Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
Phase: NA
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster, Inc.

Biosense Webster, Inc 
CONFIDENTIAL 
Prospective Review of the Safety and Effectiveness of the 
THERMOCOOL SMARTTOUCH® SF Catheter Evaluated 
for Treating Symptomatic PersistenT AF  
(PRECEPT) 
Clinical Study Protocol 
Protocol# STSF-159 
Version 6.0 
July 31, 2018 
Sponsor: 
BIOSENSE WEBSTER, INC. 
33 Technology Dr 
Irvine, CA 92618  
USA

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 2 of 77 
Table of Contents 
 Introduction .......................................................................................................................... 10 
1.1 
Background .................................................................................................................... 10 
1.2 
Rationale......................................................................................................................... 12 
1.3 
Risk Analysis.................................................................................................................. 13 
1.3.1 
Description and Analysis of Risks .......................................................................... 13 
1.3.2 
Minimization of Risks............................................................................................. 14 
1.3.3 
Precautions .............................................................................................................. 15 
1.4 
Device Description ......................................................................................................... 16 
1.4.1 
Bi-directional Catheter Description (D-1348-XX-SI) ............................................ 17 
1.4.2 
Uni-directional Catheter Description (D-1347-XX-SI) .......................................... 17 
1.5 
Study Catheters .............................................................................................................. 17 
1.6 
Supply and Support of Study Catheter ........................................................................... 18 
 Study Objective .................................................................................................................... 18 
 Study Design ........................................................................................................................ 18 
3.1 
Subject Selection ............................................................................................................ 19 
3.1.1 
Inclusion Criteria .................................................................................................... 19 
3.1.2 
Exclusion Criteria ................................................................................................... 19 
3.2 
Subject Disposition ........................................................................................................ 21 
3.3 
Subject Withdrawal/Early Termination ......................................................................... 21 
3.4 
Subjects Lost to Follow up ............................................................................................. 21 
 Study Endpoints ................................................................................................................... 22 
4.1 
Primary Endpoints .......................................................................................................... 22 
4.1.1 
Primary Effectiveness Endpoint ............................................................................. 22 
4.1.2 
Primary Safety Endpoint ......................................................................................... 23 
4.2 
Secondary Endpoints ...................................................................................................... 24 
4.2.1 
Secondary Effectiveness Endpoints ........................................................................ 24 
4.2.2 
Secondary Safety Endpoints ................................................................................... 24 
4.3 
Additional Endpoints...................................................................................................... 25 
4.4 
Health Economic Data ................................................................................................... 26 
 Treatment Description ......................................................................................................... 26 
5.1 
Patient Screening ............................................................................................................ 27 
5.2 
Informed Consent ........................................................................................................... 27 
5.3 
Pre-Procedure Assessments............................................................................................ 28 
5.4 
General AF Procedure Guidelines.................................................................................. 28 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 3 of 77 
5.5 
Recommended RF Power: 14-17, 76-81 ............................................................................... 29 
5.6 
Contact Force (CF) Settings ........................................................................................... 30 
5.7 
VISITAG® Settings ....................................................................................................... 30 
5.8 
Esophageal Monitoring .................................................................................................. 31 
5.9 
Ablation Procedure ......................................................................................................... 31 
5.10 
Post Ablation .............................................................................................................. 32 
5.11 
Post Procedure Assessments ....................................................................................... 33 
5.12 
Standard Tests and Procedures ................................................................................... 36 
5.13 
Study Medications ...................................................................................................... 38 
5.13.1 
Anticoagulation Medications .............................................................................. 38 
5.14 
Antiarrhythmic Drug (AAD) Management ................................................................ 38 
5.14.1 
Definitions ........................................................................................................... 38 
5.14.2 
AAD Usage and Primary Effectiveness Classification ....................................... 39 
5.15 
Heart Rhythm Monitoring .......................................................................................... 40 
5.16 
Neurological Assessment (NIHSS) ............................................................................ 41 
5.17 
Study Equipment ........................................................................................................ 41 
5.17.1 
Required Study Catheters and Equipment .......................................................... 41 
5.17.2 
Recommendation for Irrigation Pump Setting and RF Power Delivery ............. 41 
5.17.3 
Investigator Training ........................................................................................... 42 
5.18 
Repeat AF Ablation Procedures ................................................................................. 42 
5.18.1 
Repeat Ablation and Primary Effectiveness Classification................................. 42 
5.19 
Core Laboratory .......................................................................................................... 43 
 Adverse Events .................................................................................................................... 43 
6.1 
Adverse Event Recording............................................................................................... 43 
6.2 
Classification .................................................................................................................. 44 
6.2.1 
Primary Adverse Event ........................................................................................... 44 
6.3 
Serious AEs .................................................................................................................... 48 
6.4 
Non-Serious AEs ............................................................................................................ 48 
6.5 
Anticipated AEs ............................................................................................................. 48 
6.6 
Unanticipated Serious Adverse Device Effect ............................................................... 52 
6.7 
Clinical Investigation Device Failure/Malfunction/Deficiency ..................................... 53 
6.8 
Reporting Requirements ................................................................................................. 53 
6.9 
Intensity or Severity ....................................................................................................... 53 
6.10 
Outcome...................................................................................................................... 54 
6.11 
Causality ..................................................................................................................... 54 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 4 of 77 
6.12 
Documentation............................................................................................................ 54 
6.13 
Global Safety Monitoring Committee (GSMC) ......................................................... 55 
 Statistical Analysis Methods ................................................................................................ 55 
7.1 
Analysis Population........................................................................................................ 55 
7.2 
Analyses for Primary Endpoints .................................................................................... 55 
7.2.1 
Analyses for Primary Effectiveness Endpoint ........................................................ 55 
7.2.2 
Analyses for Primary Safety Endpoint ................................................................... 56 
7.3 
Site Heterogeneity .......................................................................................................... 56 
7.4 
Primary Effectiveness Endpoint ..................................................................................... 57 
7.5 
Primary Safety Endpoint ................................................................................................ 57 
7.6 
Total Sample Size........................................................................................................... 57 
7.7 
Analyses for Secondary and Additional Endpoints........................................................ 57 
 Administrative Responsibilities ........................................................................................... 57 
8.1 
Ethics Review ................................................................................................................. 57 
8.2 
Patient Informed Consent ............................................................................................... 58 
8.3 
Confidentiality ................................................................................................................ 58 
8.4 
Data Management .......................................................................................................... 58 
8.4.1 
Case Report Forms (CRFs) ..................................................................................... 58 
8.4.2 
Data Reporting ........................................................................................................ 58 
8.4.3 
Data Review ............................................................................................................ 58 
8.5 
Records and Reports....................................................................................................... 59 
8.5.1 
Records ................................................................................................................... 59 
8.5.2 
Record Retention .................................................................................................... 59 
8.5.3 
Procedural Data ....................................................................................................... 60 
8.5.4 
Investigator’s Final Report ..................................................................................... 60 
8.6 
Labeling .......................................................................................................................... 60 
8.7 
Deviations from Protocol and Good Clinical Practice ................................................... 60 
 Study Management .............................................................................................................. 60 
9.1 
Study Timelines.............................................................................................................. 60 
9.2 
Study Advisory Committee (SAC) ................................................................................ 60 
9.3 
Investigator Responsibilities .......................................................................................... 61 
9.4 
Sponsor Responsibilities ................................................................................................ 62 
9.5 
Training .......................................................................................................................... 63 
9.5.1 
Research Team ........................................................................................................ 63 
9.5.2 
Investigator Proctoring............................................................................................ 63 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 5 of 77 
9.6 
Sponsor Contact Information ......................................................................................... 64 
9.7 
Initiation of the Investigation ......................................................................................... 64 
9.8 
Monitoring the Study ..................................................................................................... 64 
9.9 
Termination of the Study................................................................................................ 64 
9.10 
Device Accountability ................................................................................................ 65 
9.10.1 
Device Accountability ......................................................................................... 65 
9.11 
Device Returns ........................................................................................................... 65 
9.12 
Electronic Case Report Forms .................................................................................... 66 
9.13 
Source Documentation ............................................................................................... 66 
9.14 
Subject Confidentiality/Record .................................................................................. 66 
9.15 
Data Management ....................................................................................................... 66 
 References .......................................................................................................................... 67 
 APPENDIX A: STUDY DEFINITIONS........................................................................... 75 
 
 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 6 of 77 
Protocol Agreement Form 
 
 
Study Title: Prospective Review of the Safety and Effectiveness of the THERMOCOOL 
SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT) 
I, the undersigned, have read and understand this clinical study, including the appendices. I will 
implement and conduct the clinical study in strict compliance with the study protocol and in 
accordance with good clinical practices (GCP) and all applicable laws and regulations. I will 
ensure that all persons assisting in this study are adequately informed about the protocol, study 
product(s), and their clinical study-related duties and functions. 
I agree to maintain all study related information supplied by Biosense Webster, Inc. in strictest 
confidence. When information regarding this study is submitted to an institutional review board 
(IRB)/Independent Ethics Committee (IEC), it will be forwarded with a requirement that all study 
related material is to be held strictly confidential. 
 
 
 
 
 
 
____________________________   _____________________________  _______________ 
 Principal Investigator  
   
Signature 
 
 
   
Date 
 Name (PRINT) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 7 of 77 
Protocol Summary 
Prospective Review of the Safety and Effectiveness of the THERMOCOOL 
SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT 
AF (PRECEPT) 
Title: 
Prospective Review of the Safety and Effectiveness of the 
THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating 
Symptomatic PersistenT AF (PRECEPT) 
Design: 
This is a prospective, multicenter, non-randomized clinical evaluation 
utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a 
predetermined performance goal.  
Purpose: 
The purpose of this study is to demonstrate the safety and effectiveness of 
the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug 
refractory symptomatic persistent atrial fibrillation (PsAF) following 
standard electrophysiology mapping and RF ablation procedures.  
Enrollment: 
Up to 367 subjects will be enrolled. 
Clinical Sites: 
Up to 35 sites (approximately 30 in the US and up to 5 OUS). 
Subject Population: Subjects with drug refractory symptomatic PsAF who are undergoing their 
first AF ablation procedure that meet the ACC/ESC/HRS criteria for 
persistent AF are eligible. 
Primary Endpoints: The primary effectiveness endpoint for this study will be freedom from 
documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter 
(AFL) episodes through 15-month follow-up (post 3-Month Medication 
Adjustment Period followed by a 3-Month Therapy Consolidation period 
(Day 181-450)).  
 
The primary safety endpoint is the incidence of any early onset (within 7 
days of the initial and repeat AF ablation procedure) Primary Adverse 
Events (AE), which are listed below: 
• 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 
Insuffiency)  
• Pericarditis 
• Major Vascular access complication / 
bleeding 
* Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-
procedure shall be deemed Primary AEs. 
** Hemodynamic compromise or instability is defined as Systolic BP < 80 mm Hg. 
+ Cardiac Tamponade/Perforation that occurs up to 30 days post ablation will be deemed Primary AEs. 
†  Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal evidence 
based upon neuroimaging studies. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 8 of 77 
†† Modified Rankin score assessments should be made by qualified individuals according to a certification process. 
If there is discordance between the 30 and 90 day Modified Rankin scores, a final determination of major versus 
minor stroke will be adjudicated by the neurology members of the Global Safety Monitoring Committee. 
 
Sponsor: 
Biosense Webster, Inc. 
 
33 Technology Dr 
 
Irvine, CA 92618 USA 
 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 9 of 77 
List of Abbreviations 
AAD 
Antiarrhythmic drug 
ICF 
Informed consent form 
ACC 
American College of Cardiology 
IDE 
Investigational device exemption 
ACT 
Activated clotting time 
IEC 
Independent Ethics Committee  
AE 
Adverse event 
IFU 
Instructions for use 
AF 
Atrial fibrillation 
IRB 
Institutional Review Board 
AFEQT 
Atrial Fibrillation Effect on QualiTy of life 
ITT 
Intent-to-treat 
HIPAA 
Health Insurance Portability and 
Accountability Act 
AFL 
Atrial flutter 
AHA 
American Heart Association 
LA 
Left atrium 
ANOVA 
Analysis of variance 
MI 
Myocardial infarction 
AT 
Atrial tachycardia 
MRI 
Magnetic resonance imaging 
AV 
Atrioventricular 
MV 
Mitral valve 
BP 
Blood pressure 
NIHSS 
NIH Stroke Scale 
CCS-SAF 
Canadian Cardiovascular Society Severity of 
Atrial Fibrillation scale 
PCI 
Pecutaneous coronary intervention 
 
CHF 
 
Congestive heart failure 
PIU 
Patient Interface Unit 
PP 
Per protocol 
CF 
Contact force 
PsAF 
Persistent atrial fibrillation 
CFAE 
Complex fractionated atrial electrogram 
PV 
Pulmonary vein 
 
CHADS 
 
Congestive heart failure, High blood 
pressure, Age 75+, Diabetes, previous Stroke 
or transient ischemic attack 
PVI 
Pulmonary vein isolation 
PRECEPT 
Prospective Review of the Safety and 
Effectiveness of the SMARTTOUCH® SF 
Catheter Evaluated for Treating Symptomatic 
PersistenT AF 
CPVI 
Complete pulmonary vein isolation 
CRF 
Case Report Form 
QOL 
Quality of life 
CS 
Coronary sinus 
RA 
Right atrium 
CT 
Computed tomography 
RF 
Radiofrequency 
CTI 
Cavotricuspid isthmus 
SAC 
Study advisory committee 
CVA 
Cerebrovascular accident 
SADE 
Serious adverse device effect 
ECAS 
European Cardiac Arrhythmia Society 
SAE 
Serious adverse event 
ESC 
European Society of Cardiology 
SAP 
Statistical analysis plan 
FDA 
Food Drug Administration 
SF 
Surround Flow 
GCP 
Good Clinical Practice 
SVC 
Superior vena cava 
ECG 
Electrocardiogram 
TIA 
Transient ischemic attack 
EHRA 
European Heart Rhythm Association 
TEE 
Transesophageal echocardiogram 
GSMC 
Global Safety Monitoring Committee  
TTE 
Transthoracic echocardiogram 
HRS 
Heart Rhythm Society 
TTM 
Transtelephonic monitoring 
ICD 
Implantable cardioverter defibrillator 
UADE 
Unanticipated adverse device effect 
ICE 
Intracardiac echocardiography 
USADE 
Unanticipated serious adverse device effect 
 
 
VT 
Ventricular tachycardia  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 10 of 77 
Prospective Review of the Safety and Effectiveness of the THERMOCOOL 
SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic 
PersistenT AF 
(PRECEPT) 
 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.1,2 AF is a complex, 
progressive disease that results in structural and electrical remodeling in the heart. In 2006, 
a 3-category classification system was established to distinguish and standardize the 
different levels of AF: 3  
• Paroxysmal: 2 or more AF episodes that terminate spontaneously within 7 days; 
• Persistent (PsAF): AF sustained beyond 7 days or lasting less than 7 days but 
necessitating termination by intervention; and  
• Longstanding persistent: AF greater than one year’s duration.  
The 2012 HRS/EHRA/ECAS Consensus Statement on catheter and surgical ablation 
recommended that patients be categorized by their most frequent pattern of AF during the 
six months prior to ablation.4 The 2006 ACC/AHA/ESC AF Management guidelines 
include the recommendation that catheter ablation be considered in persistent AF patients 
who are severely symptomatic after failure of one or more AADs plus rate control.3 
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.6,7 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.7 One of the goals of the present 
study is to extend these findings in the persistent AF population. The 2012 
HRS/EHRA/ECAS Consensus Statement notes that there have been no prospective 
multicenter randomized clinical trials of ablation versus antiarrhythmic drug therapy that 
have precisely defined the outcomes of AF ablation in patients with persistent AF or 
longstanding persistent AF.4 However, some of the electrical atrial remodeling may be 
reversible by destroying the foci.8 Studies that included a persistent AF sample have shown 
some improvement with PV isolation, although the rates of clinical efficacy were found to 
be lower in subjects with persistent AF than in those with paroxysmal AF at five,9 ten,8 or 
twelve10,11 months post ablation. A recent meta-analysis corroborated these findings with 
even longer follow-up times after a single ablation procedure, although due to between-
study heterogeneity, the difference between AF types did not reach significance.12 Many 
of the non-paroxysmal subjects among the included studies required multiple procedures 
to achieve long-term rhythm control.12 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 11 of 77 
The 2012 HRS/EHRA/ECAS Consensus Statement states that electrical isolation of the 
pulmonary veins (PVs) from the left atrium is “the cornerstone for most AF ablation 
procedures.”4 However, in patients with persistent AF, more extensive ablation, based on 
linear lesions or complex fractionated electrograms, should be considered.4 In such 
patients, inclusion of the atrial myocardium becomes more important, as atrial remodeling 
occurs, augmenting the number of AF drivers and shifting their locations away from the 
PV ostia4 so that the PVs become less important as AF progresses from paroxysmal to 
persistent.9 The current study will utilize a “PVI + Triggers” approach, where isolation of 
all PVs will be performed, followed by ablation of “non-PV triggers” and triggers induced 
by isoproterenol. 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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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.13 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
There have been several studies showing that there is a correlation between electrode-tissue 
contact and RF lesion generation.18-20 Until recently, there has been no reliable mechanism 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 12 of 77 
to provide a measurement of the direct CF between the tip of the RF ablation catheter and 
the endocardial tissue. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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 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. 
23,24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As noted, there are few controlled studies on the effectiveness of RF ablation specifically 
in the persistent AF population,4 but studies which included persistent AF patients in their 
study sample showed promising results for long-term freedom from AF recurrence in this 
subset.8-11,16 The results of the current study will be compared to a pre-determined 
performance goal of 40% for primary effectiveness, defined as freedom from atrial 
tachycardias through 12 months post procedure. This is in line with recommendations in 
the 2012 HRS/EHRA/ECAS Consensus Statement for success rate in persistent AF and 
longstanding persistent AF.4 
In patients with AF, elimination or amelioration of symptoms is a major driving force for 
therapy. The primary clinical benefit of catheter ablation of AF is an improvement in 
quality of life resulting from the elimination of arrhythmia-related symptoms such as 
palpitations, fatigue, or effort intolerance.4 The 2012 HRS/EHRA/ECAS Consensus 
Statement underscores the value of AF-specific QOL assessment tools.4 The Canadian 
Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF) Scale was validated in 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 13 of 77 
484 patients with documented AF (62% paroxysmal and 38% persistent/permanent).27 As 
the CCS-SAF class increases from 0 to 4, symptom severity increases. 
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 
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%).8,9,28-32  
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%).33,34 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%.33,34 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%.33,34,56,57 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 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 14 of 77 
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%).33,34 This may produce valvular insufficiency and possibly require 
surgical valve replacement.  
The application of RF energy along the posterior left atrium can result in thermal injury to 
the esophagus and the formation of an atrio-esophageal fistula. This is a rare (0.04%) but 
severe complication of RF ablation requiring surgical intervention or that may result in 
permanent impairment.35 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.36,37 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. 54-55 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%).36-40 
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%).41-45 
Hemorrhage could occur as a result of anticoagulation (risk <0.5%), which may require 
transfusion.33,34  
The percutaneous procedure carries risk of infection, either at the catheter insertion site or 
systemically, including endocarditis and septic emboli (risk <0.5%).33,34 This risk can be 
minimized by using standard aseptic technique and, when indicated, by the use of antibiotic 
agents. 
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 catheter, are 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 15 of 77 
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 LVEF for kidney dysfunction.14,17 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.15  
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 and 9.5) on the use of the 
THERMOCOOL SMARTTOUCH® SF Catheter with Contact Force Sensing Capability 
technology prior to subject enrollment.  
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.  
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 an unbiased physician review committee functioning as a Global Safety 
Monitoring Committee (GSMC) 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 persistent or recurrent 
arrhythmia should be determined by a qualified physician. Cardiac catheterization and 
electrophysiological procedures should be performed by qualified and appropriately 
trained personnel in an electrophysiology laboratory. The laboratory should contain 
sufficient resuscitative equipment and facilities to manage 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 
tamponade, pulmonary embolus, tricuspid regurgitation, myocardial infarction, bleeding at 
the catheter insertion site, sepsis, and death.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 18 of 77 
For the remainder of this protocol, “study catheter” will refer to the THERMOCOOL 
SMARTTOUCH® SF Diagnostic/Ablation Deflectable Tip Catheters with Contact Force 
Sensing Capability. 
Instructions for Use (IFU)  
A copy of the IFU for the study catheters and interface cable is included in each product 
package. 
1.6 
Supply and Support of Study Catheter 
Prior to initiating subject enrollment, Biosense Webster or a representative will provide 
training to the study site personnel. Investigators selected to participate in the study will 
have prior experience with the THERMOCOOL SMARTTOUCH® Catheters and 
received training on the use of the THERMOCOOL SMARTTOUCH® SF Catheter (see 
Section 5.17.1). The study sites will not be released investigational devices until after 
receiving IRB approval, signing the clinical study agreement, completing training (may be 
conducted in parallel with the Site Initiation Visit), and after all other required study start 
up activities are complete. 
 STUDY OBJECTIVE 
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL 
SMARTTOUCH® SF catheters in the treatment of drug refractory symptomatic persistent atrial 
fibrillation (PsAF) during standard electrophysiology mapping and RF ablation procedures. 
 STUDY DESIGN 
The PRECEPT study is a prospective, multicenter, non-randomized clinical evaluation utilizing 
the THERMOCOOL SMARTTOUCH® SF catheters in treating subjects with symptomatic PsAF 
who have failed at least one antiarrhythmia drug. Up to 367 subjects will be enrolled at up to 35 
sites (approximately 30 US and 5 OUS). Effectiveness and safety endpoints have been defined, 
and will be compared to predetermined performance goals. Subjects who sign the PRECEPT 
informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility 
criteria will then undergo the ablation procedure with the study catheter. After the study ablation 
procedure, subjects will enter a 3-Month Medication Adjustment Period followed by a 3-Month 
Therapy Consolidation Period (Day 0-180).  
The first 3 months after the ablation procedure, (Medication Adjustment Period; Day 0-90) is 
intended to allow for modifications to the subject’s medication and allow substrate remodeling to 
occur. Medication adjustment includes dose modification of currently used AAD or adding new 
AAD. The following 3-month period (Therapy Consolidation Period; Day 91-180), is to assess the 
status of the Medication Adjustment Period and perform repeat ablations as necessary. 
Cardioversion is allowed if the AF recurrence persists during the Therapy Consolidation Period.  
After the Therapy Consolidation Period, subjects will enter the Evaluation Period (Days 181-450). 
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).  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 19 of 77 
All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of 
Treatments and Evaluations). Subjects complete the PRECEPT study after the 15-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. 
Documented symptomatic persistent AF, which is defined as continuous AF 
sustains beyond 7 days and less than 1 year and is documented by the following:.  
a. Physician’s note indicating continuous AF ≥ 7 days but no more than 1 year;  
AND  
b. Two electrocardiograms (from any forms of rhythm monitoring) showing 
continuous AF, with electrocardiogram taken at least 7 days apart4 
(electrograms cannot be >365 days prior to enrollment) 
OR  
c. 24-hour Holter within 90 days of the ablation procedure showing continuous 
AF 
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: 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 20 of 77 
1. 
Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) 
2. 
Previous surgical or catheter ablation for atrial fibrillation 
3. 
Any cardiac surgery within the past 2 months (60 days) (includes PCI) 
4. 
CABG surgery within the past 6 months (180 days) 
5. 
Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, 
and valve repair or replacement and presence of a prosthetic valve) 
6. 
Any carotid stenting or endarterectomy 
7. 
Documented LA thrombus on imaging 
8. 
LA size > 50 mm (parasternal long axis view) 
9. 
LVEF < 40% 
10. 
Contraindication to anticoagulation (heparin or warfarin) 
11. 
History of blood clotting or bleeding abnormalities 
12. 
MI within the past 2 months (60 days) 
13. 
Documented thromboembolic event (including TIA) within the past 12 months 
(365 days) 
14. 
Rheumatic Heart Disease 
15. 
Uncontrolled heart failure or NYHA function class III or IV 
16. 
Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction 
≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2) 
17. 
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 
(365 days) 
18. 
Unstable angina 
19. 
Acute illness or active systemic infection or sepsis 
20. 
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac 
cause.  
21. 
Diagnosed atrial myxoma. 
22. 
Presence of implanted ICD/CRT-D. 
23. 
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. 
24. 
Gastroesophageal Reflux Disease (GERD; active requiring significant intervention 
not including OTC medication) 
25. 
Significant congenital anomaly or medical problem that in the opinion of the 
investigator would preclude enrollment in this study. 
26. 
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 
27. 
Enrollment in an investigational study evaluating another device, biologic, or drug. 
28. 
Presence of intramural thrombus, tumor or other abnormality that precludes 
vascular access, or manipulation of the catheter. 
29. 
Presence of any other condition that precludes appropriate vascular access.  
30. 
Life expectancy less than 12 months 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 21 of 77 
3.2 
Subject Disposition 
• Enrolled Subjects: subjects who sign the informed consent. 
• Excluded Subjects: subjects who are enrolled but never undergo insertion of the 
study catheter.  
• Discontinued Subjects: subjects who have the investigational catheter inserted but 
do not undergo ablation (i.e., no RF energy is delivered via the study device). These 
discontinued subjects will be followed up for 30 days. 
• Lost to Follow-up Subjects: subjects who are enrolled and have study catheter 
inserted, 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 15-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. 
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 subjection 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.”  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 22 of 77 
 STUDY ENDPOINTS 
4.1 
Primary Endpoints 
4.1.1 
Primary Effectiveness Endpoint  
The primary effectiveness endpoint is defined as the freedom from documented atrial 
fibrillation, atrial flutter and atrial tachycardia (AF/AFL/AT) (hereinafter collectively 
referred to as “atrial tachyarrhythmias") recurrence (episodes ≥ 30 secs on Holter 
recordings/TTM or continuously recorded on the standard 12-leads ECG) during the 
evaluation period (Day 181-450) and freedom from the following failure modes:  
• Acute procedural failure, including: 
o Failure to confirm entrance block in all pulmonary veins post-procedure,  
o Use of a non-study catheter to treat the study arrhythmia for the initial 
ablation procedure. 
Device deficiency of a non-investigational device leading to the use of a non-study catheter 
(i.e., Stockert 70, SMARTABLATE™ RF Generator and COOLFLOW® Pump, 
SMARTABLATE™ Irrigation Pump), during the AF procedure will not be considered an 
acute failure.  
• Non-study catheter failure: 
o Use of a non-study catheter to treat the study arrhythmia for repeat ablation 
procedure during the 3-Month Medication Adjustment or 3-Month Therapy 
Consolidation Periods. 
• Repeat ablation failure, including:  
o > 2 repeat ablation procedures during the 3-Month Medication Adjustment 
Period / 3-Month Therapy Consolidation Period (Day 0-180) after the index 
procedure. 
o Any repeat ablation procedure during the Evaluation Period. 
Refer to section 5.18 for details. 
• AAD failure: Taking a new AAD or a previously failed AAD at a greater than the 
highest ineffective historical dose for AF during the evaluation period (refer to 
section 5.14 for details). 
• Surgical failure: Undergoing surgical AF ablation or AF surgery any time after the 
index procedure. 
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 2 repeat 
ablation procedures for an atrial tachyarrhthmia during the 3-Month Medication 
Adjustment and 3-Month Therapy Consolidation Periods. 
This study is designed to compare the primary effectiveness of the investigational device 
to a pre-determined performance goal of 40%, which is indicated as the minimum 
acceptable success rate at 12 months for a persistent AF population in the 2012 HRS 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 23 of 77 
consensus statement. The literature relates success rates of ablation with various devices 
for treating persistent or nonparoxysmal atrial fibrillation ranging from 39.6% to 
52.5%.10,11,49,50 Anticipated freedom from atrial tachyarrhythmias after ablation is 50%, 
based on literature review and feedback from BWI’s Study Advisory Committee which is 
comprised of leaders in the electrophysiology field (a list of SAC members appears in 
section 9.2). With a proposed region of indifference of 10%, the performance goal of the 
primary effectiveness endpoint for this study will be 40%.  
4.1.2 
Primary Safety Endpoint  
The primary safety endpoint is the incidence of any primary adverse event occurring within 
7 days of the AF ablation procedure (including the initial and repeat procedures) using the 
study catheter per protocol. 
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 
Insuffiency)  
• Pericarditis 
• Major vascular access complication 
/ bleeding 
* Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) 
post-procedure shall be deemed Primary AEs.47,48 
** 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 qualified individuals according to a certification 
process. If there is discordance between the 30 and 90 day Modified Rankin scores, a final determination 
of major versus minor stroke will be adjudicated by the neurology members of the GSMC. 
Based upon the data reported in the BW THERMOCOOL SMARTTOUCH® IDE study 
(#G110030) and publications cited in Calkins59, the expected primary safety event rate is 
8% in the current study. The meta-analysis reported by Calkins59 combined safety events 
in patients with persistent and paroxysmal AF, comprising roughly 15% and 85% of the 
series respectively. The individual studies in the meta-analysis were therefore reviewed to 
identify those that included patients with persistent AF8, 9, 60-74. Event rates reported in these 
studies together with the event rates observed in the SMART-AF were used to derive the 
expected event rates listed in Table 4-1 for persistent AF subjects in the current study. 
Since many subjects in the current study are expected to be in AF at the time of the 
procedure, the anticipated event rate for stroke/TIA is 1.5%. Following the strict definitions 
of the 2012 HRS Consensus Statement, the expected pericarditis rate is 0.6% while the 
expected rate of cardiac tamponade/cardiac perforation is 2.00%.  The expected event rate 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 25 of 77 
Refer to section 6.3 for the definition of Serious Adverse Event.  
4.3 
Additional Endpoints 
• 15-Month Effectiveness Success – Post Medication Adjustment Period (Day 91-
450):  
o All AF Success: Clinical success is defined as freedom from documented 
all-cause (symptomatic and asymptomatic) AF/AFL/AT recurrence 
(episodes ≥ 30 secs) between the end of the 3-Month Medication Adjustment 
Period and the 15-month follow-up visit (Day 91-450) excluding other 
protocol effectiveness failure modes.   
o Symptomatic AF Success: Clinical success is defined as freedom from 
documented symptomatic AF/AFL/AT recurrence (episodes ≥ 30 secs) 
between the end of the 3-Month Medication Adjustment Period and the 15-
month follow-up visit (Day 91-450) excluding other protocol effectiveness 
failure modes.   
• 15-Month Effectiveness Success – Post Therapy Consolidation Period (Day 181-
450):  
o All AF Success: Clinical success is defined as freedom from documented 
all-cause (symptomatic and asymptomatic) AF/AFL/AT recurrence 
(episodes ≥ 30 secs) during the evaluation period (Day 181-450) excluding 
other protocol effectiveness failure modes.  
o Symptomatic AF Success: Clinical success is defined as freedom from 
documented symptomatic AF/AFL/AT recurrence (episodes ≥ 30 secs) 
during the evaluation period (Day 181-450) excluding other protocol 
effectiveness failure modes.  
• Procedural Data: 
o % PV isolation with the study device(s) by PV 
o Repeat Ablation Rate 
o Total Fluoroscopy Time 
o Overall Procedure Time 
o Duration of RF application time 
o RF Ablation parameters per application  
o Device(s) utilized (per ablation) 
o Duration of mapping time 
o VISITAG® Settings 
o CF range 
o Power range 
o Ablation index Assessment per anatomical region 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 26 of 77 
Ablation 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 ablation index. 
• Quality of Life:  
Quality of Life (QOL) status will be evaluated by assessing AFEQT and arrhythmia-
specific Symptom Frequency and Severity Checklist outcomes 
o Quality of Life – AFEQT 
o AF Symptom Frequency and Severity Checklist 
• Ablation Strategies Post-PVI: 
Ablation strategies post PVI will be recorded during the AF ablation procedure. 
Safety and effectiveness of the ablation strategies employed post PVI will be 
characterized. 
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 efficacy 
of the investigational device, 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-9 and procedure 
code, 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, necessary 
procedures/surgeries resulting from procedure, ER visits, and outpatient visits to 
address issues related to arrhythmia or 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 persistent AF candidates for ablation for participation in the study, and to offer enrollment to 
all who meet preliminary eligibility criteria.  
Centers will be selected for participation in the study based on experience with THERMOCOOL 
SMARTTOUCH® technology, ablation experience, their capacity to screen and enroll a 
reasonable number of eligible patients, and ability to perform the required study procedures, 
according to this protocol. Sponsor will attempt to include a diversified group of investigational 
sites engaging a variety of academic and private institutions geographically located throughout the 
US and possibly other regions. The trial may include up to 30% of subjects enrolled at OUS sites 
and approximately 70% of subjects enrolled at US sites. 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.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 27 of 77 
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 feasibility 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.75 
5.1 
Patient Screening 
All patients considered for RF ablation procedure for drug refractory recurrent 
symptomatic PsAF 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 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 28 of 77 
hospitalizations or ER visits that occur during the study will be requested for each 
procedure and/or hospitalization. 
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 day of 
ablation procedure. The following are allowable imaging modalities: 
o TEE 
o CT/MRI 
o Intracardiac Echocardiography (ICE) 
• Pregnancy Test – Pre-menopausal women only, performed within 24 hours prior to 
the procedure. 
• Electrocardiogram (12-Lead ECG) 
• Baseline 24-Hour Holter monitor (optional) 
• Baseline medical history 
• NIH Stroke Scale (NIHSS) assessment (within 72 hours prior to the ablation 
procedure) 
• 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; AFEQT and Symptoms Severity and 
Frequency Checklist  
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.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 29 of 77 
o An anatomical map is not required of triggers outside of the left atrium e.g. 
SVC/CS etc.  
• Introduction of the Study Catheter 
o Minimize the amount of power, contact force and time when ablating the 
posterior wall.  
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 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 30 of 77 
• Clinical Investigator judgment and monitoring of ablation effectiveness parameters 
commonly used such as EGM reduction and/or impedance changes, and/or  
• Esophageal monitoring as described in section 5.8. 
• 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. 
 
  
 
 
  
 
 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
  
• Contact force data and individual procedure working ranges will be collected for each RF 
application during a study ablation procedure for offline analysis. 
5.7 
 
 
 
 
 
 
 
 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 31 of 77 
 
 
 
5.8 
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: 
o Use of an esophageal temperature probe, 
o Esophageal visualization with CARTOSOUND® and/or ICE, 
o Esophageal visualization using barium swallow. 
 
 
 
 
 
  
 
 
 
 
5.9 
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 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 32 of 77 
• CFAE ablation (left atrial, right atrial and CS) will ONLY be considered if normal 
sinus rhythm is not spontaneously restored after ablation of PV/non-PV triggers & 
substrate modification with linear ablation  
• Ablation of non-PV triggers induced by adenosine or isoproterenol 
Prophylactic ablation of empirical sites is not allowed. 
All linear lesions require confirmation of bidirectional conduction block by pacing 
and/or mapping maneuvers. 
Figure 5-1 Study Ablation Flow Diagram 
5.10 
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.  
PVI of all PV’s 
Ablation  
“non-PV 
Triggers” 
Ablation of Triggers induced by 
Adenosine or Isoproterenol 
PV Verification 
of Entrance 
Block (30 min. 
wait period) 
Substrate Modification: Linear 
Lesion, CTI, CFAE, Ablation 
Confirmation of block 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 33 of 77 
• 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. 
5.11 
Post Procedure Assessments 
• Before hospital discharge: 
o Occurrence of arrhythmias, if any 
o Electrocardiogram (12-Lead ECG) 
o NIH Stroke Scale (NIHSS) assessment prior to hospital discharge  
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. 
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), 1-Month (30 +/- 7 days, 
telephone or office visit) and 3-Month (90 +/- 7 days; office visit): 
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 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 34 of 77 
• Follow-up measurements at 6-Month (180 +/- 14 days), 9-Month (270 +/- 28 
days), 12-Month (360 +/- 28 days) and 15-Month (450 +/- 28 days) Clinic Visits: 
o Medical / Hospitalization History  
o Occurrence of arrhythmias, if any 
o Electrocardiogram (12-Lead ECG) 
o QOL Assessments (AFEQT and AF Symptom Frequency and Severity 
Checklist) 
o 24 Hour Holter Monitor (6, 12 and 15-Month) 
o TTM Monitor (monthly transmissions starting 7 months post procedure and 
when symptomatic cardiac episodes occur) 
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 AF Recurrence 
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 (15-Month) 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 36 of 77 
5.12 
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 
Phone/ 
Office 
visit 
Follow-Up Visits 
 
 
Screening / 
Baseline 
Ablation 
Procedure1 Discharge 
7-9 
Days 
1 
Month 
+/- 1 
wks.  
3 Month 
+/- 1 wks.  
6 Month 
+/- 2 
wks.  
9 Month  
+/- 4 
wks.  
12 
Month  
+/- 4 
wks.  
15 
Month 
+/- 4 
wks. 
Unsched
uled 
Visit 
Visit no. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Informed consent1 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion & exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history / 
Hospitalization 
history 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Arrhythmias 
X 
[history] 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
NIH Stroke Scale12 
 
X 
 
X12 
 
 
 
 
 
 
 
 
ECG 
 
X 
 
X 
 
 
 
X 
X 
X 
X 
X 
NYHA 
 
X 
 
 
 
 
 
 
 
 
 
 
CCS-SAF 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
QOL assessment2 
 
X 
 
 
 
 
 
X 
X 
X 
X 
 
Pregnancy test3 
 
X 
 
 
 
 
 
 
 
 
 
 
LA thrombus 
Imaging4 
 
 
X 
 
 
 
 
 
 
 
 
 
TTE5 
 
X5 
 
X16 
 
 
 
 
 
 
 
 
Ablation assessments 
 
 
X 
 
 
 
 
 
 
 
 
 
Holter monitor (24 
hr) 
 
X 
optional 
 
 
 
 
 
X 
 
X 
X 
 
TTM monitoring13,14 
 
 
 
 
 
 
 
X13,14 
X13,14 
X13,14 
X13,14 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 37 of 77 
 
Pre-Procedure 
 
 
Phone 
Call 
Phone/ 
Office 
visit 
Follow-Up Visits 
 
 
Screening / 
Baseline 
Ablation 
Procedure1 Discharge 
7-9 
Days 
1 
Month 
+/- 1 
wks.  
3 Month 
+/- 1 wks.  
6 Month 
+/- 2 
wks.  
9 Month  
+/- 4 
wks.  
12 
Month  
+/- 4 
wks.  
15 
Month 
+/- 4 
wks. 
Unsched
uled 
Visit 
Visit no. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Device deficiency 
 
 
X 
 
 
 
 
 
 
 
 
 
Concomitant 
medications6 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Health Economic 
Data Collection7 
 
 
 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
X7 
Adverse events8,9  
X 
X 
X 
X 
X10 
X10 
X 
X 
X 
X 
X 
X 
PV stenosis imaging 
assessment11 
 
 
 
 
X11 
X11 
X11 
X11 
X11 
X11 
X11 
X11 
AF recurrence  
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
End-of study follow-
up 
 
 
 
 
 
 
 
 
 
 
X15 
 
1 Initial ablation procedure should be done within 30 days of consent. 
2 Quality of life tools (AFEQT and Symptom and Severity Checklist) 
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 via phone follow-up 
11 PV imaging (CT/MRI) for subjects who have symptoms suggestive of PV 
stenosis 
12 Performed prior to hospital discharge or 24 hours after the procedure, 
whichever is later or any time after the subject experiences a CVA/Stroke, 
perform Neuro consult as needed Refer to section 6.2.1 for additional 
details. 
13 Asymptomatic TTM: should be recorded monthly (i.e. at months 7, 8, 9, 
10, 11, 12, 13, 14, 15) and transmitted to the Core Lab. Refer to section 
5.15. 
14 TTM: all symptomatic cardiac episodes should be recorded and 
transmitted at the time the event occurs. Refer to section 5.15. 
15 15-month visit or last completed visit 
16 Subjects who develop symptoms suggestive of pericardial effusion and/or 
pericarditis should undergo a transthoracic echocardiogram (TTE) to 
assess the pericardium 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 38 of 77 
5.13 
 Study Medications 
The following medications are recommended/required (as indicated) for subjects 
undergoing a study catheter ablation for AF. 
5.13.1 
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: 20mg 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 
2012 HRS/EHRA/ECAS 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 6 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 thrombo-embolism. Systemic 
oral anticoagulation is strongly encouraged to be continued beyond 2 months post 
ablation in subjects with CHADS2 score > 1.  
5.14 
Antiarrhythmic Drug (AAD) Management 
5.14.1 
Definitions 
• Antiarrhythmic drugs (AADs)  
o The study protocol will classify and analyze the following: 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 39 of 77 
• Class I drugs (e.g., flecainide, propafenone, disopyramide, etc.) 
• 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. 
5.14.2 
AAD Usage and Primary Effectiveness Classification 
• AAD Therapy in the 3-Month Medication Adjustment Period (Day 0-90) and 
3-Month Therapy Consolidation Period (Day 91-180): 
During this interval, subjects may receive new AADs or previously failed AADs 
without affecting their primary effectiveness classification. 
• AAD Therapy in the Effectiveness Evaluation Period (Day 181-450): 
o New AADs:  
• Continued beyond the 3-Month Medication Adjustment Period / 3-Month Therapy 
Consolidation Period for treating “atrial tachyarrhythmia” will result in the subject being 
classified as a primary effectiveness failure.  
• A new AAD for an “atrial tachyarrhythmia” started in the evaluation period will result in 
the affected subject being classified as a primary effectiveness failure.  
o Previously failed AADs: 
• Started in or continued from the 3-Month Medication Adjustment Period / 3-Month 
Therapy Consolidation Period and remaining at the same or lower dose than the highest 
ineffective historical dose will not result in the affected subject being classified as a 
primary effectiveness failure. 
• Taking a previously failed AAD at a dose greater than the highest ineffective historical 
dose for AF during the evaluation period will result in the affected subject being classified 
as a primary effectiveness failure. 
Table 5-2 illustrates the corresponding classifications based on AAD therapy administered 
in the 3-Month Medication Adjustment Period / 3-Month Therapy Consolidation Period 
and the evaluation period. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 44 of 77 
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, and any death or hospitalization while on study, is 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 study catheter: 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 48 of 77 
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 
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. 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 49 of 77 
Table 6-2 Anticipated Adverse Events 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 55 of 77 
clinical course, copies of correspondence with the local IRB/EC, hospital records, death 
certificates, and autopsy reports, if applicable.  
6.13 
Global Safety Monitoring Committee (GSMC) 
In order to minimize risks to subjects enrolled in the study, the sponsor will convene a 
formal independent Global Safety Monitoring Committee (GSMC) at pre-determined 
intervals to review the adverse event reports and recommend appropriate action(s) to 
ensure subject safety. 
Primary Adverse Events and Serious Adverse Events occurring within 30 days of the 
ablation procedure and of cardiac origin will be reviewed by Biosense Webster clinical 
staff with Medical Safety Officer or designee, and submitted to the independent GSMC for 
review. 
 
 STATISTICAL ANALYSIS METHODS 
7.1 
Analysis Population 
• Modified Intent-To-Treat (mITT) Population: the modified Intent-To-Treat 
(mITT) population will consist of all enrolled subjects who meet all eligibility 
criteria AND in whom 
(1) RF energy was delivered with study catheter OR 
(2) Study catheter was inserted but no RF energy was delivered.  
• Safety Population (SP): The safety population will consist of all enrolled subjects 
who have undergone insertion of the study catheter. 
• Per Protocol (PP) Population: 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 study catheters, and have been treated for the study-
related arrhythmia 
 
7.2 
Analyses for Primary Endpoints 
7.2.1 
Analyses for Primary Effectiveness Endpoint 
The null and alternative hypotheses are: 
Hypothesis 
H0: PE < 0.40 
Ha: PE > 0.40 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 56 of 77 
PE: the freedom from documented atrial fibrillation, atrial flutter and atrial tachycardia 
recurrence at 15 months follow-up 
Null hypothesis: The freedom from documented AF/AFL/AT at 15 months is less than or 
equal to the pre-determined performance goal of 40%.  
Alternative hypothesis: The freedom from documented AF/ATL/AT at 15 months is greater 
than the pre-determined performance goal of 40%. 
Analysis Population: The per-protocol population will be used as the primary analysis 
population. Subjects with missing effectiveness endpoints data during 15 months follow-
up period will be excluded from the primary analysis. The subjects who have failed the 
primary effectiveness endpoint before 15 months will be included in the analysis. Analyses 
of the primary effectiveness endpoint will be repeated in the mITT population. Sensitivity 
analyses for missing data will be performed in the PP and mITT populations to assess the 
impact of missingness on the primary effectiveness outcome and are described in the 
Statistical Analysis Plan (SAP).  
Analysis Method: The primary effectiveness endpoint will be evaluated using the exact test 
for a binomial proportion at a two-sided significance level of 5%. If the lower bound of the 
exact two-sided 95% confidence interval of the primary effectiveness endpoint rate is 
greater than the performance goal of 40%, the study will be considered to have 
demonstrated effectiveness. 
7.2.2 
Analyses for Primary Safety Endpoint 
The null and alternative hypotheses are: 
Hypothesis 
H0: PS > 0.16  
Ha: PS < 0.16 
PS: the rate of early onset (within seven days of the ablation procedure) primary AE  
Null hypothesis: The rate of early onset primary AE is greater than or equal to the pre-
determined performance goal of 16%.  
Alternative hypothesis: The rate of early onset primary AE is less than the pre-determined 
performance goal of 16%. 
Analysis Population: The safety population (SP) will be used as the primary analysis 
population. Subjects with missing primary safety data will be excluded in the primary 
analysis. Sensitivity analyses for missing data will be performed in the SP and are described 
in the Statistical Analysis Plan (SAP). 
Analysis Method: The primary safety endpoint will be evaluated using the exact test for a 
binomial proportion at a two-sided significance level of 5%. If the upper bound of the exact 
two-sided 95% confidence interval of the primary safety endpoint rate is less than the 
performance goal of 16%, the study will be considered to have demonstrated safety. 
7.3 
Site Heterogeneity 
Each site should enroll no more than 15% of the total enrollment to minimize the possibility 
that the study results could be highly influenced by a few sites. Sites with less than five 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 57 of 77 
subjects will be combined according to geographic regions. Using this pre-determined 
criterion, sites with less than five subjects within the same geographic region will be 
combined such that the combined center(s) would have five or more subjects and no more 
than 5 sites combined. 
A Chi-square statistic will be used to examine the homogeneity across sites for the primary 
effectiveness and safety endpoints. A p-value less than 0.15 will be considered statistically 
significant for an assessment of homogeneity across sites. A non-significant result will 
support pooling of sites for the primary analyses.  
If the sites are not poolable, logistic regression models treating site as a random effect will 
be fit to examine the impact of site heterogeneity on the primary endpoints. The claim of 
trial success will be based upon the totality of the data. 
7.4 
Primary Effectiveness Endpoint 
Based on a performance goal of 40% and an anticipated freedom from AF recurrence 
of 50%, 330 subjects will be required to obtain at least 90% power at a two-sided 
significance level of 0.05 using the exact binomial method.  
7.5 
Primary Safety Endpoint 
Based on a performance goal of 16% and an anticipated rate of 8% for the primary safety 
endpoint, 232 subjects will be required to obtain at least 90% power at a two-sided 
significance level of 0.05 using the exact binomial method. 
7.6 
Total Sample Size 
It is estimated that the attrition rate is no more than 10%. In order to obtain 330 subjects, 
Biosense Webster proposes to enroll 367 (=330/0.90) subjects to account for this 
potential subject attrition.  
7.7 
Analyses for Secondary and Additional Endpoints 
Descriptive statistics will be presented for the secondary and additional endpoints. No 
formal statistical hypotheses and inferential statistics will be formulated and performed for 
the secondary and additional effectiveness and safety endpoints. Details of analyses 
methods for secondary and additional endpoints will be provided in SAP. 
 
 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. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 58 of 77 
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 
reviewed and attests to the correctness of the recorded data. Completed eCRFs will be 
reviewed and monitored remotely and at the investigational 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. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 59 of 77 
8.5 
Records and Reports 
8.5.1 
Records 
Records to be maintained by the investigator include: 
• Study protocol/Investigational Plan 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 
• 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 accountability log 
• Reports (e.g. annual 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  
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.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 60 of 77 
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. 
8.6 
Labeling 
THERMOCOOL SMARTTOUCH® SF Diagnostic/Ablation Deflectable Tip Catheter 
with Contact Force Sensing Capability and interface cable 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; 15 months of follow-up for primary endpoint).  
9.2 
Study Advisory Committee (SAC)  
The responsibilities of the SAC include: 
• Consultation on Study Design and Protocol Development 
• FDA Interactions: Reviewing periodic clinical reports prepared by the Sponsor 
including annual HA/RA reports and the final study report. 
• Enrollment Champions (addressing enrollment issues with Clinicians) 
• Help to ensure that all investigators comply with the ablation and medical treatments 
described in the protocol 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 61 of 77 
• Advising the Sponsor of unforeseen medical issues identified during the clinical 
study. 
• Addressing subject medical concerns or conditions raised by investigators as related 
to the use of the investigational device or ablation procedure. 
• Review of Evidence / Results; Assist in Data Interpretation  
• Publication Committee/ Strategy / Consultation 
Physicians serving on the Study Advisory Committee for this study are: 
Andrea Natale, MD  
St David‘s Medical Center 
Texas Cardiac Arrhythmia Research 
1015 East 32nd Sreet, Suite 500 
Austin, TX 78705 
Douglas L Packer, MD 
MAYO Clinic 
Alfred Building 
1216 2nd Street SW 
Rochester, MN 55902 
David J Wilber, MD 
Loyola University Medical Center 
2160 South 1st Avenue 
Building 110, Room 6232 
Maywood, IL 60153 
Hugh Calkins, MD 
Johns Hopkins University 
Carnegie Room 592 
601 N Wolfe Street 
Baltimore, MD 21287 
Francis E Marchlinski, MD 
University of Pennsylvania 
3400 Spruce Street, Gates 8009 
Philadelphia, PA 19104 
Vivek Reddy, MD 
Mount Sinai School of Medicine 
One Gustave L. Levy Place, Box 1030 
New York, NY, 10029 
Walid Saliba, MD 
The Cleveland Clinic  
9500 Euclid Avenue 
Cleveland, OH 44195 
Moussa Mansour, MD 
Massachusetts General Hospital,  
56 Fruit Street Gray 109 
Boston, MA 02114 
9.3 
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:  
• 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 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 62 of 77 
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/EC requirements. 
• Notifying Sponsor promptly of withdrawal of IRB/REB approval 
• Complying with IRB/REB (as applicable) and Sponsor annual report requirements 
• Maintaining accurate and current logs for the study such as Subject log, Device 
Accountability 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/EC updates as required 
9.4 
Sponsor Responsibilities 
The Sponsor (Biosense Webster) will be responsible for the following: 
• 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 IDE approval from the FDA and regional HAs/RAs  
• Providing protocol training to investigators and research personnel 
• Instructing operators and technicians in the proper use and monitoring of study 
devices 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 63 of 77 
• Monitoring the study throughout the duration of the investigation 
• Securing investigator/site compliance with the protocol and applicable regulations 
• Shipping investigational devices to each site 
• Creation and maintenance of eCRF database  
• Conducting all communications with HAs/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 
annually, which will be supplied to the FDA and to other HAs/RAs as requested. 
Annual 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 
9.5 
Training 
9.5.1 
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 
CRC 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 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.  
9.5.2 
Investigator Proctoring 
Investigators selected to participate in the study will have prior experience treating patients 
with the THERMOCOOL SMARTTOUCH® Catheters and/or the THERMOCOOL® SF 
Catheters. The research sites will not be able to order product until a participating study 
physician has completed the BWI training program in use of the STSF catheter.   

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 65 of 77 
9.10 
Device Accountability 
9.10.1 
Device Accountability 
The Sponsor will keep records of all investigational devices shipped to the site. 
Investigators are responsible for appropriate logging of the devices received, verification 
of packing slip information (i.e., lot numbers and quantity shipped), date and identity that 
each device was used in the study, and disposition information regarding return to the 
Sponsor. The Sponsor will label all devices as “Investigational device” (as applicable for 
the region) in a prominent location.  
The site Device Accountability Log will include the following information: 
• Date of receipt 
• Individual acknowledging receipt 
• Quantity received 
• Catalog number for catheters 
• Serial/lot numbers 
• Dates devices were used 
• Subject IDs for whom devices were used 
• Dates of return (as applicable) 
• Type of disposal (i.e., return to Sponsor for adverse event, complaint, etc.) 
9.11 
Device Returns 
All study catheters will be labeled “Investigational Device” and are only to be used for 
subjects enrolled in this clinical study.  
The OUS sites will use their commercially available STSF catheters per the approved IFU 
and PRECEPT Protocol requirements within the country of use.  The allowable curves for 
use in the study are those listed in the PRECEPT Protocol Section 1.4.1, Section 1.4.2 and 
commercially approved in the country of use. 
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 
• Date of use/event or if applicable, specify “unused” 
• Return type (device deficiency related, AE related, etc.) 
All tracking information must be retained. All study catheters must be returned to:  
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 66 of 77 
 
  
 
 
  
9.12 
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.  
9.13 
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. 
9.14 
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.  
9.15 
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. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 67 of 77 
 
 
REFERENCES 
1. Wann, LS, Chair, (2011) 2011 ACCF/AHA/HRS Focused Update on the Management 
of Patients with Atrial Fibrillation (Updating the 2006 Guideline). J Am Coll Cardiol 
57:223-242. 
2. Cain ME, (2002) Atrial Fibrillation-Rhythm or Rate Control. New Engl J Med 
347:1822-1823. 
3. Fuster V, Chair, Ryden LE, Co-Chair, (2006) ACC/AHA/ESC Guidelines for the 
Management of Patients with Atrial Fibrillation. J Am Coll Cardiol 48:854-906. 
4. Calkins H, Kuck KH, Cappato R, et al. 2012 HRS/EHRA/ECAS expert consensus 
statement on catheter and surgical ablation of atrial fibrillation: recommendations for 
patient selection, procedural techniques, patient management and follow-up, 
definitions, endpoints, and research trial design: a report of the Heart Rhythm Society 
(HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Heart 
Rhythm 2012;9:632-96 e21. 
5. Jazayeri MR, Hempe SL, Sra JS, et al. (1992) Selective transcatheter ablation of the 
fast and slow pathways using radiofrequency energy in patients with atrioventricular 
nodal reentrant tachycardia. Circulation 85:1318-1328. 
6. Pappone C, Augello G, Sala S, et al. (2006) A randomized trial of circumferential 
pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial 
fibrillation. J Am Coll Cardiol 48:2340-2347. 
7. Wilber D, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud 
E, Calkins H, Hall B, Reddy V, Augello G, Reynolds M, Vinekar CV, Liu CY, Berry 
SM, Berry DA, (2010) Comparison of Antiarrhythmic Drug Therapy and 
Radiofrequency Catheter Ablation in Patients with Paroxysmal Atrial Fibrillation: A 
Randomized Controlled Trial. JAMA 303:333-340. 
8. Pappone C, Oreto G, Rosanio S, Vicedomini G, Tocchi M, Gugliotta F, Salvati A, 
Dicandia C, Calabrò MP, Mazzone P, Eleonora F, Di Gioia C, Gulletta S, Nardi S, 
Santinelli V, Benussi S, Alfieri O, (2001) Atrial Electroanatomic Remodeling After 
Circumferential Radiofrequency Pulmonary Vein ablation: Efficacy of an Anatomic 
Approach in a large Cohort of Patients with Atrial Fibrillation. Circulation 104:2539-
2544. 
9. Oral H, Knight BP, Tada H, Özaydin M, Chugh A, Hassan S, Scharf C, Lai SWK, 
Greenstein R, Pelosi F, Strickberger A, Morady F, (2002) Pulmonary Vein isolation for 
Paroxysmal and Persistent Atrial Fibrillation. Circulation 105:1077-1081.  
10. Caponi D, Corleto A, Scaglione M, Blandino A, Biasco L, Cristoforetti Y, Cerrato N, 
Toso E, Morello M, Gaita F, (2010) Ablation of atrial fibrillation: dose the addition of 
three-dimensional magnetic resonance imaging of the left atrium to electroanatomic 
mapping improve the clinical outcome? Europace 12:1098-1104. 
11. Khaykin Y, Oosthuizen R, Zarnett L, Essebag V, Parkash R, Seabrook C, Beardsall M, 
Tsang B, Wulffhart Z, Verma A, (2011) Clinical predictors of arrhythmia recurrences 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 68 of 77 
following pulmonary vein atnrum isolation for atrial fibrillation: Predicting arrhythmia 
recurrence post-PVAI. J Cardiovasc Electrophysiol 22:1206-1214.  
12. Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, Sullivan T, Roberts-
Thomson KC, Sanders P, (2013) Long-term outcomes of catheter ablation of atrial 
fibrillation: A systematic review and meta-analysis. J Am Heart Assoc 2:e004549. doi: 
10.1161/JAHA.112.004549. 
13. Nakagawa H, Yamanashi WS, Pitha JV, et al. (1995) Comparison of in vivo tissue 
temperature profile and lesion geometry for radiofrequency ablation with a saline-
irrigated electrode versus temperature control in a canine thigh muscle preparation. 
Circulation 91:2264-2273. 
14. Bertaglia E, Fassini G, Anselimo M, Stabile G, Grandinetti G, De Simone A, Calo L, 
Pandozi C, Pratola C, Zoppo F, Tondo C, Iuliano A, Gaita F, (2013) Comparison of 
THERMOCOOL® Surround Flow Catheter Versus THERMOCOOL® Catheter in 
Achieving Persistent Electrical Isolation of Pulmonary Veins: A Pilot Study. J 
Cardiovasc Electrophysiol. 24: 269-273. 
15. Sciarra L, Golia P, Natalizia A, De Ruvo E, Dottori S, Scara A, Borrelli A, De Luca L, 
Rebecchi M, Fagagnini A, Bandini A, Guarracini F, Galvani M, Calo L, (2014) Which 
is the best catheter to perform atrial fibrillation ablation? A comparison between 
standard THERMOCOOL®, SMARTTOUCH, and Surround Flow catheters. J Interv 
Card Electrophysiol. 39(3):193-200. 
16. Park C, Lehrmann H, Keyl C, Weber R, Schurr P, Schiebeling-Romer J, Allgeier J, 
Herrera CS, Kienzle R-P, Shah D, Neumann F-J, Arentz T, Jadidi A, (2013) Enhanced 
efficacy of a novel porous tip irrigated RF ablation catheter for pulmonary vein 
isolation. J Cardiovasc Electrophysiol. 24(12):1328-35. 
17. Scaglione M, Blandino A, Raimondo C, Caponi D, DiDonna P, Toso E, Ebrille E, 
Cesarani F, Ferrarese E, Gaita F, (2012) Impact of ablation catheter irrigation design 
on silent cerebral embolism after radiofrequency catheter ablation of atrial fibrillation: 
Results from a pilot study. J Cardiovasc Electrophysiol. 23:801-805. 
18. Avitall B, Mughal K, Hare J, Helms R, Krum D, (1997) The effects of electrode-tissue 
contact on radiofrequency lesion generation. PACE 20:2899-2910 
19. Haines DE, (1991) Determinants of lesion size during radiofrequency catheter ablation: 
the role of electrode-tissue contact pressure and duration of energy delivery. J 
Cardiovasc Electrophysiol 2:509-515 
20. Shah D, Lambert H, Nakagawa H, Walpoth B, Saoudi N, Aeby N, Leo G, Gentil-Baron 
P. Correlation of Real Time Measurement of Ablation Catheter Tip Force with 
Subjective Tissue Contact Assessment in the Beating Heart. Heart Rhythm Society, 
May 2008, San Francisco, USA, Abstract 6099; P01-67 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 69 of 77 
21. Kuck K Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, 
Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC, (2012) A novel 
radiofrequency ablation catheter using contact force sensing: TOCCATA study. Heart 
Rhythm 9:18-23. 
22. Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, 
Peichi P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck K-H, (2012) The relationship 
between contact force and clinical outcome during radiofrequency catheter ablation of 
atrial fibrillation in the TOCCATA study. Heart Rhythm. 9:1789-1795. 
23. Marijon E1, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, 
Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP, (2013) Real-
time contact force sensing for pulmonary vein isolation in the setting of paroxysmal 
atrial fibrillation: Procedural and 1-year results. J Cardiovasc Electrophysiol 25:130-
137. 
24. Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, 
Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, 
Marchlinski FE, (2014) Paroxysmal atrial fibrillation catheter ablation with a contact 
force sensing catheter—results of the prospective multicenter SMART-AF trial. J Am 
Coll Cardiol 64:647-656 
25. Yokoyama K, Nakagawa H, Shah D, Lambert H, Leo G, Aeby N, Ikeda A, Pitha J, 
Sharma T, Lazzara R, Jackman W. Novel Contact Force Sensor Incorporated in 
Irrigated Radiofrequency Ablation Catheter Predicts Lesion Size and Incidence of 
Steam Pop and Thrombus. Circ Arrhythmia Electrophysiol. 2008; 1;354-362 
26. Natale A, Marchlinski F, Packer D, Nakagawa H, Reddy V, Pollak S, Hong A, Wilber 
D. Correlation of contact force (CF) and one-year effectiveness for paroxysmal atrial 
fibrillation (PAF) ablation in the SMART-AF study. Heart Rhythm Society, May 2014, 
San Francisco, USA, Abstract PO01-150. 
27. Dorian, P, Guerra PG, Kerr CR, et al. (2009) Validation of a New Simple Scale to 
Measure Symptoms in Atrial Fibrillation: The Canadian Cardiovascular Society 
Severity in Atrial Fibrillation Scale. Circulation Arrhythmia and Electrophysiology 
2:218-224. 
28. Gerstenfeld EP, Guerra P, Sparks PB, Hattori K, Lesh MD, (2001) Clinical Outcome 
After Radiofrequency Catheter Ablation of Focal Atrial Fibrillation Triggers. J 
Cardiovasc Electrophysiol 12:900-908. 
29. Takahasi A, Lesaka Y, Takahasi Y, Takahasi R, Kobayashi K, Takagi K, Kuboyama 
O, Nishimori T, Takei H, Amemiya H, Fujiwara H, Hiraoka M, (2002) Electrical 
Connections Between Pulmonary Veins; Implication for Ostial Ablation of Pulmonary 
Veins in Patients with Paroxysmal Atrial Fibrillation. Circulation 105:2998-3003. 
30. Yamane T, Shah DC, Jaïs P, Hocini M, Deisenhofer I, Choi K-J, Macle L, Clémenty J, 
Haïssaguerre M, (2002) Electrogram Polarity Reversal as an Additional Indicator of 
Breakthroughs From the Left Atrium to the Pulmonary Veins. J Am Coll Cardiol 
39:1337-1344. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 70 of 77 
31. Macle L, Jaïs P, Weerasooriya R, Hocini M, Shah DC, Choi K-J, Scavée C, Raybaud 
F, Clémenty J, Haïssaguerre M, (2002) Irrigated-Tip Catheter Ablation of Pulmonary 
Veins for Treatment of Atrial Fibrillation. J Cardiovasc Electrophysiol 113:1067-1073. 
32. Deisenhofer I, Schneider MAE, Böhlen-Knauf M, Zrenner B, Ndrepepa G, Schmieder 
S, Weber S, Schreieck J, Weyerbrock S, Schmitt C, (2003) Circumferential Mapping 
and Electric Isolation of Pulmonary Veins in Patients With Atrial Fibrillation. Am J 
Cardiol 91:159-163. 
33. Huang SKS, Wilber DJ (eds): Radiofrequency Catheter Ablation of Cardiac 
Arrhythmias: Basic Concepts and Clinical Applications, 2nd ed. Grouponk, NY: Futura 
Publishing Company, Inc. (2000); Lin AC, Wilber D, Complications Associated With 
Radiofrequency Catheter Ablation. Pages 737-746. 
34. Scheinman MM, Huang S, (2000) The 1998 NASPE Prospective Catheter Ablation 
Registry. PACE 23:1020-1028. 
35. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, 
Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E, (2010) Updated worldwide 
survey on the methods, efficacy, and safety of catheter ablation for human atrial 
fibrillation. Circ Arrhythm Electrophysiol 3:32-38. 
36. Sacher F, Monahan KH, Thomas SP, Davidson N, Adragao P, Sanders P, HociniM, 
Takahashi Y, Rotter M, Rostock T, et al. (2006) Phrenic nerve injury after atrial 
fibrillation catheter ablation: characterization and outcome in a multicenter study. J Am 
Coll Cardiol 47:2498-2503. 
37. Bai R, Patel D, Di BL, Fahmy TS, Kozeluhova M, Prasad S, Schweikert R, Cummings 
J, Saliba W, ndrews-Williams M, et al. (2006) Phrenic nerve injury after catheter 
ablation: should we worry about this complication? J Cardiovasc Electrophysiol 
17:944-948. 
38. Kovoor P, Ricciardello M, Collins L, Uther JB, Ross DL, (1998) Risk to Patients From 
Radiation Associated With Radiofrequency Ablation for Supraventricular Tachycardia. 
Circulation 98:1534-1540. 
39. Nahass GT (1995) Fluoroscopy and the Skin: Implications for Radiofrequency Catheter 
Ablation Am J Cardiol 76:174-176. 
40. Calkins H, Niklason L, Sousa J, el-Atassi R, Langberg J, Morady F, (1991) Radiation 
Exposure During Radiofrequency Catheter Ablation of Accessory Atrioventricular 
Connection, Circulation 84:2376-2382. 
41. Cox B, Durieux ME, Marcus MA, (2003) Toxicity of Local Anaesthetics. Best Pract 
Res Clin Anaesthesiol.17: 111-136. 
42. Mertes PM, Laxenaire MC, (2002) Allergic Reactions Occurring During Anaesthesia. 
Eur J Anaesthesiol. 19:240-262. 
43. Morcos SK, Thomsen HS, Webb JA; Contrast Media Safety Committee of the 
European Society of Urogenital Radiology (2001) Prevention of Generalized Reactions 
to Contrast Media: A Consensus Report and Guidelines. Eur Radiol 11:1720-1728. 
44. Gruchalla RS, (2003) 10. Drug Allergy. J Allergy Clin Immunol. 111:S548-S559. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 71 of 77 
45. Bick RL, Frenkel EP, (1999) Clinical Aspects of Heparin-Induced Thrombocytopenia 
and Thrombosis and Other Side Effects of Heparin Therapy. Clin Appl Thromb 
Hemost. 5:S7-S15.  
46. Wann LS, Curtis AB, Ellenbogen KA, Estes NA 3rd, Ezekowitz MD, Jackman WM, 
January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, et al. (2011) 
2011 ACCF/AHA/HRS Focused Update on the Management of Patients with Atrial 
Fibrillation (Update on Dabigatran). A report of the American College of Cardiology 
Foundation/American Heart Association Task Force on Practice Guidelines. Heart 
Rhythm 8:e1-8. 
47. Holmes DR, Monahan KH, Packer D, (2009) Pulmonary Vein Stenosis Complicating 
Ablation for Atrial Fibrillation. JACC Intv. 2:267-276. 
48. Oh Jk, Seward JB, Tajik AJ. The Echo Manual. Lippincott Williams & Wilkins 2006, 
pp 143-153. 
49. Matsuo S, Yamane T, Date T, Hioki M, Narui R, Ito K, Tanigawa S-I, Nakane T, 
Yamashita S, Tokuda M, Inada K, Nojiri A, Kawai M, Sugimoto K-I, Yoshimura M, 
(2011) Completion of mitral isthmus ablation using a steerable sheath: Prospective 
randomized comparison with nonsteerable sheath. J Cardiovasc Electrophysiol 
22:1331-1338. 
50. Richter B, Gwechenberger M, Kriegisch M, Albinni S, Marx M, Gossinger HD, (2013) 
Combined circular multielectrode catheter and point-by-point ablation is superior to 
point-by-point ablation alone in eliminating atrial fibrillation. Int J Cardiol. 
dx.doi.org/10.1016/j.ijcard.2013.06.016. 
51. NAVISTAR® THERMOCOOL® Catheter Clinical Report IDE #G030236. 
(MASTER_Final_AF_PMA_Results_12Aug08_THERMOCOOL.pdf) 
52. Packer et al. (2013) Summary of Safety and Effectiveness Data for Cardiac 
CryoAblation Catheter. (CryoAblation SSED Packer 2013.pdf) 
53. Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, 
Pascotto P, Fazzari M, Vitale DF, (2006). Catheter ablation treatment in patients with 
drug-refractory atrial fibrillation: A prospective, multi-centre, randomized, controlled 
study (Catheter Ablation for the Cure of Atrial Fibrillation Study). Eur Heart J 27:216-
221. 
54. Shah D, Dumonceau JM, Burri H, Sunthorn H, Schroft A, Gentil-Baron P, Yokoyama 
Y, Takahashi A, (2005). Acute pyloric spasm and gastric hypomotility: an extracardiac 
adverse effect of percutaneous radiofrequency ablation for atrial fibrillation. J Am Coll 
Cardiol. Jul 19;46(2):327-30. 
55. Kuwahara T, Takahashi A, Takahashi Y, Kobori A, Miyazaki S, Takei A, Fujino T, 
Okubo K, Takagi K, Fujii A, Takigawa M, Watari Y, Hikita H, Sato A, Aonuma K, 
(2013). Clinical characteristics and management of periesophageal vagal nerve injury 
complicating left atrial ablation of atrial fibrillation: lessons from eleven cases. J 
Cardiovasc Electrophysiol. Aug;24(8):847-51. doi: 10.1111/jce.12130. Epub 2013 Mar 
29.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 72 of 77 
56. Cappato R, Calkins H, Chen SA, et al. (2005) Worldwide survey on the methods, 
efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 
111:1100-1105.  
57. Bunch TJ, Asirvatham SJ, Friedman PA, Monahan KH, Munger TM, Rea RF, Sinak 
LJ, Packer DL. (2005) Outcomes after cardiac perforation during radiofrequency 
ablation of the atrium. J Cardiovasc Electrophysio. 16:1172-11797. 
58. Leon MB et al. Standardized Endpoint Definitions for Transcatheter Aortic Valve 
Implantation Clinical Trials: A Consensus Report From the Valve Academic 
Research Consortium. J Am Coll Cardiol. 2011 57:253-269. 
59. Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, 
Sledge I. (2009) Treatment of atrila fibrillation with antiarrhythmic drugs or 
radiofrequency ablation: Two systematic literature reviews and meta-analyses. Circ 
Arrhythmia Electrophysiol. 2:349-261 
60. Arentz, T; Ott, P; von Rosenthal, J; Blum, T; Kalusche, D;(2003) Effect of atrial 
overdrive pacing on pulmonary vein focal discharge in patients with atrial fibrillation. 
Europace.2003;5: 25-31 
61. Bhargava, Mandeep; Marrouche, Nassir F; Martin, David O; Schweikert, Robert A; 
Saliba, Walid; Saad, Eduardo B; Bash, Dianna; Williams-Andrews, Michelle; 
Rossillo, Antonio; Erciyes, Demet; Khaykin, Yaariv; Burkhardt, J David; Joseph, 
George; Tchou, Patrick J; Natale, Andrea; (2004) Impact of age on the outcome of 
pulmonary vein isolation for atrial fibrillation using circular mapping technique and 
cooled-tip ablation catheter:. J Cardiovasc Electrophysiol.2004;15: 8-13 
62. Cheema, Aamir; Dong, Jun; Dalal, Darshan; Vasamreddy, Chandrasekhar R; Marine, 
Joseph E; Henrikson, Charles A; Spragg, David; Cheng, Alan; Nazarian, Saman; 
Sinha, Sunil; Halperin, Henry; Berger, Ronald; Calkins, Hugh; (2006) Long-term 
safety and efficacy of circumferential ablation with pulmonary vein isolation. J 
Cardiovasc Electrophysiol.2006;17: 1080-5 
63. Gerstenfeld, Edward P; Dixit, Sanjay; Callans, David; Rho, Robert; Rajawat, 
Yadavendra; Zado, Erica; Marchlinski, Francis E; (2002) Utility of exit block for 
identifying electrical isolation of the pulmonary veins. J Cardiovasc 
Electrophysiol.2002;13: 971-9 
64. Gerstenfeld, Edward P; Callans, David J; Dixit, Sanjay; Zado, Erica; Marchlinski, 
Francis E; (2003) Incidence and location of focal atrial fibrillation triggers in patients 
undergoing repeat pulmonary vein isolation: implications for ablation strategies. J 
Cardiovasc Electrophysiol.2003;14: 685-90 
65. Haissaguerre M, Sanders P, Hocini M, Takahashi Y, Rotter M, Sacher F, Rostock T, 
Hsu LF, Bordachar P, Reuter S, Roudaut R, Clementy J, Jais P. (2005) Catheter 
Ablation of Long-Lasting Persistent Atrial Fibrillation: Critical Structures for 
Termination. J Cardiovasc Electrophysiol. 
66. Kottkamp H, Tanner H, Kobza R, Schirdewahn P, Dorszewski A, Gerds-Li JH, 
Carbucicchio C, Piorkowski C, Hindricks G. (2004) Time Courses and Quantitative 
Analysis of Atrial Fibrillation Episode Number and Duration After Circular Plus 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 73 of 77 
Linear Left Atrial Lesions: Trigger Elimination or Substrate Modification: Early or 
Delayed Cure? J Am Coll Cardiol. 44:869-77 
67. Macle L, Jais P, Weerasooriya R, Hocini M, Shah DC, Choi KJ, Scavee C, Raybaud 
F, Clementy J, Haissaguerre M. (2202) Irrigated-Tip Catheter Ablation of Pulmonary 
Veins for Treatment of Atrial Fibrillation. J Cardiovasc Electrophysiol. 13:1067-1073 
68. Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul 
T, Khunnawar C, Ngarmukos T. (2004) A New Approach for Catheter Ablation of 
Atrial Fibrillation: Mapping of the Electrophysiologic Substrate. J Am Coll Cardiol. 
43:2044-43 
69. Nakashima H, Kumagai K, Tojo H, Yasuda T, Noguchi H, Matsumoto N, Saku K. 
(2002) Simultaneous Catheter Mapping of the Pulmonary Veins in Focal Atrial 
Fibrillation Significance of Rapid Focal Activation, Effectiveness for Catheter 
Ablation. (2002) Jpn Heart J. 43:357-365 
70. Nilsson B, Chen X, Pehrson S, Kober L, Jilden J, Svenden JH. (2006) Recurrence of 
pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for 
atrial fibrillation: A randomized trial of the ostial versus the extraostial ablation 
strategy. Am Heart J. 152:537.e1-537.e8 
71. Stabile G, Turco P, La Rocca V, Nocerino P, Stabile E, Simone AD. (2003) Is 
Pulmonary Vein Isolation Necessary for Curing Atrial Fibrillation? Circulation. 
108:657-660  
72. Thomas SP, Aggarwal G, Boyd AC, Jin Y, Ross DL. (2004) A comparison of open 
irrigated and non-irrigated tip catheter ablation for pulmonary vein isolation. 
Europace. 6:330-335 
73. Vasamreddy C, Lickfett L, Jayam V, Nasir K, Bradley D, Eldadah Z, Diskfeld T, 
Berger R, Calkins H. (2004) Predictors of Recurrence Following Catheter Ablation of 
Atrial Fibrillation Using an Irrigated-Tip Ablation Catheter. J Cardiovasc 
Electrophysiol. 15:692-697 
74. Vasamreddy C, Dalal D, Eldadah Z, Dickfeld T, Jayam VK, Henrickson C, 
Meininger G, Don J, Lickfett L, Berger R, Calkins H. (2005) Safety and efficacy of 
circumferential pulmonary vein catheter ablation of atrial fibrillation. Heart Rhythm 
2:42-48 
75. Michowitz Y, Rahkovich M, Oral H, Zado ES, Tilz R, John S, Denis A, Di Biase L, 
Winkle RA, Mikhaylov EN, Ruskin JN, Yao Y, Josephson ME, Tanner H, Miller JM, 
Champagne J, Della BP, Kumagai K, Defaye P, Luria D, Lebedev D S, Natale A, Jais 
P, Hindricks G, Kuck KH, Marchlinski FE, Morady F, Belhassen B. (2014) Effects of 
Gender on the Incidence of Cardiac Tamponade Following Catheter Ablation of 
Atrial Fibrillation: Results from a Worldwide Survey in 34,943 AF Ablation 
Procedures. Circ Arrhythm Electrophysiol. 7:274-280 
76. Ejima K, Arai K, Suzuki T, Kato K, et al. (2014) Long-term outcome and 
preprocedural predictors of atrial tachyarrhythmia recurrence following pulmonary 
vein antrum isolation-based catheter ablation in patients with non-paroxysmal atrial 
fibrillation. J Cardiol. 64:57-63. Epub 2013 Dec 25. 
77. Oza SR, Hunter TD, Biviano AB, Dandamudi G, et al. (2014) Acute Safety of an 
Open-Irrigated Ablation Catheter with 56-Hole Porous Tip for Radiofrequency 
Ablation of Paroxysmal Atrial Fibrillation: Analysis from 2 Observational Registry 
Studies. J Cardiovasc Electrophysiol. 25:852-8. Epub 2014 Apr 9.  

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 74 of 77 
78. Kaiser DW, Streur MM, Nagarakanti R, Whalen SP, Ellis CR. (2013) Continuous 
warfarin versus periprocedural dabigatran to reduce stroke and systemic embolism in 
patients undergoing catheter ablation for atrial fibrillation or left atrial flutter. J Interv 
Card Electrophysio. 37:241-47. Epub Apr 28.  
79. Stepanyan G, Badhwar N, Lee RJ, Marcus GM, et al. (2014) Safety of new oral 
anticoagulants for patients undergoing atrial fibrillation ablation. J Interv Card 
Electrophysiol. 40:33-38. Epub Mar 19.  
80. Khaykin Y, Skanes A, Champagne J, Themistoclakis S, et al. (2009) A Randomized 
Controlled Trial of the Efficacy and Safety of Electroanatomic Circumferential 
Pulmonary Vein Ablation Supplemented by Ablation of Complex Fractionated Atrial 
Electrograms Versus Potential-Guided Pulmonary Vein Antrum Isolation Guided by 
Intracardiac Ultrasound. Circ Arrhythm Electrophysiol. 2009 2:481-87.  
81. Di Biase L, Santangeli P, Natale A. (2013) How to ablate long-standing persistent 
atrial fibrillation? Curr Opin Cardiol. 28:26-35 
 
 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 75 of 77 
 
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 
(investigational) whether or not related to the investigational product. 
This definition includes events related to the investigational medical device 
and/or the comparator, and events related to the procedure in which the 
investigational device was used. 
Adverse Device Effects 
(ADE’s) 
Adverse events related to the use of an investigational 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 investigational 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 investigational 
medical device and/ or intervention procedure.  
Atypical Flutter 
Macroreentrant circuits within the atria where activation rotates around 
large obstacles that does not meet the criteria for Typical Flutter.  
Catheter Insertion 
Defined as the study 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. 
Longstanding persistent 
AF 
Continuous AF of > 12 months duration  
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. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 76 of 77 
Term 
Definition 
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.  
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. 

PRECEPT 
Clinical Study Protocol (STSF-159) 
 
Biosense Webster, Inc 
 
Version 6.0 – July 31, 2018 
CONFIDENTIAL 
Page 77 of 77 
Term 
Definition 
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 
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).