A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Hansen Medical

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Protocol Number: 
HMP010 
Version:  
 
Rev. M 
Date:   
 
11 December 2014  
IDE: 
 
 
G090274 
Hansen Medical, Inc. 
800 East Middlefield Rd. 
Mountain View, CA 94043 
Telephone:  650-404-5800 
Facsimile:   650-404-2793

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Study Information 
Study Title
A prospective, single arm study of the Hansen System for introducing 
and positioning RF ablation catheters in subjects with paroxysmal 
atrial fibrillation (PAF)
Sponsor
Hansen Medical, Inc.
800 East Middlefield Rd.
Mountain View, CA 94043
Telephone:  650-404-5800
Facsimile: 650-404-2793
Principal Investigator
Dr. Andrea Natale
Co-Principal Investigator Dr.  G. Joseph Gallinghouse
Sponsor Contacts
Tammy Drew
Project Lead, Senior CRA, Clinical Research
Telephone: 650-404-2765
Facsimile:  650-404-2793
Intended Use for Clinical 
Study
The Hansen Medical Sensei® X Robotic Catheter System and 
Accessories are intended to facilitate manipulation, positioning and 
:
for collecting electrophysiological data within the heart atria with 
electroanatomic mapping and recording systems, using the 
following percutaneous catheters: the Polaris-
Diagnostic catheters made by Boston Scientific Corporation, and 
Medical, and
for manipulating specified cardiac RF ablation catheters for the 
treatment of drug refractory recurrent symptomatic paroxysmal 
atrial fibrillation, when used with compatible three-dimensional 
mapping systems.
This is a premarket IDE study in the United States.
Outside of the United States, this is a post market study used according 
to its intended use per Instructions for Use.
Study Design
A prospective, single-arm, multi-center, US and outside the US (OUS) 
study to evaluate the safety and effectiveness of the Sensei® Robotic 
Catheter System and Artisan family of guide catheters for introducing and 
positioning specified commercially available RF ablation catheters in 
subjects with symptomatic, drug-refractory paroxysmal atrial 
fibrillation. Primary safety and effectiveness outcomes must meet pre-
established target performance goals. A Bayesian adaptive design is 
used in the study that allows for interim analyses to be performed 
initially after 125 subjects have been enrolled and after every 25 
subjects thereafter.  Stopping rules have been incorporated to evaluate 
for early success or futility.
Number of Subjects and 
Investigative Sites
A minimum of 7 and up to 14 US and outside the US (OUS) 
investigational sites will enroll a minimum of 125 subjects up to a 
maximum of 250 subjects. Sites may not enroll greater than a
predefined number of subjects at each interim analysis without prior 

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approval by the Sponsor.
Study Objective
To evaluate the safety and effectiveness of the family of Artisan guide 
catheters when used to remotely introduce and position commercially 
available cardiac RF ablation catheters to treat subjects with 
paroxysmal atrial fibrillation.
Primary Endpoints
Safety:
The incidence of Major Complications, including the early onset 
(within 7 days of the ablation procedure) predefined complications; 
and the incidence of esophageal injury or pulmonary vein stenosis 
through day 180.
Effectiveness: 
Chronic Success is defined as: 
Freedom from symptomatic atrial fibrillation (AF), atrial 
flutter, and atrial tachycardia episodes from days 91 - 365
after the initial ablation procedure, as documented by event 
recording, ECGs, and Holter monitoring.
No use of Class I,  Class II ,Class III or Class IV
antiarrhythmic medications during days 91 - 365 after the 
initial ablation procedure with the following exceptions:
Addition of Anti- Arrhythmic (AAD) medication 
which was previously ineffective for AF and 
does not exceed the previous historical maximum 
dosage (24 hour total dose).
Use of Atrioventricular (AV) nodal blocking 
agents such as beta blockers (BB) and/or calcium 
channel blockers (CCB) that are maintained at 
the current dose (does not exceed previous 
historical maximum dosage (24 hour total dose)).
No more than two additional ablation procedures within 90 
days of the initial ablation procedure and no additional 
ablation procedures after day 90.
No use of a non-study device for ablation of any atrial 
fibrillation target. Commercially available non-study 
devices may be used for atrial flutter and atrial tachycardia 
ablation targets.
No ablation of an atrial fibrillation target made by 
removing the ablation catheter from the Artisan catheter 
and manually manipulating the ablation catheter.
Pulmonary vein isolation of at least 3 out of 4 veins 
confirmed by pulmonary vein entrance block during the
last procedure within the blanking period.
No surgical ablation for atrial fibrillation, atrial flutter, or 
atrial tachycardia within 90 days of the study procedure.

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No direct current (DC) cardioversion for atrial fibrillation, 
atrial flutter, or atrial tachycardia within days 91 - 365
after the initial ablation procedure.
No catheter or surgical ablation for atrial fibrillation, atrial 
flutter, or atrial tachycardia within days 91-365 after the 
initial ablation procedure.
Secondary Endpoints
Acute Procedural Success: Acute pulmonary vein isolation of at least 
three out of four veins, as documented by testing entrance block, 
during the procedure.
Chronic Safety: Incidence of Major Complications reported from day 
8 through day 365.
Primary Hypothesis
Safety:
To determine if the Major Complication rate meets the pre-established 
target performance goal (TPG) of 16%.
H0:
s
16%    vs.    H1: 
s < 16%,
Effectiveness:  
To determine if the effectiveness rate meets the pre-established target 
performance goal (TPG) of 54%.
H0:
E
54%    vs.   H1: 
E > 54%,
Both primary hypothesis (Safety and Effectiveness) shall be met for 
study success.
Sample Size
The total sample size will be determined by a Bayesian adaptive 
design. The trial will enroll a minimum of 125 subjects and up to a 
maximum of 250 subjects. Interim analyses will be conducted starting 
after the first 125 subjects are enrolled, and continue every 25 subjects 
thereafter.
Subject Population
Subjects eligible for study participation must be diagnosed with
symptomatic paroxysmal atrial fibrillation refractory to medical 
treatment, suitable for treatment with RF catheter ablation, meet 
all inclusion and no exclusion criteria and be willing to comply 
with all protocol testing and follow-up.
Inclusion Criteria:
1.
Subjects with paroxysmal atrial fibrillation who have had two or 
more spontaneously terminating episodes of atrial fibrillation that 
last longer than 30 seconds and shorter than 7 days, in the nine 
months prior to enrollment. At least one episode must be 
documented with ECG, TTM, Holter monitor, or telemetry.
2.
Failure of at least one Class I IV anti-arrhythmic drug (AAD) for 
PAF as evidenced by recurrent symptomatic PAF, or intolerable 
side effects due to AAD.  AADs are defined in Appendix B.
3.
Signed informed consent.
4.
Age 18 years or older.
5.
Able and willing to comply with all pre-, post-, and follow-up
testing and requirements.

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1.
Atrial fibrillation secondary to electrolyte imbalance, thyroid 
disease, or reversible or non-cardiac cause.
2.
Previous ablation for atrial fibrillation.
3.
Atrial fibrillation episodes that last less than 7 days and are 
terminated by cardioversion.
4.
Previous valvular cardiac surgery procedure.
5.
Cardiac artery bypass graft procedure within the previous 180 
days.
6.
Previous septal defect repair.
7.
Expecting cardiac transplantation or other cardiac surgery within 
the next 180 days.
8.
Coronary PTCA/stenting within the previous 180 days. 
9.
Documented left atrial thrombus on ultrasound imaging (TEE).
10. Documented history of a thrombo-embolic event within the 
previous 365 days.
11. Diagnosed atrial myxoma.
12. Presence of an implanted ICD.
13. Presence of permanent pacing leads.
14. Significant restrictive, constrictive, or chronic obstructive 
pulmonary disease or any other disease or malfunction of the lungs 
or respiratory system with chronic symptoms.
15. Significant congenital anomaly or medical problem that in the 
opinion of the investigator would preclude enrollment in this 
study.
16. Women who are pregnant.
17. Acute illness or active infection at time of index procedure 
documented by either pain, fever, drainage, positive culture and/or 
leukocytosis (WBC > 11.000 mm3) for which antibiotics have 
been or will be prescribed.
18. Creatinine > 2.5 mg/dl (or > 221 µmol/L).
19. Unstable angina.
20. Myocardial infarction within the previous 60 days.
21. Left ventricular ejection fraction less than 40%.
22. History of blood clotting or bleeding abnormalities.
23. Contraindication to anticoagulation medicine.
24. Contraindication to computed tomography or magnetic resonance 
imaging procedures.
25. Life expectancy of less than 1 year.
26. Enrollment in another investigational study.
27. Uncontrolled heart failure (NYHA class III or IV heart failure).
28. Presence of an intramural thrombus, tumor, or other abnormality 
that precludes catheter introducing or positioning.
29. Presence of a condition that precludes vascular access.
30.
31. INR greater than 3.0 within 24 hours of procedure.
32. Use of amiodarone therapy within the 3 months prior to the 
Exclusion Criteria

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ablation procedure.
Medical Device
Subjects will be treated with one of the specified commercially 
available RF ablation catheters within one of the family of Artisan 
guide catheters controlled by the Sensei® X Robotic Catheter System.
The ablation catheter shall be commercially available in the United 
States, and if used in Europe, the catheter shall be CE marked. The 
ablation catheter will be used per its instructions for use, although 
potentially outside its intended use.
Screening/Baseline
Demographics  
Medical history
Physical exam
NYHA Class 
CT/MR within 3 months prior to initial ablation procedure to 
evaluate pulmonary veins and left atrial morphology and 
dimensions
12-lead ECG
Labs, including CBC, BUN, serum creatinine (CR), INR*, 
pregnancy test
Anti-arrhythmic taken within the past 2 years; Anti-platelet or 
Anticoagulation medication taken within the past 3 months
Echocardiogram Transthoracic Echocardiogram (TTE) /
Transesophageal Echocardiogram (TEE) within 3 months prior to 
the index procedure to assess cardiac structure, function, LA size
and EF
Echocardiogram Transesophageal Echocardiogram (TEE) within 
24 hours prior to the procedure to exclude left atrial thrombus
Note:  If preferred by the investigator, TEE or ICE within 24 hours or
at the onset of the procedure for both structural and thrombus 
evaluations.
Intra/post-procedural 
Testing
Cardiac echocardiogram prior to the introducing of the ablation
catheter (e.g., TEE, TTE, ICE, or IVUS) 
Cardiac echocardiogram 5 minutes after removal of the ablation
catheter (e.g., TEE, TTE, ICE, or IVUS)
12-lead ECG prior to leaving  EP lab
At Physician discretion the following may be performed:
Venogram or ICE to determine location, morphology and 
dimensions of each pulmonary vein
Routine EP study
Cardioversion 
Phrenic nerve pacing
Esophageal temperature probe
Follow-up Testing
Pre-Discharge:
12-lead ECG
Serum creatinine, BUN, CBC

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Discharge medications (Antiarrhythmic, Anti-platelet and 
Anticoagulation only)
Follow-Up:
Adverse event assessment via phone: 7 days
NYHA classification and adverse event assessment: 30 days, 90 
days, 180 days and 365 days
12-lead ECG will be done at 30 days, 90 days, 180 days and 365
days
Event recorder (for transtelephonic monitoring) issued to subject
at the 90 day visit to be in effect through day 365 to document 
symptomatic recurrence of AF
As of the 90-day visit, asymptomatic transtelephonic monitoring 
(TTM) is required weekly for 8 weeks and to document 
symptomatic recurrence of AF
After the weekly TTM for 8 weeks, asymptomatic transtelephonic 
monitoring is required once per month and to document
symptomatic recurrence of AF throughout the end of the study
CT or MR will be required at 180 days to assess PV stenosis.
24 Hour Holter monitoring at 180 days and 365 days
Cardiac CT or MR at 365 days in subjects showing more than 
50% narrowing of a pulmonary vein at the 180 day cardiac CT or 
MR

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Table of Contents  
1.0
Introduction ......................................................................................................................11
1.1
Background ...................................................................................................................................11
1.2
Prior Investigations ....................................................................................................................... 12
1.3
Advantages and Disadvantages ................................................................................................... 17
1.4
Alternatives ...................................................................................................................................18
1.5
Additional Information................................................................................................................. 18
2.0
Purpose ..............................................................................................................................18
2.1
Study Purpose ............................................................................................................................... 18
2.2       Study Objectives............................................................................................................................ 16
3.0
Device Description ............................................................................................................19
3.1
Device Name ................................................................................................................................ 19
3.2
Principles of Operation................................................................................................................. 16
3.3 
Intended Use ................................................................................................................................. 19
4.0
Labeling ......................................................................................................................................23
5.0
Study Design ......................................................................................................................23
5.1
Duration of Study ......................................................................................................................... 24
5.2
Primary Safety Endpoints ............................................................................................................ 20
5.3
Primary Effectiveness Endpoint .................................................................................................. 21
5.4 
Secondary Endpoints .................................................................................................................... 22
5.5
Additional Analyses ..................................................................................................................... 27
6.0
Statistical Hypotheses .......................................................................................................27
6.1
Primary Safety Endpoint .............................................................................................................. 27
6.2
Primary Effectiveness Endpoint .................................................................................................. 27
6.3
Secondary Safety Endpoint  Chronic Safety ............................................................................. 28
6.4
Secondary Effectiveness Endpoint  Acute Procedural Success ...............................................28
6.5
Justification for Sample Size: ...................................................................................................... 28
6.6
Target Performance Goal  ............................................................................................................ 29
6.7        Data Analysis................................................................................................................................ 24
6.8
Poolability .....................................................................................................................................30
6.9
Subject withdrawal and Missing Data ......................................................................................... 31
7.0
Study Procedures ..............................................................................................................31
7.1
Inclusion and Exclusion Criteria ................................................................................................. 26
7.2
Assignment of Subject Identification Number ........................................................................... 33
7.3
Baseline, Pre-Procedure, Procedure, Pre-Discharge and Follow-up.........................................33
7.4
Missed Follow-up Visits .............................................................................................................. 45
7.5
Subject Withdrawal or Lost to Follow-up................................................................................... 45
7.6
Bias Control Measures - Core Laboratory Data Analysis ..........................................................45
7.7
Clinical Events Committee .......................................................................................................... 46
7.8
Adverse Events ............................................................................................................................. 47
7.9
Data and Safety Monitoring Board.............................................................................................. 51
7.10
Data Collection and Evaluation ................................................................................................... 51
7.11
Source Documentation ................................................................................................................. 52
7.12
Protocol Deviations/ Violations ................................................................................................... 52
8.0
Risk Analysis .....................................................................................................................53

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8.1
Potential Risks .............................................................................................................................. 53
8.2
Minimization of Risks .................................................................................................................. 56
8.3
Potential Benefits .......................................................................................................................... 57
8.4
Mechanical Failures or Malfunction ........................................................................................... 57
9.0
Selection of Clinical Investigators ...................................................................................57
9.1
Clinical Investigator Requirements ............................................................................................. 57
9.2
Subject Population ........................................................................................................................ 58
9.3
Subject Enrollment ....................................................................................................................... 59
10.0
Investigator Responsibilities ............................................................................................59
10.1
Essential Documents for Study Start ........................................................................................... 59
10.2
Specific Investigator Responsibilities ......................................................................................... 60
10.3
Compliance ...................................................................................................................................60
10.4
Device Accountability .................................................................................................................. 61
10.5
Investigator Reports ..................................................................................................................... 61
11.0
Institutional Review Board ..............................................................................................62
12.0
Sponsor and Monitor responsibilities .............................................................................62
12.1
Sponsor .........................................................................................................................................62
12.2
Sponsor Reports ........................................................................................................................... 63
12.3
Study Management and Monitoring ............................................................................................ 63
12.4
Monitoring Procedures ................................................................................................................. 64
13.0
Ethical Considerations .....................................................................................................66
13.1
Human Subjects Protection .......................................................................................................... 66
13.2
Emergency Actions ...................................................................................................................... 66
13.3
Amending the Protocol ................................................................................................................ 66
13.4
Study Termination ........................................................................................................................ 67
14.0
Publication Policy .............................................................................................................67
15.0
Study Definitions ..............................................................................................................67
16.0
References .........................................................................................................................68

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List of Figures 
Figure 1: Sensei® Robotic Catheter Control System.........................................................................20
Figure 2: Distal TipArticulation of The Family of Artisan Catheters  .............................................21
Figure 3: Artisan Catheter Attached to the RCM .............................................................................18
Figure 4: IntelliSense Displays (highlighted in yellow) ...................................................................19
 ...37
List of Tables 
Table 1: Hansen Remote vs. Manual Biosense Webster Positioning in Peer Reviewed 
Publications12 
Table 2: Hansen vs. Manual Manipulation of ThermoCool®
Table 3: 
Table 4: Hansen Remote vs. Manual Positioning of ThermoCool® for Paroxysmal Atrial 
Fibrillation
Table 5: Hansen Remote vs. Manual Positioning of ThermoCool® for Atrial Flutter
Table 6: Current ARTISAN IDE Study Status
Table 7: Maximum Subjects per Site at Each Interim Analysis
Table 8: Definition of Study Time Points
Table 9: Schedule of Study Assessments
Table 10: Adverse Event Severity
Table 11: Adverse Event Outcome
Table 12: Adverse Event Causality
Table 13: DO NOT REPORT: Adverse events related to the initial ablation
Table 14: Investigator Reporting Requirements
Table 15: Sponsor Reporting Requirements
Table 16: eCRF Completion
List of Appendices 
Appendix A
Adverse Event Definitions
Appendix B
Classes of Anti-Arrhythmic Drugs (Vaughn- Williams Classification)
Appendix C
Clinical Study Informed Consent Template
Appendix D
Sample HIPAA Waiver
Appendix E
NYHA Classification
Appendix F
Sample Size Publications
Appendix G
Electronic Case Report Forms (eCRFs)
Appendix H
Acronyms
Appendix I
Instructions For Use
Appendix J
Study Device Returns (SOP 05430)
Appendix K
Study Contact Information
Appendix L
Major Complication Definitions
Appendix M
Bayesian Adaptive Design for a Study of the Sensei® Robotic System
Appendix N    CHADS2   
Appendix O    IRB Names, Locations, and Chairpersons 

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1.0
Introduction 
1.1
Background 
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disturbance, increasing in 
prevalence with age. AF is often associated with structural heart disease, although a substantial 
proportion of patients with AF have no detectable heart disease. Hemodynamic impairment and 
thromboembolic events related to AF result in significant morbidity, mortality, and health care 
cost.  Catheter ablation therapy is widely recognized as a useful modality for patients with cardiac 
rhythm fibrillation that are refractory to medical and ICD treatment, and is increasingly used 
earlier in treatment.1
Physicians specializing in Interventional Cardiology (IC) and/or Electrophysiology (EP) are often 
confronted by the need to precisely place and control a variety of therapeutic and non-therapeutic 
catheters in the cardiovascular space.  A variety of shapeable and steerable sheaths and guide 
catheters have been developed to meet this need. These manually controlled catheters traditionally 
rely upon the ability of the experienced physician to apply varying amounts of distal curvature via 
pull wires within a steerable catheter.  This tip curvature is then used in combination with insertion 
and torque to manipulate the distal tip of the catheter in a desired fashion.  The manual control 
complex mapping, ablation and other therapeutic procedures. Maintaining stable tissue contact at 
the point of ablation is important in achieving efficient heat transfer to tissues without increasing 
the power requirement6, but micro-movement can be difficult to assess.  Therefore, stable tissue 
contact relies on operator skill to exert forces at cardiac tissue that is constantly shifting due to 
cardio-respiratory movement.7 Robotic catheter manipulation may be one way to overcome or 
improve the problem of catheter stability. 
In minimally invasive surgery, robotic assisted control of the surgical instruments has helped 
physicians perform difficult dexterous surgical tasks safely and efficaciously.  Robotic remote 
control of catheters has recently been introduced to assist physicians in the safe, accurate 
placement of the distal catheter tip during percutaneous cardiac procedures. In ablative procedures 
it is not known whether improving catheter tip stability has a significant effect on lesion quality 
compared to the manual approach, but some recent publications of both animal and human studies 
comparing the Hansen Sensei® Robotic System and Artisan Guide Catheter to manual delivery of 
the ablation catheter suggest that contact pressure conferred by the robotic system results in 
improved lesion delivery compared to a manual approach7 and that the use of robotic manipulation 
during ablation procedures has an event rate similar to manual manipulation.10,11,12,13 It has been 
the convention to deliver energy for up to sixty seconds for slow pathway modification and 
accessory pathways to produce irreversible tissue necrosis. One study suggested that by 30 
seconds, robotic ablation appears to exceed the manual ablation signal attenuation at 60 seconds. 
The study confirmed that transmural lesions were produced at 30 seconds of robotic ablation.
Therefore, it may be possible to use shorter ablation times or lower power settings for robotic 
approaches. This may in turn reduce the likelihood of complications for example, the risk of 

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damage to contiguous structures and the risk of steam pop which is most likely to occur after 30 
seconds 8 at temperatures greater than 400C7, 9.
Studies have also demonstrated that remote navigation for right and left atrial mapping and 
radiofrequency ablation for atrial fibrillation and atrial flutter were found to be safe and 
feasible.2,3,4,5  In these feasibility studies, remote navigation was shown to have a decrease in
procedure time and improved success compared to current manual methods.2 The Hansen Sensei®
X Robotic Catheter System and family of Artisan guide catheters are a remote manipulation 
system, originally cleared by the FDA in 2007 as a delivery system to facilitate manipulation, 
positioning and control, for collecting electrophysiological data within the heart atria with 
electroanatomic mapping and recording systems.  Sensei® X and Artisan were first CE marked in 
2007 to facilitate the manipulation and precise positioning of percutaneous catheters within the 
atria of the heart.  Although widely used in Europe with approved ablation catheters, in the US 
marketing and training on the system is limited to the collection of electrophysiological data and 
mapping.  The intent is to achieve US regulatory clearance of the Hansen Sensei® Robotic System 
and the family of Artisan guide catheters for use with specified, commercially available ablation 
catheters in subjects with paroxysmal atrial fibrillation.  
1.2
Prior Investigations  
Table 1 below summarizes the dual-arm Hansen vs. Manual clinical publications.  Individual 
summaries follow in the lettered sections. These investigations were conducted at three hospitals 
by six physicians - two academic centers in Europe and one community hospital in the U.S.  In 538 
subjects, the studies found similar rates of acute effectiveness, chronic effectiveness, and serious 
complications.  The studies found significantly lower levels of subject and physician exposure to 
fluoroscopic radiation when the Hansen System was used.  
None of the following Hansen vs. manual clinical investigations was sponsored by Hansen 
Medical; and, Hansen Medical had no part in the development, execution, or publication of the 
studies. 
Table 1: Hansen Remote vs. Manual Biosense Webster ThermoCool® Positioning in Peer-
Reviewed Publications 
Parameter
Hansen
System
Manual
Total
Total Number of Subjects
270
278
538
Atrial Flutter Subjects
25
25
50
Atrial Fibrillation Subjects
245
243
488
Acute Procedural Success (isolation as defined 
and reported in each study)
100%
100%
100%
Chronic Procedural Success (as defined and 
reported within each study)
84%
81%
82%
Fluoroscopy Time (minutes)
37.7 ± 18.7
47.8± 16.9
42.8± 17.7
Safety: Serious Complications
tamponade, groin hematoma, ST elevation, 
esophageal ulcer
1.2%
0.8%
1.0%
The following sections summarize each dual-arm publication: 

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a) Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to 
manual navigation and ablation:  
Medical Center, a community hospital in Austin, Texas, used a 
ThermoCool® catheter to treat 390 subjects; 197 were treated manually and 193 were treated using 
the Sensei® Robotic System and Artisan Guide Catheter to manipulate the ThermoCool® catheter.10
Table 2: Hansen vs. Manual Manipulation of ThermoCool® for Atrial Fibrillation 
Parameter
Hansen System
Manual
Number of Subjects
193
135 paroxysmal
55 persistent
6 long-lasting persistent
197
127 paroxysmal
55 persistent
11 long-lasting persistent
Acute Isolation
100%
100%
Procedure Time
3.09 ± 0.82 hours
3.05 ± 0.83 hours
Fluoroscopy Time
48.9 ± 24.6 minutes
58.4 ± 20.4 minutes
Long-term Outcomes
(freedom from recurrence)
Overall: 85% at 14.1±1.3 months
Paroxysmal: 89.8% 14.2±1.3 
months
Persistent: 70.9% 14.0±1.2 months
Long-Lasting: 100% 14.5±1.4 
months
Overall: 81% at 14.1±1.3 months
Paroxysmal: 85.2% 14.2±1.3 
months
Persistent: 72.7% 14.0±1.2 months
Long-Lasting: 67% 14.5±1.4 
months
Safety
2 (1.0%) pericardial tamponade
1 (0.5%) groin hematoma
1 (0.5%) pericardial tamponade
1 (0.5%) groin hematoma
b) Reduced fluoroscopy during the ablation of atrial fibrillation: benefits of robotic 
navigation. 
Physicians at Hamburg UKE in Hamburg, Germany used an irrigated ablation catheter to treat 
atrial fibrillation in 60 subjects in a prospective randomized trial; 30 were treated manually and 30 
were treated with the Sensei® Robotic System and Artisan Guide Catheter manipulating the 
irrigated catheter.11
Table 3: Steven et al (Atrial Fibrillation) 
Parameter
Hansen System
Manual
Number of Subjects
30
30
Acute Outcome: Pulmonary Vein Isolation 
100%
100%
Chronic Outcome: Freedom from Atrial 
Fibrillation at 6 months
73%
77%
Procedure Time
156 ± 44.4 minutes
134 ± 12 minutes
Fluoroscopy Time
9 ± 3.4 minutes
22 ± 6.5 minutes
Physician Exposure Time
7 ± 2.1 minutes
22 ± 6.5 minutes
c) Hansen remote navigation for ablation of paroxysmal atrial fibrillation: 
Physicians at IKEM in Prague, Czech Republic used a ThermoCool® catheter to map and treat 
paroxysmal atrial fibrillation in 38 subjects; 22 of the subjects were treated using the Sensei®
Robotic System and Artisan Guide Catheter to manipulate the ThermoCool® catheter and 16 
subjects were treated by manually manipulating the ThermoCool® catheter.12 

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Table 4: Hansen Remote vs. Manual Positioning of ThermoCool® for Paroxysmal Atrial 
Fibrillation 
Parameter
Hansen System
Manual
Number of Subjects
22
16
Outcome: freedom from 
symptoms and recurrence (90 
day blanking period)
91% (5 ± 1 month follow up)
81% (9 ± 3 month follow up)
Procedure Time
207 ± 29 minutes
250 ± 62 minutes
Fluoroscopy Time
15 ± 5 minutes
27 ± 9 minutes
RF Duration
1641 ±  609 seconds
2188 ± 865 seconds
Safety
No complications
No complications
d) Hansen Remote vs. Manual Ablation of Atrial Flutter with a ThermoCool® ablation 
catheter: 
Physicians at Hamburg UKE used a ThermoCool® catheter to treat atrial flutter in 50 subjects; 25 
were treated manually and 25 were treated with the Sensei® Robotic System and Artisan Guide 
Catheter manipulating the ThermoCool® catheter.13 
Table 5: Hansen Remote vs. Manual Positioning of ThermoCool® for Atrial Flutter 
Parameter
Hansen System
Manual
Number of Subjects
25
25
Acute Outcome: 
Bidirectional Isthmus Block 
100%
100%
Procedure Time
79.4 ± 30.6 minutes
58.4 ± 17.7 minutes
learning curve data: 
105.3 ± 34.8 min (subjects1-10)    
60.6 ± 6.3 min (subjects16-25)
Fluoroscopy Time
5.8 ± 3.6 minutes
8.2 ± 4.6 minutes
Physician Exposure Time
1.9 ± 1.1 minutes
8.2 ± 4.6 minutes
RF Duration
321.7 ±  214.6 seconds
496.4 ± 213.9 seconds
RF Energy 
8279 ± 5767 joules
16308 ± 6870 joules
Safety
No complications
No complications
e) Sensei Study versus Manual Procedures Using a Contact Force Sensing Catheter 
A recent article was published regarding the use of the Sensei system with a contact force sensing 
catheter (Ullah, et al., Comparison of robotic and manual persistent AF ablation using catheter 
contact force sensing: an international multicenter registry study, Pacing Clin Electrophysiol. 2014 
Sep 15. doi: 10.1111/pace.12501).  The study compared the use of Sensei with the ThermoCool®
SmartTouch catheter to manual procedures performed with the ThermoCool® SmartTouch catheter 
in patients with persistent atrial fibrillation.  The study showed a significant increase in one year 
freedom from atrial fibrillation in the Sensei group as compared to the manual group (64% versus 
36%, p=0.01).  The study also showed a 41% decrease in fluoroscopy time in the Sensei group and 
no significant differences in procedure time or complication rate between the two groups. 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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f)
Current IDE Study: 
A current IDE study is being performed per the investigational protocol linked with IDE number 
G090274.  
The original protocol, Revision A dated December 21st 2009 was not approved by the FDA. In 
response, Revision B, dated March 19th 2010 was presented to the FDA along with responses to 
the non-approval letter on March 23rd 2010. Sections of the protocol that were updated were: Study 
Design, Chronic Procedural Success, Statistical Hypotheses, Safety, Major Adverse Event 
Definitions, Study Definitions, Sample Size Determination and Power Analysis, Acute Procedural 
Success, Effectiveness- Chronic Procedural Success, Study Design and Statistical Considerations, 
Clinical Event Committee, Primary Hypothesis, Primary Endpoints, Data Safety Monitoring 
Committee, Study Procedure, Secondary Endpoints, Randomization, Prior Investigations, 
Poolability, Training of Clinical Investigators, Pre-Procedural Evaluation, Study Procedure: Post 
Procedural Care, Core Laboratory Data Analysis, Additional Analyses, Follow-up Evaluation, 
Inclusion and Exclusion Criteria, Table 7: Schedule to Study Assessments, Figure 4: Remote 
versus Manual Introduction and Positioning of the ThermoCool Catheter, and Appendix B: Classes 
of Anti-Arrhythmic Drugs (Vaughn-Williams Classifications).  As a response to Revision B, 
conditional approval was granted on April 22nd 2010.
Protocol Revision C, dated May 6th 2010 was updated to address the FDA responses to the
Conditional Approval Letter. Protocol Revision C was submitted to the FDA on May 11th 2010.
Sections that were modified in Revision C includes: Primary Safety Endpoints, Secondary Chronic 
Safety Endpoints, Primary Safety Endpoint, Study Information, Major Adverse Event Definitions, 
Sample Size Determination and Power Analysis, Acute Procedure Success, Secondary 
Effectiveness Endpoint- Acute Procedural Success, Inclusion and Exclusion Criteria, System 
Training, Study Procedure, Study Definitions, Holter Monitoring and Event Recording, Primary 
Effectiveness Endpoint, Analysis of Endpoints, and Poolability.   
Another conditional approval letter was provided in response to previous submissions, on June 11th
2010.
Protocol Revision D, dated September 7th 2010, addressed and was submitted along with the IDE 
Conditional Approval Letter responses submitted on September 14th 2010. The sections in 
Revision D were: Justification for Sample Size, Study Procedure, Training of Clinical 
Investigators, Study Definitions, Poolability and Essential Documents for Study Start.  
Protocol Revision E, dated September 30th 2010, was in response to interactive communications 
with the FDA, but mainly administrative updates were made.  
On October 15th, 2010, the clinical study was unconditionally approved as a response to the 
September 14th 2010 submission.  
Protocol Revision F, dated April 28th 2011, was submitted to the FDA along with the IDE Annual 
Report. Revision F, was also updated to remove the requirement of cardiac enzyme testing.  

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Protocol Revision G, dated May 29th 2012, was submitted along with the IDE Annual Report. 
Updates in Revision G were mainly administrative. 
Protocol Revision H, dated April 23rd 2013, was submitted to the FDA as a modified study plan, 
and received conditional approval on May 24th 2013. The study was changed from a randomized 
control study versus manual use of the NaviStar ThermoCool catheter to a single arm, target 
performance goal based study.  
Protocol Revision I, dated June 28th 2013, was submitted to the FDA, responding to the questions 
listed in the Conditional Approval Letter; full study approval was granted on August 7th 2013.
Inadvertently, another Protocol Revision I was submitted to the FDA but dated July 25th 2013. The 
only clinical site to have submitted the June 28th 2013 Revision I to their IRB was Texas Cardiac 
Arrhythmia Research Foundation. The protocol Revision I dated July 25th 2013 addresses 
questions the FDA noted about the 2013 Annual Report. Protocol Revisions noted in the June 28th
2013 submission are contained within and superseded by the July 25th 2013 revision. The initial 
revision had updates to: Study Information, Study Design, Secondary Endpoints, Secondary Safety 
Endpoints, Justification for Sample Size, Data Analysis, Poolability, Patient Withdrawal and 
Missing Data, Assignment of Subject Identification Number, Study Procedure, Table 8: Study 
Definition of Time Points, Holter Monitoring, Data and Safety Monitoring Board, Study 
Definitions, Appendix C: Clinical Study Informed Consent Template, Appendix G: Case Report 
Forms (CRFs), and Appendix L: Major Complication Definitions. The later revision contained the 
addition of esophageal temperature monitoring, addition of PPI (proton pump inhibitors) for 4 
weeks post procedure, clarification of death and atrio-fistula FDA reporting.  
Protocol Revision J, dated July 24, 2014, was submitted to the FDA to implement changes in the 
way in which the use of antiarrhythmic drugs were evaluated in the study.  The changes were 
intended to make the evaluation of AAD use equivalent to the way in which the data were 
analyzed in the previous IDE study for the Biosense Webster NaviStar ThermoCool Catheter.  
Several other administrative changes were included. 
Protocol Revision K, dated August 26, 2014, was submitted in response to minor questions and 
clarifications from the FDA on Revision J. 
Protocol Revision L, dated October 30, 2014, expanded the study to use commercially available 
cardiac RF ablation catheters meeting a set of identified specifications to the study.  The inclusion 
of additional RF ablation catheters enables the use of the EnSite mapping system in addition to 
CARTO.  The protocol was also updated to address the poolability analysis to be performed for the 
different ablation catheters.  In addition, the protocol was updated to clarify when a clinical report 
may be submitted for early success and when a final clinical study report will be completed. 
Protocol Revision M, dated December 11, 2014, is the current revision.  It further specifies the list 
of commercially available cardiac RF ablation catheters by trade name and model.  The 
specification of the catheters resulted in minor modifications to the IFU and CRFs. 
As mentioned previously, the study was unconditionally approved by FDA in October 2010 as a 
randomized study.   Fifty two subjects were enrolled in the randomized study at seven sites over a 
2.5 year period.  Thirty five subjects were enrolled in the treatment arm and were treated using the 

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Hansen System with the ThermoCool® catheter.  Seventeen subjects underwent manual delivery of 
the ablation catheter during the treatment procedure in the control arm using only the 
ThermoCool® catheter.   
In March 2013, enrollment in the current study was suspended to seek FDA approval for a 
modified study design and investigational plan.  The study was re-initiated using a modified design 
and protocol (Rev H) after conditional IDE approval was granted by FDA.  Currently, 61 subjects 
have been enrolled in the Target Performance Goal (single arm) study.   
An interim analyses is planned to assess the primary safety and effectiveness endpoints once 125 
subjects have been enrolled.  There have been no reported unanticipated adverse events 
experienced by the study subjects.  Four annual IDE progress reports have been submitted and 
accepted by the FDA.  These reports have described study enrollment progress, subject 
demographics, procedure description, protocol deviations, and reported adverse events. Table 6 
provides an enrollment overview of the current IDE status.
Table 6: Current ARTISAN IDE Study Status 
ARTISAN AF IDE Study   
Number of Investigational Sites 
10
Number of Subjects Enrolled in the Single-Arm Study
74
1.3
Advantages and Disadvantages  
Studies have shown that catheter ablation is a safe and effective treatment option for patients with 
atrial fibrillation, despite the inherent risks.2, 3 The Hansen System, including the family of Artisan 
guide catheters, provide the potential for enhanced navigation, control and stability of tissue 
contact at the point of ablation over manual manipulation of a commercially available ablation 
catheter when used in subjects with atrial fibrillation.
The Sensei® X Robotic Catheter System and the family of Artisan guide catheters are CE marked 
to facilitate manipulation and precise positioning of percutaneous catheters within the atria of the 
heart. As reflected in a wide body of literature, pulmonary vein isolation procedures and subject
demographics in Europe are representative of procedures and demographics in the United States. 
Literature review of ablation cases done in Europe with the Sensei® X Robotic Catheter System 
and Artisan Guide Catheter used to manipulate marketed catheters show a similar event rate to 
standard percutaneous cardiovascular and ablation procedures.10,11,12,13 
The Sensei® X Robotic Catheter System, family of Artisan guide catheters, and accessories are 
510(k) cleared to facilitate manipulation, positioning and control of both the Polaris DX and 
Livewire Steerable electrode catheters for mapping within the atria of the heart.  To date, over 
14,000 commercial procedures have been performed using the Sensei X Robotic Catheter System 
and family of Artisan Guide Catheters to manipulate catheters within the atria of the heart.  
The Sensei® X Robotic Catheter System and family of Artisan guide catheters were extensively 
tested for the CE mark and 510(k) clearance.  Full risk analyses have been conducted for the 
Hansen System for navigating a commercially available ablation catheter. 

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The primary risks associated with use as proposed in this study are not necessarily associated with 
the Hansen System, but are inherent in performing any interventional electrophysiological or 
ablation procedure. These risks include major adverse cardiac events (MACE) as listed in section 
8.0 Risk Analysis.  The MACE rates associated with the use of the Hansen System are not 
anticipated to be greater than those associated with manual positioning of intra-cardiac ablation 
catheters. 
1.4
Alternatives
Alternative therapy for symptomatic paroxysmal atrial fibrillation includes the following: 
Pharmacological therapy for rate and/or rhythm control,
Electrical cardioversion,
Surgical intervention to create atrial lesions, 
Implantable devices to control heart rate, 
Ablation therapy with approved guide catheters. 
1.5
Additional Information 
Even though the Hansen System is only used to position a therapy catheter and does not provide 
therapy, the FDA Guidances for Industry and Staff Cardiac Ablation Catheters Generic 
Indication for Use and Clinical Study Designs for Percutaneous Catheter Ablation for Treatment 
of Atrial Fibrillation have been referenced during the formation of this proposed study.  Because 
the ThermoCool® catheter was initially used in the study within its indication, labeling for the 
ThermoCool® catheter has also been referenced for creation of the study protocol.  The 
investigational plan also references the 2012 HRS/EHRA/ECAS Expert Consensus Statement on 
Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for subject Selection, 
Procedural Techniques, Subject Management and Follow-up, Definitions, Endpoints, and 
Research Trial Design. 
2.0
Purpose  
2.1
Study Purpose
The purpose of this clinical study, in the United States, is to demonstrate that the family of 
Artisan guide catheters controlled by the Sensei® X Robotic Catheter System can safely and 
effectively introduce and position a commercially available RF ablation catheter for the 
treatment of subjects with paroxysmal atrial fibrillation. This is a post market study outside the 
United States, with the Artisan catheters and Sensei X System used according to CE mark and 
per Instructions for Use. 
This study will gather data to assess the following primary study endpoints:  
1. The Major Complication rates including acute events through seven days (as defined in 
this investigational plan) and the incidence of esophageal injury and pulmonary vein 
stenosis through day 180.  
2. The Chronic Success rate from day 91 through day 365.

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2.2
Study Objective 
To evaluate the safety and effectiveness of the family of Artisan guide catheters when used 
to remotely introduce and position specified commercially available cardiac RF ablation 
catheters to treat subjects with paroxysmal atrial fibrillation.  
3.0
Device Description 
3.1
Device Name
Hansen Medical Sensei® X Robotic Catheter System and the family of Artisan guide 
catheters. 
3.2
Principles of Operation
The Hansen Medical device consists of two primary components, the Sensei® X Robotic 
Catheter System and the family of Artisan guide catheters (remotely controlled steerable 
guide catheters).  The physician remotely directs the movement of the Artisan Guide 
Catheter with the Sensei® X Robotic Catheter System. 
The Sensei® X Robotic Catheter System is an electronically controlled mechanical system 
for remotely controlling the family of Artisan guide catheters. The Sensei® X Robotic 
Catheter System is comprised of a physician workstation, an electronics rack, and a subject
side Remote Catheter Manipulator (RCM).  The system allows the clinician to direct the 
catheter tip to a desired intra-cardiac location based on visual feedback from 3-D
electroanatomic maps, fluoroscopic images and Intra-Cardiac Echocardiography (ICE) 
images while seated at the remote workstation.  The RCM electromechanically manipulates 
the steerable guide catheter in response to commands received from the physician through a 
special three-dimensional joystick called the Instinctive Motion Controller (IMC) at the 
physician workstation (Figure 1). 

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Figure 1: Sensei® X Robotic Catheter Control System
The family of Artisan guide catheters consists of the Artisan and the Artisan Extend Guide 
Catheters (Figure 2).  Each guide catheter is a conventional pull-wire actuated open-lumen 
guide catheter. The inner lumen is 8F diameter and the guide catheter fits through a 
standard 14F hemostatic introducer sheath. The guide catheters attach to the RCM (Figure 
3) through a sterile drape barrier and the RCM in turn actuates the catheter pull-wires in 
response to commands from the physician seated at the workstation.  The Artisan and 
Artisan Extend are guide catheters and do not have therapeutic or diagnostic capabilities on
their own.
The Artisan was originally cleared with the Sensei® Robotic Catheter System under 510(k) 
K052480 in May, 2007 and CE marked in September 2006. The Artisan Extend, cleared 
under 510(k) K122275 in August, 2012 and CE marked in February, 2013, is an extension 
to the Artisan family of guide catheters. The navigation capabilities of these catheters are 
identical.  The difference between the two catheters is the proximal flush assembly that 
remains outside of the body throughout the procedure and is the hemostatic introduction 
point for commercially available catheter-based devices.  

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                           Figure 2:  Distal Tip Articulation of The Family of Artisan Guide Catheters 
Figure 3: Artisan Catheter Attached to the RCM
The Sensei® X system also has a feature called IntelliSense, cleared under 510(k) K073225,
that provides the physician with information about the relative level of contact force being 
applied through the family of Artisan guide catheters. The feature uses force sensors at the 
proximal opening of the Artisan Guide Catheter to grip the mapping catheter. The output 
from the force sensors is presented to the physician at the Sensei® X workstation in grams 
on an instantaneous analog graphic scale, on a running strip-chart scale and via a light, non-
directional buzz on the IMC that increases as the reading increases. A sample of the 
IntelliSense output scale on the workstation screen is shown in Figure 4. 

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Figure 4: IntelliSense Displays (highlighted in yellow)
3.3
Intended Use
No changes are being made to the Sensei® X Robotic Catheter System or the family of 
Artisan guide catheters to execute this proposed IDE study.  Data from this proposed IDE 
clinical study will be used to support a submission to extend the intended use to include 
introducing and positioning of  specified commercially available RF ablation catheters for 
use in subjects with paroxysmal atrial fibrillation in the United States.
3.4
Ablation Catheters
The Sensei X Robotic Catheter System and Artisan guide catheters will be used in this 
study with commercially available cardiac RF ablation catheters that meet the following 
specifications1. The following catheters will be used in the study: the Biosense Webster 
ThermoCool,(NaviStar, SmartTouch and Celsius), St. Jude Medical Safire, and the Boston 
Scientific Blazer II.  If the ablation catheter does not meet the specifications below, it 
should not be used in the study. 
72                                                
1 Catheters evaluated through bench testing included the Biosense Webster NaviStar ThermoCool, Biosense 
Webster Celsius ThermoCool, Biosense Webster ThermoCool SmartTouch, St. Jude Medical CoolPath, St. 
Jude Medical Safire BLU, St. Jude Medical Safire, and the Boston Scientific Blazer II. 

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Commercially available radiofrequency cardiac ablation catheter 
Irrigated tip catheter 
Compatible with CARTO or EnSite Velocity mapping systems 
Compatible with an 8Fr sheath  
110
Compatibility with multi-plane deflectable sheaths 
Symmetrical tip bending performance.  This is observed by setting the ablation 
catheter in the neutral/straight position and attempting to manually deflect the tip in 
multiple planes.  If the bending performance is symmetrical, the catheter can be 
used.
The investigator may choose which ablation catheter is to be used for ablation treatment, as 
long as the catheter meets the specifications listed. 
4.0
Labeling 
Copies of Instructions for Use for the Hansen Medical Sensei X System and the family of 
Artisan guide catheters are provided in Appendix I. 
5.0
Study Design  
This is a prospective, single-arm, multi-center, US and OUS study to evaluate the safety 
and effectiveness of the family of Artisan guide catheters with the Sensei® X Robotic 
Catheter System for introducing and positioning one of a set of specified commercially 
available ablation catheter in subjects with paroxysmal atrial fibrillation.  Up to 14 
investigational sites will participate in this study to enroll a minimum of 125 and up to a 
maximum of 250 subjects.   
Interim analyses will be conducted starting after the first 125 subjects are enrolled, and 
continuing every 25 subjects thereafter.  At each interim analysis, enrollment may be 
stopped for expected success or for futility.  If there is at least 95% probability that both the 
safety and effectiveness analysis will meet the success criteria if enrollment stops at the 
current sample size and all patients are followed to the 12-month endpoint, then enrollment 
will stop early for expected success.  Up to three additional interim analyses will be 
performed: after full enrollment and at 3 and 6 months after full enrollment to assess the 
criteria for an early declaration of success.  If there is at least 99.9% probability that both 
the safety and effectiveness analyses will meet the success criteria after all enrolled 
subjects are followed to the 12-month endpoint, and if a minimum of 80 and 100 patients 
have complete follow-up for the effectiveness and safety endpoints, respectively, then the 
trial will declare early success.  A clinical study report can then be prepared for submission 
to the FDA.   

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Subsequently, the final analysis will occur when the 12-month follow-up is complete for all 
enrolled subjects.  An updated final clinical study report will then be prepared and 
submitted to the FDA to close out the IDE study. 
Based on the interim analyses defined for the study, the maximum number of subjects 
allowed at any site at each interim analysis is defined in the following table. 
Table 7: Maximum Subjects per Site at Each Interim Analysis 
Interim Analysis Sample Size
Maximum Subjects per Site
125
25
150
30
175
35
200
40
225
45
250
50
Study subjects with symptomatic, drug-refractory paroxysmal atrial fibrillation will 
undergo a catheter-based ablation procedure as part of this study to eradicate the aberrant 
atrial rhythm.  If necessary, up to two additional catheter ablation procedures within the 90-
day blanking period following the initial ablation procedure may be performed.
to ensure no evidence of left atrial thrombus.  A routine EP study may be performed to 
evaluate the location, morphology, and dimensions of each pulmonary vein by venogram.  
Intra-cardiac echocardiography (ICE) may also be performed prior to the ablation 
procedure at the physician
discretion.  
A subject is required to meet all the inclusion and none of the exclusion criteria to 
participate in the study.  Enrollment occurs when a subject signs the Informed Consent 
Form.  The subject must then meet all additional intra-procedural enrollment criteria (i.e. 
no intramural thrombus, etc.).  If the subject does not meet all intra-procedural enrollment 
criteria, the subject will not be treated with the study device and will be withdrawn from 
the study.  The screening, baseline, and withdrawal case report forms should be completed.  
The investigator shall report any acute procedural adverse events on the adverse event 
form. 
These subjects who are withdrawn prior to the procedure will count against the maximum 
enrollment limit.  However, the company requests that the maximum enrollment limit is 
increased accordingly to account for those who signed the Informed Consent Form but did 
not undergo the study procedure. 
5.1 
 Duration of Study
Subjects will be enrolled for up to one year and have follow-up evaluations at 7 days, 30 
days, 90 days, 180 days and 365 days post initial ablation procedure.  All subjects will be 
evaluated on the day of discharge or within 48 hours (whichever comes first), at 7 days post 
procedure by telephone and 30 days for safety, then 90 days, 180 days, and 365 days post 
procedure for safety and efficacy.  The total duration of the trial will be determined by the 

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adaptive design, and will be governed by the actual accrual rate and whether any of the pre-
specified rules for early stopping are met.  Expected study duration could range from 24 
months to 42 months. 
5.2
Primary Safety Endpoints
The primary safety endpoint is defined as the incidence of Major Complications, as defined 
below: 
Major Complications during the procedure through 7 days: 
Death 
Stroke 
Myocardial Infarction 
Diaphragmatic paralysis 
Transient Ischemic Attack (TIA) 
Cardiac Tamponade 
Pericarditis 
Pneumothorax 
Hospitalization or Emergency Room Visit  
Vascular Access Complication 
Heart Block 
Pulmonary Edema 
Pericardial Effusion resulting in pericardiocentesis or surgical intervention 
Thromboembolism 
Major Complications during the procedure through 180 days: 
Pulmonary vein stenosis  
Atrio-esophageal fistula  
Major Complication definitions can be found in Appendix L of this protocol.  All Major 
Complications, as reported by the clinical investigator, will be reviewed and adjudicated by 
the Clinical Events Committee (CEC). 
All adverse events will be documented and collected once the informed consent has been 
signed.
In the event of a study subject death, all possible efforts will be made to obtain relevant 
certificates, to determine the cause of death. 
5.3
Primary Effectiveness Endpoint
The primary effectiveness endpoint is chronic success. Chronic success is defined to be: 

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Freedom from symptomatic atrial fibrillation, atrial flutter, and atrial tachycardia 
episodes from days 91 - 365 after the initial ablation procedure, as documented by 
event recording, ECGs, and Holter monitoring. 
No use of Class I, Class II, Class III or Class IV antiarrhythmic medications during 
days 91 - 365 after the initial ablation procedure with the following exceptions.
Addition of Anti- Arrhythmic (AAD) medication which was previously 
ineffective for AF and does not exceed the previous historical maximum 
dosage (24 hour total dose). 
Use of Atrioventricular (AV) nodal blocking agents such as beta blockers (BB) 
and/or calcium channel blockers (CCB) that are maintained at the current dose 
(does not exceed previous historical maximum dosage (24 hour total dose). 
No more than two additional ablation procedures within 90 days of the initial ablation 
procedure and no additional ablation procedures after day 90. 
No use of a non-study device for ablation of any atrial fibrillation target. Commercially 
available non-study devices may be used for atrial flutter and atrial tachycardia ablation 
targets. 
No ablation of an atrial fibrillation target made by removing the  ablation catheter from 
the Artisan catheter and manually manipulating the ablation catheter.  
Pulmonary vein isolation of at least 3 out of 4 veins confirmed by pulmonary vein 
entrance block during the last procedure within the blanking period. 
No surgical ablation for atrial fibrillation, atrial flutter, or atrial tachycardia within 90 
days of the initial ablation. 
No direct current (DC) cardioversion for atrial fibrillation, atrial flutter, or atrial 
tachycardia within days 91 - 365 after the initial ablation procedure. 
No catheter or surgical ablation for atrial fibrillation, atrial flutter, or atrial tachycardia 
within days 91 - 365 after the initial ablation procedure. 
5.4 
Secondary Endpoints 
Acute Procedural Success
Acute procedural success is defined as the successful ablation of at least three of four 
pulmonary veins as shown by pulmonary vein entrance block per vein during the initial 
ablation procedure.  A subject is considered to be an acute procedural failure if acute 
procedural success cannot be obtained by using the Hansen system and, as a result, 
manual manipulation is needed to complete the ablation procedure with the ablation 
catheter. 
Chronic Safety
Chronic safety is defined as the incidence of Major Complications during the period 
from 8 365 days following the initial ablation procedure (excluding pulmonary vein 
stenosis and atrio-esophageal fistula from 8 180 days, which are included in the 

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primary safety endpoint).  The incidence of pulmonary vein stenosis and atrio-
esophageal fistula is included during the period from 181 365 days. 
5.5
Additional Analyses
Length of hospital stay, 
Total ablation time,
Total ablation energy, 
Total fluoroscopy time, 
Total procedure time (defined as the duration of time from obtaining vascular 
access to sheath removal), 
Non-AF targets ablated manually, 
Ablative lesion sets in addition to those required for pulmonary vein isolation, 
Adverse events, 
Serious Adverse Events, 
Chronic success rates for subjects treated with a single procedure.  
6.0
Statistical Hypotheses 
6.1
Primary Safety Endpoint
The primary safety endpoint is defined as the incidence of Major Complications, including 
all early onset (within 7 days of the ablation procedure) Major Complications, and the 
incidence of esophageal injury or pulmonary vein stenosis through 180 days. The study is 
designed to determine if the Major Complication rate meets the pre-established target 
performance goal (TPG) of 16%. The null hypothesis and alternative hypothesis are: 
H0:
s
16%    vs.    H1: 
s < 16%, 
where 
s is the probability of having a primary safety event.  The null hypothesis is rejected 
when at least 95% of the posterior distribution below 16%. 
6.2
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is chronic success as demonstrated by the freedom from 
symptomatic atrial arrhythmia from days 91 to 365 (as well as additional criteria defined in 
Section 5.3).  The study is designed to determine if the effectiveness rate meets the pre-
established target performance goal (TPG) of 54%. The null hypothesis and alternative 
hypothesis are: 
H0:
E
54%    vs.   H1: 
E > 54%, 

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where 
E is the probability of meeting the primary effectiveness endpoint.  The null 
hypothesis is rejected when at least 95% of the posterior distribution is above 54%. 
6.3
Secondary Safety Endpoint Chronic Safety
The secondary safety endpoint is demonstration of the long term safety of remotely
introducing and positioning ablation catheter through the Artisan Guide Catheter.  The 
secondary safety endpoint is defined as the incidence of Major Complications from days 8
to 365.
The proportion and the one-sided 95% upper confidence level will be calculated for long 
term safety using the Kaplan-Meier method to account for censoring.  No hypothesis test 
will be performed for the secondary safety endpoint.
6.4 
Secondary Effectiveness Endpoint Acute Procedural Success 
The secondary effectiveness endpoint is acute success of remotely introducing and 
positioning of commercially available ablation catheter through the Hansen system. The 
secondary effectiveness endpoint is defined as the rate of acute procedure success for at 
least three out of four pulmonary veins as shown by pulmonary vein entrance block per 
vein during the initial ablation procedure.  A subject is considered to be an acute failure if 
acute procedural success cannot be obtained by using the Hansen system and, as a result, 
manual manipulation was needed to complete the ablation procedure. 
The rate is estimated using proportions per subject.  A one-sided 95% lower confidence 
level will be calculated for acute success rate.  No hypothesis test will be performed for this 
secondary effectiveness endpoint.
6.5       Justification for Sample Size 
This study will use a Bayesian adaptive design.  The total sample size will be no less than 
125 subjects and will not exceed 250 subjects (however, the maximum may be increased to 
replace subjects who have been withdrawn prior to the procedure).  It is estimated that 5% 
of the subjects enrolled will be withdrawn prior to the study procedure.  
rate for the primary safet
equal 72%, then the probability of study success using this adaptive design would be 98%.  
See Appendix M for details of the adaptive procedure.  
6.6      Target Performance Goals 
The target performance goals for the study are primarily based upon the pivotal IDE study 
conducted by Biosense Webster on the NaviStar® ThermoCool® device for the treatment 
of subjects with symptomatic paroxysmal atrial fibrillation (ClinicalTrials.Gov Identifier: 
NCT00116428).  The results of the study were submitted to FDA in PMA Supplement 
P030031/S011.  The inclusion and exclusion criteria and study endpoints for this study are 
equivalent to the NaviStar® ThermoCool® study. 

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The NaviStar® ThermoCool® study reported a primary safety endpoint of 11% and a 12 
month primary effectiveness rate of 64%.  The target performance goals are defined by 
incorporating a clinically nonsignificant difference to the reported safety and effectiveness 
ThermoCool® rates.  The approach is analogous to the choice of a non-inferiority margin 
for a randomized non-inferiority study. 
For the primary safety endpoint, a 5% margin is added to the NaviStar® ThermoCool®
results, resulting in a target performance goal rate of 16%.  For the primary effectiveness 
endpoint a 10% margin is subtracted from the ThermoCool® rate, resulting in a target 
performance goal of 54%. 
6.7      Data Analysis  
All statistical analyses will be done using the SAS software version 9.3 or later (Copyright 
© 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All 
rights reserved), R software or StatXact (Copyright © 2010, 1989-2012, Cytel Software 
Corporation). 
All data will be collected as detailed in the clinical trial schedule.  Subject demographics, 
medical history, risk factors, procedure characteristics, and outcome variables will be 
summarized using descriptive statistics for continuous variables (e.g. mean, standard 
deviation) and frequency tables or proportions for discrete variables. 
subjects who signed an informed consent form.  Subjects who are not enrolled due to not 
meeting the intra-procedural criteria are considered to be withdrawn from the study.  
Subjects who have already had a 14F introducer sheath introduced who subsequently are 
withdrawn during the procedure prior to treatment with the study device will be monitored 
for any acute adverse events related to the introduction of the 14F introducer sheath.  Acute 
safety data for these subjects will be reported as a separate cohort, since these subjects are 
not treated with the study device.  Additional subjects may be enrolled to replace subjects 
who were withdrawn due to not meeting the intra-procedural enrollment criteria.  The 
primary statistical analysis will be performed on the cohort of subjects who are enrolled,
meet the intra-procedural enrollment criteria, and are treated with the study device.
The following additional endpoints will be analyzed but will not be tested for statistical 
significance and will be reported as proportions, or means and standard deviations. 
Length of hospital stay, 
Total ablation time,
Total ablation energy, 
Total fluoroscopy time, 
Total procedure time, 
Non-AF targets ablated manually, 
Ablative lesion sets in addition to those required for pulmonary vein isolation, 

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Adverse events, 
Serious Adverse Events, 
Chronic success rates for subjects with a single procedure. 
6.8     Poolability
Investigational Site 
Investigational sites will use a common protocol, the sponsor will adequately monitor the 
study to assure protocol compliance, and the data gathering and validation mechanisms will 
be the same across all study sites. The results for the primary endpoint will be stratified by 
clinical site. Sites with five or less subjects will be pooled together into a single pseudo 
site. The rates for the primary safety and primary effectiveness endpoints will be compared 
across sites using a F
Exact test.  The p-value cut off for significance will be p=0.15.  
Note that differences in results across sites due to a site/investigator effect cannot truly be 
assessed in a single arm study since it can be confounded with differences in demographics 
and baseline characteristics across sites. Hence, should the resulting p-value for the site to 
site comparison be less than 0.15 a comparison of demographics/baseline characteristics 
(including age, gender, cardiac history, CHADS score, lesion sets) across site will be made. 
All variables that differ across sites (p<0.15) will be included in a multivariate logistic 
regression model along with site, using the endpoint outcome as the dependent variable in 
order to determine if the observed site differences persist after adjustment for these 
characteristics.

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Geographic Region 
A similar analysis will be performed to compare results across the two regions, for all US 
sites combined and for all OUS sites combined.  The study will include a maximum of 
seven OUS sites, and these sites may not enroll more than 50% of the total subjects 
enrolled in the study. The primary endpoints will  be presented stratified by US versus 
OUS sites
are found (p<0.15), then any baseline differences detected will be included in a multivariate 
model along with site as independent variables and the outcome variable as the dependent 
variable. This multivariate analysis will be performed to assess the effect of site after 
adjusting for potential confounders.  
Ablation Catheter  
A similar analysis will be performed to compare results from various ablation catheters 
used during the study. The primary endpoints will be presented stratified by ablation 
catheter type, and the results will be compared using a F
  If differences in 
outcomes are found (p<0.15), then any baseline differences detected will be included in a 
multivariate model along with the ablation catheter as independent variables and the 
outcome variable as the dependent variable. This multivariate analysis will be performed to 
assess the effect of ablation catheter after adjusting for potential confounders.     
Subject Withdrawal and Missing Data 
Missing data at interim analyses and final analysis will be handled using a multiple
imputation approach. Missing final outcomes for the primary efficacy and safety endpoints 
will be multiply imputed using a piece-wise exponential time-to-event model.  Sensitivity 
analyses will be performed to evaluate subjects who are not compliant with the
transtelephonic monitoring (TTM) requirements.  See Appendix M for the statistical 
details of this model, which includes sample size
7.0
Study Procedures 
7.1
Inclusion and Exclusion Criteria
Subject Inclusion and Exclusion Criteria - Subjects are required to meet all the 
inclusion/exclusion criteria to be eligible for participation (including intra-procedural 
criteria). 
The following sections outline the specific inclusion and exclusion criteria for the study.  
Subjects who meet all of the general inclusion criteria and none of the exclusion criteria 
will be eligible for study participation. 
Inclusion Criteria 
To be eligible for enrollment in the study the following criteria must be met: 

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1. Subjects with paroxysmal atrial fibrillation who have had two or more spontaneously 
terminating episodes of atrial fibrillation that last longer than 30 seconds and shorter 
than 7 days, in the nine months prior to enrollment.  At least one episode must be 
documented with ECG, transtelephonic monitoring (TTM), Holter monitor, or 
telemetry. 
2. Failure of at least one Class I  IV anti-arrhythmic drug (AAD) for PAF as evidenced 
by recurrent symptomatic PAF, or intolerable side effects due to AAD.  AADs are 
defined in Appendix B.   
3. Signed informed consent. 
4. Age 18 years or older. 
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements. 
Exclusion Criteria: 
Subjects are ineligible for enrollment in the study if they meet any of the following 
criteria: 
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or 
non-cardiac cause. 
2. Previous ablation for atrial fibrillation. 
3. Atrial fibrillation episodes that last less than 7 days and are terminated by 
cardioversion. 
4. Previous valvular cardiac surgery procedure. 
5. Cardiac artery bypass graft procedure within the previous 180 days. 
6. Previous septal defect repair. 
7. Expecting cardiac transplantation or other cardiac surgery within the next 180 days. 
8. Coronary PTCA/stenting within the previous 180 days. 
9. Documented left atrial thrombus on ultrasound imaging (TEE). 
10. Documented history of a thrombo-embolic event within the previous 365 days. 
11. Diagnosed atrial myxoma. 
12. Presence of an implanted ICD. 
13. Presence of permanent pacing leads. 
14. Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any 
other disease or malfunction of the lungs or respiratory system with chronic symptoms. 
15. Significant congenital anomaly or medical problem that in the opinion of the 
investigator would preclude enrollment in this study. 
16. Women who are pregnant.

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17. Acute illness or active infection at the time of index procedure documented by pain, 
fever, drainage, positive culture and/or leukocytosis (WBC > 11.000 mm3) for which 
antibiotics have been or will be prescribed. 
18. Creatinine 2.5 mg/dl (or 
221 µmol/L). 
19. Unstable angina. 
20. Myocardial infarction within the previous 60 days. 
21. Left ventricular ejection fraction less than 40%. 
22. History of blood clotting or bleeding abnormalities. 
23. Contraindication to anticoagulation. 
24. Contraindication to computed tomography or magnetic resonance imaging procedures. 
25. Life expectancy of less than 1 year. 
26. Enrollment in another investigational study. 
27. Uncontrolled heart failure (NYHA class III or IV heart failure). 
28. Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter 
introducing or positioning. 
29. Presence of a condition that precludes vascular access. 
30. Left 
31. INR greater than 3.0 within 24 hours of procedure.* 
32. Use of amiodarone therapy within the 3 months prior to the ablation procedure 
within 24 hours pre-procedure, another INR may be done on day of procedure, if 
INR results < 3.0, subject may be enrolled. 
7.2
Assignment of Subject Identification Number 
All subjects screened and enrolled in the study will be assigned a subject ID number.  The 
format is alpha numeric and three parts.  The first part represents the three character site 
i.e., 01A, 02A, etc.  The second part is numeric (three digits), assigned sequentially 
beginning with 001 for the first subject.  The thi
Thus, the first subject, Mickey Sue Mouse at site 01 will be assigned 01A-001-MSM; the 
next subject, Donald Duck (no middle name), will be assigned an identification number of 
01A-002-D-D, etc. Per regulations, we cannot collect subject initials for all of the OUS 
sites participating in this study, therefore we 
The subject initials for OUS sites will be: site identifier (assigned by Hansen Medical) 
identifying sequential number- OUS.  
7.3
Baseline, Pre-Procedure, Procedure, Pre-Discharge and Follow-up
The definition of study time points and schedule of study assessments to take place during 
the study are outlined in Table 8 and Table 9below.  The events and assessments that are to 

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take place at each study time point are described in detail below.  Standard of care for 
events and assessments may vary from site to site. 
Screening/Baseline Evaluation  within 30 days of enrollment 
The following baseline data must be collected from all subjects prior to enrollment in the 
study. Subjects will be screened for eligibility by the investigator or designee.  Subjects 
who meet the eligibility criteria for participation will be required to read and sign an 
Informed Consent Form prior to baseline evaluation.  A medical history inclusive of 
medications will be taken and a physical examination will be performed to assess overall 
physical status. 
Test results that are within the timeframes specified below may be used even though the 
standard of care tests with the intent to minimize stress and discomfort to the subject and 
reduce costs.  Required screening evaluations include the following. 
The following evaluations will be conducted at the baseline visit:  
Inclusion/Exclusion criteria assessment, 
Informed consent, 
Demographics, 
Medical history, 
Medication history: Antiarrhythmics (2 years); Anti-platelets & Anticoagulation (3 
months), 
Physical examination, 
Vital signs, 
New York Heart Association (NYHA) Class (see Appendix E), 
Laboratory evaluations, 
CBC, 
INR (only if subject previously on anticoagulation therapy), 
Serum Creatinine, 
Blood Urea Nitrogen (BUN), 
Pregnancy test (women of child bearing potential) within 7 days of 
procedure,
If a subject become pregnant during this study, she must notify the 
site staff 
TTE to assess cardiac structure, function, LA size and EF (within 3 months prior to 
procedure),
CT or MR (within 3 months prior to procedure) to evaluate pulmonary vein and 
left atrial morphology and dimensions.

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Note: If a CT or MR is performed at baseline, the same imaging specifications 
performed at baseline must be performed at the follow-up visit for 180 and 365 day.
Pre-Procedure Evaluation Within 24 hours of procedure 
Within 24 hours prior to the initial ablation the following will be done: 
Blood will be drawn to measure for INR value*, 
12-lead electrocardiogram (ECG) performed to check for cardiac rhythm and 
indication of myocardial ischemia, 
TEE/ICE should be performed to assess for possible atrial thrombus 24 hours prior 
to procedure or the day of the procedure.  Also to establish that thrombus, cardiac 
structure, function, LA size and EF meet protocol criteria. 
within 24 hours pre-procedure, another INR may be done on day of 
procedure, if INR results < 3.0, subject may be enrolled.
Table 8: Definition of Study Time Points 
Interval
Time Point and Window (if applicable)
Screening/Baseline
Within 30 days except for pregnancy test (within 7 days), from 
initial ablation
Pre-procedure
Within 24 hours prior to the initial ablation.
Enrollment
Subject is considered to be enrolled once they sign the Informed 
Consent Form.
Discharge
0
48 hours or prior to discharge; whichever comes first.
7-Day Follow-up
7 days + 3 days.
30-Day Follow-up
30 days ± 14 days post initial ablation procedure.
90-Day Follow-up
90 days ± 14 days post initial ablation procedure.
180- Day Follow-up
180 days (6 months) ± 30 days post initial ablation procedure.
365- Day Follow-up
365 days ± 30 days post initial ablation procedure.

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Study Procedure 
Pulmonary vein (PV) isolation is the required ablation procedure.  Additional optional 
ablation procedures are allowed based on clinical findings after the PV isolation is 
completed.  Any non-PV foci identified in the left atrium (LA) and/or right atrium (RA) 
that trigger AF should be ablated. Isolation of the superior vena cava (SVC) should be 
performed if AF triggers are identified inside the SVC.  Atrial linear lesions are allowed 
only if any arrhythmia is induced post PV isolation.  
In the US, several catheters are approved for the treatment of various cardiac 
arrhythmias.  Only commercially available catheters that meet the specifications 
defined in this protocol may be used in this study.  The subjects will be prepared, 
hemostatic introducers will be inserted, and anesthesia will be delivered per the 
standard protocol for the electrophysiology (EP) lab.  A 30cm 14F femoral 
introducer sheath is recommended for introducing of the Artisan catheter.  
A single or double trans-septal puncture will be completed per standard EP lab 
protocol to access the left atrium.  
Systematic anticoagulation with heparin shall be administered per standard EP lab 
protocol with a recommended activated clotting time (ACT) of 300-400 seconds 
checked every 30 minutes. 
Evaluation of the location, morphology, and dimensions of each pulmonary vein 
by venogram or ultrasound may be performed at the discretion of the investigator.  
To evaluate the presence of intracardiac thrombus, TEE should be performed 24
hours prior to the procedure or the day of the procedure. 
Diagnostic catheters, such as coronary sinus and circular mapping catheters may 
be appropriately placed during the procedure at the discretion of the investigator. 
A routine EP study may be performed at the discretion of the investigator. 
Precautionary measures such as phrenic nerve pacing may be performed at 
investigator discretion prior to ablation. 
An esophageal temperature probe shall be placed to monitor esophageal 
temperature when ablating of the posterior left atrial wall.
If the subject is in atrial fibrillation, cardioversion may be performed at the 
discretion of the investigator. 
A baseline structural echocardiogram (trans-thoracic, trans-esophageal, intra 
cardiac or IVUS) will be performed just prior to the introduction of the ablation 
catheter and a start time will be noted for the ablation portion of the procedure.  
If subject meets any of the intra-operative exclusion criteria, withdraw the subject 
from the study.  The screening, baseline, and withdrawal case report forms should 
be completed.  Any acute procedural adverse events shall be reported on the 
adverse event form. 

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The ablation catheter shall be inserted into the Artisan catheter.  If the ablation 
catheter does not fit smoothly through the Artisan catheter, the poorly fitting 
catheter should not be used and should be replaced with another catheter. 
Ablation of the cavotricuspid isthmus may be performed only in subjects with a 
history of typical atrial flutter or inducible cavotricuspid isthmus dependent atrial 
flutter.
SVC isolation shall be performed if AF triggering potentials are noted in the SVC. 
The ablation catheter will be remotely manipulated to map and ablate within the 
atria.  
The ablation catheter shall be placed within the Artisan catheter and 
manually introduced into the subject under fluoroscopic guidance. 
A CARTO or EnSite Velocity three-dimensional electroanatomic mapping 
system shall be used to map the anatomical locations of pulmonary veins 
and ablative lesions.
A circumferential anatomical approach shall be used to electrically isolate 
the pulmonary veins.  
Recommended Ablation Parameters: 
Place ablative lesions 1-2 cm outside of the pulmonary veins in order to 
minimize the risk of pulmonary vein stenosis.  Target Sensei® IntelliSense 
readings of 10-20g, with a maximum of 40g, during lesion creation. 
RF power should typically be set to 20-25W with a nominal maximum 
power of 30W. Starting at 20-25W in an anatomical region, RF power 
may be increased after 15 seconds in 5W increments to achieve a 
transmural lesion as shown by local atrial electrogram attenuation or 
splitting. Ablation duration at a single anatomical lesion location is 
recommended to be limited to 30 seconds. If the ablation output time for 
the RF generator is set for longer than 30 seconds, the ablation catheter
should be moved so that the ablation duration in a particular location 
When ablating on the posterior left atrial wall, power should be reduced to 
mitigate the occurrence of an atrio-esophageal fistula.  RF power should 
typically be set to 15-20W, and should not exceed 20W.  Esophageal 
temperature should be monitored and energy delivery should be 
terminated if the esophageal temperature reaches or exceeds 41°C, as 
measured from the esophageal temperature probe. 
Remember that stable contact between the catheter tip and the tissue 
increases the efficiency of RF power transfer to the tissue. 
For power levels up to 30W, a flow rate of 17 ml/min should be used 
(refer to the catheter Instructions for Use for specific recommendations for 
flow rate). If the temperature increases to greater than 50°C or the 

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immediately, the ablation catheter should be removed and the coagulum 
removed (if present), and irrigation flow confirmed before the catheter is 
used again. 
Verification of electrical PV isolation:  A circular or basket catheter shall 
be used for verification of PV isolation by demonstrating entrance block 
for each pulmonary vein.  Confirmation of PV isolation in at least 3 of 4 
pulmonary veins must be achieved to meet the criteria for acute procedural 
success. 
A second structural cardiac echocardiogram (trans-thoracic, trans-esophageal, 
intra cardiac or IVUS) will be performed five minutes after the ablation catheter is 
removed from the subject to assess for the presence of a pericardial effusion. The 
time of this evaluation will be documented.   
Refer to the Hansen Medical Artisan IFUs and the ablation catheter IFU for more 
catheter use information. 
It should be recorded in case report forms if it is not possible to safely 
complete treatment of a pulmonary vein due to proximity of the phrenic 
nerve or esophagus. 
Additional optional ablation lesions shall be noted (for example: mitral 
isthmus, cavo-tricuspid isthmus, or non-pulmonary vein foci). 
For every RF energy application, the following ablation information will 
be collected: force, power, impedance value, temperature, irrigation flow 
rate, and ablation duration. Refer to the case report forms for specific 
items. 
Post-Procedural Care:   
Subjects will be monitored in the recovery room until stable per the investigative 
-treatment procedures.   
Low molecular weight or intravenous heparin should be used as a bridge to 
resumption of systemic anticoagulation following catheter ablation and sheath 
removal. All subjects should be on anticoagulation therapy for at least two months 
following the procedure.  Decisions regarding the use of anticoagulation therapy 
for longer than two months following procedure should be bas
risk factors for stroke and not the presence or type of AF. A CHADS2 score will 
be used to determine the risk of stroke for the subjects and their need for 
anticoagulation therapy. Discontinuation of anticoagulation therapy beyond two 
months post ablation is not recommended in subjects who have a congestive heart 
failure, history of high blood pressure, age (75 years), diabetes, prior stroke or 
transient ischemic attack CHADS2 score of 
appropriate for subjects with a CHADS2 score of 1. Refer to Appendix N for the 
CHADS2 score.
This anticoagulation strategy is based on the 2012 HRS Consensus Task Force 
recommendations, as listed on Table 4, Page 24 of the referenced HRS document. 
Each subject may be treated again using the Hansen System up to two more times 
during the blanking period. 

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Any follow-up ablation procedure conducted within the study timeline for 
each patient, will need to be documented. The repeat ablation procedural 
date(s) and if the procedure was conducted manually or robotically will be 
the data points collected in the study database.  
Proton pump inhibitors should be administered for 4 weeks post ablation. 
Antiarrhythmic Drug (AAD) Therapy 
If the subject is being maintained on beta blocking agents, calcium channel 
blockers or digitalis for a condition other than for AAD purposes, this medication 
investigation unless deemed unnecessary or detrimental to the subject by the 
treating physician. 
Procedure through 90 days (blanking period) 
After the ablation procedure, subjects may be placed on AAD therapy: 
As prophylaxis for early AF recurrence 
For treatment of left atrial flutter 
A new medication or a previously prescribed medication may be used. 
It is recommended to withdraw AAD therapy 4-6 week post procedure to 
If symptomatic AF recurs following removal of AAD therapy 
during the blanking period, subjects may be offered an additional 
ablation procedure and/or placed on long term AAD therapy at the 
discretion of the investigator with a previously ineffective, but 
tolerated AAD dose.   
Class I, Class II, Class III and Class IV drugs may be used except 
amiodarone 
It is recommended that subjects be started on long term AAD 
therapy no later than 1-2 weeks prior to the end of the blanking 
period to ensure that adequate dosing is achieved. 
91 - 365 days (after the blanking period) 
Subjects may continue or start a previously used AAD medication 
up to the maximum historical dose 2 years prior to the procedure  
As a component of the primary effectiveness endpoint, success with respect to 
AAD therapy is defined as: 
Freedom from AAD therapy from 90-365 days (after the blanking 
period) 
Use of previously used AAD medication from 90-365 days which 
does not exceed the maximum historical dose 2 years prior to the 
procedure 

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An AAD failure is defined as: 
Use of previously used AAD medication from 90-365 days (after 
the blanking period) which exceeds the maximum historical dose 2 
years prior to the procedure 
New AAD therapy (not previously taken prior to procedure or 
during the blanking period) started after the blanking period 
This antiarrhythmic treatment strategy is based on the NaviStar® ThermoCool®
IDE study.  The strategy acknowledges that it is common practice to reinitiate 
antiarrhythmic drug therapy to attempt to control the AF. 
Pre-Discharge Evaluation 
Subjects will be evaluated for any change in antiarrhythmic, anti-platelet or 
anticoagulation medication from baseline medication, Major Complications (MC) and 
adverse events (AE) before hospital discharge or within 48 hours, whichever comes 
first The following evaluations will be performed at this pre-discharge visit: 
Record any changes in baseline anticoagulants, anti-platelets, or anti-arrhythmic
medications, 
Major Complications,  
Adverse events, 
CBC,
BUN/CR,
12-lead ECG, 
Physical examination, including pulse rate, respiration rate, and blood pressure. 
Follow-up Evaluation 
7 days (± 3 days) post procedure 
A scripted phone call will be made to the subject to assess for Major 
Complications, concomitant medications (antiarrhythmic, anti-platelet,  
anticoagulation, or proton pump inhibitor) and adverse events since discharge 
from the hospital.
30 days (± 14 days) post procedure 
Subjects will be asked to return for a follow-up visit at 30 ± 14 days.  At this 
follow-up visit, subjects will undergo an evaluation for changes in medications 
(antiarrhythmic, anti-platelet or anticoagulation), Major Complications and 
adverse events.  The following evaluations will be performed at this follow-up 
visit: 
Physical examination including, pulse rate, respiration rate, and blood 
pressure, 

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NYHA classification, 
Concomitant medications (antiarrhythmic, anti-platelet, anticoagulation, 
or proton pump inhibitor),
12-lead ECG, 
Major Complications, 
Adverse events. 
90 days (± 14 days) post procedure 
Subjects will be asked to return for a follow-up visit at 90 days (± 14 days).  At 
this follow-up visit, subjects will undergo an evaluation for changes in 
medications (antiarrhythmic, anti-platelet or anticoagulation), Major 
Complications and adverse events.  The following evaluations will be performed 
at this follow-up visit: 
Physical examination,
NYHA classification, 
Concomitant medications (antiarrhythmic, anti-platelet or anti-
coagulation),
12-lead ECG, 
Event recorder issued to subject at this visit to be in effect through day 365 
(1 year) to document symptomatic recurrence of AF.  Asymptomatic 
trans-telephonic monitoring (TTM) is required weekly for the first 8 
weeks and for any symptomatic episodes.  After 8 weeks, asymptomatic 
transtelephonic monitoring is required once per month and with 
symptomatic episodes throughout the end of the study.   
Major Complications,
Adverse events, 
Discontinuation of AAD. 
180 days (± 30 days) post procedure 
Subjects will be asked to return for a follow-up visit at 180 days (± 30 days).  At 
this follow-up visit, subjects will undergo an evaluation for changes in 
medications (antiarrhythmic, anti-platelet or anticoagulation), Major 
Complications and adverse events.  This visit will specifically evaluate the 
presence of esophageal injury or pulmonary vein stenosis. 
The following evaluations will be performed at this follow-up visit: 
Physical examination,
NYHA classification, 

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Concomitant medications (antiarrhythmic, anti-platelet or 
anticoagulation),
12-lead ECG, 
24 hour Holter monitor,
Cardiac CT or MR*, 
Major Complications, 
Adverse events. 
Note: The safety CT/MR imaging must have the same Imaging parameters as the
Baseline.  For example, if a CT performed at baseline, a CT must be performed at 
this visit with the same imaging specifications. 
365 days (± 30 days) post procedure 
Subjects will be asked to return for a follow-up visit at 365 (± 30 days).  At this 
follow-up visit, subjects will undergo an evaluation for changes in medications 
(anti-arrhythmic, anti-platelet or anticoagulation), Major Complications and 
adverse events.  The following evaluations will be performed at this follow-up 
visit: 
Physical examination,
NYHA classification, 
Concomitant medications (antiarrhythmic, anti-platelet or 
anticoagulation),
12-lead ECG, 
24 hour Holter monitor,
Major Complications, 
Adverse events, 
Cardiac CT or MR: only required in subjects showing more than 50% 
narrowing of a pulmonary vein at the 180 day cardiac CT or MR imaging. 
The imaging modality and parameters must be the same as the initial 
baseline imaging.
Study Exit. 
If at any time during the follow-up period a subject shows potential signs of 
pulmonary vein stenosis or atrio-esophageal fistula, the standard of care should be 
followed inclusive of the appropriate imaging for diagnosis.  All reports of 
imaging done outside of the protocol required follow-up are to be forwarded to 
the Sponsor.  

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Table 9: Schedule of Study Assessments 
Screening/ 
Baseline
(testing 
within 30 d)
Pre-
Procedure
(within 24 
hrs.)
Procedure
Pre-
Discharge
7-Day 
Follow-up
( 3d)
30 Day
Follow-up
( 14d)
90 Day
Follow-up
( 14d)
180 Day
Follow-up
( 30d) 
365 Day
Follow-up
( 30d)
Informed Consent
X
Demographics and Medical History
X
Physical Exam/Vital Signs
X
X
X
X
X
X
Medication History1
X
X
X
X1
X
X
X
Cardiac CT/MR*
X8
X
X11
12 lead ECG
X
X9
X
X
X
X
X
NYHA Class
X
X
X
X
X
TEE/ICE
X5
TTE
X10
X 6
Esophageal temperature monitoring
X
24 hr. Holter Monitor
X
X
Event Recorder (3 thru 12 months)
X7
X
X
CBC 
X
X
BUN/Creatinine
X
X
X4
INR2
X
X
Pregnancy Test (within 7 days)
X3
Adverse Events
X
X
X
X
X
X
X
Device Performance
X
Proton Pump Inhibitor Administration
X
X
discontinue
1. Antiarrhythmic Anti-platelet, Anticoagulation 
2. Only if subject on anticoagulation therapy 
3. Within 7 days of Procedure. Applicable to female of childbearing potential. 
4. Applicable only to subject in chronic renal failure or who had an elevated creatinine during index hospitalization. 
5. Within 24 hours of procedure, or at the onset of the procedure for both structural and thrombus evaluation. 
6. TTE, TEE, ICE or IVUS required prior to ablation catheter insertion and 5 minutes after ablation catheter removal.  
7. Each subject is to be given an event recorder at the 90 day visit. Subjects should continue to use event recorder as instructed thru the 365 day f/u visit. 
8. Within 3 months of initial ablation procedure 
9. Done at end of procedure prior to leaving EP lab. 
10. Within 3 months prior to procedure  
11. Subjects showing pulmonary vein (PV) narrowing of more than 50% at 180 day f/u visit shall have a cardiac CT or MR scan to evaluate for PV stenosis at 365 days. 
*Note: If a CT or MR is performed at baseline, the same imaging specifications must be used at the follow-up visit for 180 and 365 days.

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Figure 5: Study Algorithm for Subject Participation 
Consent & Enroll Subject
Meet Intra-Operative 
Criteria?
Procedure: Introduce and Position ablation 
catheter Remotely through Artisan Guide  
Catheter
Follow-Up Endpoints: 7 Days
Safety Endpoint  MCs & AEs
Procedural Endpoints: Safety Endpoint  Major Complications (MCs) & AEs
Secondary Endpoint  Acute PV Isolation
90 Day 
Effective-
ness 
Blanking 
Period
Follow-Up Endpoints: 30 Days
Safety Endpoint  MCs & AEs
Optional Treatment:
<90 Day 90, may 
perform up to 2
additional ablations 
using Hansen System 
and/or resume AAD
Follow-Up Endpoints: 90 Days
Safety Endpoint  MCs & AEs
Effectiveness Endpoint  ECG and Start Event Recording 
After 90 Days
Safety   MCs & AEs
Effectiveness Endpoint  ECG, TTM, All Class I & III antiarrhythmia drugs 
discontinued after blanking period and Continue Event Recording
Follow-Up Endpoints: 180 Days
Safety   CT or MR with PV stenosis analysis, MCs & AEs
Effectiveness Endpoint  ECG, 24-Hr Holter Monitor, and Continue Event Recording 
through 365 days
Follow-Up Endpoints: 365 Days
Safety   CT or MR for subjects with >50% PV narrowing at 180 days, AEs
Effectiveness Endpoint  ECG, 24-Hr Holter Monitor
Withdraw Subject
No
Yes

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7.4
Missed Follow-up Visits
If a subject refuses to return for any follow-up visit, the investigator or research personnel 
will attempt to obtain at least vital status and whether or not the subject has experienced 
episodes of AF.  A Protocol Deviation eCRF will be completed for each missed visit.  
The investigator will remain responsible for subject follow-up and data integrity.  A 
subject may be exited from the study if he/she has missed two consecutive follow-up 
appointments.  However, 3 documented attempts by investigator and study staff must be 
made prior to subject withdrawal.  An escalation of the follow-up attempts should be 
Escalation includes telephone calls, certified letters, email 
notification, and calls to family members.   
7.5
Subject Withdrawal or Lost to Follow-up
A subject may voluntarily withdraw from the study at any time.  The investigator and 
research staff should encourage all subjects to return for the Protocol required follow-up 
visits.  If a subject refuses study follow-up, he/she should be encouraged to be followed 
by a physician per the standard of care and the investigation site should attempt to collect 
vital status and study related adverse events. 
A subject will be considered lost to follow-up and terminated from the study by the 
Sponsor once the subject has missed two consecutive follow-up appointments and three 
documented attempts have been made by the investigator to contact the subject or 
must include a certified letter.  The Investigator must complete the appropriate eCRF 
7.6
Bias Control Measures - Core Laboratory Data Analysis 
Cardiac CT/MR 
A cardiac core laboratory will be utilized to allow for the objective evaluation of pre- and
post-procedure CT/MR imaging.  Evaluations of these images will be performed by the 
core lab s technical personnel trained in the evaluation of the images to detect the 
presence or absence of pulmonary vein stenosis per the core lab protocol.  The core lab 
will provide an imaging protocol for each type of imaging test listed in the protocol.  
Uniformity of these tests maximizes the accuracy of the comparison between the pre- and 
post-procedure results of each subject and comparison of test results between sites.  A
baseline cardiac CT/MR (performed within 3 months of the study procedure) must be 
completed for each study subject and submitted to the cardiac core laboratory for 
comparison to the study-required CT/MR image/s.  
Holter Monitoring and Event Recording 
A core laboratory will be used to evaluate the events obtained from the 24-hour Holter 
monitors and ECG data at the 6 and 12 month follow-up visits for recurrence of an atrial 
arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia) episode.  Initial 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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evaluations will be done by a technical person trained in the evaluation for these tests and 
the initial evaluations will be affirmed by a physician.
In addition to the clinical sites following the study subjects, the core lab also will track the 
subjects to ensure that each subject remains active in the use of their event monitor.  
Subjects will be provided a TTM monitor at the 90-day visit. The core lab will create and 
provide copies of the required TTM schedules for subjects to transmit their weekly and 
monthly transmissions in accordance with the protocol requirements.  Subjects are required 
to submit asymptomatic readings weekly for 8 weeks following the blanking period, then 
once a month on a monthly basis for the remainder of the study. Study subjects also will 
be instructed to use the event monitor at any time following their 90 day through day 365 
follow up visit for any recurrence of their symptoms.  The core lab will accept subject
transmission 24 hours a day and 7 days per week.  If a study subject misses their scheduled 
transmission, the core lab will contact the site until the subject is reached and a transmission 
has been received.   
Study subjects will be considered compliant with the use of the TTM device if they transmit 
within ±3 days of their scheduled transmission date and achieve at least 80% of their 
scheduled transmissions. If the TTM compliance rate is less than 80%, it will be considered 
as a major protocol deviation. 
7.7
Clinical Events Committee 
A committee of physicians, with a specialty related to the study procedure and not 
associated with Hansen Medical will be selected as the Clinical Events Committee (CEC) 
for this trial. Responsibilities of the CEC are listed below: 
The approval of specific criteria used to define and categorize clinical events and 
clinical endpoints in the study in conjunction with the Sponsor. 
Reviewing and adjudicating all investigator-indicated device-related adverse events 
and all adverse events that have the potential to be Major Complications, including 
the occurrence of early onset events 7 days post ablation procedure) and the incidence 
of esophageal injury and pulmonary vein stenosis through 180 days.
 Review and adjudicate the following potential Major Complications (Section 7.8.3) 
that occur within 7 days of the ablation procedure, including: 
- Death,
- Stroke, 
- Myocardial infarction, 
- Diaphragmatic paralysis, 
- Transient ischemic attack (TIA), 
- Cardiac tamponade, 
- Pericarditis,
- Pneumothorax, 
- Hospitalization or emergency room visit,

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- Vascular access complications,
- Heart block, 
- Pulmonary edema,
- Pericardial effusion resulting in pericardiocentesis or surgical intervention,
- Thromboembolism. 
Review and adjudicate the occurrence of pulmonary vein stenosis or atrio-esophageal 
fistula through day 180.
Review and adjudicate adverse events reported as possibly/probably device-related.
Re-adjudicate events in question or when data subsequently changes or new data 
become available. 
See Appendix L for a definition of all Major Complications. 
7.8
Adverse Events
Adverse events (AEs) are defined as any unfavorable and unintended sign, symptom, or 
disease possibly associated with the study procedure, study device or required study 
testing.  This does not imply that there is a relationship between the adverse event and the 
device under investigation.  All AEs will be recorded onto the Electronic Data Capture 
(EDC) case report form for visits (post procedure) documented in the permanent medical 
record. The investigator is ultimately responsible for reporting AEs to the Sponsor.  The 
investigator will evaluate the AE in detail, including the date of onset, description, severity, 
duration, outcome, and causality as specified in this section. 
Intensity or Severity of an Adverse Event: 
The intensity or severity of each AE must be assessed according to the following 
classification:  
Table 10: Adverse Event Severity 
Mild 
An event that results in minimal transient impairment of a body function or damage 
to a body structure, and/or does not require intervention other than monitoring.
Moderate 
An event which results in moderate transient impairment of a body function or 
damage to a body structure, or which requires intervention, such as the 
administration of medication or cardioversion, to prevent permanent impairment of 
body function or damage to body structure.  
Severe
An event which is life threatening, which results in a permanent impairment of a 
body function or damage to a body structure, or which requires significant 
intervention, such as the major surgery, to prevent permanent impairment of body 
function or damage to body structure.  

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Outcome: 
The outcome of each AE must be assessed according to the following classification:  
Table 11: Adverse Event Outcome 
Resolved
Subject fully recovered with no observable residual effects.
Improved
.
Unchanged
AE is ongoing.
Worsened
.
Death
Subject died as a result of the AE (whether or not the AE is related to the 
investigational device or procedure).
Causality: 
The causality of each AE must be assessed according to the following classification:  
Table 12: Adverse Event Causality
Device related
The investigational device directly caused or contributed to the AE.
Possibly device related
The investigational device may have caused or contributed to the AE.
Procedure related
The event is directly associated by timing and/or is pathophysiologic with 
standard electrophysiology or ablation procedure described in this protocol.
Possibly procedure 
related
The event may be associated by timing and/or is pathophysiologic with 
standard electrophysiology or ablation procedure described in this protocol.
Not related
The event is not associated with the investigational device or the procedure 
described in this protocol.
Anticipated Adverse Events 
Procedure and device-related complications that may be anticipated in subjects 
undergoing electrophysiology ablation treatment are listed in Section 8.1.under the risk 
management section.  These pre-defined complications are considered anticipated AEs. 
Additionally, adverse events that are inherent to an interventional procedure and expected 
to occur in most subjects for a projected duration according to the opinion of the 
investigator may be considered unavoidable.  Such events include, but are not limited to, 
those listed in Table 13. Such adverse events that are considered expected and 
unavoidable to the study (ablation) procedure should not be reported during the study. 

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Table 13: DO NOT REPORT: Adverse events related to the initial ablation 
Description of the Event
Time Frame from the Index Procedure
Anesthesia-related nausea and/or vomiting.
Resolved within 48 hours with or without antiemetics.
Headache related to NPO status.
Resolved within 24 hours with or without pain 
medication.
Back pain related to laying on table.
Resolved within 48 hours with or without pain 
medication.
Pain at access site.
Resolved within 72 hours with or without pain 
medication.
Sleep problems or insomnia.
Resolved within 72 hours with or without sleeping 
medication.
Mild to moderate bruising or ecchymosis at 
access site.
Resolved within 7 days post procedure.
Vaso-Vagal reaction with access site introducer 
sheath removal.
Reversed with fluid bolus and/or atropine 
administration. 
Self-limiting pericarditis attributable to the 
ablation procedure defined as pleuritic chest 
discomfort with or without pericardial rub and 
ECG changes which did not require prolonged 
hospitalization.
Physician discretion
Nodal dysfunction rhythms (sick sinus 
syndrome, sinus bradycardia, sinus arrest or 
AV blocks) that resulted in symptomatic 
bradycardia, unrelated to the ablation procedure 
or pre-existing disease states, treated with
pacemaker implantation 
N/A
Recurrent AF is not considered an AE.  If 
recurrent AF triggers an event considered to be 
an AE (hospitalization >24hrs, stroke, etc.) then 
that event will be documented on the AE case 
report form.
N/A
Serious Adverse Events (SAEs): 
A Serious Adverse Event is any untoward medical occurrence that: 
1. Results in death,
2. Is life-threatening, 
3. Requires hospitalization or prolongation of existing hospitalization *,
4. Results in persistent or significant disability/incapacity, 
5. Requires medical or surgical intervention to prevent serious outcome.
*An observational, overnight hospital admission < 24 hours in duration does not qualify as a SAE. 
All serious adverse events must be reported by eCRF (entering the information into the 
study electronic database) by the investigator or their designee within 24 hours of 
receiving the report.  The investigator should follow all unresolved serious adverse events 
until the events are resolved, the subject is lost to follow-up, the subject has withdrawn 

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consent, or the adverse event is otherwise explained.  Investigators also are required to 
inform their IRB/EC of serious adverse events (as outlined in their IRB/EC procedures) 
and in accordance with FDA and local regulatory requirements.  All related medical 
records will be required for submission to Hansen Medical for serious adverse events 
reported.
Any death or atrio-esophageal fistula shall be reported to the FDA by Hansen Medical no 
The Hansen Medical contact for questions is: 
Tammy Drew 
Project Lead, Senior Clinical Research Associate  
Telephone:  650-404-2765 
E-mail: tammy_drew@hansenmedical.com 
Major Complications 
Major Complications are adverse events which may occur in conjunction with or 
following atrial ablation that are included in the primary safety endpoint for this study.  
The list and definitions for adverse events that are considered Major Complications are 
outlined in Appendix L. 
Should a Major Complication occur, the investigator is required to report by eCRF all 
available information regarding the Major Complication to the Sponsor promptly upon 
learning of the event.  Additional time may be required in order to obtain the background 
details related to a Major Complication; however, the report of its occurrence should be 
made to the Sponsor once the investigator first learns of the event.  All related medical 
records will be required for submission to Hansen Medical for Major Complications that
are reported. 
All potential Major Complications reported will be reviewed and adjudicated by the 
CEC.  Major Complications will be classified as either a Primary Safety Endpoint or a 
Chronic Safety Event depending on the event occurrence following the ablation 
procedure, (Refer to definitions in Sections 5.2 and 5.4). 
Unanticipated Adverse Device Effects 
An unanticipated 
on health or safety or any life-threatening problem or death caused by, or associated with, 
a device, if that effect, problem or death was not previously identified in nature, severity, 
or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated 
Part
812.39).

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The investigator must notify the Sponsor and IRB/EC of any UADE occurring during the 
clinical study no later than 10 working days after the investigator learns of the event.  All 
UADEs must be documented by the investigator including the date of onset, a complete 
description of the event, possible reason(s) for the event, severity, duration, actions taken 
and outcome.  Copies of all supporting documents should be sent to Hansen Medical.   
Any UADEs that occur during the course of the Study will be reported to the 
participating investigators and their IRBs/ECs.  A report from the Sponsor will be 
submitted to the FDA no later than 10 working days after being notified by the 
investigator.
7.9
Mechanical Failures or Malfunction  
If study device failures or malfunctions occur, contact Hansen Customer Service at 1-
866-426-0804, and refer to the Return Material Authorization (RMA) process in 
Appendix J.
Examples of possible device malfunctions include: 
Packaging is defective, 
Device physically deforms or breaks, even if caused by user error, 
Device fails to perform as intended. 
7.10
Medical Device Vigilance reporting (EU sites) 
For European investigational sites, the Medical Device Vigilance System will be used to
report incidents to the appropriate regulatory agencies
7.11
Data and Safety Monitoring Board 
The Data and Safety Monitoring Board (DSMB) is comprised of an independent group of 
experts serving in an individual capacity to provide their expertise and recommendations 
to Hansen Medical concerning the conduct of the study.  The board is composed of 
members including a biostatistician and physicians from one or more of the following 
disciplines: cardiology, neurology, and/or cardiac electrophysiology.  This board will 
assemble to review the results of each interim analysis or on an urgent basis (as needed) to 
review all CEC-adjudicated Major Complications and device-related adverse events.  The 
board has the responsibility to advise the Sponsor about the appropriateness of continuing, 
or terminating the study based on the findings of their review.  The board will generate 
reports to support their findings.   
7.12
Data Collection and Evaluation
Data gathered during the course of the study will be documented through electronic data 
capture (EDC).  Missing, incomplete or inconsistent data will be requested from the 
investigation site personnel and appropriate corrections will be made.  An audit trail will 
identify all changes and corrections to the electronic data.  Training on the use of the EDC 
system along with instructions for completion of the EDC eCRFs will be provided to the 
study site personnel by Hansen Medical or its designee.  

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7.13
Source Documentation 
Regulations require that an investigator maintain information in the stu
record to corroborate data collected on the eCRF.  To comply with these regulatory 
should be maintained and made available as required by Hansen Medical and/or its 
designee as well as regulatory inspectors. Access to original medical records must be 
provided.  Complete medical (clinical and hospital) records include but are not limited to 
the following documentation.   
Medical history/physical condition of the subject before involvement in the study, 
date and reports on study required testing sufficient to verify clinical protocol entry 
criteria.
Description of device usage during study procedure (procedural logs, drugs 
administered during the procedure, device identification information and disposition, 
date, time, imaging results and clinical findings, study specific worksheets etc.). 
f enrollment, procedure date, the study sponsor (Hansen 
Medical), site name, the subject
assigned study identification number, and 
documentation and confirmation that the appropriate informed consent was obtained 
from the subject.
Dated and signed notes 
-required visit. 
Lab test results.   
All ECG, Ultrasound, CT, MR and any other imaging reports, etc.   
Dated printouts or reports of special assessments (ECG report, imaging report, 
laboratory results etc.). 
Adverse event reporting and follow-up of the adverse event.  Information in the 
medical record should include at a minimum the following:  event description, 
severity, seriousness, onset date, date site became aware of event, duration, relation to 
study device, treatment, and outcome of the adverse event. 
This
includes number and type of attempts to ensure subject compliance to study-required 
visits. 
Source Documentation must be available at all times for inspection by the study monitors 
and regulatory inspectors. 
7.14
Protocol Deviations/Violations
A protocol deviation occurs when a clinical investigator and/or study site personnel do not 
conduct the study according to the clinical investigational plan (protocol).  All deviations 
must be recorded on the eCRF: Protocol Deviation.  United States regulations (21 CFR 
812.140) require that investigators maintain accurate, complete, and current records 
relating to the clinical study.  This includes documents showing the dates and reasons for 
each deviation from the clinical investigational plan.  Depending upon the nature of the 
protocol deviation, expedited reporting and prior approval from Hansen Medical may be 

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required.  All deviations will be summarized and submitted in IDE progress reports, annual 
reports, and the final study report to the FDA. 
If Hansen Medical finds that an investigator is not complying with the executed study 
agreements, the investigational plan, the FDA regulations, or the requirements of the 
reviewing IRB, prompt action will be taken to secure compliance.  In addition, the 
participation of the investigator may be terminated (21 CFR 812.46).  Additional 
information is provided in Section 13.4
Study Termination. 
Deviations with Expedited Reporting Requirements  
For the following types of protocol deviations (per 21 CFR 812.150), an investigator is 
required to notify Hansen Medical and the IRB within 5 business days of the deviation.   
Emergency Deviation from the Investigational Plan (a deviation to protect the life 
or physical well-being of a subject in an emergency). 
Failure to Obtain Informed Consent from the subject.  
Failure to apply any of the inclusion and exclusion criteria for subject enrollment 
into the study. 
Notification to Hansen Medical and/or the IRB should be documented and maintained in 
the clinical study file at the site and at Hansen Medical.   
Deviations Requiring Prior Approval  
An investigator is required to obtain prior approval from clinical study management at 
Hansen Medical and the IRB before initiating deviations from the Investigational Plan 
that affect the scientific soundness of the plan, or the rights, safety, and welfare of the 
subjects (non-emergent situation).  However, prior approval is not required in situations
not attend scheduled follow-up visit, laboratory test was performed incorrectly, and test 
equipment did not operate properly. 
Non-Urgent Deviations  
Protocol deviations which do not have the urgency associated with expedited notification 
or prior Hansen Medical/ IRB approval (as discussed in the above paragraphs) will be 
reported upon discovery, such as during completion of eCRFs or a monitoring visit.   
8.0
Risk Analysis 
8.1
Potential Risks
The primary risks associated with use as proposed in this study are not necessarily 
associated with the Hansen System, but are inherent in performing any interventional 
electrophysiological or ablation procedure.  These risks include major adverse cardiac 
events (MACE), venous perforation and dissection, cardiac tissue damage, and cardiac 
wall perforation with accompanying clinically significant hemo-pericardium and/or 

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cardiac tamponade requiring further intervention.  When used on the left side of the heart, 
additional risks include distal emboli leading to myocardial infarction and/or stroke, 
pulmonary vein (PV) stenosis, esophageal injury/atrio-esophageal fistula and phrenic 
nerve injury.  The MACE rates associated with the use of the Hansen System are not 
anticipated to be greater than those associated with manual positioning of intra-cardiac 
ablation catheters. 
2012 HRS Consensus Task Force identifies the general risks with atrial mapping and 
ablation procedures (Table 6, Page 41 of the referenced HRS document) include but are 
not limited to: 
Systemic
Allergic reactions 
Drug reactions 
Death 
Fever 
Infection/sepsis 
Low blood pressure 
Ischemia/infarction of tissue/organ 
Cardio-Pulmonary 
Angina/coronary ischemia 
Arrhythmias 
Atrial/septal defect requiring repair 
Bradycardia or other conduction disturbances 
Cardiac arrest  
Cardiac effusion 
Congestive heart failure 
Damage to the heart valves and/or supporting structures 
Dyspnea 
Endocarditis 
Hemoptysis 
Myocardial infarction 
Need for a permanent pacemaker 
Perforation of the cardiac muscle 
Pericarditis 

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Pulmonary edema 
Pulmonary embolism 
Pulmonary hypertension 
Pleurisy 
Pulmonary vein stenosis 
Pulmonary vein obstruction 
Respiratory arrest 
Tamponade 
Ventricular fibrillation 
Vascular 
Aneurysm 
Arteriovenous fistula 
Blood clots in peripheral arteries and/or veins 
Pain and tenderness at access site 
Perforation or rupture of a blood vessel 
Pseudoaneurysm 
Temporary or total occlusion of the blood vessel 
Thrombophlebitis 
Thromboembolic episodes 
Vascular access complications requiring intervention (e.g. bleeding and/or 
hematoma, vessel dissection, pseudoaneurysm, retroperitoneal hemorrhage, and 
infection) 
Vessel spasm 
Neurological 
Silent cerebral embolism 
Stroke or other neurological complication (e.g., paralysis, paraplegia or aphasia) 
Transient ischemic attacks (TIAs) 
Changes in mental status 
Femoral neuropathy 
Nerve injury/peripheral neuropathy 
Vagal nerve injury 
Other 
Esophageal injury, e.g. Atrio-esophageal fistula 

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Bleeding from anticoagulant medications 
Gastric motility/pyloric spasm 
Headache 
Heparin induced thrombocytopenia (HIT) 
Permanent or temporary nerve damage to the heart or diaphragm 
Renal failure/insufficiency, transient or chronic 
Surgery required for treatment of an adverse event 
Increased exposure to radiation 
Subjects will be offered sedation throughout the procedure. General risks of sedation 
include but are not limited to: 
Allergic reaction 
Aspiration 
Cardiac arrest 
Death 
Low/high blood pressure 
Nausea and/or vomiting 
Respiratory difficulties 
Headache 
Clinical evaluation of the Hansen System in humans is justified because the risks are reasonable 
in relation to the expected benefits of device use.   
Other risks potentially associated with the Artisan Extend Catheter include: 
Prolongation of the procedure 
General vessel damage 
Damage to vessels adjacent to the vessels used for advancing the system 
8.2
Minimization of Risks 
Efforts will be made throughout the course of this investigation to minimize these risks to 
subjects choosing to participate.  The following general efforts will be made to minimize 
these risks: 
Clearly defining the subject inclusion/exclusion criteria that ensure only appropriate 
subjects are enrolled. 
Clear conduct and documentation of the subject consent process by the investigator or 
the delegated authority at the site. 
Ensuring that the treatment and follow-up of subjects are consistent with current 
medical practices. 

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Selecting investigators who are experienced in EP and ablation procedures. 
Training to the study protocol.
Specific investigator eligibility criteria to participate in study (see Section 9.1).  
Frequent monitoring visits to investigational sites and status reports to the principal 
investigator and study administration personnel.
Additionally, every subject participating in this study will undergo the following to 
determine their anatomical suitability for the study procedure: 
Cardiac CT or MR  
ECG
TTE and/or TEE 
Intra-procedural echocardiogram  
Post procedure, subjects will be closely monitored in order to ensure for early detection 
& intervention for any observed adverse events. 
8.3
Potential Benefits
Although there is no guarantee of benefit, the Hansen System may offer the following 
benefits to the delivery of the ablation catheter with the intent to isolate and treat the 
pulmonary veins 
Effective single treatment success rate, 
Reduced procedure time, 
Reduced exposure time to ionizing radiation for the subject and physician. 
9.0
Selection of Clinical Investigators 
9.1
Clinical Investigator Requirements
Investigators selected will be responsible for fulfilling the clinical study requirements 
specified in this investigational plan.  The study center must have the necessary resources 
to comply with the requirements.  The following criteria will be used to select 
investigators for participation in the clinical study: 
Investigator is qualified by training and expertise in EP and ablation procedures. 
Investigator and sub-investigators must have previous experience using the 
Hansen System.  Hansen Medical must give approval for each physician, 
individually, to treat subjects.  This will be based on prior experience and training.  
Principal investigators shall attest to having performed at least 100 manual 
ablation procedures.  In addition, physicians must have completed at least 20 
Hansen remote procedures in the past 12 months to be qualified to be part of the 
study.  Physicians may be asked to cease study participation if they consistently 
fail to enroll 2 study subjects per month.  

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Investigational sites must have an established Institutional Review Board (IRB) or 
identified contract IRB.  IRBs must operate and function in conformance with 21 
CFR Part 56. 
Investigational sites must possess adequate research personnel to manage the 
administration of the study at the investigative site and to collect the data for 
sponsor submission.  
Investigator and clinical research staff have experience with US IDE studies and 
have the time to conduct the study in accordance with the investigational plan. 
Agreement to comply with the investigational plan and regulatory requirements. 
Adequate volume of potential subjects who meet the eligibility criteria. 
The number of simultaneous competing clinical studies should be such that the 
study investigator commits to enrolling a minimum of 2 subjects per month into 
the Hansen study. 
Investigators are expected to enroll at least 2 subjects per month within the first 3 
months after receipt of a Sponsor site activation letter. 
Appropriate facilities, resources, and equipment to conduct the study. 
Commitment by investigational personnel (investigator and study personnel) to 
undergo required study training. 
Commitment and able to complete study initiation activities in a timely manner 
(2-4 months). 
All investigators will sign the appropriate study-related agreements (Investigator/Sub-
Investigator Agreement, Clinical Research agreement) before study initiation.  
Training of Clinical Investigators 
All principal investigators have completed Hansen Medical Level II training and records 
are on file at Hansen Medical in the Training department. 
9.1.1.1 Protocol Training  
The training of appropriate clinical site personnel will be the responsibility of Hansen 
Medical or its designee.  To ensure uniform data collection and protocol compliance, 
a formal educational session to study personnel will include: review of the protocol, 
review of inclusion and exclusion criteria, instructions on procedural data collection 
and submission, and regulatory requirements.   
9.2
Subject Population 
The study population considered eligible for this study includes adult subjects diagnosed
with symptomatic paroxysmal atrial fibrillation refractory to medical treatment, suitable 
for treatment with a commercially available ablation catheter, who meet the inclusion 
criteria and do not meet any of the exclusion criteria and are willing to comply with all 
protocol required testing and follow-up. All subjects who are considered eligible for 
pulmonary vein ablation will be consecutively screened for inclusion into this study.   

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A Subject Screening Log will be maintained at each center to document select 
information about the subjects screened for enrollment.  This log will document which 
subjects met the eligibility criteria and which subjects did not.  For those that did not 
meet the eligibility criteria, the reasons for non-enrollment will be documented. Should a 
study eligible subject refuse consent, reason for refusal should be noted on the screening 
log, as well.  The Screening Log will be evaluated and discussed at each monitoring visit. 
9.3
Subject Enrollment 
Initiation of enrollment into the clinical study will begin following FDA supplemental 
IDE approval, investigative site Institutional Review Board (IRB), Ethics Committee 
(EC) approval and collection of all required regulatory documents by Hansen Medical.  A 
site should be in receipt of a site activation letter from the sponsor in order to initiate 
enrollment into the study.  Subject eligibility will initially be determined by the 
investigator based on the inclusion/exclusion criteria.  All subjects must be considered 
candidates for pulmonary vein isolation via a catheter ablation procedure.  The 
investigator will inform the subject of his/her eligibility and discuss the clinical study 
with the subject including the risks, benefits and required follow-up procedures before 
obtaining informed consent (see Appendix C for Informed Consent template).  Informed 
consent and The Health Insurance Portability and Accountability Act (HIPAA)
documents must be obtained prior to accessing any study related subject information or 
performing any baseline study-specific procedures. The informed consent process must 
10.0 Investigator Responsibilities 
10.1
Essential Documents for Study Start  
Investigators are required to provide Hansen Medical the following information prior to 
subject enrollment at the clinical site: 
Executed Non-Disclosure agreement. 
Copy of Principal In
signed & dated within 2 years.  
Signed and dated sub-
their participation in the study. 
Copy of current Prin
Sub-
be collected prior to their participation in the study. 
Executed Clinical Study Agreement. Signed Sub-Investigator Agreements must 
be collected prior to their participation in the study. 
Executed Site contract inclusive of budget agreement. 
Financial disclosure for Principal Investigator. Sub-Investigator financial 
disclosures must be collected prior to their participation in the study. 
IRB membership list or General assurance number. 
Laboratory certification and normal ranges for the determinations described by 
the protocol. 

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Copy of the IRB approval letter and IRB-approved informed consent document. 
Training Records, as applicable (investigational plan, data collection) for all site 
personnel currently involved in study activities. 
Completed Delegation of Authority (DOA) log listing all personnel currently 
involved in this study.  The DOA is a living document and should be updated as 
study personnel are added to or leave the study. 
Investigator signed Protocol Acknowledgement Form. 
10.2
Specific Investigator Responsibilities 
Subject Informed Consent 
Each potential subject that meets the inclusion/exclusion criteria for this clinical study 
will be informed of the requirements for participating in the clinical study.  Subjects will 
be provided with a copy of the Informed Consent Form and an opportunity to discuss any 
questions with the Investigator or trained designee.  Subjects will be informed that their 
medical records will be subject to review by the Sponsor, its designees and the FDA, and 
will be asked to sign an Authorization for the Use and Disclosure of Protected Health 
Information.   
Subjects will be informed that they may refuse to participate in this clinical study without 
loss of benefits to which they are otherwise entitled, and that if they choose to participate, 
they may withdraw at any time without prejudice to future care.  Once a subject agrees to 
the study requirements, the Informed Consent Form and Authorization for the Use and 
Disclosure of Protected Health Information (Sample HIPAA Consent found Appendix 
D) must be signed and dated by the subject or legal representative and the Investigator (or 
designee).  The original signed Informed Consent Form for each subject will be retained 
by the investigative site and is subject to review by the FDA and the Sponsor.  A copy of
Appendix C.
10.3
Compliance 
The investigator is ultimately responsible for all aspects of this study pertaining to study 
activities at the investigation site.  The investigator agrees to supervise and direct the 
performance of the study and specifically (but not limited too) be responsible for the 
following throughout participation in the clinical study: 
Ensure the clinical study is conducted according to the Investigator Agreement, 
the study protocol, all conditions of the FDA and IRB/EC approvals, and 
applicable FDA and any other local regulations. 
Ensure the clinical personnel at the investigation site assigned to the clinical study 
have participated in training on the clinical protocol, case report forms, and study 
device and data collection requirements. 
When delegating study tasks, the investigator is responsible for providing 
adequate supervision of those to whom tasks are delegated. The investigator is
accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  The investigator should ensure that 

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any individual to whom a task is delegated is qualified by education, training, and 
experience (and state licensure where relevant) to perform the delegated task. 
Identify a Study Coordinator for the site.  Working with and under the authority 
of the investigator, the study coordinator assures that all study requirements are 
fulfilled, and is the contact person at the site for all aspects of study 
administration. 
Protect the rights, safety, and welfare of subjects under his/her care. 
Track device usage in subjects. 
Report all adverse events to the Sponsor and IRB/EC as specified in this 
investigational p
/EC.
Ensure that informed consent is properly obtained and the process documented in
. 
10.4
Device Accountability
The Sensei® X Robotic Catheter Systems and the family of Artisan guide catheters for 
this study will be labeled with the current, 510(k) cleared indication.  Separate 
investigational device IFUs describing use specific for the clinical trial are provided with 
the protocol and include the statement "CAUTION-Investigational Device. Limited by 
Federal (or United States) Law to Investigational Use."  See Appendix I for copies of the 
investigational device Sensei® X, Artisan and Artisan Extend Guide Catheter IFUs.  A 
device tracking log and completion instructions will be provided to the Investigational 
Site personnel for the purpose of device tracking.  Device tracking logs will be reviewed 
at the site on a regular basis by study monitors.   
With the exception of devices requiring investigation for performance-related issues, 
single-use (disposable) items will not be retained. 
In order to return a device to Hansen Medical (e.g., for evaluation of a performance 
issue), call Customer Service @ 1-866-426-0804 and follow the flow sheet in Appendix 
J.
10.5
Investigator Reports
The investigator is responsible for the preparation, review, signature, and submission of 
the reports listed below.  These are subject to FDA inspection.

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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Table 14: Investigator Reporting Requirements 
REPORT
SUBMIT TO
DESCRIPTION
Unanticipated Adverse 
Device Effect (UADE)
SPONSOR and 
IRB/EC
The investigator must submit to the Sponsor and 
reviewing IRB a report of any UADE as soon as 
possible but not more than 10 working days after the 
investigator first learns of the effect.
Withdrawal of IRB Approval
SPONSOR
The investigator must report a withdrawal of the 
reviewing IRB approval within 5 working days.
Progress Report
SPONSOR and 
IRB/EC
The investigator must submit this report at regular 
intervals, but not less than once per year.
Deviation from Protocol
in Emergency Situation (if it 
was made to protect the life 
or physical well-being of a 
subject)
SPONSOR and 
IRB/EC
Deviation must be reported within 5 working days. 
Deviation from Protocol
Other
SPONSOR and 
IRB/EC
If the deviation may affect the scientific soundness of 
the plan or the rights, safety, and welfare of the subject 
(and is not an emergency), the deviation must be 
approved by SPONSOR, the reviewing IRB, and FDA 
prior to implementation.  If the deviation does not affect 
these issues (study soundness, rights, safety, etc.), then 
only SPONSOR must approve the deviation prior to 
implementation.
Final Report
SPONSOR and 
IRB/EC
This report must be submitted within 3 months after the 
termination or completion of the study.
All Case Report Forms
SPONSOR and 
IRB/EC (if 
requested)
Please refer to guidelines in Table 16.
Note:  reporting must be followed as required by national laws 
11.0 Institutional Review Board/ Ethics Committee 
It is the responsibility of the investigator to obtain approval of the protocol, subsequent protocol 
amendments, and informed consent from the IRB/EC at the study site prior to commencement of 
the study and enrollment of the first subject at a given site.  All correspondence with the IRB/EC 
should be retained in the study regulatory binder.  Copies of IRB approvals should be forwarded 
to Hansen Medical.  All adverse events and protocol deviations must be reported and study 
reports submitted per IRB/EC requirements, with copies also forwarded to Hansen Medical. 
12.0 Sponsor and Monitor Responsibilities 
12.1
Sponsor
The Sponsor will be responsible for ensuring the investigators have the necessary skills, training 
and information to properly conduct the clinical study.  The Sponsor will ensure proper 
monitoring of the clinical study, ensure IRB/EC approval is obtained and provide information to 
the investigators, the reviewing IRBs/EC and FDA concerning the progress and new information 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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about the clinical study.  The Sponsor will conduct the clinical study in accordance with 
applicable ISO, ICH and FDA regulations.  The Sponsor of this study is: 
Hansen Medical, Inc. 
800 East Middlefield Rd.  
Mountain View, CA  94043 
Telephone: 650-404-5800 
Facsimile:  650-404-2793
12.2
Sponsor Reports 
Hansen Medical is responsible for the preparation of, the accuracy of the data contained in, the 
review of and the submission of the reports listed below.  These reports also are subject to FDA 
inspection and the retention requirements described for sponsor records. 
Table 15: Sponsor Reporting Requirements 
REPORT
SUBMIT TO
DESCRIPTION
Unanticipated 
Adverse Device 
Effect (UADE)
FDA, IRB/EC,
Investigators 
SPONSOR will report UADE evaluation within 10 working days 
after receiving notice of the effect.
Withdrawal of 
IRB/EC Approval
FDA, IRB/EC,
Investigators 
Notification will be made within 5 working days after receipt of 
approval withdrawal.
Withdrawal of FDA 
Approval
IRB/EC and  
Investigators 
Notification will be made within 5 working days after receipt of 
the withdrawal of approval.
Current 
Investigator List
FDA
SPONSOR will provide an updated investigator list as required 
by 21 CFR 812.150(b) (4).
Progress Report
FDA, IRB/ECs, 
Investigators
An annual progress report will be submitted.
Recall and Device 
Disposition
FDA, IRB/ECs, 
Investigators
Notification will be made within 30 working days after the 
request is made, and will include the reasons for any request that 
an investigator return, repair or otherwise dispose of any devices. 
Final Report
FDA, IRB/ECs, 
Investigators
SPONSOR will notify FDA within 30 working days of the 
completion or termination of the study.  A final report will be 
submitted within 6 months after completion or termination.
12.3    Study Management and Monitoring 
The Clinical Project Manager is qualified by training and experience to oversee the progress of 
the study and will ensure that the investigators and their staffs understand and adhere to both the 
regulatory requirements and the study protocol.  The Clinical Project Manager will assist in 
resolution of any problems that may arise during the study.  The Sponsor may work with a CRO 
to assist in investigative site monitoring for this study. The CRO will be directly supervised and 
coordinated by the Clinical Project Manager. 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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The Project Lead for this study is: 
Tammy Drew 
Hansen Medical, Inc. 
800 East Middlefield Rd.  
Mountain View, CA  94043 
Telephone: 650-404-2765 
Facsimile: 650-404-2793 
E-mail: Tammy_Drew@hansenmedical.com
The Sponsor or designee will monitor all data submitted during the clinical study using their 
standard operating procedures for the monitoring process. 
12.4     Monitoring Procedures 
The monitoring procedures for this clinical study will include a pre-investigation site visit, 
review of completed data forms and other study documents, and periodic on-site monitoring.  
One hundred percent (100%) monitoring will be done for this study.  A final monitoring visit 
will also be conducted.  The study monitor(s) will assist with communication between the 
investigator and Hansen Medical. 
12.4.1 Pre-Investigation Site Visit 
Sites will be qualified to assure they have adequate EP and ablation experience, adequate 
time, subject population, facilities, staff support, commitment to the clinical study, etc. 
In addition, an initiation visit will be conducted to assure that each investigator and 
investigation site staff understands the protocol and the i
obligations.  Topics 
to be discussed will include: 
FDA regulations pertaining to the clinical study, including obligations of 
investigators and inspection procedures by FDA and the Sponsor. 
IRB/EC approval, continuing annual review and approval, and documentation to 
be provided. 
Training of investigators and coordinators and other study personnel to ensure site 
understanding of responsibilities and FDA regulations pertaining to the clinical 
study and the protocol. 
Informed consent requirements for each subject participating in the clinical study.  
Written informed consent must be obtained using the Informed Consent Form 
approved by the reviewing IRB/EC and Sponsor.  Documentation of the Informed 
Consent process must be in each subject s chart.
Record keeping requirements including required source documentation and device 
accountability. 
Completion and timely submission of eCRFs. 
Administrative, AEs, UADEs, and other reports and time frames. 

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Written site qualification and initiation visit reports will be filed with Hansen Medical.  
The monitor will document the resolution of any concerns and the completion of any 
appropriate follow-up activities resulting from the visit. 
12.4.2 Periodic Site Visits 
Periodic on-site monitoring visits will be made to ensure adherence to all applicable 
regulations, including: 
T
,
Appropriate informed consent practices,
The accurate completion of all required case report forms,
The accurate completion of all queries, 
The complete and accurate reporting of all adverse events, 
The maintenance of current IRB/EC approval and submission of required study 
progress reports to the IRB/EC,
The maintenance of records and reports,
The resolution of any study management issues. 
The study monitor(s) will be responsible to complete a review of source documents for 
accuracy, completeness, and legibility.  At a minimum, it is recommended that 
corresponding eCRFs be completed in EDC and ready for monitoring according to the 
time frames below.  
Table 16: eCRF Completion 
eCRF 
Recommended  Completion 
Time
Enrollment Form
Within 24 Hours
Index Procedure Forms (baseline through discharge)
Within 14 Days
7 day Phone Call 
Within 7 Days
30, 90, 180 & 365 Day eCRFs
Within 14 Days
Serious Adverse Event Form
Fax Within 24 Hours
Device Performance Form, if a failure mode noted
Within 24 Hours
Study Exit Form due to AE or Lost to F/U
Within 72 Hours
Other Forms (Protocol Deviation, AE Narrative Summary, etc.)
Within 14 Days
Event Recorder
Within 14 Days
Holter Monitor 
Within 14 Days

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12.4.3 Clinical Monitor Reports 
Site monitoring visits will be documented in a written monitoring report, prepared by the 
de 
the progress of the study and identification of any follow-up activities or concerns from 
review of the subject records, study management documents, and informed consent 
forms.  Resolution of concerns and completion of assigned tasks will also be documented 
in the monitoring report.  A summary of the report will be given to the investigator in the 
form of a follow-up visit letter. 
12.4.4 Final Monitoring Review and Study Closeout 
A close-out or final visit will be conducted at each site.  Any ongoing responsibilities will 
be discussed with the investigator and the investigation site personnel.  A final 
monitoring report will be completed.  A study closure letter will be sent to the 
investigator indicating the status of the study.  It is the responsibility of the investigator to 
/EC in writing with the submission of the closure letter.   
13.0 Ethical Considerations 
13.1  Human Subjects Protection 
The study will be performed in accordance with the relevant parts of the ICH Guidelines for   
GCP, 21 CFR 812, 50 and 56, and the Declaration of Helsinki. 
Sponsor and Investigator will comply with applicable sections of ISO 14155:2011 and any 
regional or national regulations, as appropriate.  
Investigator will not begin the clinical investigation until Investigator obtains the required 
written approval or favorable opinion from the IRB/ EC or regulatory authority, if appropriate.  
Investigator will follow any additional requirements imposed by the IRB/EC or regulatory 
authority, if appropriate.  
Sponsor will provide insurance for subjects, if required by national regulations.  
13.2       Emergency Actions 
Hansen Medical accepts the right of the investigator to deviate from the protocol in an 
emergency when necessary to safeguard the life or the physical well-being of a study subject. 
The investigator must give notice of any emergency deviations and justification for the 
deviation to the study personnel responsible at Hansen Medical and the IRB/ EC as quickly as 
possible after the episode, in any event no later than 5 working days after the emergency. 
13.3
Amending the Protocol 
This protocol is to be followed exactly.  If needed, Hansen Medical must write amendments in 
order to alter the protocol.  If any changes are required that affect the rights, safety, or welfare of 
the subjects or the scientific soundness of the study plan, they will be submitted to FDA as an 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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amendment or supplement to the IDE. Upon approval by the FDA, submission to each IRB/EC 
will occur.  
No amendment to the protocol can be implemented before achieving all regulatory approvals, as 
per country specific regulations.
13.4
Study Termination
Hansen Medical, the US FDA and/or the European EC have the right to terminate this study at 
any time and remove all study materials from the site.  A study may be terminated for any of the 
following reasons: 
Unsatisfactory rate of subject enrollment or compliance to eligibility criteria. 
Repeated noncompliance with the investigational plan. 
Inaccurate, incomplete, and/or untimely submission of data. 
The rate or severity of adverse events in the Hansen study or other similar studies 
indicates a potential health hazard to the subjects caused by the device.
14.0 Publication Policy  
Sponsor will limit its review to a determination of whether Confidential Information is disclosed
and shall not attempt to censor or in any way interfere with presentation or conclusions beyond 
the extent necessary to protect Confidential Information, to allow Sponsor to protect its rights in 
patentable or copyrightable material, and to check for technical correctness of Sponsor 
information.  When reasonably requested by Sponsor, Institution and Principal Investigator will 
delay publication up to an additional 60 days to allow Sponsor to protect its rights in patentable 
or copyrightable material. 
15.0 Study Definitions 
AF Episode: An episode of AF 30 seconds or longer in duration on Holter or Trans-telephonic 
Monitoring (TTM), or 10 seconds in duration on 12-lead ECG.
Atrial Tachyarrhythmia Episode: An episode of atrial tachycardia, tachyarrhythmia (atrial 
fibrillation, atrial flutter or atrial) 30 seconds or longer in duration on Holter or Trans-telephonic 
Monitoring (TTM), or 10 seconds in duration on 12-lead ECG. 
Blanking period:  90 day period between the index ablation procedure and the continuation of 
the 12 month follow-up period. If a subject is symptomatic during the 90 day blanking period, 
he/she may be placed on a previously ineffective Anti arrhythmic Drug (AAD).  If a subject 
remains symptomatic, the AAD dose may be increased, a new AAD added, or the subject may be 
treated again using the Hansen System up to two more times before day 90.  At the 90 day visit, 
subject will need to discontinue any class I, class II, class III and class IV AADs or maintain 
seline, at a dosage level less than or equal to the maximum 
baseline dosage.  Calcium channel and beta blocker medications may continue for uses other 
than an antiarrhythmic drug. 
Bleeding: A Major Complication of AF ablation if it requires and/or is treated with transfusion or 
results in a 20% or greater fall in HCT. 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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Discontinued Subjects: Subjects in whom the ablation catheter was inserted but did not undergo 
ablation was not possible due to non-study equipment failure or if their arrhythmia was 
determined to be a non-study arrhythmia (e.g. atrial flutter).  These subjects will be followed for 
7 days for safety endpoint evaluation. 
Enrollment: Subject is considered to be enrolled once they have signed the informed consent 
form.
Paroxysmal AF: An atrial fibrillation where a subject has two or more spontaneously terminating 
episodes of atrial fibrillation that last longer than 30 seconds and shorter than seven days. 
Screening Failure: Subject is excluded from enrollment from the study if they do not meet 1 or 
more of the pre-operative inclusion/exclusion criteria.  
Symptomatic AF: Symptoms of AF that were experienced by the subject, made them seek 
medical attention, and were concurrent with a documented episode by ECG, event monitor 
and/or Holter monitoring.  Symptoms may have included palpitations, irregular, rapid or slow 
pulse, dizziness, weakness, chest discomfort and breathlessness. 
16.0 References 
1.   Kazuhiro, S., et al; How to determine and assess endpoints for left atrial ablation.  Heart 
Rhythm. March 2007, Vol. 4, No. 3 p. 374-380.
2.   Saliba, W., et al; Atrial Fibrillation Ablation Using a Robotic Catheter Remote Control System.  
JACC, 2008 Mar; Vol. 51, No. 25, p. 2407-2411. 
3.   Reddy, V.Y., et al; View-synchronized robotic image-guided therapy for atrial fibrillation 
ablation: experimental validation and clinical feasibility. Circulation, 2007. 115(21): p. 2705-
14.
4.   Al-Ahmad, A., et al; Early experience with a computerized robotically controlled catheter 
system. J Interv Card Electrophysiol, 2005. 12(3): p. 199-202.
5
Faddis M.N.,et al; Magnetic guidance system for cardiac electrophysiology. JACC, 2003 Sep; 
42(11), 1952-1958. 
6. Simmers TA, et al: Effects of intracavitary blood flow and electrode-target distance on 
radiofrequency power required for transient conduction block in a Langendorff-perfused 
canine model. J Am Coll Cardiol 1998; 31:231-235.
7. Michael Koa-Wing, BSc, MRCP, et al;  Robotically assisted ablation produces more rapid and  
greater signal attenuation than manual ablation.  J Cardiovasc Electrophysiol. 2009; article 
published on-line Oct 13 in advance of print.
8. Nakagawa H, Yamanashi WS,et al; Comparison of in vivo tissue temperature profile and lesion 
geometry for radiofrequency ablation with a saline-irrigated electrode versus temperature 
control in a canine thigh muscle preparation. Circulation 1995; 91:2264-2273.

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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9. Cooper J.M.,et al; Ablation with an internally irrigated radiofrequency catheter: learning how 
to avoid steam pops. Heart Rhythm 2004; 1:329-333.
10. Di Biase L ,Gallinghouse GJ, et al; Ablation of Atrial Fibrillation Utilizing Robotic Catheter 
Navigation in Comparison to Manual Navigation and Ablation: Single Center Experience. J
Cardiovasc Electrophysiol 2009; article published on-line Jul 28 in advance of print 
11. Steven D, Servatius H., et.al; Reduced fluoroscopy during atrial fibrillation ablation: Benefits 
of robotic guided navigation. J Cardiovasc Electrophysiol 2009, article published on-line Sept 
28 in advance of print. 
12. Kautzner J, Peichl P.,et al; Early experience with robotic navigation for catheter ablation of 
paroxysmal atrial fibrillation.  Pace 2009;32:S1-S4. 
13. Steven D, Rostock T.; Et Al; Robotic versus conventional ablation for common-type atrial 
flutter: A prospective randomized trial to evaluate the effectiveness of remote catheter 
navigation. Heart Rhythm 2008; 5(11): 1556-1560.
14. Jais, P., B. Cauchemez; et al. Catheter ablation versus antiarrhythmic drugs for atrial 
fibrillation: the A4 study. Circulation  2008; 118(24): 2498-505.
15.  Hocini, M., P. Jais; et al.; Techniques, evaluation, and consequences of linear block at the left 
atrial roof in paroxysmal atrial fibrillation: a prospective randomized study. Circulation 2005; 
112(24): 3688-96
16. Kanj, M. H., O. Wazni, et al.; Pulmonary vein antral isolation using an open irrigation ablation 
catheter for the treatment of atrial fibrillation: a randomized pilot study. J Am Coll Cardiol  
2007; 49(15): 1634-41.
17. Ouyang, F., D. Bansch, et al.;  Complete isolation of left atrium surrounding the pulmonary 
veins: new insights from the double-Lasso technique in paroxysmal atrial fibrillation. 
Circulation  2004; 110(15): 2090-6.
18. Arentz, T., R. Weber, et al.;  Small or large isolation areas around the pulmonary veins for the  
treatment of atrial fibrillation? Results from a prospective randomized study. Circulation 2007; 
115(24): 3057-63.  
19.  Dagres, N., G. Hindricks, et al;. Complications of Atrial Fibrillation Ablation in a High-
Volume Center in 1,000 Procedures: Still Cause for Concern.  J Cardiovasc Electrophysiol 
2009; accepted awaiting publication 
20. Calkins, H., J. Brugada, 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. Heart Rhythm 2007; 4(6): 816-61. 

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21. Chambers, D., M. Rodgers, et al.; Not only randomized controlled trials, but also case series 
should be considered in systematic reviews of rapidly developing technologies. J Clin 
Epidemiol 2009; 62(12):1253-1260.e4 
22. O'Neill, M. D., P. Jais, et al.; Catheter ablation for atrial fibrillation. Circulation 2007; 116(13): 
1515-23. 
23. Fuster, V., L. E. Ryden, et al.; ACC/AHA/ESC 2006 Guidelines for the Management of
Patients with Atrial Fibrillation: a report of the American College of Cardiology/American 
Heart Association Task Force on Practice Guidelines and the European Society of Cardiology 
Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the 
Management of Patients With Atrial Fibrillation). Circulation 2006; 114(7): e257-354. 
24. Calkins H, Reynolds MR, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or 
radiofrequency ablation: two systematic literature reviews and meta-analysis. Circ Arrhythm 
Electrophysiol. 2009 Aug: 2(4):349-61.   
25.  Calkins, H., J. Brugada, et al.; HRS/EHRA/ECAS expert Consensus Statement on catheter and 
surgical ablation of atrial fibrillation: recommendations for patient selection, procedural 
techniques, patient management and follow-up, definitions, endpoints, and research trial 
design.  A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical 
ablation of atrial fibrillation. Heart Rhythm Society 2012. 
26. Bai R, DiBiase L, Valderrabano M, Lorgat F, Mlcochova H, Tilz R, Meyerfeldt U, Hranitzky
PM, Wazni O, Kanagaratnam P, Doshi RN, Gibson D, Pisapia A, Mohanty P, Saliba
W, Ouyang F, Kautzner J, Gallinghouse GJ, Natale A. Worldwide experience with
the robotic navigation system in catheter ablation of atrial fibrillation: methodology, efficacy 
and safety.
Journal of Cardiovascular Electrophysiology, Aug 2012; 23(8):820-6.
27. Lorgat F, Pudney E, Van Deventer H, Chitsaz S
Robotically controlled ablation for atrial fibrillation: the first real-world experience in Africa 
with the Hansen robotic system.
Cardiovascular Journal of Africa, Mar 2012; 23: 00-00
28. Thomas D, Scholz E, Schweizer P, Katus H, Becker R
Initial experience with robotic navigation for catheter ablation of paroxysmal and persistent 
atrial fibrillation
Journal of Electrocardiology, Mar 2012; 45(2):95-101.
29. Valderrábano M, Dave AS, Báez-Escudero JL, Rami T.
Robotic catheter ablation of left ventricular tachycardia: initial experience.
Heart Rhythm, Dec 2011; 8(12):1837-46.
30. Hlivák P,
H, Peichl P, Cihák R, Wichterle D, Kautzner J.
Robotic navigation in catheter ablation for paroxysmal atrial fibrillation: midterm efficacy and 
predictors of postablation arrhythmia recurrences.

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
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Journal of Cardiovascular Electrophysiology, May 2011;22(5):534-40.
31. Kaiser, CP 
Texas Health Arlington Memorial Hospital: Becoming a Center of Excellence 
Cardiovascular Business Magazine, May 2011, ISSN 1937-6952
32. Rillig A, Meyerfeldt U, Birkemeyer R, Treusch F, Kunze M, Miljak T, Zvereva V, Jung W.
Remote robotic catheter ablation for atrial fibrillation: how fast is it learned and 
what benefits can be earned?
Journal of Interventional Cardiac Electrophysiology, Nov 2010; 29(2):109-17.
33. de Groot NM, Houben RP, Smeets JL, Boersma E, Schotten U, Schalij MJ, Crijns H, Allessie
MA
Electropathological substrate of longstanding persistent atrial fibrillation in patients with 
structural heart disease: epicardial breakthrough.
Circulation, Oct 2010;122(17):1674-82.
34. Willems S, Steven D, Servatius H, Hoffmann BA, Drewitz I, Müllerleile K, Aydin
MA, Wegscheider K, Salukhe TV, Meinertz T, Rostock T.
Persistence of pulmonary vein isolation after robotic remote-navigated ablation for atrial 
fibrillation and its relation to clinical outcome.
Journal of Cardiovascular Electrophysiology, Oct 2010;21(10):1079-84.
35. Tilz RR, Chun KR, Metzner A, Burchard A, Wissner E, Koektuerk B, Konstantinidou
M, Nuyens D, De Potter T, Neven K, Fürnkranz A, Ouyang F, Schmidt B
Unexpected high incidence of esophageal injury following pulmonary vein isolation using 
robotic navigation.
Journal of Cardiovascular Electrophysiology, Aug 2010;21(8):853-8.  
36. Rillig A, Meyerfeldt U, Birkemeyer R, Wiest S, Sauer B, Staritz M, Jung W
Oesophageal temperature monitoring and incidence of oesophageal lesions after pulmonary 
vein isolation using a remote robotic navigation system.
Europace, Mar 2010, 12, 655-661
37. Rillig A, Meyerfeldt U, Kunze M, Birkemeyer R, Miljak T, Jackle S, Hajredini B, Treusch F, 
Jung W
Europace, Jan 2010; 12, 331 336
38. Koa-Wing M, Kojodjojo P, Malcolme-Lawes LC, Salukhe TV, Linton NW, Grogan
AP, Bergman D, Lim PB, Whinnett ZI, McCarthy K, Ho SY, O'Neill MD, Peters NS,Davies
DW, Kanagaratnam P.
Robotically assisted ablation produces more rapid and greater signal attenuation than 
manual ablation.
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39. Wazni OM, Barrett C, Martin DO, Shaheen M, Tarakji K, Baranowski B, Hussein A, Callahan
T, Dresing T, Bhargava M, Kanj M, Tchou P, Natale A, Saliba W.
Experience with the hansen robotic system for atrial fibrillation ablation--lessons learned and 
techniques modified: Hansen in the real world.
Journal of Cardiovascular Electrophysiology, Nov 2009;20(11):1193-6.
40. Schmidt B, Tilz RR, Neven K, Julian Chun KR, Fürnkranz A, Ouyang F.
Remote robotic navigation and electroanatomical mapping for ablation of atrial fibrillation: 
considerations for navigation and impact on procedural outcome.
Circulation Arrhythmia and Electrophysiology, Arp 2009; 2(2):120-8.
41.
A Systematical Analysis of In Vivo Contact Forces on Virtual Catheter Tip/Tissue Surface 
Contact during Cardiac Mapping and Intervention. 
Journal of Cardiovascular Electrophysiology, June 2008, 19: 632 640.
42. DiBiase L, Natale A, Barrett C, Tan C, Elayi CS, Ching CK, Wang P, Al-Ahmad A, Arruda M, 
Burkhardt J, Wisnoskey BJ, Chowdhury P, DeMarco S, Armaganijan L, Litwak KN, 
Schweikert RA, Cummings JE
Formation: Experience with Robotic Navigation System. 
Journal of Cardiovascular Electrophysiology, April 2009; 20: 436 440.
43. Ullah, et al.,  
Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: 
an international multicenter registry study,  
Pacing Clin Electrophysiol. 2014 Sep 15. doi: 10.1111/pace.12501 
Book Chapters 
44. Gallinghouse GJ, Di Biase L, Natale A 
Utilization of the Hansen Robotic Catheter Navigation System: The Austin Approach 
Cardiotext Publishing, Published Jan. 2013, Hardcover, ISBN: 9781935395249

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
Appendix A - 1 
Appendix A Adverse Event Definitions 
In addition to the definitions of Major Complications provided in Appendix L of the protocol, 
the following definitions apply to expected adverse events that may occur and must be reported 
throughout this clinical study.  Events reported should represent a new onset or increase in the 
severity of the condition from the time of enrollment (the subject is considered to be enrolled at 
the time of the procedure). 
A.  SYSTEMIC 
COMPLICATIONS
DEFINITION
Allergic reaction (to 
contrast, drugs, 
anesthesia)
Allergy symptoms include but are not limited to: eye or skin redness, hives, rash, eye 
or skin itch, swelling, difficult breathing, respiratory arrest, sudden death.
Fever
Oral temperature  > 101°F
Infection
The invasion of the body by pathogenic microorganisms and their multiplication which 
can lead to tissues damage and disease requiring treatment, e.g. endocarditis, 
pericarditis, sepsis.
Sepsis
Systemic infection with confirmed positive blood cultures.
Low Blood Pressure
Any blood pressure that is below the normal expected for an individual and has 
accompanying symptoms of hypo-perfusion (confusion, light-headedness, dizziness, 
syncope, etc.)
Ischemia/infarction of 
tissue/organ
Decrease blood supply to body tissue due to obstruction of blood flow.
Other Systemic
Complications
Any new or exacerbated significant systemic complication that causes clinically 
B. CARDIO-
PULMONARY
DEFINITION
Angina/coronary 
ischemia
Chest, neck, arm, back, or other pain related to decreased coronary blood flow.
Arrhythmias
The development of a new atrial and/or ventricular arrhythmia or significant increase 
in the severity of a preexisting arrhythmia, that requires intervention or results in the 
signs and symptoms of vital organ hypoperfusion, such as dizziness, lightheadedness, 
or syncope, or any episode of cardiac arrest.
Atrial/Septal defect 
requiring repair
Defined as a significant residual atrial septal opening. Reported as clinically significant 
if intervention is performed for the primary purpose of repairing the ASD. If cardiac 
surgery is indicated for reasons other than residual ASD and the ASD is repaired at the 
same time, this does not meet the definition of clinically significant ASD.
Cardiac Arrest
Sudden cessation of heartbeat and cardiac function, resulting in the loss of effective 
circulation.
Congestive Heart 
Failure
Failure of the heart to pump blood with normal efficiency.  Development of an acute 
episode of or exacerbation of existing low cardiac output or fluid overload 
accompanied by peripheral and/or pulmonary edema.
Endocarditis
Inflammation of the endocardium. Left untreated can cause systemic emboli and 
cardiac valve dysfunction. 
Damage to heart valves 
and / or supporting 
structures
Defined as damage to a heart valve or supporting structure which requires intervention 
as a result of damage.
Dyspnea
New onset or increasing episodes of shortness of breath.

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
Appendix A - 2 
B. CARDIO-
PULMONARY
DEFINITION
1st and 2nd degree heart 
block not requiring 
treatment
New onset 1st or 2nd degree heart block not requiring treatment. 
Hemoptysis
Coughing up blood.
Need for a permanent 
pacemaker
Bradycardia rhythm that becomes chronic (lasting more than a few days), results in 
intolerable symptoms or is believed to be irreversible requiring implantation of a 
permanent pacemaker.
Perforation of cardiac
muscle
Perforation of the heart muscle requiring additional treatment (including efforts to seal 
the perforation or pericardial drainage), or resulting in significant pericardial effusion, 
tamponade, myocardial infarction, or death.
Pulmonary 
Hypertension
Increased pressure in the pulmonary vessels eventually leading to heart failure.  
Symptoms can include chest pain (frontal), dyspnea with activity, lightheadedness with 
activity, dizziness, fatigue, weakness.
Pulmonary vein 
obstruction
An obstruction in the pulmonary vein that can decrease blood flow to the atria.
Pleurisy
Pleurisy is an inflammation of the pleura often causing symptom of stabbing pain in 
the chest aggravated by breathing, chest tenderness, cough, and shortness of breath. 
Often associated with a pericardial rub heard on auscultation.
Respiratory Arrest
Sudden complete cessation of respiratory movement.
Ventricular fibrillation
An abnormally rapid heart rhythm that originates from a ventricle where the ventricles 
beat rapidly in a chaotic, purposeless fashion not allowing the heart to pump blood 
effectively to the body.
Other Cardio-
Pulmonary
Complications
Any new or exacerbated significant cardiac or pulmonary complication that causes 
required.
C.  VASCULAR 
COMPLICATIONS
DEFINITION
Air Embolism
Obstruction of the circulation by air that has gained entrance to a blood vessel(s).
Aneurysm
Localized widening (dilatation) of an artery, vein, or the heart. At the area of an 
aneurysm, there is typically a bulge and the wall is weakened and may rupture.
Atrio-venous fistula
Formation of an abnormal connection between the lumens of an artery and a vein as 
documented by CT, ultrasound, angiography, or direct observation.
Access site discomfort
Pain and/or tenderness at the access site.
Bleeding
Bleeding requiring observation resulting in prolonged hospitalization and/or 
transfusion and/or treatment other than applying pressure & bandage.
Hematoma
A mass of usually clotted blood that forms in tissue, organ or body space as a result of 
leakage from a blood vessel that requires additional treatment beyond applying 
pressure.
Retroperitoneal 
hemorrhage
Bleeding into the retroperitoneal space. RPH is often associated with femoral artery 
sheath placement superior to the inferior epigastric artery resulting in vessel 
perforation.
Perforation or rupture 
of a blood vessel
Defined as perforation in an access vessel wall or the aorta confirmed by 
extravasations of contrast under fluoroscopy.

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
Appendix A - 3 
C.  VASCULAR 
COMPLICATIONS
DEFINITION
Pseudoaneurysm
Enlargement of the aorta, iliac, or femoral arteries, which contain some or all of the 
medial layer, the adventitia, and periaortic tissue most commonly associated with 
previous aortic operative procedures, trauma, and/or infection.  Pseudoaneurysms 
typically present as a well-defined collection of blood outside the vessel wall from 
contained rupture.
Temporary or total 
occlusion of an artery
Vessel lumen narrowing or obstruction by atherosclerotic plaque, thrombus, or 
embolism causing a decrease or occlusion of blood supply to the extremities.
Thrombophlebitis
Inflammation of a vein that occurs when a blood clot forms.
Vessel Spasm
A sudden constriction of a vessel limiting blood flow downstream.
Other Access site 
complications
Any new or exacerbated significant vascular complication that causes clinically 
releva
D.  NEUROLOGIC
COMPLICATIONS
DEFINITION
Change in Mental 
Status
A delirium or acute confusional state associated with a disturbance in cognition, mood, 
attention, arousal, and self-awareness, as evidenced on clinical assessment, which 
arises acutely, either without prior intellectual impairment or superimposed on chronic 
intellectual impairment. 
Femoral Neuropathy
Pain and numbness in the anterior thigh associated with quadriceps muscle weakness 
and decreased patellar reflex lasting > 1 month after treatment.
Nerve Injury/Peripheral 
Neuropathy
Direct damage to nerves surrounding the access site, operative field, and the resultant 
signs and/or symptoms of such damage.
Other neurologic 
complications
Any new or exacerbated significant neurologic complication that causes clinically 
E.  OTHER 
COMPLICATIONS
DEFINITION
Headache 
Headache lasting >24 hours and/or not relieved by pain medication.
Heparin induced 
thrombocytopenia 
(HIT)
Development of thrombocytopenia (low platelet counts) due to the administration of 
Heparin.  It predisposes to thrombosis, the formation of abnormal blood clots inside a 
blood vessel.
Renal Insufficiency
Slowly progressive failure of renal function resulting from some disease, e.g., diabetes, 
cancer, hypertension, glomerulonephritis, that causes gradual destruction of the 
kidneys, or if creatinine levels are available, an increase of > 25% above the pre-
procedure creatinine level.
Renal failure
Defined as a new need for dialysis or a creatinine increasing to 3.5 mg/dL or greater.  
Not included as Renal Failure is any Renal Dysfunction defined as an increase of 
creatinine over 1.0 mg/dL over the baseline.
Surgery required for 
treatment of an 
Adverse Event
Emergent or Urgent surgery required to treat an adverse event.
Increased exposure to 
radiation
Radiation exposure resulting in symptoms consistent with overexposure to radiation.
Other possible adverse 
effects
Any new or exacerbated significant complication that causes clinically relevant 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
Appendix B - 4 
Appendix B
Classes of Anti-Arrhythmic Drugs (Vaughn- 
Williams Classification) 
CLASS IA Sodium channel block (intermediate association/ disassociation)
Uses: APB and VPB suppression, SVT and VT suppression, AF or atrial flutter, and Ventricular 
Fibrillation suppression 
Disopyramide 
Procainamide 
Quinidine 
CLASS 1B
Sodium channel block (fast association/ disassociation) 
Uses: Suppression of ventricular tachycardia and atrial fibrillation 
Lidocaine 
Mexiletine 
Phenytoin 
Tocainide 
CLASS IC  
Uses: APB and VPB suppression, SVT and VT suppression, AF or atrial flutter, and ventricular 
fibrillation suppression 
Flecainide 
Propafenone 
Moricizine 
CLASS II - -Blockers 
Uses: Supraventricular tachyarrhythmias (APB, ST, SVT, AF, atrial flutter) and ventricular arrhythmias 
(often in a suppressive role) 
Atenolol 
Carvedilol 
Acebutolol 
Betaxolol 
Bisoprolol 
Esmolol 
Metoprolol 
Nadolol 
Propranolol 
Timolol 
CLASS III Potassium channel blocker   
Uses: Any tachyarrhythmia except Torsades de Pointes ventricular tachycardia 
Amiodarone 
Azimilide 
Bretylium 
Dofetilide 
Dronedarone 
E-4031
Ibutilide 
Sotalol 

Clinical Protocol for Hansen Medical IDE - HMP010 Rev M 
Appendix B - 5 
CLASS IV - Calcium channel blockers 
Uses: Termination of SVT and slowing of rapid AF or atrial flutter 
Diltiazem 
Verapamil
Class V 
Uses: Suppression of SVT, especially in Heart Failure with AF, contraindicated in ventricular 
Adenosine 
Digoxin 
Magnesium Sulfate