Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Phase: PHASE3
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster, Inc.

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STELLAR 
 
 
Safety and Effectiveness Evaluation of the Multi-Electrode 
Radiofrequency Balloon Catheter for the Treatment of Symptomatic 
Paroxysmal Atrial Fibrillation (STELLAR)  
 
Protocol Number:  
BWI_2017_04  
 
IDE Number:  
G180139 
 
Sponsor: 
Biosense Webster, Inc., a division of Johnson & Johnson with registered 
office at 33 Technology Drive, Irvine, CA 92618 
 
Funded by: 
Biosense Webster, Inc., a division of Johnson & Johnson 
 
Version: 
11.0  
 
Date: 
15 Nov 2022 

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6.3. 
DEVICE STORAGE AND STABILITY ............................................................................................................ 38 
6.4. 
DEVICE PREPARATION ............................................................................................................................ 39 
6.5. 
INSTRUCTIONS FOR USE .......................................................................................................................... 39 
7. 
STUDY MEDICATIONS ............................................................................................................................. 48 
7.1. 
ANTIARRHYTHMIC DRUGS ........................................................................................................................ 48 
7.2. 
STUDY SPECIFIC ANTICOAGULATION REQUIREMENTS ................................................................................. 49 
8. 
STUDY SCHEDULE, PROCEDURES, AND ASSESSMENTS ................................................................. 50 
8.1. 
SCREENING AND INFORMED CONSENT ..................................................................................................... 50 
8.2. 
PRE-PROCEDURE/BASELINE ASSESSMENTS, EVALUATIONS AND PROCEDURES ......................................... 51 
8.5. 
REPEAT PROCEDURES ............................................................................................................................ 56 
8.6. 
PRE-DISCHARGE AND FOLLOW-UP ASSESSMENTS .................................................................................... 56 
8.7. 
UNSCHEDULED VISIT ............................................................................................................................... 58 
8.8. 
SCHEDULE OF EVENTS TABLE ................................................................................................................. 58 
9. 
ASSESSMENT OF SAFETY ..................................................................................................................... 60 
9.1. 
SPECIFIC SAFETY PARAMETERS .............................................................................................................. 60 
9.2. 
ADVERSE EVENT DEFINITIONS ................................................................................................................. 60 
9.2.1. 
Adverse Events (AE) .................................................................................................................... 60 
9.2.2. 
Serious Adverse Event (SAE) ...................................................................................................... 60 
9.2.3. 
Primary Adverse Event ................................................................................................................. 61 
9.2.4. 
Non-Serious Adverse Events ....................................................................................................... 63 
9.2.5. 
Adverse Device Effect / Serious Adverse Device Effect .............................................................. 63 
9.2.6. 
Unanticipated (Serious) Adverse Device Effect ........................................................................... 64 
9.2.7. 
Study Device Deficiency, Failure or Malfunction .......................................................................... 64 
9.3. 
CLASSIFICATION OF AN ADVERSE EVENT .................................................................................................. 64 
9.3.1. 
Severity of Event .......................................................................................................................... 64 
9.3.2. 
Causality ....................................................................................................................................... 64 
9.3.3. 
Outcome ....................................................................................................................................... 65 
9.3.4. 
Expectedness ............................................................................................................................... 66 
9.4. 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP ............................................... 68 
9.5. 
REPORTING PROCEDURES ...................................................................................................................... 68 
9.5.1. 
Adverse Event Documentation and Reporting Requirements ..................................................... 68 
9.5.2. 
Serious Adverse Events Reporting .............................................................................................. 69 
9.5.3. 
Unanticipated Device Effect Reporting ........................................................................................ 70 
9.5.4. 
Events of Special Interest............................................................................................................. 70 
9.6. 
SAFETY OVERSIGHT................................................................................................................................ 70 
10. DEVIATIONS FROM THE CLINICAL STUDY PLAN ................................................................................ 70 
11. INVESTIGATIONAL PRODUCT MATERIALS AND ACCOUNTABILITY ................................................ 71 
11.1. MATERIALS ............................................................................................................................................. 71 

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11.2. DEVICE ACQUISITION AND ACCOUNTABILITY ............................................................................................. 71 
11.3. DEVICE RETURNS ................................................................................................................................... 72 
12. CLINICAL MONITORING .......................................................................................................................... 72 
12.1. EARLY TERMINATION MONITORING VISIT .................................................................................................. 72 
14. ETHICS AND PROTECTION OF HUMAN SUBJECTS ............................................................................ 85 
14.1. ETHICAL STANDARD ................................................................................................................................ 85 
14.2. INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE ................................................................................. 86 
14.3. INFORMED CONSENT PROCESS ............................................................................................................... 87 
14.3.1. Consent/Assent and Other Informational Documents Provided to Subjects ............................... 87 
14.3.2. Consent Procedure and Documentation ...................................................................................... 87 
14.4. SUBJECT AND DATA CONFIDENTIALITY ..................................................................................................... 87 
14.4.1. Research use of Stored Data ....................................................................................................... 88 
15. SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ......................................... 88 
16. QUALITY ASSURANCE AND QUALITY CONTROL ............................................................................... 89 
17. DATA HANDLING AND RECORD KEEPING ........................................................................................... 89 
17.1. DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES ......................................................................... 89 
17.1.1. Data Collection ............................................................................................................................. 89 
17.1.2. Data Reporting ............................................................................................................................. 89 
17.1.3. Data Verification and Review ....................................................................................................... 90 
17.1.4. Final Data Analysis ....................................................................................................................... 90 
17.2. STUDY RECORD RETENTION AND ARCHIVING ........................................................................................... 90 
18. STUDY SUSPENSION OR TERMINATION .............................................................................................. 91 
19. DATA AND PUBLICATION POLICY......................................................................................................... 91 
20. DOCUMENT FILING .................................................................................................................................. 91 
21. SCIENTIFIC REFERENCES ...................................................................................................................... 92 
22. APPENDIX ................................................................................................................................................. 98 

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22.1. APPENDIX A: MRI METHODOLOGY ........................................................................................................... 98 
22.1.1. Subject Preparation for Cerebral MRI .......................................................................................... 99 
22.1.2. Cerebral MRI Technique .............................................................................................................. 99 
 
 
List of Figures and Tables 
FIGURE 3.2.1A: AVERAGE COMPOSITE ENDPOINT PLOT .......................................................................... 29 
FIGURE 6.6.1A: HELIOSTARTM CATHETER DISTAL SEGMENT ................................................................... 39 
FIGURE 6.6.1B: HELIOSTARTM CATHETER WITH RADIOPAQUE UNIQUE MARKERS ............................. 40 
FIGURE 6.6.2A: CIRCULAR MAPPING CATHETER DEPLOYED VIA THE GUIDEWIRE LUMEN OF RF 
BALLOON CATHETER ...................................................................................................................................... 41 
FIGURE 6.6.2B: DETAILED LASSOSTARTM CATHETER SCHEMATIC ......................................................... 42 
FIGURE 6.6.2C: LOOP TIP ................................................................................................................................ 42 
FIGURE 6.6.2D: CONNECTIVITY OF THE LASSOSTARTM CATHETER WITH THE CARTO® SYSTEM ...... 43 
TABLE 6.6.4A: HIGH-LEVEL DESCRIPTION OF THE CATHETER INTERFACE CABLE ............................ 44 
FIGURE 6.6.4A: SCHEMATIC OF THE CATHETER INTERFACE CABLE ..................................................... 44 
FIGURE 6.7.1A: CONNECTIVITY DIAGRAM OF HELIOSTARTM CATHETER ............................................... 46 
TABLE 6.7.2A: REQUIRED STUDY DEVICES ................................................................................................. 46 
TABLE 6.7.3A: RECOMMENDED RF ENERGY DELIVERY PARAMETERS WHEN THE HELIOSTARTM 
CATHETER IS CONNECTED TO THE NMARQ® GENERATOR AND USED FOR ATRIAL ABLATION ....... 48 
TABLE 7.1A: AAD USAGE AND IMPACT ON PRIMARY EFFECTIVENESS CLASSIFICATION .................. 49 
TABLE 8.8A: SUMMARY OF SUBJECT ASSESSMENTS .............................................................................. 59 
TABLE 9.2.3A: PRIMARY ADVERSE EVENTS ................................................................................................ 61 
TABLE 9.3.1A INTENSITY OR SEVERITY DEFINITIONS ............................................................................... 64 
TABLE 9.3.2A ADVERSE EVENT CAUSALITY CLASSIFICATIONS.............................................................. 65 
TABLE 9.3.3A ADVERSE EVENT OUTCOME CLASSIFICATIONS ................................................................ 65 
TABLE 9.3.4A PROVIDES A COMPREHENSIVE LIST OF ANTICIPATED AES. ........................................... 66 
TABLE 9.5.1A AE REPORTING REQUIREMENTS .......................................................................................... 69 
TABLE 17.1.2A. RESPONSIBILITIES FOR PREPARING AND SUBMITTING REPORTS ............................. 90 
FIGURE 22.1A: FLAIR AND DWI MRI ............................................................................................................... 98 
TABLE 22.1A: MRI PROTOCOL ....................................................................................................................... 98 
 

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Key Roles and Responsible Parties 
 
SPONSOR:   
Biosense Webster, Inc. 
part of the Johnson & Johnson family of companies 
33 Technology Drive 
Irvine, CA 92618 
USA 
Tel: +1 800-729-9010 
 
 
 
CRO(S) AND CORE LAB(S): 
The sponsor maintains a list of CRO(s) and Core Lab(s) and their contact information. 
 
INVESTIGATORS: 
The sponsor maintains a list of study Investigators and their contact information. 
 
 
 
 

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Protocol Agreement and Statement of Compliance Form 
 
Study Title:   Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency 
Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation 
(STELLAR) 
 
Study Number: 
 BWI_2017_04 
 
I, the undersigned, have read this protocol and agree to conduct this clinical investigation in 
accordance with the design and specific provisions outlined herein. I understand that I am accepting 
responsibility to personally supervise this study, and to ensure the investigation is conducted in 
accordance with Good Clinical Practices (GCP), applicable country and state regulations, the 
Declaration of Helsinki, the signed clinical study contract with Sponsor and with the protocol outlined 
herein. I will conduct this study as outlined herein and will attempt to complete the study within the 
time period designated by the Sponsor.    
 
I will provide for training in the protocol and all pertinent instructions to all individuals who will assist in 
the conduct of this study. I will discuss their responsibilities with them to ensure they are fully informed 
regarding the device and the conduct of the study.  
 
I will fulfill the requirements of my Institutional Review Board (IRB)/Ethics Committee (EC), or other 
oversight committee, to ensure complete and continual oversight of this clinical investigation until it is 
closed. I will use an Informed Consent Document approved by the Sponsor and my reviewing IRB/EC 
(where required).  
 
I agree to report all information or data in accordance with the protocol and, in particular, I agree to 
report any serious adverse events, device related adverse events, or procedure related adverse events 
as defined in this protocol to the Sponsor, and comply with all adverse event reporting requirements 
of my reviewing IRB/EC.  I agree to permit the Sponsor, its authorized representatives, my reviewing 
IRB/EC, and any regulatory authority/body access to all records relating to the clinical investigation. 
 
The below signature confirms my agreement to accept the above responsibilities. I will accept 
respective revisions or amendments to this protocol as provided by the Sponsor. 
     
 
 
 
 
 
Principal Investigator 
Name (PRINT) 
 
 
 
 
 
Signature 
 
Date 
Site Name 
 
 
 
Site Address 

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Protocol Summary 
 
Study Name: 
STELLAR 
 
Study Title: 
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency 
Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation. 
 
Study 
Number: 
 
BWI_2017_04 
Study  
Description: 
This clinical study is a prospective, multicenter, single-arm clinical evaluation of 
the Multi-Electrode Radiofrequency (RF) Balloon catheter (HELIOSTARTM). The 
purpose of this study is to evaluate the overall safety and effectiveness of the 
HELIOSTARTM catheter, in conjunction with the Multi-Electrode Circular 
Diagnostic catheter (LassoStarTM) and Multi-Channel RF Generator, for the 
treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF).  Embedded 
within the Main Study will be a Neurological Assessment Evaluable (NAE) subset 
and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram 
(MRA) image (CT/MRA) subset with consecutive enrollment and a prospective 
design. The same subject can participate in both the NAE and cardiac CT/MRA 
subsets. 
 
The study will enroll subjects with drug refractory, symptomatic PAF who are 
candidates for catheter ablation. The first 1-3 subjects for each ablating 
physician will be considered roll-in subjects to verify consistent workflow for 
study device components and to minimize any learning curve effects. The roll-in 
subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in 
the primary endpoint analyses. The roll-in phase will include a maximum of 240 
subjects and the main study phase will include a maximum of 400 evaluable 
subjects.  Subjects will be evaluated prior to the procedure, prior to discharge, 
and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76-
104 days), 6 months (150-210 days), and 12 months (315-405 days) unless 
otherwise specified in the protocol. 
 
Objective: 
Primary Objective:  
To demonstrate the safety and 12-month effectiveness of the HELIOSTARTM 
catheter for the treatment of drug refractory PAF. Specifically: 
• 
To demonstrate the safety based on the incidence of early-onset (within 7 
days of ablation procedure) primary adverse events. 
• 
To demonstrate the 12-month effectiveness based on the proportion of 
subjects with freedom from documented asymptomatic and symptomatic 
Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL, of 
unknown origin+) episodes based on electrocardiographic data through 
the effectiveness evaluation period (day 91-365 post index procedure). 
+AFL of unknown origin is defined as all AFL except those cavo-tricuspid isthmus (CTI) 
dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation 
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Secondary Objectives: 
• 
To determine the acute procedural success, defined as confirmation of 
entrance block in clinically relevant pulmonary veins (all pulmonary veins 
except those that are silent and/or cannot be cannulated) after adenosine 
and/or isoproterenol challenge, of the HELIOSTARTM catheter (with or 
without the use of a focal catheter). 
• 
To demonstrate the 12-month effectiveness based on freedom from 
documented symptomatic AF/AT/AFL (of unknown origin) episodes 
based on electrocardiographic data through the effectiveness evaluation 
period. 
• 
To evaluate treatment success for subjects treated with the 
HELIOSTARTM catheter including subjects who were taking 
antiarrhythmic drug (AAD) medication past the blanking period. 
• 
To determine the single procedure treatment success rate for subjects 
treated with the HELIOSTARTM catheter. 
• 
To assess subject quality of life at 12 months compared to baseline, via 
the Atrial Fibrillation Effect on Quality-of-Life (AFEQT™) Questionnaire, 
for subjects treated with the HELIOSTARTM catheter. 
 
Endpoint: 
Primary Endpoints: 
• 
Safety 
Incidence of early onset Primary Adverse Events (PAEs) (within 7 days of 
an ablation procedure which uses the HELIOSTARTM catheter).  PAEs 
include the following adverse events (AEs) and are defined in section 9.2.3 
of the protocol:  
• 
Device or procedure related death* 
• 
Atrio-Esophageal Fistula* 
• 
Myocardial Infarction 
• 
Cardiac Tamponade/Perforation* 
• 
Thromboembolism 
• 
Stroke/ Cerebrovascular Accident (CVA) 
• 
Transient Ischemic Attach (TIA) 
• 
Phrenic Nerve Paralysis (permanent) 
• 
Pulmonary Vein Stenosis* 
• 
Pericarditis 
• 
Pulmonary Edema 
• 
Major Vascular Access Complication/Bleeding 
• 
Hospitalization (initial or prolonged)** 
*    Events are considered and analyzed as primary AEs even if they 
occur greater than one week (7 days) post-procedure. 
** Excludes hospitalization solely due to arrhythmia recurrence or non-
medically urgent cardioversion. 
 
• 
Effectiveness 
Freedom from documented asymptomatic and symptomatic Atrial 
Fibrillation, Atrial Tachycardia, or Atrial Flutter of unknown origin+ episodes 
based on electrocardiographic data (≥30 seconds on arrhythmia 

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monitoring device) through the effectiveness evaluation period (91-365 
days post index procedure). Additionally, if a subject meets any one of the 
following criteria, then the subject will be considered an effectiveness 
failure: 
• 
Failure to achieve acute procedural success. Acute procedural 
success is defined as confirmation of entrance block in clinically 
relevant PVs (all PVs except those that are silent and/or cannot 
be cannulated) after adenosine and/or isoproterenol challenge 
(with or without the use of a focal catheter). 
• 
Greater than 2 repeat ablations for AF/AT/AFL (of unknown 
origin+) in the blanking period (≤ 90 days post index procedure) or 
a repeat ablation or surgical treatment for AF/AT/AFL (of unknown 
origin+) during the effectiveness evaluation period. 
• 
Direct current (DC) cardioversion for AF/AT/AFL (of unknown 
origin+) during the effectiveness evaluation period. 
• 
Continuous AF/AT/AFL (except CTI dependent) on a standard 12-
lead ECG during the effectiveness evaluation period. 
• 
A Class I and/or Class III AAD is prescribed/taken for atrial 
arrhythmia other than CTI dependent AFL at any time beyond  the 
3-month follow-up visit window (i.e., at any time beyond day 105 
to 365 post index procedure). 
• 
Oral Amiodarone is prescribed post index ablation procedure. 
• 
Failure to use the HELIOSTARTM catheter for isolation of clinically 
relevant PVs (all PVs except those that are silent and/or cannot 
be cannulated) in the index procedure or repeat procedures 
during the blanking period. 
+AFL of unknown origin is defined as all AFL except those CTI dependent AFL 
as confirmed by accepted EP maneuvers (e.g. entrainment or activation 
mapping) in an EP study.  
 
Secondary Endpoints: 
• 
Acute procedural success defined as confirmation of entrance block in 
clinically relevant PVs (all PVs except those that are silent and/or cannot 
be cannulated) after adenosine and/or isoproterenol challenge (with or 
without the use of a focal catheter). 
• 
Alternative 12 Month Success: Defined as acute procedural success and 
freedom from documented symptomatic AF/AT/AFL (of unknown origin) 
episodes based on electrocardiographic data (≥30 seconds on arrhythmia 
monitoring device) through the effectiveness evaluation period. Greater 
than 2 repeat ablations for AF/AT/AFL (of unknown origin) in the blanking 
period, a repeat ablation or surgical treatment for AF during the 
effectiveness evaluation period, DC Cardioversion during the 
effectiveness evaluation period, Continuous AF/AT/AFL (except CTI 
dependent) on a standard 12-lead ECG during the effectiveness 
evaluation period, class I and/or III AAD usage at any time beyond the 3-
month follow-up visit window (i.e., at any time from day 105 to 365 post 
index procedure), oral Amiodarone usage after the index procedure, or 
failure to use the HELIOSTARTM catheter for isolation of clinically relevant 

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PVs (all PVs except those that are silent and/or cannot be cannulated) in 
the index procedure or repeat procedures during the blanking period 
constitutes treatment failure.    
• 
12 Month Symptomatic Recurrence Endpoint: Defined as acute 
procedural success and freedom from documented symptomatic 
AF/AT/AFL (of unknown origin) episodes based on electrocardiographic 
data (≥30 seconds on arrhythmia monitoring device) through the 
effectiveness evaluation period. Any AAD use throughout the study 
period will not be considered an effectiveness failure. Greater than 2 
repeat ablations for AF/AT/ AFL (of unknown origin) in the blanking 
period, a repeat ablation or surgical treatment for AF during the 
effectiveness evaluation period, DC Cardioversion during the 
effectiveness evaluation period, Continuous AF/AT/ AFL (except CTI 
dependent) on a standard 12-lead ECG during the effectiveness 
evaluation period, or failure to use the HELIOSTARTM catheter for 
isolation of clinically relevant PVs (all PVs except those that are silent 
and/or cannot be cannulated) in the index procedure or repeat 
procedures during the blanking period constitutes treatment failure.   
• 
Quality of life at 12 months compared to baseline as assessed by pre and 
post ablation AFEQT™ Questionnaire. 
• 
12 Month Single Procedure Treatment Success: Defined as acute 
procedural success and freedom from documented symptomatic 
AF/AT/AFL (of unknown origin) episodes based on electrocardiographic 
data (≥30 seconds on arrhythmia monitoring device) through the 
effectiveness evaluation period. Repeat ablation or surgical treatment for 
AF at any time, DC Cardioversion during the effectiveness evaluation 
period, Continuous AF/AT/ AFL (except CTI dependent) on a standard 
12-lead ECG during the effectiveness evaluation period, class I and/or III 
AAD usage at any time beyond the 3-month follow-up visit window (i.e., 
at any time from day 105 to 365 post index procedure), oral Amiodarone 
usage after the index procedure, or failure to use the HELIOSTARTM 
catheter for isolation of clinically relevant PVs (all PVs except those that 
are silent and/or cannot be cannulated) in the index procedure constitutes 
treatment failure.   
 
Population: 
Patients undergoing catheter ablation for the treatment of drug refractory 
symptomatic PAF. 
 
Phase:  
Pivotal 
 
Clinical Sites: 
Up to 40 clinical sites in the United States (US) and outside the United States 
(OUS). 

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Study 
Duration: 
The study duration is anticipated to be approximately 3.5 years; 2.5 years for the 
enrollment phase and an additional 1 year to complete follow-up. 
 
Subject Study 
Duration: 
Enrolled subjects who undergo the ablation procedure with the investigational 
device will be followed for 12 months post index procedure. 
 
Study 
Inclusion 
criteria:  
 
1. Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent self-
terminating AF). 
a) At least two (2) symptomatic AF episodes within last six (6) months 
from enrollment. 
b) At least one (1) electrocardiographically documented AF episode within 
twelve (12) months prior to enrollment. Electrocardiographic 
documentation may include, but is not limited to, electrocardiogram 
(ECG), Holter monitor, or telemetry strip. 
2. Failed at least one (1) Class I or Class III AAD as evidenced by recurrent 
symptomatic AF, contraindication to the AAD, or intolerable side effects to the 
AAD.   
3. Age 18 -75 years.  
4. Able and willing to comply with all pre-procedure, post-procedure, and follow-
up testing and visit requirements. 
5. Signed Patient Informed Consent Form (ICF). 
 
Study 
Exclusion 
criteria: 
 
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-
cardiac cause (e.g. documented obstructive sleep apnea and acute alcohol 
toxicity). 
2. Previous surgical or catheter ablation for AF. 
3. Patients known to require ablation outside the PV ostia and CTI region (e.g. 
atrioventricular reentrant tachycardia, atrioventricular nodal reentry 
tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-
White). 
4. Previously diagnosed with persistent or long-standing persistent AF and/or 
Continuous AF > 7 days. 
5. Any percutaneous coronary intervention within the past 2 months. 
6. Valve repair or replacement or presence of a prosthetic valve. 
7. Any carotid stenting or endarterectomy within the past 6 months. 
8. Coronary artery bypass grafting, cardiac surgery (e.g., ventriculotomy, 
atriotomy), or valvular cardiac surgical procedure within the past 6 months. 
9. Documented left atrium (LA) thrombus within 1 day prior to the index 
procedure. 
10. LA antero posterior diameter > 50 mm.  
11. Left Ventricular Ejection Fraction (LVEF) < 40%. 

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12. Contraindication to anticoagulation (e.g., heparin). 
13. History of blood clotting or bleeding abnormalities. 
14. Myocardial infarction within the past 2 months. 
15. Documented thromboembolic event (including transient ischemic attack) 
within the past 12 months. 
16. Rheumatic Heart Disease. 
17. Uncontrolled heart failure or New York Heart Association (NYHA) function 
class III or IV. 
18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 
months.  
19. Unstable angina. 
20. Acute illness or active systemic infection or sepsis. 
21. Diagnosed atrial myxoma or presence of an interatrial baffle or patch. 
22. Presence of implanted pacemaker or implantable cardioverter defibrillator 
(ICD). 
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. Significant congenital anomaly or medical problem that, in the opinion of the 
investigator, would preclude enrollment in this study. 
25. Women who are pregnant (as evidenced by pregnancy test if pre-
menopausal), lactating, or who are of child bearing age and plan on 
becoming pregnant during the course of the clinical investigation. 
26. Enrolled in an investigational study evaluating another device, biologic, or 
drug. 
27. Has known pulmonary vein stenosis. 
28. Presence of intramural thrombus, tumor or other abnormality that precludes 
vascular access, or manipulation of the catheter. 
29. Presence of an inferior vena cava filter. 
30. Presence of a condition that precludes vascular access. 
31. Life expectancy or other disease processes likely to limit survival to less than 
12 months. 
32. Presenting contra-indication for the devices (e.g., TTE, Holter, CT, etc.) used 
in the study, as indicated in the respective instructions for use. 
 
Additional exclusion criteria for NAE subjects: 
33. Contraindication to use of contrast agents for magnetic resonance imaging 
(MRI) such as advanced renal disease, etc. (at PI discretion). 
34. Presence of iron-containing metal fragments in the body. 
35. Unresolved pre-existing neurological deficit. 

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1. 
Background Information and Scientific Rationale 
1.1. 
Background Information 
Atrial Fibrillation 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 to 
approximately 10% in patients over 80 years of age.1-3 The primary clinical benefit of AF 
ablation is improvement in quality of life (QoL) resulting from the elimination of arrhythmia-
related symptoms such as palpitations, fatigue, or effort intolerance.3,4  In recognition of 
this, the elimination of symptomatic atrial arrhythmias was recommended by the 2012 
HRS/EHRA/ECAS 
and 
2017 
HRS/EHRA/ECAS/APHRS/SOLAECE 
Consensus 
Statements on Catheter and Surgical Ablation of Atrial Fibrillation.3,5 The opinion of the 
European Society of Cardiology (ESC), as expressed in their 2016 AF Management 
Guidelines, is that “Catheter ablation of symptomatic paroxysmal AF is recommended to 
improve AF symptoms in patients who have symptomatic recurrences of AF on 
antiarrhythmic drug therapy and who prefer further rhythm control therapy, when 
performed by an electrophysiologist who has received appropriate training and is 
performing the procedure in an experienced center.”2,6 
 
The 2017 HRS/EHRA/ECAS/APHRS/SOLAECE consensus statement states that “PVI is 
now widely accepted as the cornerstone of AF ablation procedures” and that “electrical 
isolation of the PVs is recommended during all AF ablation procedures.”3   Point-by-point 
ablation with RF catheters has provided positive results for treating many types of 
supraventricular arrhythmias,7,8 including PAF.7-13 However, the procedure is technically 
complex and has a long learning curve. Radiofrequency ablation success is highly 
dependent on operator skill and is associated with a high degree of PV reconnection.14-16 
Additionally, RF ablation carries a major complication rate of roughly 4.5%.17   
 
In order to reduce technical complexity and potentially decrease major complications, 
balloon ablation catheters were developed. Balloon catheters use tissue cooling 
(cryoballoon), heating (hot balloon) or selective destruction with a laser (laser balloon) to 
create lesions and isolate PVs. 
 
The second-generation cryoballoon (CB-2), so-called because of design improvements 
over the original first-generation cryoballoon, uses injected refrigerant to ablate tissue that 
comes in contact with the distal hemisphere of the balloon (cooling zone).   While the CB-
2 often allows single-shot pulmonary vein isolation (PVI),18-20 there is still some operator 
skill involved and various investigators have developed a pull-back technique (incomplete 
occlusion at the beginning of freezing) to minimize phrenic nerve (PN) injury.20-23 In 
addition, PN pacing is required throughout the procedure on the right side so freezing can 
be immediately aborted if PN palsy (PNP) is observed.21,22,24-26  Because of this, there is 
a greater rate of reconduction in the right superior pulmonary vein (RSPV).27  Investigators 
who use the CB-2 differ in their recommendation of a “bonus freeze”,27-30 optimal dosing 
of cryoenergy (240 sec18,24 vs. 180 sec20,31 or even less,26,28), minimum temperature32, the 
need for an endoluminal esophageal temperature cutoff26,33,34, and whether both sizes (23 
mm and 28 mm35) should be used versus using the larger balloon exclusively.19,25,30,34,36 
Further disadvantages of this technique are that it is not appropriate for focal touch-ups or 
repeat ablation of conduction gaps,27,29 and that the larger balloon, which most 
investigators seem to prefer35, may not fit an especially narrow PV ostium.  
 
The hot balloon (HB) is a compliant balloon that uses a heated saline/contrast mixture to 
heat the surrounding tissue and generate thermal lesions. Advantages of the HB system 
over conventional RF ablation are the possibility of single-shot PVI37 and reduced risk of 

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perforation/mechanical injury to endocardium.38  A disadvantage to this system is that it 
still requires a fair amount of operator skill and finesse,39,40 and the balloon position should 
be checked often by fluoroscopy and repositioned if indentation is noted.40,41  The need 
for esophageal temperature monitoring and, when applicable, cooling41 also increases 
procedural complexity. The need for PN pacing and/or fluoroscopic monitoring of the 
diaphragm is still paramount with this system in order to prevent PNP.40,41  Because central 
balloon temperature, RF time, and the diameter to which the balloon is inflated are all 
dependent upon the thickness of the target ablation tissue (each PV, e.g.),40,41 extensive 
pre-procedure imaging (intracardiac echocardiography 12 or 3-D Computed Tomography) 
is required.40,41 Like the CB-2, HB is not useful for focal touchups or repeat ablation of 
gaps/ sites of reconduction. To ablate such areas, a conventional irrigated tip RF catheter 
is still needed.40 
 
The laser balloon (LB) is a compliant balloon that can be inflated to a broad range of 
diameters and contains a central catheter shaft with a fiberoptic endoscope and a second 
fiber for laser energy delivery.  Applications of laser energy last 20-30 seconds and cover 
a 30o arc with the aim of overlapping lesions by 30-50% to achieve transmurality.42,43  
Esophageal temperature monitoring and PN pacing are still necessary.  Ablation in or near 
the blood source requires decreased energy output;44 however, the threat of 
thermocoagulation exists.45  A common finding with LB ablation is that long procedure 
times are required for conventional RF ablation.42,44,46-53 It takes anywhere from 25-50 
lesions to successfully isolate one PV.46-49,54 Higher energy output is associated with 
decreased procedure time, but at the expense of greater risk of steam pop and balloon 
damage due to overheating.46 A disadvantage inherent to this system is that the catheter 
shaft itself obscures about one fifth of the circumference of the PV ostium, so rotation of 
the catheter is required to complete ablation of the PV.42,49 The same problem of obscuring 
the view occurs with a spiral mapping catheter, so it must be inserted after the balloon is 
deflated; 
therefore 
electrical 
mapping 
and 
ablation 
cannot 
be 
performed 
simultaneously.42,53  Furthermore, the endoscopic images are 2-dimensional and therefore 
do not show the level of the ablation line in relationship to the PV ostium.42  The possibility 
of misalignment increases each time the LB is repositioned.53  Finally, since the LB is not 
designed as an over-the-wire device, there may be an increased risk of pericardial 
tamponade.48,52 
 
A common advantage to all of these balloon ablation systems is good contact with the 
target tissue regardless of individual anatomy. A disadvantage is the difficulty of avoiding 
healthy or already-ablated tissue.   

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1.5. 
Potential Risk  
1.5.1. Known Potential Risks 
Pericarditis: With any balloon-based ablation, pericarditis can occur due to mechanical 
or thermal irritation of the myocardium.49  This tends to be underreported47 as it is usually 
transient and resolves without intervention. 
 
Phrenic nerve palsy: While the reported incidence of PNP following HB ablation (< 4%)39-
41,55 or LB ablation (≤ 6%)42-50,52,53,56 is low, the incidence of PNP with CB-2 ablation was 
reported to range from < 1%18,27-30,34-36 to 27%,19-23,25,28,32,56-58 even with continuous 
phrenic nerve pacing during right-sided ablation and abortion of freezing upon loss of 
capture. In most cases, PNP with CB-2 is a transient complication,24 recovering before the 
end of the procedure,22,25,32,36 or, if not, by the time of discharge.19,21,26,28,35,58  However, in 

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a few cases it has been observed to persist for 1019,29,30 to 2020,23 months, suggesting that 
the injury is permanent.  
 
Injury to the PN may occur as a result of RF application in the region of the right pulmonary 
veins. The reported incidence of PNP varies from 0% to 0.48% when RF energy is used 
for point-by-point ablation.59,60   
 
Atrioesophageal fistula (AEF): AEF is a rare but catastrophic complication of AF ablation 
that can occur due to the anatomical proximity of the esophagus to the posterior wall of 
the LA and that is associated with a high mortality rate.61  AEF has not been observed in 
clinical experience with the HB or LB.  Only one patient (1.8% of 55 patients) presented 
with AEF in one prospective observational study with the CB-225 and this was the only 
case found in 18 series of consecutive procedures totaling over 2000 patients.18-23,25,26,28-
30,32,34-36,56-58   
 
While AEF is uncommon with balloon-based ablation systems, damage to the esophagus 
is fairly common.  One study found that superficial thermal lesions developed in 2% of 
patients and thermal ulcerations in 10% of patients following CB-2 ablation.34  Another 
study showed an incidence of esophageal lesions of 3.19% with CB-2.26  Esophageal 
lesions were reported in 1-10% of patients following ablation with the HB.40,41,55 Cooling 
saline is sometimes infused into the esophagus during HB ablation,40,41,55 but this carries 
with it the further risk of aspiration.41  Esophageal injury is most often found after LB 
ablation, with mild thermal lesions found in 7%42 to 8%51 of patients and more severe 
ulcerations found in 5% to 15%.42,51,56  The severity of esophageal lesions was greater 
with LB compared to RF catheter ablation in a head-to-head study.51 Moreover, 
esophageal temperatures in excess of 38.5o-39oC necessitating cessation of energy 
delivery and/or repositioning of the balloon occur more than half of the time with LB 
ablation.42,43,46  The clinical significance of esophageal lesions, if any, is not known.20,33,34  
 
Many electrophysiologists attempt to mitigate esophageal damage by monitoring 
endoluminal temperature during the ablation procedure. A cutoff temperature of 3oC has 
100% sensitivity and 100% specificity for predicting esophageal thermal lesions following 
CB-2 ablation.29  However, esophageal temperature during LB ablation has poor 
specificity for esophageal injury, with no significant correlation between maximal 
esophageal temperature and incidence and severity of esophageal thermal lesions.51 
 
Pulmonary vein stenosis:  PV stenosis has not been reported following CB-2 ablation.  
In clinical experience with HB ablation, PV stenosis was reported in < 2-5% of patients,39-
41,62 and was usually asymptomatic.41  Similarly, with LB ablation, PV stenosis is rarely 
reported.  In one study, mild stenosis (up to 25% narrowing of the PVs) was found in 44% 
of patients and moderate stenosis (26-50% narrowing) in 6%; there were no cases of 
severe stenosis (> 50% narrowing).48  The risk of pulmonary adverse events (e.g., PV 
stenosis, thrombus and hypertension) associated with an RF ablation procedure targeting 
the pulmonary veins is considered small (< 4%).11,12,63-66 
 
Thrombus formation: A thrombus may form on the ablation electrode during the 
application of RF current that could become dislodged and embolize to produce stroke, 
myocardial infarction, or other ischemic injury. The risk of thrombus is minimal with CB-2, 
but microthrombi were found in preclinical studies following HB ablation.37  In the clinical 
setting with HB, 5 patients of 238 (2.1%) developed a cerebral infarction.  However, in 
each case, this was attributed to arrhythmia recurrence and insufficient anticoagulation.40  

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With LB, data suggest that more energy applications and higher energy output facilitate 
thermocoagulation.45,54 Thrombus formation following ablation may also occur on the 
endocardium may produce arterial or pulmonary embolus.  
 
Pericardial effusion/ cardiac tamponade: Cardiac perforation may result in cardiac 
tamponade and may require percutaneous pericardial drainage or surgical repair.  
Pericardial effusion was reported in 0.6% - 7.3% of patients ablated with CB-2,22,35,36,57 
and cardiac tamponade in 0.2% - 3%.18,20,23,32  Pericardial effusion may occur at a rate of 
15% in patients treated with the HB.38  With the LB, LA perforation has occurred from 
mechanical trauma due to a whipping motion of the sheath toward the LA roof after balloon 
retraction.42,52 Aside from these reports, the incidence of pericardial effusion has been < 
2%48,49 and cardiac tamponade ≤5%47-49,52 with the LB. Significant hemodynamic 
compromise can result in neurologic injury or death.  This risk is greatest in a thin-walled 
chamber (ie, right atrium, LA, or right ventricle).  However, the risk of perforation due to 
steam pop is reduced when the minimum amount of energy output required to achieve 
transmurality is used.46   
 
Cerebral ischemic lesions: The incidence of TIA is < 3% following CB-2 ablation;20,28,36 
however, in most studies imaging for silent ischemic brain lesions was not performed.  In 
one study in which post procedural imaging was obtained, 13.6% of LB-treated patients 
were observed to have new embolic brain lesions, and another 2.3% had diplopia 
secondary to an ischemic lesion.45  There were similar findings of diplopia due to a 
suspected ischemic event (1.4%) in another LB study.47  The incidence of asymptomatic 
cerebral lesions seen on MRI 1-2 days post-procedure in a randomized controlled study 
was 24% for LB, which was not significantly different from RF catheter ablation or first-
generation CB.54   
 
According to the 2017 HRS guidelines, the incidence of ACE lesions can vary from 2%-
15% as a complication to AF ablation.3  It is defined as an occlusion of a blood vessel in 
the brain due to an embolus that does not result in any acute clinical symptoms and is 
therefore ‘silent’. Emboli can result from a thrombus, gas, air, tissue or fat. Source of micro-
emboli include thrombi, which can develop on sheaths, materials, air introduction through 
sheath or during catheter exchange.  
 
Coronary artery occlusion: RF current may cause occlusion of a coronary artery, either 
by direct thermal damage, spasm, or thrombosis. Research suggests that the risk of 
coronary occlusion is less than 0.5%.67,68 Because coronary arterial occlusion could 
produce myocardial infarction, angina or death, the physician will attempt to restore 
coronary blood flow through pharmacological, catheter and/or surgical intervention as 
medically indicated. 
 
Heart block: The application of RF current close to the atrioventricular (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. 
 
Cardiac perforation: Cardiac perforation may result from catheter manipulation or 
application of RF current (risk is < 1%).67,68  This may result in cardiac tamponade and 
may require percutaneous pericardial drainage or surgical repair.  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. 
 
 

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Cardiac valve injury: Injury to a cardiac valve may result from catheter manipulation or 
the application of RF current (risk < 1%).67,68 This may produce valvular insufficiency and 
possibly require surgical valve replacement.  
 
Vascular access / bleeding complication: Vascular access complication, femoral 
arteriovenous fistula, hematoma, and pseudoaneurysm are commonly reported following 
CB-2 (typically < 4%),18-22,25,28,32,35,36,56-58 or LB ablation (< 6%).47,50,69,70 Arterial or venous 
injury, including arterial dissection, thrombosis, occlusion or hemorrhage at the catheter 
insertion sites or at other sites along the vessels (risk < 1%).67,68 These types of injuries 
may cause hemorrhage, hematoma or ischemic injury to an extremity or major organ.   
 
Hemorrhage could occur as a result of anticoagulation (risk < 0.5%), which may require 
transfusion.67,68 
 
Radiation exposure: 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%).71-73 
 
Allergic Reaction: 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%).74-78 
 
Gastric Hypomotility and Periesophageal Vagal Nerve Injury:  Injury to the vagal 
anterior esophageal plexus can occur when RF energy is applied to the posterior wall of 
the LA, which can cause acute pyloric spasm and gastric hypomotility. Common 
symptoms include nausea, vomiting, bloating, and abdominal pain developing within a few 
hours to a few weeks after the ablation procedure3. 
 
Infection: The percutaneous procedure carries risk of infection, either at the catheter 
insertion site or systemically, including endocarditis and septic emboli (risk < 0.5%).67,68 
This risk can be minimized by using standard aseptic technique and, when indicated, by 
the use of antibiotic agents. 
 
Additional contraindications: Additional contraindications for RF ablation include: 
hemodynamic instability, bacteremia, coagulopathy, prosthetic tricuspid valve, intra-atrial 
or venous thrombosis, and pregnancy. 

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4. 
Study Population 
4.1. 
Subject Inclusion Criteria 
Candidates for this study MUST meet ALL the following criteria: 
1. Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent self-
terminating AF). 
a. At least two (2) symptomatic AF episodes within last six (6) months from 
enrollment. 
b. At least one (1) electrocardiographically documented AF episode within 
twelve (12) months prior to enrollment. Electrocardiographic 
documentation may include, but is not limited to, ECG, Holter monitor, or 
telemetry strip. 
2. Failed at least one (1) Class I or Class III AAD as evidenced by recurrent 
symptomatic AF, contraindication to the AAD, or intolerable side effects to the 
AAD.   
3. Age 18 -75 years.  
4. Able and willing to comply with all pre-, post- and follow-up testing and visit 
requirements. 
5. Signed Patient Informed Consent Form. 
 
4.2. 
Study Exclusion Criteria  
Candidates will be excluded if ANY of the following criteria apply: 
1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-
cardiac cause (e.g., documented obstructive sleep apnea and acute alcohol 
toxicity). 
2. Previous surgical or catheter ablation for AF. 
3. Patients known to require ablation outside the PV ostia and CTI region (e.g. 
atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, 
atrial tachycardia, ventricular tachycardia, and Wolff-Parkinson-White).  
4. Previously diagnosed with persistent or long-standing persistent AF and/or 
Continuous AF > 7 days. 
5. Any percutaneous coronary intervention within the past 2 months. 
6. Valve repair or replacement or presence of a prosthetic valve. 
7. Any carotid stenting or endarterectomy within the past 6 months.  
8. Coronary artery bypass grafting, cardiac surgery (e.g., ventriculotomy, atriotomy), 
or valvular cardiac surgical procedure within the past 6 months. 
9. Documented left atrium (LA) thrombus within 1 day prior to the index procedure. 
10. LA antero posterior diameter > 50 mm. 
11. Left Ventricular Ejection Fraction (LVEF) < 40%. 
12. Contraindication to anticoagulation (e.g., heparin). 
13. History of blood clotting or bleeding abnormalities. 
14. Myocardial infarction within the past 2 months. 

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15. Documented thromboembolic event (including transient ischemic attack) within 
the past 12 months. 
16. Rheumatic Heart Disease. 
17. Uncontrolled heart failure or New York Heart Association (NYHA) function class 
III or IV. 
18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 
months.  
19. Unstable angina. 
20. Acute illness or active systemic infection or sepsis. 
21. Diagnosed atrial myxoma or presence of an interatrial baffle or patch. 
22. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). 
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. Significant congenital anomaly or medical problem that, in the opinion of the 
investigator, would preclude enrollment in this study. 
25. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), 
lactating, or who are of child bearing age and plan on becoming pregnant during 
the course of the clinical investigation. 
26. Enrolled in an investigational study evaluating another device, biologic, or drug. 
27. Has known pulmonary vein stenosis. 
28. Presence of intramural thrombus, tumor or other abnormality that precludes 
vascular access, or manipulation of the catheter. 
29. Presence of an inferior vena cava filter. 
30. Presence of a condition that precludes vascular access. 
31. Life expectancy or other disease processes likely to limit survival to less than 12 
months. 
32. Presenting contra-indication for the devices (e.g., TTE, Holter, CT, etc.) used in 
the study, as indicated in the respective instructions for use. 
 
Additional exclusion criteria for NAE subjects: 
33. Contraindication to use of contrast agents for MRI such as advanced renal 
disease, etc. (at PI discretion). 
34. Presence of iron-containing metal fragments in the body. 
35. Unresolved pre-existing neurological deficit. 
 
4.3. 
Strategies for Recruitment and Retention 
Historically, women and minorities have been underrepresented in or excluded from many 
clinical studies79-81. Site selection is expected to provide geographical diversity to provide 
opportunities for the inclusion of women and minorities in the trial. Sites will be instructed 
to screen all patients who may be eligible for participation in the study without regard to 
sex or race. Statistical analysis of primary safety and effectiveness endpoints will be 
carried out to evaluate any differences between gender.  Subjects will be encouraged to 
remain in the study until they have completed the protocol required follow-up period. 
 

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4.4. 
Subject Withdrawal or Termination 
4.4.1. Reasons for Withdrawal or Termination 
Subjects are free to withdraw from participation in the study at any time upon request 
without penalty or loss of benefits to which they may otherwise be entitled.  
   
An investigator may terminate a subject’s participation in the study if:  
• 
Any clinical adverse event, laboratory abnormality, or other medical condition 
or situation occurs where continued participation in the study would not be in 
the best interest of the subject.  
• 
The subject no longer meets eligibility criteria or meets an exclusion criterion 
(either newly developed or not previously recognized) that precludes further 
study participation. 
• 
Early termination of the site and/or study by the sponsor. 
• 
Subject withdraws consent. 
• 
Subject is lost to follow up. 
 
Subjects should be encouraged to remain in the study until they have completed the 
protocol required follow-up period. 
 
4.4.2. Handling of Subject Withdrawals or Termination 
If a subject is removed or withdraws from the study, the date and reason for withdrawal 
will be recorded on the appropriate electronic case report form (eCRF). If the subject is 
withdrawn due to an AE or SAE, the Investigator should follow the subject until the AE/SAE 
has adequately resolved, stabilized, or is explained.   
 
If a subject is unable to complete follow-up or cannot be contacted by telephone, 3 
separate telephone calls should be made to obtain subject related safety information. All 
attempts should be documented in the source documents. If the subject does not respond 
to the 3 telephone calls, then the investigator MUST send a certified letter to the subject. 
If the subject does not respond to the letter within 4 weeks, then the subject will be 
considered “lost to follow-up” for the study.   
 
Subjects who have signed the ICF but are found to be ineligible PRIOR to insertion of the 
study catheter will be recorded as screen failures in the eCRF.   
 
4.5. 
Subject Accountability 
• 
Pre-Screen Failure: Patients that are pre-screened, but do NOT sign an ICF. 
Information on reasons for pre-screen failures will be captured and descriptive analysis 
will be performed.  
• 
Enrolled Subjects: Subjects who sign the study ICF. 
o Excluded Subjects: Subjects who are enrolled but never undergo insertion of 
the study catheter. Excluded subjects will not be included in the primary 
endpoint analyses and will only be followed between the time of ICF signature 
and exclusion from the study for adverse event reporting. Subjects who signed 
the ICF but are found to be ineligible prior to the procedure will be recorded as 
screen failures in the eCRFs.   
o Evaluable Subjects:  All enrolled subjects who have the study catheter 
inserted.  

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 
Roll-In Subjects: Enrolled Subjects who have the study catheter 
inserted and RF delivered with the study catheter during the Roll-In 
phase of the ablating investigator. These subjects will not be included 
in the primary endpoint analyses and will be analyzed separately.  
 
Discontinued Subjects: Evaluable subjects who have the study 
catheter inserted but do not undergo ablation (i.e., no RF energy is 
delivered with the study catheter).  Discontinued subjects will remain in 
follow-up for 3 months post catheter insertion.  If a SAE is reported for 
a discontinued subject, the subject will be followed until event resolution 
(with or without sequelae), stabilization, or until the event is adequately 
explained. 
 
Lost to Follow-up Subjects: Subjects who are enrolled and evaluable, 
but contact is lost after most recent follow-up visit (despite 3 
documented attempts to contact the subject). 
 
Withdrawn / Early Termination Subjects:  Subjects who withdraw 
consent for study participation or are withdrawn/terminated from the 
study by the investigator prior to completion of all follow-up visits. 
 
Completed Subjects:  Enrolled subjects who have not been excluded, 
discontinued, withdrawn, terminated early, or lost-to-follow-up prior to 
the final study visit. 
 
5. 
Responsibilities 
5.1. 
Investigator Responsibilities 
Investigators at each participating clinical site will have the following responsibilities: 
• 
Supervising the study at their respective site. 
• 
Assuring compliance by site personnel within the provisions of the protocol. 
• 
Providing the Sponsor with: 
o Signed, dated Investigator Agreement 
o Written institutional review board (IRB) / ethics committee (EC) approval 
letters and IRB/EC-approved consent forms 
o Signed, dated Financial Disclosure form for each participating investigator 
o Curriculum vitae for each investigator 
o Copy of current medical license for each study investigator, as applicable. 
• 
Maintaining an accurate and current Delegation of Authority log which identifies 
individuals authorized to perform work for the study. 
• 
Completing the appropriate training on the device and the study protocol prior to 
enrolling and treating subjects. 
• 
Maintaining accurate and current logs for the study as requested by the study 
team, including but not limited to:  
o Subject pre-screening log 
o Delegation of authority log 
o Device Accountability log 
o Adverse event log. 

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• 
Obtain initial and amendment (if applicable) IRB/EC approval and, if applicable, 
routine review/approval for the study protocol and informed consent as instructed 
by the IRB/EC. 
• 
Obtain Patient ICF prior to subject participation. 
• 
Perform medical procedures as described in this protocol. 
• 
Order tests required by the study protocol. 
• 
Follow subjects until the end of the study. 
• 
Accurately complete and sign eCRFs in a timely manner. 
• 
Maintain relevant source documentation and allow Sponsor direct access to 
perform monitoring or auditing duties.  
• 
Maintain records and provide reports according to prevailing regulatory 
requirements. 
• 
Share relevant study-related information with delegated study staff. 
• 
Inform the appropriate entities (e.g., Sponsor, CA, IRB/EC) in a timely manner 
regarding the occurrence of AEs and/or product malfunctions/deficiencies. 
• 
Immediately notify the sponsor of any pending Regulatory Authority 
audits/inspection at the study site and allow access to study records for authorized 
regulatory entities. 
• 
Make sufficient effort to maintain contact with treated subjects who fail to comply 
with the follow-up requirements. 
• 
Maintaining study records for at least 2 years, or as specified per country specific 
record retention requirements, after the study is completed and or terminated. 
The Sponsor will notify the Investigator of either of these events. 
• 
Comply with IRB/EC and Sponsor annual report requirements, including the final 
report. 
 
5.2. 
Sponsor Responsibilities 
The Sponsor (Biosense Webster, Inc.) will be responsible for the following: 
• 
Conduct pre-study site assessment and approval. 
• 
Create and modify (if applicable) study documents including but not limited to the 
protocol, case report forms (CRFs), and informed consent.  
• 
Select appropriately qualified and trained individuals, including monitors, to 
conduct the study.  
• 
Conduct protocol and device training for investigators and research personnel as 
applicable. 
• 
Establish study-specific committees for study oversight. 
• 
Obtain signed study contracts from investigators/hospitals, contract research 
organizations (CROs), and other involved parties. 
• 
Ship investigational devices to each site. 
• 
Monitor sites for the duration of the study. 
• 
Maintain study database. 
• 
Inform investigator of his/her responsibilities.  
• 
Submit and obtain approval for study from applicable regulatory agencies. 

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• 
Prepare reports summarizing the status of the study no less than annually.  
These reports will be supplied to the Principal Investigator at each site. 
• 
Prepare and submit final clinical study report to applicable regulatory agencies. 
• 
Update Report of Priors, instructions for use (IFU), investigator’s brochure (IB), 
and Risk Analyses, as applicable. 
• 
Prepare and update investigators on safety issues, if needed. 
• 
Report to study investigators and regulatory agencies, as required. 
• 
Have AEs reviewed by the study specific committees and/or study specific 
reviewers, as required. 
• 
Communicate with the Food and Drug Administration (FDA) / Competent 
Authority (CA) as needed. 
• 
Submit any amendments to the Clinical Study Protocol/Investigational Plan to the 
FDA/CA. 
 
5.3. 
Training 
The training of applicable clinical site personnel will be the responsibility of the Sponsor. 
Prior to initiating subject enrollment at a site, appropriate study training will be provided.  
Investigators selected to participate in the study will be experienced in intracardiac 
mapping and AF ablation with balloon and/or focal ablation catheters. Investigators will 
undergo device training in accordance with the physician training charter.  
 
To ensure uniform data collection and protocol compliance, the Sponsor will conduct a 
training session that will include reviewing the protocol, eCRF and data collection process, 
and the adverse event reporting process.  The sponsor will reinforce the training or provide 
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7. 
Study Medications 
7.1. 
Antiarrhythmic drugs   
During this study, current AF management guidelines and the institution’s standard of care 
practices are to be followed as closely as possible for AAD therapy.   
 
A Class I and/or Class III AAD can be administered for AF and terminated before the end 
of the 3-month follow-up visit window (i.e., day 104). If a Class I/III AAD is prescribed 
/administered after day 104 post procedure or oral amiodarone is prescribed/administered 
at any time post procedure, it MUST be accompanied by documentation of arrhythmia. If 
a Class I and/or Class III AAD is continued or started past Day 104, the subject will be 
considered a primary effectiveness failure. If oral Amiodarone is prescribed and/or taken 
at any time post index ablation procedure, the subject will be considered a primary 
effectiveness failure.  
 
Table 7.1A illustrates the corresponding status of primary effectiveness endpoints based 
on AAD therapy administered in the blanking and post-blanking periods. 
 

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• 
FOLLOWING an ablation procedure that uses the HELIOSTARTM catheter  
o Anticoagulation therapy is strongly recommended for at least 2 months 
following ablation. 
o Decisions regarding continuation of systemic anticoagulation beyond 2 
months post ablation should be based on the subject’s stroke risk profile.  
o Systemic anticoagulation will be continued beyond two months post-
procedure in subjects with a CHA2DS2-VASc score of ≥ 2 (unless deemed 
contraindicated based on clinical considerations). 
 
8. 
Study Schedule, Procedures, and Assessments 
8.1. 
Screening and Informed Consent 
The Patient ICFs used must have approval from Biosense Webster and the study site's 
IRB/EC prior to patient enrollment in the study. An approved Patient ICF may be translated 
as appropriate.  A copy of a blank approved Patient ICF must be maintained by each 
investigator in a designated study administrative file.  
 
Patients presenting to the institution with symptomatic PAF and who are considered for 
an ablation procedure should be pre-screened by the investigator or designated member 
of the research team for study eligibility per the protocol inclusion and exclusion criteria 
that can be evaluated as part of the patients’ standard of care. Sites should pre-screen all 
patients who require a documented ablation procedure for symptomatic PAF without 
regard to sex or race. A pre-screening log will be used to document all patients who were 
reviewed for potential inclusion into the study. 
 
The study investigator or designee will obtain written informed consent from the patient, 
or patient’s legal representative if applicable, prior to the patient’s participation in the study. 
The patient should NOT undergo any study specific tests or examinations that fall outside 
the standard of care without first signing the Patient ICF for this clinical investigation. 
Patients should be made aware that by signing the ICF, they are granting approval for 
study personnel to review their medical records and to collect/analyze personal medical 
information. Patients should also be informed that study personnel will maintain 
confidentiality of the medical records at all times. The background of the proposed study 
and the potential benefits and risks of the study should be explained to the patient before 
the ICF is signed.  
 
If a patient is unable to read or write, informed consent shall be obtained through the aid 
of an independent witness who will be present throughout the process. The written Patient 
ICF and any other information shall be read aloud and explained to the prospective patient 
and, whenever possible, the patient shall sign and date the ICF. The independent witness 

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must also sign and date the ICF attesting that the information was accurately explained 
and that consent was freely given.  
 
The investigator and/or designee must also clearly document the process of obtaining 
informed consent in the patient’s source documents. The voluntary process of informed 
consent confirms the patient’s willingness to participate in the study. It’s the investigator’s 
responsibility to ensure that the informed consent process is performed in accordance with 
GCP, 21 CFR Part 50, ISO14155, and with applicable local and federal regulations. If new 
information becomes available that can significantly affect a study subject’s future health 
and/or medical care, this information shall be provided to the subject(s) affected. If 
relevant, all affected subjects shall be asked to confirm their continuing informed consent 
in writing by dating and signing an amended Patient ICF. 
 
8.2. 
Pre-Procedure/Baseline Assessments, Evaluations and Procedures 
Assessments and data that MUST be collected prior to the ablation procedure are 
described below. Assessments/data should be completed within 90 days prior to the study 
ablation procedure, unless otherwise specified. 
• 
Demographics: Including but not limited to age, race (where allowed), ethnicity 
(where allowed), and gender. 
• 
Medical History: Including arrhythmia, heart disease, thromboembolic events, 
lung/respiratory problems, etc. 
• 
AF History: Including the first evidence of AF, number of episodes, symptoms, 
etc. 
• 
NYHA: NYHA Classification will be used to assess the extent of heart failure for 
subjects with congestive heart failure. 
• 
CHA2DS2 VASc Score: Will be used to assess the risk of stroke. 
• 
Medication History: Medication history (cardiac medication, AAD medication, 
anticoagulation regimen and any other clinically significant medication history) 
shall be gathered by interview or from medical records following enrolment but 
prior to the ablation procedure and should be recorded in the eCRF. 
• 
Anticoagulation Therapy: Anticoagulation therapy information shall be gathered 
by interview or collected from medical records following enrolment but prior to the 
ablation procedure.  
• 
Height and weight will be measured. 
• 
Physical Exam (including standardized neurological assessment and 
cardiovascular/ pulmonary examination): Exam should be performed by a 
physician prior to the ablation procedure. The following items will be evaluated as 
part of the standardized neurological assessment: vision, hearing, speech, level 
of consciousness, orientation and ability to move all extremities.  
• 
Electrocardiogram: Data from 12-lead ECG recordings will be collected if 
available. 
• 
Transthoracic Echocardiogram (TTE): TTE will be used to determine the atrial 
size and left ventricle ejection fraction (LVEF). Equivalent exams may be 
substituted if needed and clinically acceptable. 
• 
Cardiac Multi Slice Computed Tomography (CT) or Magnetic Resonance 
Angiogram (MRA) image: CT/MRA MUST be of sufficient quality to evaluate the 
number, size and anatomy of the pulmonary veins and the left atrial anatomy. It is 
mandatory to conduct the CT/MRA assessment within 6 months prior to the study 
ablation procedure. All CT/MRA images collected for the study should be sent to 
the study core lab. For subjects in the CT/MRA subset and those with symptoms 
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o Major axis (mm) 
o Minor axis (mm) 
o Average diameter (mm) 
• 
Left Atrial Thrombus Detection: Imaging for detection of left atrial thrombus or 
other structural contraindications to an ablation procedure is mandatory the day 
before or the day of the ablation procedure. Presence of a thrombus will require 
postponement of the ablation procedure or exclusion of the subject from further 
study involvement. The imaging methods to be used for atrial thrombus detection 
are TEE or ICE. 
• 
Pregnancy Test: MUST be done for all women of childbearing age and potential 
within 72 hours prior to the ablation procedure. 
• 
Quality of Life (AFEQT™): AFEQT™ MUST be collected prior to procedure. 
• 
Adverse Events: AEs MUST be collected from the time the subject signs the 
informed consent onwards. 
• 
Neurological Assessment (NAE Subjects only): The following assessment are 
required to be performed within 72 hours pre-procedure for subjects included in 
the NAE subset, including:  
o Cerebral MRI (see appendix A for methodology) 
o Neurological Exam 
o National Institutes of Health Stroke Scale (NIHSS) 
o Modified Rankin Scale (mRS)  
o Mini-Mental State Examination (MMSE) 
NIHSS and mRS assessments will be performed by a site staff certified in the 
administration of the assessments. The MMSE will be performed by site staff with 
documented training in the administration of such tools. A certified neurologist, 
blinded to the cerebral MRI data, will perform neurologic exams. Cerebral MRIs 
will be analyzed by a central core lab to determine the frequency, size, and 
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8.5. 
Repeat Procedures 
Repeat procedures may be performed at the discretion of the investigator. Repeat 
procedures during the blanking period (90 days post index procedure) must be conducted 
with the investigational device, with or without focal touch-up, if the arrhythmia is due to 
PV triggers. Repeat procedures performed after the blanking period may be managed per 
investigator discretion using a commercially available ablation catheter and generator. The 
follow-up schedule will remain based on the initial ablation procedure. All pre-discharge 
and 7-day post-ablation assessments as summarized in Table 8.8A are to be collected for 
repeat procedures.   
 
8.6. 
Pre-Discharge and Follow-up Assessments 
The subject will be required to complete follow up visits through 12 months post index 
ablation procedure. Discharged subjects will receive a telephone call at 7 days post 
ablation procedure to assess any occurrence of Adverse Events; otherwise, any Adverse 
Events can be found in subjects’ in-hospital source records.  Additional follow-up visits are 
to be conducted at 1 month, 3 months, 6 months, and 12 months post index procedure.   
Follow-up visits and/or calls should be scheduled according to the following timeframes:  
7 day (7D, day 7-14), 1 month ± 7 days (1M, day 23-37), 3 month ± 14 days (3M, day 76-
104), 6 months ± 30 days (6M, day 150-210), and 12 month ± 45 days (12M, day 315-
405). Follow-up visit schedule will not reset if subject undergoes a repeat AF ablation 
procedure.  
 
Pre-Discharge / Follow-up assessments and data to be collected are described below.  
• 
Cardiac Medication Regimen: All cardiac medication prescribed since the 
ablation procedure until the end of follow-up will be recorded, including the type 
and name of the medication, associated indications, start and end dates, etc. Data 
will be collected at the pre-discharge visit, the 7 day, 1M, 3M, 6M, and 12M follow-
up, and at any unscheduled visits.  
• 
Anticoagulation Medication Regimen: Information is to be collected at the pre-
discharge visit, 1M, 3M, 6M, and 12M follow-up, and at any unscheduled visits.  
• 
Physical Exam (including standardized neurological assessment and 
cardiovascular/ pulmonary examination): Physical Exam is to be performed by 
a physician at discharge and physician, physician assistant, or nurse practitioner 
at subsequent clinical visits (1M, 3M, 6M (if clinical visit), and 12M visits). The 
following items will be evaluated as part of the standardized neurological 
assessment: vision, hearing, speech, level of consciousness, orientation and 
ability to move all extremities.  If the neurological assessment demonstrates 
abnormal findings, the subject should have a formal neurological consult and 
examination with appropriate imaging (i.e., DW-MRI), used to confirm any 
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• 
Quality of Life questionnaire: AFEQT™ is to be collected at the 3M, 6M (if 
clinical visit), and 12M visits. 
• 
Transthoracic Echo (TTE):  TTE should be conducted within 48 hours of the 
index procedure. Equivalent exams may be substituted if needed and clinically 
acceptable.  
• 
Electrocardiogram (12-Lead ECG): Data from 12-lead ECG recordings will be 
collected at the 3M and 12M follow-up visit. ECG data will be collected at baseline, 
pre-discharge, 1M follow-up visit, and unscheduled visits if completed as standard 
of care and at 6M if a clinical visit occurs and ECG is completed as standard of 
care. If an ECG is unable to be obtained (e.g. due to telemedicine visit), subjects 
will be instructed to transmit 1 TTM transmission (60 seconds) in lieu of an ECG 
recording at the time of the follow-up visit. Any 12-lead ECG tracings obtained 
beyond 3 months (90 days) showing an arrhythmia will be reviewed and 
adjudicated by an independent cardiologist.  
• 
Transtelephonic Monitoring (TTM): Subjects will be provided with a TTM device 
no later than at the 1M follow-up visit (TTM device may be provided at discharge 
if collected as standard of care) and required to record and transmit a minimum of 
1 transmission (60 seconds) every week through the end of month 5 of follow-up. 
Starting at month 6 of follow-up, subjects will be required to record and transmit a 
minimum of 1 transmission (60 seconds) every month until the effectiveness 
evaluation period is completed (12 months post index procedure). Subjects will 
also be instructed to transmit any symptom-triggered episode that occurs from the 
time they receive the TTM device through the 12M follow-up visit. A core lab will 
be used to evaluate and assess the TTM tracings. 
• 
24 Hour Holter: Holter monitor will be used at the 12M follow-up visit to monitor 
the subjects’ heart rhythm for 24 hours continuously. A core lab will be utilized to 
evaluate and assess the 24-hour Holter recordings. 
• 
Cardiac Multi Slice CT/MRA Image: CT/MRA will be completed at the 3M follow-
up visit for subjects in the CT/MRA subset. In addition, any subjects who have 
symptoms suggestive of PV stenosis should undergo CT/MRA imaging. Post 
procedure CT/MRA should be performed with contrast, unless there is a 
contraindication, and must be of sufficient quality to evaluate the number, size and 
anatomy of the pulmonary veins. All CT/MRA images collected for the study should 
be sent to the study core lab. 
• 
Adverse Events: AEs must be collected from the time the subject signs the 
informed consent onwards.  
• 
AFL/AT/AF recurrence: Any post-procedure atrial arrhythmia that is documented 
by devices other than the sponsor provided TTM/Holter Monitor and/or ECG will 
be recorded at 1M, 3M, 6M, and 12M follow-up as well as at any unscheduled 
visits. 
• 
Repeat Ablation: Any ablation procedure performed after the index procedure will 
be recorded at 1M, 3M, 6M, and 12M follow-up as well as at any unscheduled 
visits. 
 
For NAE subjects: 
• 
Cerebral MRI is required to be performed between 12-48 hours (preferably 
between 24-48 hours) post index procedure to evaluate the presence/absence of 
cerebral lesions and/or neurological defects. If there are findings noted on the post-
ablation cerebral MRI, a follow-up MRI will be required at each follow-up visit until 
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determine the number, size, and anatomical location of cerebral micro-emboli, if 
any. See appendix A for methodology. 
• 
Neurological Exam is required to be performed between 24-48 hours post index 
procedure to evaluate the neurological condition and presence of neurological 
deficits occurring post study ablation procedure. The Neurological Exam may be 
performed earlier than 24 hours if neurological symptoms/signs developed post 
ablation. If there are findings of microemboli/neurologic deficits, a follow-up 
neurologic exam will be required at each follow-up visit until resolution is observed. 
A certified/qualified neurologist, blinded to the MRI data, must perform neurologic 
exams. 
• 
National Institutes of Health Stroke Scale (NIHSS) assessment is required to 
be performed between 24-48 hours post index procedure to evaluate the 
neurological condition and presence of neurological deficits of the subject’s post 
study ablation procedure. The NIHSS can be administered earlier than 24 hours if 
neurological symptoms/signs developed post ablation. If there are findings of 
microemboli/neurologic deficits, a follow-up NIHSS assessments will be required 
at each follow-up visit until resolution is observed. This assessment will be 
performed by site staff certified in the administration of the NIHSS 
• 
Modified Rankin Scale (mRS) assessment is required to be performed at the 1 
month follow-up visit to evaluate the neurological condition and presence of 
neurological deficits occurring post study ablation procedure. If there are findings 
of microemboli/neurologic deficits, follow-up mRS assessments will be required at 
each follow-up visit until resolution is observed. This assessment will be performed 
by site staff certified in the administration of the mRS.  
• 
Mini-Mental State Examination (MMSE) is required to be performed at the 1 
month follow-up visit to assess changes in cognitive status post study ablation 
procedure. If there are findings of microemboli and/or new cognitive deficits, follow-
up MMSE assessments will be required at each follow-up visit until resolution is 
observed. The MMSE will be performed by site staff with documented training in 
the administration of such tools. 
 
8.7. 
Unscheduled visit 
If a subject returns for a potential study related cardiovascular or neurological visit outside 
of the protocol-defined visit schedule provided in Table 8.9A, the visit will be considered 
“unscheduled” (UNS).  An Investigator may request an unscheduled visit in the presence 
of a new or worsening cardiovascular condition or neurological deficit. If the unscheduled 
visit is for a repeat ablation procedure, the protocol follow-up schedule is based on the 
index ablation procedure.  For all unscheduled visits, an unscheduled visit eCRF must be 
completed and the subject must also return for their next scheduled study visit. 
 
8.8. 
Schedule of Events Table 
At each visit, the following assessments should be performed (Equivalent exams may be 
substituted if needed). 

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9. 
Assessment of Safety 
9.1. 
Specific Safety Parameters 
⸙ Pursuant MDR 2017/745, in the occasion relevant (local) regulations, guidance(s) and 
processes on safety determinations, definitions and reporting become in full force during 
the course of the study, the Sponsor shall adhere to the applicable definitions and 
processes.  
 
9.2. 
Adverse Event Definitions 
9.2.1. Adverse Events (AE)  
An AE is any untoward medical occurrence in a subject whether or not related to the 
investigational medical device. Specifically, an adverse event (AE) is any undesirable 
experience (sign, symptom, illness, abnormal laboratory value, or other medical event) 
occurring to a subject during the course of the study, whether or not it is related to the 
device or procedure.   
 
The following clinical events will not be considered an adverse event for this clinical 
study: 
• 
Any medical condition that is present at the time of screening. Such conditions 
should be added to the medical history, if not previously reported. However, if the 
study subject’s condition deteriorates at any time during the study, it should be 
recorded as an AE. 
• 
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  
• 
Minor pericarditis attributable to the ablation procedure defined as pleuritic chest 
discomfort with or without pericardial rub and ECG changes. 
• 
Recurrence of pre-existing AF/AT/AFL 
• 
AF/AFL/AT recurrence requiring DC cardioversion during the blanking period 
and/or pharmacological cardioversion at any time throughout the duration of the 
study.  However, new onset of left atrial flutter occurring post-ablation is an AE. 
• 
Re-ablation for AF or pre-existing AFL/AT itself is not an AE, however any 
complication associated with the repeat ablation procedures is considered an AE 
and shall be reported within the applicable timelines. 
 
9.2.2. Serious Adverse Event (SAE) 
A serious adverse event (SAE) is any event that meets one or more of the following 
criteria: 
• 
Leads to a death 
• 
Leads to a serious deterioration in the health of a subject that resulted in: 
o A life-threatening illness or injury 
o A permanent impairment of a body structure or a body function 
o In-patient hospitalization or prolongation of an existing hospitalization* 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function 
o Chronic disease (MDR 2017/745) ⸙ 
• 
Leads to fetal distress, fetal death or a congenital abnormality or birth defect. 
*Planned hospitalization for a condition present prior to the subject’s enrollment in the study will not 
meet the definition of an SAE. An AE would meet the criterion of “hospitalization” for seriousness if 
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the regulating Ministry of Health (MoH) as well as the EC according to the deadlines in 
force.  
 
9.5.3. Unanticipated Device Effect Reporting 
All UADE/SADE/USADE must be reported to the Sponsor, via eCRF, as soon as 
possible but no later than 72 hours upon awareness of the event by the study site 
personnel. An investigator shall submit to the reviewing IRB/EC a report of any 
unanticipated adverse device effect occurring during an investigation as soon as possible, 
but no later than 10 working days after the investigator first learns of the effect, where 
applicable. 
 
9.5.4. Events of Special Interest 
All Study device deficiencies that resulted or may have resulted in a SAE must be 
reported to the Sponsor, via eCRF, as soon as possible but no later than 72 hours 
upon awareness of the event (or per local country requirements, whichever is earlier) by 
the study site personnel.  If a device deficiency is detected or suspected, it should be 
documented on the eCRF and the device returned to the Sponsor.  
 
Complaints related to marketed products manufactured and/or distributed by Biosense 
Webster used during the procedure, are to be reported per current Biosense Webster 
procedures and other policies as necessary (i.e., institutional policies, EC policies, and 
local regulations). Investigators are instructed to return devices in accordance with current 
company procedures and other relevant regulations. 
 
A device deficiency related to a medical device not manufactured by Biosense Webster 
should be reported by the investigator to their respective manufacturer as per relevant 
regulation. Complaints related to non-Biosense Webster, Inc. products must be handled 
per institutional policies, EC policies, and local regulations. 
 
Event reporting to relevant competent authorities in accordance with the jurisdictional 
regulations will occur by the sponsor and/or by the investigator, depending upon the local 
requirements and will be done in EU per MEDDEV 2.12/1 guidelines for CE-marked 
devices manufactured by Biosense Webster and per MEDDEV 2.7/3 guidelines for non 
CE-marked devices manufactured by Biosense Webster. 
 
9.6. 
Safety Oversight 
Safety oversight will be conducted as described in the safety management plan. 
Aggregate safety data will be reviewed regularly throughout the course of the study by the 
study safety lead or designee to promptly identify new issues or trends which may have 
an impact on the conduct of the study and/or subject safety. Under the rules of an 
approved study-specific charter, safety data will also be reviewed by an established DMC 
which may recommend appropriate action(s) to ensure subject safety. A Clinical Events 
Committee (CEC) will be implemented to adjudicate the primary safety endpoint events. 
The CEC will operate as described in the CEC Charter. 
 
10. 
Deviations from the Clinical Study Plan 
The investigator is responsible for ensuring that the clinical investigation is conducted in 
accordance with the procedures and evaluations described in this protocol. The study 
monitors shall verify that the conduct of the study is in compliance with the currently 
approved protocol and applicable regulations, and shall identify any issues of non-
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Issues of non-compliance include but are not limited to repeated protocol deviations, 
failure to obtain proper informed consent, non-conformance to IRB/EC requirements, 
failure to report Adverse Events/product malfunctions/other product issues, and other non-
conformance to GCP. 
 
A protocol deviation is defined as an instance of failure to follow, intentionally or 
unintentionally, the requirements of the protocol (e.g., missed test or procedure, visit out 
of window, non-adherence to inclusion/exclusion criteria). Investigators are not allowed to 
deviate from the protocol. Protocol deviations will be monitored closely and may require 
reporting to the IRB/EC and/or regulatory authority per IRB/EC/regulatory authority 
requirements. 
 
Under emergency circumstances, deviations from the protocol to protect the rights, safety 
and well-being of a subject may proceed. Such deviations shall be documented as 
protocol deviations in the eCRF and reported to the IRB/EC/regulatory authority as 
required. 
 
11. 
Investigational Product Materials and Accountability 
11.1. Materials 
Biosense Webster, Inc., Irwindale, CA USA, is the manufacturer of the catheters to be 
used in this study. Biosense Webster implements manufacturing precautions to protect 
the health and safety of subjects who undergo procedures with the investigational 
catheters. The investigational catheters are built in a clean room environment, and 
sterilized using EtO gas, in a manner similar to standard, commercially approved Biosense 
Webster products.  
 
Complete manufacturing records of every lot of catheter manufactured for human use 
during this study are maintained at Biosense Webster, Inc. Each lot of catheters is 
released for human use under a Confirmation of Conformity from Regulatory Affairs that 
will certify that the investigational catheters meet all Essential Requirements for product 
release except those features that are being investigated in this clinical investigation. 
 
11.2. Device Acquisition and Accountability 
The study site will receive the necessary amount of study-related materials prior to 
commencement. Study-related devices (investigational and non-investigational) will be 
shipped to the site after completion of required documentation (essential regulatory 
documents, Clinical trial agreement, IRB/EC approval, regulatory agency approval). 
Investigational Study Devices will be labeled as Investigational and are only to be used 
for subjects enrolled in this clinical study. Study-related materials may be augmented 
throughout the study on an as needed basis. 
 
The Sponsor will keep records of all investigational devices shipped to the site.  
Investigational site personnel are responsible for ensuring that appropriate device logging 
is completed.  
 
The following information should be recorded in the Device Accountability Log: 
• 
Date of receipt 
• 
Person in receipt of the devices 
• 
Quantity received 
• 
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• 
Catalog number for catheters 
• 
Serial/lot numbers 
• 
Expiry Date 
• 
Date devices was used 
• 
Subject ID on whom device was used 
• 
Date of return 
• 
Reason for return (i.e. used without issue, malfunction, expired, end of study…) 
  
11.3. Device Returns 
All Investigational Devices (used and unused) will be returned to the Sponsor’s attention 
per the instructions on the investigational device return forms. Device deficiencies should 
be documented by completing the appropriate eCRF. All returned devices should be 
labeled with at minimum: Study name (STELLAR), subject identification number, if there 
was a complaint (adverse event)/malfunction or not. Tracking information should be 
retained in the event the package has been lost and requires tracking.  
 
12. 
Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human 
subjects are protected, that the reported trial data are accurate, complete, and verifiable, 
and that the conduct of the trial is in compliance with the currently approved 
protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). Each 
site will undergo periodic monitoring of the study, which may involve visits from a Sponsor 
representative qualified to perform such visit.  Monitoring activities may include, but are 
not limited to, the following: 
• 
Protocol adherence 
• 
Source documentation verification and accuracy of the eCRFs  
• 
Verification that informed consent is being obtained for all subjects participating in 
the study in accordance with requirements described in the study protocol 
• 
Verification of completeness of the Regulatory Binder 
• 
Verification of accuracy of all study logs such as the Delegation of Responsibility 
Log, etc.  
• 
Compliance with applicable regulations 
• 
Identification and action to resolve any issues or problems with the study. 
 
Data are to be submitted as soon as possible after collection via e-CRF. Missing or unclear 
data will be corrected as necessary throughout the trial. Biosense Webster may request 
further documentation such as physician and/or cardiac EP lab procedure notes when 
complications or malfunctions are observed and reported. 
 
Further details on clinical monitoring are provided in the study specific monitoring plan. 
 
12.1. Early Termination Monitoring Visit 
If early termination of the study is required, each site will undergo a monitoring visit as 
described in the monitoring plan to conclude any outstanding issues, collect all 
outstanding CRF information, verify device accountability, and discuss any other items 
relevant to the conclusion of the study.  Subjects will be notified of the termination of the 
study. Any enrolled subjects will continue to be followed per the study protocol 
requirements until a study closeout plan is implemented that outlines alternative follow-up 
procedures. 
 

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14. 
Ethics and Protection of Human Subjects 
14.1. Ethical Standard 
As the Sponsor of this study, Biosense Webster has the overall responsibility for the 
conduct of the study, including assurance that the study meets the regulatory 
requirements of the Food and Drug Administration and the MDD 93/42/EC and the local 
government. The Sponsor will also maintain compliance with Good Clinical Practice (ICH 
version 6, revision 2, 11 June 2015), the European standard EN ISO 14155 (Clinical 
Investigation of Medical Devices for Human Subjects), the Declaration of Helsinki (Ethical 
Principles for Medical Research Involving Human Subjects, Brazil, October 2013), 
Sponsor general duties (21 CFR 812.40), selection of investigators (21 CFR 812.43), 
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maintaining records (21 CFR 812.140 [b]), and submitting reports (21 CFR 812.150 [b)]), 
and to local regulations where required. 
 
• 
General Duties  
Biosense Webster’s general duties consist of submitting the IDE application to 
appropriate regulatory agencies, assuring that sites have received IRB/EC 
approvals prior to shipping the devices, selecting investigators, ensuring proper 
clinical site monitoring and verifying that subject informed consent is obtained. 
 
• 
Data Quality and Reporting 
Biosense Webster is responsible for providing quality data that satisfy federal 
regulations and informing proper authorities of serious unanticipated adverse 
events and deviations from the protocol.   
 
• 
Selection of Investigators 
Potential investigational sites will undergo an evaluation to ensure that the site has 
the appropriate facilities and personnel to conduct the study in compliance with the 
clinical investigational plan. Based on outcome of evaluation process, Biosense 
Webster will select qualified investigators, ship devices only to participating 
investigators, obtain a signed Investigator’s Agreement and provide the 
investigators with the information necessary to conduct the study. 
 
• 
Supplemental Applications  
As appropriate, Biosense Webster will submit changes in the Clinical Investigation 
Plan to the investigators to obtain applicable re-approvals from IRBs/ECs. 
 
• 
Maintaining Records  
Biosense Webster will maintain copies of correspondence, data, adverse device 
effects and other records related to the study. Biosense Webster will maintain 
records related to the signed Investigator Agreements. 
 
• 
Submitting Reports  
Biosense Webster will submit any required regulatory reports identified in this 
section of the regulation.  This includes unanticipated adverse device effects, 
withdrawal of IRB/EC approval, current investigators list, annual progress reports, 
recall information, final reports and protocol deviations. 
 
14.2. Institutional Review Board/Ethics Committee 
The investigator will obtain written and dated approval from the responsible IRB/EC for 
the study protocol (or amendment[s]) and informed consent before enrolling study 
subjects.  Biosense Webster and the IRB/EC must approve in writing any changes to the 
protocol that affect the rights safety and/or welfare of the subjects or may adversely affect 
the validity of the study.  
 
A copy of the IRB/EC approval letter addressed to the investigator must be sent to 
Biosense Webster certifying study approval prior to subject enrollment.  Investigators are 
responsible for submitting and obtaining initial and continuing review (per local 
requirements) of the study by their IRB/EC. 
 

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14.3. Informed Consent Process 
14.3.1. Consent/Assent and Other Informational Documents Provided to Subjects 
Patient informed consent must be obtained and documented according to the 
principles of informed consent in the latest version of the Declaration of Helsinki 
(Brazil, 2013), ISO 14155, using the document approved by the reviewing IRB/EC. 
Informed consent is mandatory and must be obtained from all subjects prior to their 
participation in the study. 
 
14.3.2. Consent Procedure and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study and continues throughout the individual’s study participation. 
Discussion of risks and possible benefits of participation will be provided to the patients 
as part of the informed consent process. Consent forms will be IRB/EC-approved and the 
patient will be asked to read and review the document. The investigator, or designee, will 
explain the research study to the patient and answer any questions that may arise. All 
patients will receive a verbal explanation in terms suited to their comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research 
subjects. Information should be given to the patient in a language and at a level of 
complexity understandable to the patient in both oral and written form by the principal 
investigator or designee. Patients will have ample opportunity to review the written consent 
form and to ask questions prior to signing.  
 
Prior to participation in the trial, the Patient ICF should be signed and personally dated by 
the patient or his/her legal representative. If a witness is used for an illiterate or 
compromised patient, the witness should also sign the consent form, attesting that 
informed consent was freely given by the patient or his/her legal representative. The 
patients may withdraw consent at any time throughout the course of the trial. The rights 
and welfare of the patient will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. A 
signed and dated copy of the Patient ICF must be collected from each enrolled subject 
and kept in the study subject files and medical records. The site should provide each 
subject with a copy of their fully executed ICF.  
 
Biosense Webster, Competent Authority (where applicable), and the reviewing IRB/EC 
must approve any modifications to the Patient ICF for this clinical investigation.  A copy of 
the IRB/EC approved Patient ICF must be maintained by each investigator.  
 
Documentation of the consent process for each subject should be maintained by each 
investigator.  
 
Patients should not be coerced, persuaded, or unduly influenced to participate or continue 
to participate in the trial. 
 
14.4. Subject and Data Confidentiality 
During this clinical investigation, representatives of the Sponsor will comply with in-
country privacy laws and regulations regarding contact with subjects, their medical 
record information, copying of information, and protection of the subject identities. 
 
All information and data sent to Biosense Webster concerning subjects or their 
participation in this clinical investigation will be considered confidential. Only authorized 
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i.e. Core Lab, Clinical Research Associate, CRO, etc.) and/or representatives of the FDA 
or Competent Authorities acting in their official capacities will have access to these 
confidential files upon request (including, but not limited to, laboratory test result reports, 
ECG reports, admissions/discharge summaries for hospital admission occurring during a 
subjects study participation and autopsy reports for deaths occurring during the clinical 
investigation). Some of the countries to which the study subjects and investigators 
personal data may be transferred may not offer as comprehensive a level of protection of 
personal data as within the European Union but Sponsor will put adequate measures in 
place to act in compliance with regional policies and requirements and to ensure a 
sufficient level of data protection. All data used in the analysis and reporting of this 
evaluation will exclude identifiable reference to the subject. 
 
14.4.1. Research use of Stored Data 
• 
Intended Use: Data collected under this protocol may be used to study Atrial 
Fibrillation. 
• 
Storage: Access to stored data will be limited. Data will be stored using codes 
assigned by the sponsor. Data will be kept in password-protected computers. Only 
investigators and the sponsor will have access to the data. 
 
15. 
Source Documents and Access to Source Data/Documents 
Data entered on to the eCRFs will be taken from source documentation, such as hospital 
procedure reports, admission and discharge summaries, other hospital or investigator 
office/clinic documents, and system data (CARTO®, generator).  If unique study 
parameters are not documented on standard hospital or office reports, a worksheet may 
be developed to record this information.  The worksheet shall be signed by the PI or 
authorized designee and will serve as the basis for monitoring the eCRFs.  Electronic 
subject records will be considered as source documents. A print-out of a completed eCRF 
cannot be used as source documentation.  
 
Investigators should maintain information in the subject’s medical records, which 
corroborate data collected on the eCRFs.  In order to comply with these regulatory 
requirements, at minimum, the following is a list of information that should be maintained. 
• 
Medical history/physical condition of the study subject before involvement in the 
study sufficient to verify protocol selection criteria (if not already present). 
• 
Dated and signed notes from the day of entry into the study including the study 
Sponsor (Biosense Webster), protocol number, clinical site, subject number 
assigned and a statement that consent to participate in the study was obtained. 
• 
Dated and signed notes from each study visit with reference to the eCRFs for 
further information, if appropriate (for specific results of procedures and exams). 
• 
Reports on AEs and their resolution, including supporting documents such as 
discharge summaries, EP lab reports, ECGs, lab results. 
• 
Notes regarding protocol-required medication and prescription medications taken 
during the study (including start and stop dates). 
• 
Notes on subject’s condition upon completion of or withdrawal from the study. 
 
Only authorized Biosense Webster personnel or representatives, authorized site 
personnel, local government authorities, or the FDA, acting in their official capacities, will 
have access to these confidential files. 
 

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16. 
Quality Assurance and Quality Control 
QC procedures will be implemented beginning with the data entry system and ongoing 
QC checks will be run on the database. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution.  
 
Following written SOPs, monitors will verify that the clinical trial is conducted and 
data are generated, documented, and reported in compliance with the protocol, 
GCP, and the applicable regulatory requirements. If noncompliance is identified, 
Sponsor is required by regulation to implement measures to secure compliance.  
 
The investigational site will provide direct access to all trial related sites, source 
data/documents, and reports for the purpose of monitoring and auditing by the sponsor, 
and inspection by local and regulatory authorities. 
 
17. 
Data Handling and Record Keeping 
17.1. Data Collection and Management Responsibilities 
The Sponsor will be responsible for all data management activities. These activities 
include development of an electronic data collection (EDC) system and utilizing a validated 
EDC system into which all study data will be entered. The Sponsor will be responsible for 
reviewing all data to ensure the overall integrity of the database. 
 
17.1.1. Data Collection 
Electronic Case Report Forms (eCRFs) will be used to collect all subject data during this 
clinical investigation. eCRFs have been developed to capture the information outlined in 
this clinical investigation Plan. Modification to the eCRF will only be made if deemed 
necessary by the sponsor. Data on these eCRFs will be monitored (source verified) and 
the monitor will ask the site representative to correct if necessary to match the source 
documents. Changes made to the data will be tracked in the electronic audit trail. The 
investigator will be required to sign designated eCRFs as verification that they have been 
reviewed and the data entered are correct. Data from these eCRFs will be sent to the 
Sponsor, and/or 3rd party affiliate acting on behalf of the Sponsor, and used in the analysis 
of clinical investigation results.  
 
At the completion of the study ablation procedure, two back-up copies of the CARTO® and 
generator log files will be made. One copy should be kept at the site within the investigator 
site or subject binders, and one fully anonymized copy will be provided to / collected by 
the Sponsor. 
 
If performed and recorded, a copy of the fully anonymized angiography images (preferably 
with contrast), confirming position of the balloon and occlusion of the PVs will be provided 
to / collected by the Sponsor. 
 
17.1.2. Data Reporting 
The investigator, or a designated individual, is responsible for ensuring that clinical 
investigation data are properly recorded on each subject’s eCRF and related documents. 
Completed eCRF will be reviewed and monitored by the sponsor personnel, or an 
appropriately qualified and trained designee, throughout the clinical investigation. To this 
end, the Investigator and institution must permit inspection of the trial files and subject 
eCRFs by such representatives and/or responsible government agencies. 
 

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18. 
Study Suspension or Termination 
This study may be temporarily suspended or prematurely terminated at the discretion of 
the Sponsor. The Sponsor may also terminate a site prior to study completion if the 
Sponsor believes the site is no longer capable of participating (e.g., cannot fulfill subject 
enrollment or protocol compliance goals, site suspension by IRB/EC). If the study is 
prematurely terminated or suspended, the PI will promptly inform the IRB/EC and will 
provide the reason(s) for the termination or suspension.  
 
If suspension or premature termination occurs, the terminating party shall justify its 
decision in writing and promptly inform the other parties with whom they are in direct 
communication. The principal investigator and sponsor shall keep each other informed of 
any communication received from either the IRB/EC or the regulatory authority. 
 
If early termination of the study is required due to safety concerns or the occurrence of 
unanticipated adverse or device events, each site will undergo a monitoring visit to 
conclude any outstanding issues, collect all outstanding CRF information, verify device 
accountability, and discuss any other items relevant to the conclusion of the study. Any 
enrolled subjects will continue to be followed per the study protocol requirements. 
 
If, for any reason, the sponsor suspends or prematurely terminates the study at an 
individual study site, the sponsor shall inform the responsible regulatory authority as 
appropriate and ensure that the IRB/EC is notified, either by the principal investigator or 
by the sponsor. If the suspension or premature termination was in the interest of safety, 
the sponsor shall inform all other principal investigators. 
 
Circumstances that may warrant termination or suspension include, but are not limited to:  
• 
Determination of unexpected, significant, or unacceptable risk to subjects  
• 
Demonstration of efficacy that would warrant stopping  
• 
Insufficient compliance to protocol requirements  
• 
Data that are not sufficiently complete and/or evaluable  
• 
Determination of futility  
 
Study may resume once concerns about safety, protocol compliance, data quality are 
addressed and satisfy the sponsor, IRB/EC and/or regulatory agency. 
 
19. 
Data and Publication Policy 
Publications and/or presentation of clinical investigation results will be coordinated 
between Biosense Webster, Inc. and the clinical investigation author(s). Authorship will be 
determined prior to development of any manuscript. All information concerning the study, 
investigational medical device, sponsor operations, patent application, manufacturing 
processes, and basic scientific data supplied by the sponsor to the investigator and not 
previously published, are considered confidential and remain the sole property of the 
sponsor. 
 
20. 
Document Filing 
A copy of all approved versions of the Investigation Protocol will be kept by the site in the 
Investigator Site File and will be kept by the sponsor in the Sponsor Trial Master File. 
 

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21. 
Scientific References 
1. 
Cain ME. Atrial fibrillation--rhythm or rate control. N Engl J Med. Dec 5 
2002;347(23):1822-1823. 
2. 
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS Guideline for 
the Management of Patients With Atrial Fibrillation: Executive SummaryA Report of the 
American College of Cardiology/American Heart Association Task Force on Practice 
Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology. 
2014;64(21):2246-2280. 
3. 
Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE 
Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Heart 
Rhythm. May 12 2017. 
4. 
Calkins H, Brugada J, Packer DL, et al. HRS/EHRA/ECAS expert consensus statement on 
catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, 
procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on 
Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the 
European Heart Rhythm Association (EHRA) and the European Cardiac Arrhythmia 
Society (ECAS); in collaboration with the American College of Cardiology (ACC), 
American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). 
Endorsed and approved by the governing bodies of the American College of Cardiology, 
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Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm 
Society. Europace. Jun 2007;9(6):335-379. 
5. 
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 
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8. 
Jazayeri MR, Hempe SL, Sra JS, et al. Selective transcatheter ablation of the fast and slow 
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tachycardia. Circulation. Apr 1992;85(4):1318-1328. 

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9. 
Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and 
radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a 
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Marrouche NF, Dresing T, Cole C, et al. Circular mapping and ablation of the pulmonary 
vein for treatment of atrial fibrillation: impact of different catheter technologies. J Am Coll 
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11. 
Oral H, Knight BP, Tada H, et al. Pulmonary vein isolation for paroxysmal and persistent 
atrial fibrillation. Circulation. Mar 5 2002;105(9):1077-1081. 
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Pappone C, Oreto G, Rosanio S, et al. Atrial electroanatomic remodeling after 
circumferential radiofrequency pulmonary vein ablation: efficacy of an anatomic approach 
in a large cohort of patients with atrial fibrillation. Circulation. Nov 20 2001;104(21):2539-
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13. 
Haissaguerre M, Shah DC, Jais P, et al. Electrophysiological breakthroughs from the left 
atrium to the pulmonary veins. Circulation. Nov 14 2000;102(20):2463-2465. 
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Nademanee K, Gidney BA. Pulmonary vein isolation without reconnection: a decade of 
trying. J Cardiovasc Electrophysiol. Jul 2010;21(7):738-740. 
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Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, 
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Feb 2010;3(1):32-38. 
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Furnkranz A, Bordignon S, Schmidt B, et al. Improved procedural efficacy of pulmonary 
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Chierchia GB, Di Giovanni G, Ciconte G, et al. Second-generation cryoballoon ablation 
for paroxysmal atrial fibrillation: 1-year follow-up. Europace. May 2014;16(5):639-644. 
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Mugnai G, de Asmundis C, Ciconte G, et al. Incidence and characteristics of complications 
in the setting of second-generation cryoballoon ablation: A large single-center study of 500 
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Casado-Arroyo R, Chierchia GB, Conte G, et al. Phrenic nerve paralysis during 
cryoballoon ablation for atrial fibrillation: a comparison between the first- and second-
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22. 
Martins RP, Hamon D, Cesari O, et al. Safety and efficacy of a second-generation 
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23. 
Saitoh Y, Irfan G, Ciconte G, et al. Persistence of Phrenic Nerve Palsy Following 28-mm 
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Furnkranz A, Bordignon S, Dugo D, et al. Improved 1-year clinical success rate of 
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Furnkranz A, Bordignon S, Bohmig M, et al. Reduced incidence of esophageal lesions by 
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27. 
Bordignon S, Furnkranz A, Perrotta L, et al. High rate of durable pulmonary vein isolation 
after second-generation cryoballoon ablation: analysis of repeat procedures. Europace. 
May 2015;17(5):725-731. 
28. 
Furnkranz A, Bordignon S, Schmidt B, et al. Incidence and characteristics of phrenic nerve 
palsy following pulmonary vein isolation with the second-generation as compared with the 
first-generation cryoballoon in 360 consecutive patients. Europace. Apr 2015;17(4):574-
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29. 
Metzner A, Reissmann B, Rausch P, et al. One-year clinical outcome after pulmonary vein 
isolation using the second-generation 28-mm cryoballoon. Circ Arrhythm Electrophysiol. 
Apr 2014;7(2):288-292. 
30. 
Metzner A, Rausch P, Lemes C, et al. The incidence of phrenic nerve injury during 
pulmonary vein isolation using the second-generation 28 mm cryoballoon. J Cardiovasc 
Electrophysiol. May 2014;25(5):466-470. 
31. 
Chierchia GB, Di Giovanni G, Sieira-Moret J, et al. Initial experience of three-minute 
freeze cycles using the second-generation cryoballoon ablation: acute and short-term 
procedural outcomes. J Interv Card Electrophysiol. Mar 2014;39(2):145-151. 
32. 
Aryana A, Morkoch S, Bailey S, et al. Acute procedural and cryoballoon characteristics 
from cryoablation of atrial fibrillation using the first- and second-generation cryoballoon: 
a retrospective comparative study with follow-up outcomes. J Interv Card Electrophysiol. 
Nov 2014;41(2):177-186. 
33. 
Furnkranz A, Bordignon S, Schmidt B, et al. Luminal esophageal temperature predicts 
esophageal lesions after second-generation cryoballoon pulmonary vein isolation. Heart 
Rhythm. Jun 2013;10(6):789-793. 
34. 
Metzner A, Burchard A, Wohlmuth P, et al. Increased incidence of esophageal thermal 
lesions using the second-generation 28-mm cryoballoon. Circ Arrhythm Electrophysiol. 
Aug 2013;6(4):769-775. 
35. 
Straube F, Dorwarth U, Vogt J, et al. Differences of two cryoballoon generations: insights 
from the prospective multicentre, multinational FREEZE Cohort Substudy. Europace. Oct 
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