AF ablation procedure (including the initial and repeat 
procedures) using the STSF catheter with EPU, except atrio-esophageal fistula and PV stenosis, 
which may also be considered as primary adverse events if occurring greater than seven (7) days 
post the ablation procedure 49,50.  
 
The PAE rate will be compared against the performance goal of 14% by testing the following 
hypotheses:  
 

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𝐻0: 𝑞≥0.14         vs.         𝐻𝐴: 𝑞< 0.14 
where 𝑞 is the PAE rate. 
7.5.2 
Secondary Endpoints 
No formal statistical hypothesis and inferential statistics will be formulated and performed for 
the secondary effectiveness and safety endpoints. 
7.5.2.1 
Secondary Effectiveness Endpoints 
• Acute Procedural Success 
o % of subjects with ipsilateral PVI (entrance block) at the end of the procedure  
o % of subjects with ipsilateral PVI (entrance block) after first encirclement 
(evaluated prior to the 30-minute waiting period and adenosine challenge)  
o % of touch-up (ablation of acute reconnection) among all targeted veins  
o Anatomical location of acute PV reconnection after first encirclement 
• Repeat ablation procedures during 12-month period post-procedure 
o Incidence (%) of repeat ablation procedures  
o % PVs re-isolated among all of the targeted PVs at repeat procedure  
o % repeat ablation procedures requiring new linear lesions and/or identifying new 
foci outside of initially isolated area among the repeat ablation procedures 
• 12-Month Single Procedure Success  
o The 12-month single procedure success is defined as freedom from documented 
AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a 
single ablation procedure and off AADs. Any repeat ablation procedure or AAD 
therapy will be deemed effectiveness failure for this analysis. 
7.5.2.2 
Secondary Safety Endpoints  
• 12-Month PAE Rate: Cumulative incidence of primary adverse events occurring within 
seven (7) days following an AF ablation procedure using study catheters with EPU and 
any late onset atrio-esophageal fistula or PV stenosis through 12 months 
• Incidence of Unanticipated Adverse Device Effects (UADEs) 
• Incidence of Serious Adverse Events (SAEs) within 7 days (early onset), >7 to 30 days 
(peri-procedural) and >30 days (late onset) of initial ablation  
• Incidence of bleeding complication (ISTH definitions): a) major, b) clinically relevant 
non-major and c) minor bleeding  

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7.5.3 
Additional Endpoints 
No formal statistical hypothesis and inferential statistics will be formulated and performed for 
the additional endpoints.  
• Procedural Data: 
o Total procedure time, PVI time, RF application time, mapping time and RF 
application time per lesion  
o Total Fluoroscopy Time  
o Fluid delivered from the study catheter  
o Location of RF applications, number of RF applications 
o RF Ablation parameters per application (e.g. temperature, power, impedance, CF 
etc.) 
o Device(s) utilized (per ablation) 
o VISITAG™ Settings 
o CF range 
o Power range 
o Tag Index Assessment per anatomical region 
• Quality of Life (QOL): SF-12  
7.5.4 
Health Economic Data 
The primary health economic data will include the cost and frequency of hospitalization for the 
study index ablation procedure, as well as any additional hospitalizations during the study 
period. The health care utilization during hospitalizations will be assessed by utilizing all data 
available for this study such as copies of the subject’s hospital bills (UB04) and/or itemized 
hospital bills.   
The health economic data associated with follow up care will include any repeat ablation 
procedure for treating arrhythmia, any inpatient or outpatient visit (including ER admissions) to 
address post-procedural complications or any procedure related condition and any inpatient or 
outpatient visit (including ER admissions) related to arrhythmia and cardiovascular conditions.   
7.6 Level of Significance 
The type I error for the interim and final analyses of the primary endpoints is controlled at one-
sided 5%. Please refer to Appendix C for the operating characteristics of the Bayesian adaptive 
design including the type-I error simulation results. 

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7.7 Analysis Sets 
For the analysis of study endpoints, the analysis populations defined in the following will be 
used: 
• Safety Population: The SP will consist of all enrolled subjects who have undergone 
insertion of the STSF/ST catheters and use of the VISITAG SURPOINT™ Module with 
EPU. The safety population (SP) will be used to analyze safety endpoints. 
• Per Protocol (PP) Population: The PP population will be used for the analysis of 
effectiveness endpoints. The PP population will include subjects who satisfy the 
following criteria: 
o are enrolled and meet all eligibility criteria 
o have undergone RF ablation  
o are treated with the STSF/ST catheters with the VISITAG SURPOINT™ Module 
with EPU, and have been treated for the study-related arrhythmia 
 
• Full Set Effectiveness Population: The full set effectiveness population will be used to 
analyze the effectiveness endpoints. This population will include those who have met the 
following criteria:  
o are enrolled  
o have undergone RF ablation  
o are treated with the STSF/ST catheters with the VISITAG SURPOINT™ Module 
with EPU, and have been treated for the study-related arrhythmia 
7.8 Sample Size Justification 
The final analyses for primary safety and effectiveness endpoints will apply Bayesian methods 
and use a beta-binomial model. 
The power calculations for the Bayesian adaptive design are presented in the simulation report 
Appendix C Table 6 (probability of success).  Under the assumption of 65% success rate for 
primary effectiveness and 8% rate for primary safety, with 330 subjects, assuming 10-15% 
attrition rate,  we will provide 90% power for declaring success for each of the primary  
endpoints controlling the type-I error at 5%.  
7.9 Statistical Analysis Methods 
7.9.1 
General Conventions  
In general, descriptive statistics will summarize all primary, secondary, and additional endpoints 
as appropriate.  For continuous variables, number of subjects/events, mean, standard deviation, 
median, 25% percentile, 75% percentile, minimum, and maximum will be provided.  For 
categorical variables, frequency and percentage will be presented for each category.  

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7.9.2 
Subject Disposition 
Disposition of the study subjects are defined as the following.  
• Enrolled Subjects: subjects who sign the informed consent. 
• Excluded Subjects: subjects who do not have the STSF/ST catheters inserted or have 
the STSF/ST catheters inserted but do not undergo ablation with VISITAG 
SURPOINT™ Module.  
• Lost to Follow-up Subjects: subjects who are enrolled and have STSF/ST catheter 
inserted and undergo ablation with VISITAG SURPOINT™ Module, but contact is lost 
after most recent follow-up visit (despite 3 documented attempts). 
• Withdrawn / Early Termination Subjects: subjects who withdraw consent for study 
participation or are withdrawn by the investigator or are terminated from the study prior to 
completion of all follow-up visits. 
• Completed Subjects: enrolled subjects who completed the 12-month follow-up visit. 
7.9.3 
Demography and Baseline Characteristics 
Subject demographics, medical history, AAD medical history and other baseline data will be 
summarized descriptively for all enrolled subjects as well as the safety and PP populations. 
7.9.4 
Analysis of Primary Endpoints  
The primary effectiveness endpoint is the proportion of patients that are free from primary 
effectiveness failure at Month 12. The failure modes are defined in the section 7.5.1.1. The 
effectiveness success rate at Month 12 will be compared against the performance goal of 50%. 
The primary safety endpoint is the proportion of subjects who have any  primary adverse events 
occurring within seven (7) days following an AF ablation procedure using study catheters with 
EPU, except atrio-esophageal fistula and PV stenosis, which may also be considered as primary 
adverse events if occurring within three (3) months post the ablation procedure.The PAE rate 
will be compared against the performance goal of 14%. The final analyses will apply the 
Bayesian methods using a beta-binomial model 
7.9.4.1 
Final Analysis 
The primary goal of the trial is to demonstrate effectiveness and safety. For the trial to be 
successful, both endpoints must be statistically significant relative to their respective PG goals. 
The effectiveness endpoint will be assessed by testing the hypotheses:  
𝐻0: Pr(𝑝> 0.5|𝑥, 𝑛) ≤0.97    vs.         𝐻𝐴: Pr(𝑝> 0.5|𝑥, 𝑛) > 0.97     
where 𝑝 is the responder rate, 𝑥 is the observed number of patients that are failure-free through 
12 months ("responders"), and n is the number of subjects in the PP population.  If the predictive 
posterior probability of the primary effectiveness endpoint meeting the 50% PG is greater than 
97%, then we meet the threshold for primary effectiveness success.  
We model the number of responders  
𝑋∼Binomial(𝑛, 𝑝), 

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We use a Beta(0.01, 0.01) prior distribution. This prior is centered at 50% and has an effective 
sample size of 0.02 observations.  
Then the posterior distribution is  
(𝑝|𝑥, 𝑛) ∼Beta(0.01 + 𝑥, 0.01 + 𝑛−𝑥). 
Subjects with missing data on the effectiveness endpoint will have their outcomes multiply 
imputed from a longitudinal model. 
Similarly, the hypothesis test for the safety endpoint is:  
𝐻0: Pr(𝑞< 0.14|𝑦, 𝑛) ≤0.95         vs.         𝐻𝐴: Pr(𝑞< 0.14|𝑦, 𝑛) > 0.95 
where 𝑞 is the PAE rate, y is the observed number of subjects who had PAE and n is the number 
of subjects in the safety population. If the predictive posterior probability of the primary safety 
endpoint meeting the 14% PG is greater than 95%, then we meet the threshold for primary safety 
success.  
We model the number of patients with PAE as 
𝑌∼Binomial(𝑛, 𝑞) 
with Beta(1, 1) prior distribution on 𝑞. No imputation for missing data will be performed for the 
safety endpoint. 
The trial will be considered a success if BOTH 
1. 
Pr(𝑝> 0.5|𝑥, 𝑛) > 0.97 AND 
2. 
Pr(𝑞< 0.14|𝑦, 𝑛) > 0.95. 
These thresholds control the overall Type I error rate for the trial below one-sided 5%. The Type 
I error for each endpoint individually is also below 5%. The protocol Appendix C contains a 
detailed description of the statistical methods planned for testing the hypotheses around the 
primary effectiveness and safety endpoints.   
Note that the final analysis will be performed if early success is not declared at either of the two 
interim looks. If early success is declared at either of the two interim looks, a summary of the 
primary endpoints based on full 12-month follow-up will be provided. In addition, both safety 
and effectiveness results will also be descriptively summarized separately for subjects treated 
with the ST and STSF catheters. 
7.9.4.2 
Interim Analysis 
Two interim analyses are planned. The first will occur once all subjects who are treated using 
STSF catheter with EPU have completed their 3 months follow-up. The second interim will 
occur when all subjects who are treated using STSF catheter with EPU have completed their 6 
months follow-up. The planned interim analysis will be based on data collected only in subjects 
treated using STSF with EPU.  
For the safety endpoint, among patients with more than 3 months of follow-up at the time of the 
interim analyses, any atrio-esophageal fistula and PV stenosis occurring post procedure will be 
deemed PAE. 

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At each interim analysis, the trial will declare early success if the predictive probability of 
success at the final analysis is greater than or equal to 99%. Early success will be declared at an 
interim if: 
1. 
The safety objective has been met, and 
2. 
The effectiveness endpoint has greater than or equal to 99% predictive probability 
of success. 
The predictive probability is the probability of observing the success rate larger than 0.50 if the 
study continues to the end, given the observed data.  If early success is declared, the subjects will 
be continued to be to be followed up for the remainder of the follow-up period. 
7.9.4.3 
Handling of Missing Data 
At the time of each interim analysis, some subjects will not have completed the full 12-month 
evaluation period. For example, recently enrolled subjects who are currently failure-free but have 
only been observed for a portion of the observation period will have "censored" final outcomes. 
Some subjects may still be within the 13-week blanking period, and have no follow-up time 
during the observation period. Some subjects may be lost to follow-up. A longitudinal model will 
be employed to enable final observations to be multiply imputed for those subjects with partial or 
no follow up. Details are included in the protocol Appendix C. 
The model is a piecewise exponential model for the time-to-failure during the 39-week post-
blanking period. The model has three distinct segments: (0, 2], (2, 8], and (8, 39] weeks. The 
probability of failure during each interval is exponentially distributed, with different hazard rates 
in each segment. The model is:  
𝑓(𝑡) = exp(−𝑡ℎ(𝑡)), 
where  
ℎ(𝑡) = {
𝜆1
0 < 𝑡≤2;
𝜆2
2 < 𝑡≤8;
𝜆3
8 < 𝑡≤39.
 
              
These intervals are based on the model used in the ThermoCool Pivotal trial. 
 Noninformative Gamma (1, 1) prior distributions will be used for each 𝜆 in the model. 
7.9.4.4 
Sensitivity Analyses 
Provided in detail in the SAP.  
7.9.5 
Additional Analysis for Primary Effectiveness Endpoint 
Provided in detail in the SAP.  
7.9.6 
Analysis of Secondary Endpoints  
Provided in detail in the SAP.  
7.9.7 
Analysis of Additional Endpoints 
Provided in detail in the SAP.  

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7.9.8 
Analysis of Health Economic Data 
Provided in detail in the SAP.  
7.10 
Data Monitoring Committee 
No Data Monitoring Committee will be formed for this study.  
 
 ADMINISTRATIVE RESPONSIBILITIES 
8.1 Ethics Review 
Study materials including informed consent must be reviewed and approved by an 
appropriately-constituted IRB/IEC/REB before enrollment of subjects. Biosense Webster 
and the IRB must approve in writing any changes to the protocol. 
Proof of IRB/IEC/REB review and approval must be obtained prior to subject enrollment. 
Investigators are responsible for submitting and obtaining initial and continuing review 
(per local regulations) of the study by their IRB/IEC/REB. 
8.2 Patient Informed Consent 
Biosense Webster and the reviewing IRB/IEC/REB must approve any modifications to the 
ICF or PI/ICF.  The ICF may be translated as appropriate. Certification of accurate 
translation will be required.  
Informed consent is mandatory and must be obtained from all subjects prior to their 
participation in this study. Copies of all signed consents must be retained in the records of 
the study, and an unsigned sample copy of the approved ICF must also be in the study file. 
Subjects must each receive a copy of the ICF. 
8.3 Confidentiality 
All information and data sent to Biosense Webster concerning subjects or their 
participation in this study will be considered confidential. Only authorized Biosense 
Webster personnel or representatives, or representatives of Health Authorities (HA) or 
Regulatory Authorities (RA) acting in their official capacities will have access to these 
confidential files. No data transmitted to Sponsor for evaluation and reporting will contain 
identifiable references to individual subjects. 
8.4 Data Management 
8.4.1 
Case Report Forms (CRFs) 
Electronic CRFs will be used to collect all subject data during the study.  
8.4.2 
Data Reporting 
The investigator, or a designated individual, is responsible for recording data from the trial 
on the eCRFs supplied by Biosense Webster. The investigator or a delegated individual is 
required to electronically sign eCRFs on the appropriate pages to verify that he/she has 

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reviewed and attests to the correctness of the recorded data. Completed eCRFs will be 
reviewed and monitored remotely and at the research site by Biosense Webster personnel 
or designees throughout the trial. To this end, the investigator and institution must permit 
inspection of trial files including original (source) records and subject eCRFs by sponsor 
representatives and responsible government agencies. 
8.4.3 
Data Review 
Biosense Webster will track the amount of missing data and contact sites as appropriate to 
instruct them on steps to minimize missing data and remain compliant with protocol 
required assessments. Missing or unclear data points will be queried as necessary 
throughout the trial. Biosense Webster may request further documentation such as 
physician and/or cardiac EP lab procedure notes when complications or device deficiencies 
are observed and reported. Biosense Webster will be responsible for auditing the database 
and confirming the overall integrity of the data. 
8.5 Records and Reports 
8.5.1 
Records 
Records to be maintained by the investigator may include but not limited to: 
• Study protocol and all amendments with signature pages 
• Signed clinical study agreement and Statement of Investigator 
• IRB/IEC/REB approval letter, including approved ICF document 
• Evidence of IRB/IEC/REB compliance 
• Other significant IRB/IEC/REB correspondence  
• Significant sponsor correspondence relating to the study 
• Medical licences and CVs for all investigator(s) 
• Financial Disclosure for key study staff 
• Records of protocol and supporting training 
• Site personnel delegation of authority/responsibility 
• Clinical Monitor/Site Visit sign-in log 
• Device log 
• Reports (e.g. Interim Post- Approval Study Status reports, , final reports from 
investigator and Sponsor) 
The following records must be maintained for each subject enrolled in the study: 
• Signed Patient ICF 
• All completed electronic CRFs and supporting source documentation 
• Supporting documentation of any AEs and/or death  

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• Full Case CARTO backup [including complete VISITAG export] and CARTO 
Case recording 
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 study. 
Biosense Webster reserves the right to secure data clarification and additional medical 
documentation on subjects enrolled in this study. 
8.5.2 
Record Retention 
Records and reports of the study will remain on file at sites for a minimum of two (2) years 
after its completion/termination. Records for U.S. sites must be maintained in accordance 
with 21 CFR 812.140 [d], and for OUS sites, according to local requirements.  
If the principal investigator plans to leave the study site, he/she is responsible for 
identification of another individual at site who will assume the obligation for file 
maintenance and management of any continuing subjects. Biosense Webster and pertinent 
HA/RA, per its requirements, should be notified of this change.  
Records and reports may be discarded upon notification by Biosense Webster to the study 
site. Site personnel should contact Biosense Webster prior to destruction of any study-
related records and reports to ensure appropriate record retention. 
8.5.3 
Procedural Data 
It is the responsibility of the investigator to provide timely completion of CRFs to the 
sponsor. 
8.5.4 
Investigator’s Final Report 
Upon completion or termination of the Biosense Webster study, the principal investigator 
must submit a final written report to the approving Investigational Review Board/Ethics 
Committee (as required by the IRB/IEC/REB) and provide a copy to Biosense Webster. 
The report should contain the information required by the IRB/IEC/REB and be submitted 
in the time frame required by the IRB/IEC/REB. 
8.5.5 
Interim Post-Approval Study Status Report 
An Interim Post-Approval Study Status Report will be provided to the FDA on the status 
of the post-approval study every 6 months for the first 2 years after the PMA approval 
and annually, thereafter. 
The interim status report will include the following data to be posted by FDA on PAS 
website:  
• Number of study sites enrolled 
• Number of patients enrolled per site 
• Summary data on subject enrollment and accountability 
• Demographic data 

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• Summary data on SAEs, NSAEs, Device malfunctions, Catheter use, follow-up 
duration. 
8.6 Labeling 
THERMOCOOL SMARTTOUCH® and THERMOCOOL SMARTTOUCH® SF 
Diagnostic/Ablation Deflectable Tip Catheters with Contact Force Sensing Capability 
Instructions for Use is included in each product package.  
8.7 Deviations from Protocol and Good Clinical Practice 
The investigator should not deviate from the protocol except in medical emergencies. In 
emergencies, prior approval for a protocol deviation will not be required, but the Biosense 
Webster clinical operations personnel should be notified as soon as possible. IRB/REBs 
must also be notified promptly of significant protocol deviations as they are defined by the 
IRB/REBs.  
 
 STUDY MANAGEMENT 
9.1 Study Timelines 
Study Duration: The study is expected to last Approximately 2.5 years (~1.0 years for 
enrollment; 12 months of follow-up for primary endpoint).  
Expected date of study initiation   
3Q 2018 
Expected monthly number of study sites with 
IRB approvals  
1 to 5 sites per month  
Expected number of subjects enrolled per 
month  
1.7 subjects per site/month; average 20 
subjects per month over 12 months 
Expected date of enrollment completion  
3Q2019 
Expected date of study follow-up completion  
3Q2020 
Expected date for Final Report submission  
4Q2020 
 
9.2 Investigator Responsibilities 
The Principal Investigator is responsible for supervision of all study activities and is 
ultimately responsible for overall compliance with protocol, GCP, local and regional 
regulations, and IRB/REB requirements. Many study activities may be formally delegated 
to support staff, but the Principal Investigator retains responsibility for supervision of all 
study activities. 
Specific responsibilities include:  

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• Obtaining IRB/REB approval and renewals 
• Providing Sponsor with: 
o Written IRB/REB approval letters and IRB/REB-approved consent forms, 
o Signed, dated Investigator Agreement, 
o Signed and dated Financial Disclosure form at study outset and any time 
financial changes occur, for up to one year following completion of the study 
o Curriculum vitae for each Investigator and key research staff member 
• Maintaining an accurate and current Study Personnel Log which identifies all 
individuals authorized to perform work for the study at each site 
• Completing appropriate training on the study device and the study protocol prior to 
enrolling and treating subjects 
• Obtaining informed consent (including privacy language) from patients 
• Performing the ablation procedure 
• Complying with the clinical protocol 
• Notifying the Sponsor and IRB/REB of adverse events, deaths, and deviations as 
defined in this protocol and per IRB/REB requirements. 
• Notifying Sponsor promptly of withdrawal of IRB/REB approval 
• Complying with IRB/REB (as applicable) and Sponsor interim post-approval study 
status report requirements 
• Maintaining accurate and current logs for the study such as Subject log, Device Log 
• Completing eCRFs accurately and as soon as possible after collection of data 
• Reviewing and signing designated eCRFs 
• Maintaining relevant source documentation to support future verification of data on 
the eCRFs. 
• Complete all subject follow-up visits, including efforts to maintain contact with 
subjects who fail to comply with the follow-up schedule. Before a subject may be 
classified as ‘lost to follow-up’, the Investigator or authorized personnel should 
document attempts to contact the subject.  
• Retaining study records as described in 8.5.2. The Sponsor will notify the 
Investigator when records may be destroyed.  
• Preparing a final report and periodic IRB/REB updates as required 
9.3 Sponsor Responsibilities 
The Sponsor (Biosense Webster) will be responsible for the following: 

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• Preparing of study documents including but not limited to the protocol, eCRFs and 
template informed consent, if no local template is preferred 
• Completing pre-study site assessments and approvals 
• Obtaining approval from the FDA  
• Providing protocol training to investigators and research personnel 
• Instructing operators and technicians in the proper use and monitoring of study 
devices 
• Monitoring the study throughout the duration of the investigation 
• Securing investigator/site compliance with the protocol and applicable regulations 
• Creation and maintenance of eCRF database  
• Conducting all communications with Health authorities (HAs)/ Regulatory 
authorities (RAs) 
• Submitting study supplements for regulatory approval (as necessary), e.g., request 
for study expansion 
• Preparing reports summarizing the status of the clinical study no less often than 
biannually for the first 2 years followed by annually thereafter, which will be 
supplied to the FDA and to other HAs/RAs as requested. Interim post-approval 
study status reports may also be provided to each HA/RA, and possibly to the 
Principal Investigator as requested 
• Access to clinical study data provides opportunities to conduct further research 
that may help advance medical science and improve patient care. This helps 
ensure the data provided by research participants are used in the creation of 
knowledge and understanding. To this end, the study results on all pre-
specified outcomes, including negative outcomes, will be submitted to 
ClinicalTrials.gov no later than one year after completion of the primary 
endpoint (unless an extension has been approved via certification from the 
Secretary of Health and Human Services). Results submission could be 
delayed if an extension is granted to the results submission deadline; however, 
the release of all results on pre-specified outcomes will be hastened if the study 
is terminated early 
9.4 Training 
9.4.1 
Research Team 
The training of appropriate clinical site personnel will be the responsibility of the Sponsor 
or the Sponsor’s representative. In some cases, training may be performed by an existing 
site staff member who has already been trained by the Sponsor (such as assigning a new 
Clinical Research Coordinator to the study). To insure uniform data collection and protocol 
compliance, the Sponsor will present a formal educational session to study site personnel 
that will include review of the Clinical Study Protocol, techniques for the identification of 
eligible subjects, instructions on in-hospital data collection, follow-up schedules, and 

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regulatory requirements. Remote as well as on-site contacts will be used to monitor study 
performance indicators such as enrollment compliance, data submission rate, data errors, 
protocol questions, and GCP compliance.  
9.5 Sponsor Contact Information 
 
 
 
9.6 Initiation of the Investigation 
Potential research sites will undergo prestudy evaluations to ensure their qualification for 
supporting the study. Selected sites will be provided with appropriate study-specific 
training prior to commencement of activities. 
9.7 Monitoring the Study 
Each site will undergo periodic monitoring of the study, which involves a visit from a 
trained Sponsor representative. Monitoring visits may include, but will not be limited to, 
the following: 
• Verification of accuracy of study logs such as the Delegation of Responsibility, etc. 
• Verification that informed consent is obtained for all subjects  
• Verification of completeness of the Regulatory Binder.  
• Data source verification with the eCRFs.  
• Identification and action to resolve any issues or problems with the study. 
Monitoring activities will be documented through such means as contact reports and 
follow-up summaries of status and action items.  
9.8 Termination of the Study 
The study may be suspended or terminated early at the discretion of the Sponsor, for 
reasons such as incidence of unanticipated serious adverse device effects that may pose a 
risk to other subjects. In any early termination, already enrolled subjects will continue to 
be followed per the study protocol requirements.  
Sponsor may also terminate a site prior to completion if it believes the site is no longer 
capable of participating (e.g., cannot fulfill subject enrollment or protocol compliance 
goals, site suspension by IRB/REB).  
At termination of the investigation, each active site will undergo closeout monitoring to 
conclude any outstanding issues, resolve all data discrepancies and make sure any 
outstanding eCRFs are completed, discuss responsibilities with the Principal Investigator, 

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and discuss any other items relevant to the conclusion of the study. The termination process 
will be documented by a written report. 
9.9 Device Log 
9.9.1 
Device Log 
The Research sites will use their commercially available STSF/ST catheters per the 
approved IFU and SURPOINT COA Protocol requirements.  The site will keep a device 
log of the catheter used during the study. 
The site Device Log will include the following information: 
• Catalog number for catheters 
• Serial/lot numbers 
• Dates devices were used 
• Subject IDs for whom devices were used 
• Dates of return (as applicable) 
Devices suspected of deficiency or device associated with a (device related or possibly 
related) adverse event should be returned immediately to BWI and will undergo thorough 
analysis. Returned devices must be decontaminated per hospital policy and labeled with 
the following: 
• Subject identification number, or if unused, site number 
• Complaint number 
• Date of use/event or if applicable, specify “unused” 
• Return type (device deficiency related, AE related, etc.) 
All tracking information must be retained. Catheters must be returned to:  
9.10 
Electronic Case Report Forms 
Electronic CRFs (eCRFs) have been developed to capture the information outlined in this 
Study Protocol. Data on these eCRFs will be monitored, corrected if necessary, and entered 
into a validated database. All changes made to the data will be tracked in the electronic 
audit trail, recording the current value, previous value, reason for change, date timestamp 
of data entry/change, and the name of the person who changed the data. The investigator 
will electronically sign all subject eCRFs as verification that the data have been reviewed 
and correctly reflects source documentation. Data from these eCRFs will be used to provide 
analysis of this study.  

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9.11 
Source Documentation 
Data entered into the eCRFs may be taken from source documentation, such as hospital 
procedure reports, admission and discharge summaries, and other hospital or physician 
office/clinic documents. If no standard hospital or office document exists to capture some 
of the information that may be unique to this study, a worksheet may be developed to record 
this information. Data collection instruments should clearly identify the individual 
collecting the data and the date of collection. The instrument of original capture of all study 
data will serve as the source document for future verification of for those data parameters. 
Privacy regulations will be observed during the use of these source documents during 
monitoring. 
9.12 
Subject Confidentiality/Record 
All representatives of the Sponsor have undergone training for Privacy regulations and 
appropriate conduct for their compliance. For the duration of this study, all representatives 
of the Sponsor will comply with all privacy regulations regarding contact with subjects, 
their medical record information, copying of information, protection of the subject 
identities, and other aspects.  Authorization for limited access to Protected Health 
Information by Sponsor personnel will be obtained as part of subject informed consent. 
Site personnel should also be attentive to privacy considerations and should not transmit 
PHI outside of PI control (e.g., via .pdf or FAX) without redaction of patient identifiers.   
Privacy considerations such as above will also be covered in protocol training for both 
Sponsor representatives and study site personnel.  
9.13 
Data Management 
The Sponsor will be responsible for all data management activities. These activities include 
development of a database, utilizing validated database software, into which all study data 
will be entered by the clinical sites. The Sponsor will be responsible for ensuring the overall 
integrity of the database. 
 
 
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APPENDIX A: STUDY DEFINITIONS 
Term 
Definition 
Adverse Event (AE) 
Any unfavorable and unintended sign, medical occurrence, disease or 
injury (including abnormal laboratory findings) in subjects, users or other 
persons temporally associated with the use of a medicinal product or device 
whether or not related to the sponor’s product. 
This definition includes events related to the medical device and/or the 
comparator, and events related to the procedure in which the device was 
used. 
Adverse Device Effects 
(ADE’s) 
Adverse events related to the use of the medical device. This definition 
includes adverse events resulting from insufficient or inadequate 
instructions for use deployment, implantation, installation, or operation, or 
any malfunction of the medical device. This definition includes any event 
resulting from use errors or from intentional misuse of the investigation 
medical device. 
AF/AT/AFL Episode 
An episode of AF/AT/AFL ≥ 30 seconds in duration.  
AF Episode 
An atrial fibrillation episode is defined as AF which is documented by ECG 
monitoring and has a duration of at least 30 seconds, or if less than 30 
seconds, is present continuously throughout the ECG monitoring tracing. 
The presence of subsequent episodes of AF requires that sinus rhythm be 
documented by ECG monitoring between AF episodes 
Anticipated AE 
An effect which by its nature, incidence, severity or outcome has been 
identified as possible complications associated with the medical device and/ 
or intervention procedure.  

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Term 
Definition 
Atypical Flutter 
Macroreentrant circuits within the atria where activation rotates around 
large obstacles that does not meet the criteria for Typical Flutter.  
Bleeding Complications 
(ISTH definition): 
Major (ISTH definition):  
Fatal bleeding AND/OR symptomatic bleeding in a critical area or organ, 
such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, 
pericardial, or intramuscular with compartment syndrome AND/OR 
bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or 
more, or leading to transfusion of two or more units of blood. 
Clinically relevant nonmajor bleed (ISTH definition):  
An acute or subacute clinically overt bleed that does not meet the criteria 
for a major blrrd but ptomps a clinical response such that it leads to one of 
the following: hospital admission for bleeding; physician guided medical or 
surgical treatment for bleeding; change in antithrombotic therapy 
(including interruption or discontinuation). 
Minor bleeding (ISTH definition): 
All nonmajor bleeds. Minor bleeds are further divided into clinically 
relevant and not. 
Catheter Insertion 
Defined as the STSF/ST catheter breaching the sheath and entering the 
bloodstream.   
Device Deficiency 
Inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance, such as malfunction (failure of a medical 
device to perform in accordance with its intended purpose when used in 
accordance with the instructions for use or protocol), misuse or use error 
and inadequate labeling.  
Documented 
AF/AT/AFL episode 
An AF/AT/AFL episode documented by an electrocardiographic 
monitoring tool. This may include ILR, ECG, TTM, Holter monitor, or 
telemetry strip.  
Reporting of a symptomatic episode by a patient or in a referral letter is 
not considered a documented AF episode. 
Paroxysmal AF  
Paroxysmal AF is defined as recurrent AF (≥ 2 episodes) that terminates 
spontaneously within 7 days. Episodes of AF of ≤ 48 hours duration that 
are terminated with electrical or pharmacologic cardioversion should also 
be classified as paroxysmal AF episodes. 
Permanent AF  
Not appropriate in the context of patients undergoing catheter ablation of 
AF; refers to a group of patients where a decision has been made not to 
pursue restoration of sinus rhythm by any means, including catheter or 
surgical ablation. 
Persistent AF (PsAF) 
Persistent AF is defined as continuous AF that is sustained beyond 7 days 
and less than 1 year.  

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Term 
Definition 
Serious adverse event 
(SAE) 
1. Any adverse event that: 
• 
Led to a death 
• 
Led to a serious deterioration in health that either: 
o Resulted in a life-threatening illness or injury, or 
o Resulted in a permanent impairment of a body structure or 
a body function, or 
o Required in-patient hospitalization or prolongation of 
existing hospitalization, or 
o Resulted in medical or surgical intervention to prevent life 
threatening illness or injury or permanent impairment to a 
body structure or a body function 
• 
Led to fetal distress, fetal death or a congenital abnormality or birth 
defect 
2. Any Device Deficiency that could have led to an SAE  
 
A planned hospitalization for pre-existing condition, or a procedure 
required by the protocol, without a serious deterioration in health, is not 
considered to be a serious adverse event. 
Medical and scientific judgment should be exercised in deciding whether 
expedited reporting is appropriate in other situations, such as important 
medical events that may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the subject or may require 
intervention to prevent one of the outcomes listed in the definition above. 
Serious Adverse Device 
Effects (SADE’s) 
Adverse device effects that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Symptomatic 
AF/AT/AFL Episode 
Symptom(s) which is/are exhibited by the subject which made them seek 
medical attention, and are concurrent with a documented episode of 
AF/AT/AFL by either ECG, TTM, Holter monitor, or telemetry recording. 
Symptoms may include but are not limited to: palpitations, irregular pulse 
(e.g., rapid, racing, pounding, fluttering, bradycardia), dizziness, weakness, 
chest discomfort, and breathlessness. 
 
Typical Flutter 
Atrial flutter is caused by a reentrant rhythm in either the right or left 
atrium. Typically initiated by a premature electrical impulse arising in the 
atria, atrial flutter is propagated due to differences in refractory periods of 
atrial tissue. This creates electrical activity that moves in a localized self-
perpetuating loop. For each cycle around the loop, there results an electric 
impulse that propagates through the atria. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current version of the risk analysis 
report. 
NOTE: Anticipated SADE: an effect which by its nature, incidence, 
severity or outcome has been previously identified in the risk analysis 
report 

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Clinical Study Protocol (BWI_2017_06) 
 
Biosense Webster, Inc 
 
Version 4.0  March 8, 2019  
CONFIDENTIAL 
Page 91 of 91 
Term 
Definition 
Ventricular Tachycardia 
(VT) 
Ventricular tachycardia: a tachycardia (rate > 100/min) with three or more 
consecutive beats that originates from the ventricles independent of atrial or 
AV nodal conduction. Continuous VT for > 30 s or that requires an 
intervention for termination (such as cardioversion).