A Clinical Evaluation Using EnSite Precision Cardiac Mapping System (Software Version 2.0.1 or Higher) in a Real-World Environment
Conditions: Cardiac Arrhythmia
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
 
87173 CIP Posting Cover Page Ver C 
Template 
Page 1 of 1 
 
NCT Number: NCT03260244 
EnSite Precision Observational Study 
A Clinical Evaluation using EnSite Precision Cardiac Mapping System (software version 2.0.1 or higher) 
in a Real-World Environment 
Study Document No: SJM-CIP-10159 
Version A 
Date: 26-Jun-2017 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
5050 Nathan Lane North 
Plymouth, MN 55442        
 
 
 
 
US 
 
 
 

 
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EnSite Precision Observational Study 
A Clinical Evaluation using EnSite Precision Cardiac Mapping System (software version 2.0.1 or 
higher) in a Real-World Environment 
CRD_871 
Study Document No: SJM-CIP-10159 
Version A 
Date: 26-Jun-17 
Clinical Investigation Plan (CIP) 
 
 
Sponsor  
 
 
St. Jude Medical / Abbott 
        
 
 
 
5050 Nathan Lane North 
Plymouth, MN  55442        
 
 
 
 
US 
 
 
 

 
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PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical study. 
 
 
Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

 
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Table of Contents 
 
1 
Synopsis ................................................................................................................................................................ 6 
 
Objective(s) .................................................................................................................................................. 6 
 
Devices Used ............................................................................................................................................... 6 
 
Indications for Use ........................................................................................................................................ 6 
 
Design .......................................................................................................................................................... 7 
 
Endpoints ..................................................................................................................................................... 7 
 
Study Population .......................................................................................................................................... 7 
 
Inclusion/Exclusion Criteria .......................................................................................................................... 7 
1.7.1 
Inclusion Criteria ...................................................................................................................................... 7 
1.7.2 
Exclusion Criteria ..................................................................................................................................... 7 
 
Enrollment .................................................................................................................................................... 8 
 
Study Assessments ...................................................................................................................................... 8 
2 
Introduction ............................................................................................................................................................ 9 
3 
Background and Justification for Clinical Study ..................................................................................................... 9 
4 
Devices Used ....................................................................................................................................................... 10 
 
Identification and Description of the Clinical Study Devices ....................................................................... 10 
4.1.1 
Identification ........................................................................................................................................... 10 
4.1.2 
Device Description and Intended Purpose ............................................................................................. 10 
4.1.3 
Device Handling and Storage ................................................................................................................ 10 
5 
Clinical Study Design ........................................................................................................................................... 11 
 
Clinical Study Design.................................................................................................................................. 11 
 
Objectives ................................................................................................................................................... 11 
 
Endpoints ................................................................................................................................................... 11 
 
Study Population ........................................................................................................................................ 11 
5.4.1 
Inclusion Criteria .................................................................................................................................... 12 
5.4.2 
Exclusion Criteria ................................................................................................................................... 12 
6 
Procedures........................................................................................................................................................... 12 
 
Informed Consent Process ......................................................................................................................... 12 
 
Point of Enrollment ..................................................................................................................................... 13 
 
Scheduled Procedures ............................................................................................................................... 13 
6.3.1 
Baseline Visit (within 10 days from Informed Consent) .......................................................................... 13 
6.3.2 
Procedure Visit (within 14 days from Baseline) ...................................................................................... 13 
6.3.3 
Scheduled Follow-ups ............................................................................................................................ 14 
 
Unscheduled Visits ..................................................................................................................................... 15 
 
Study Flow Chart ........................................................................................................................................ 16 
 
Description of Activities Performed by Sponsor Representatives ............................................................... 17 

 
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Subject Study Completion .......................................................................................................................... 18 
 
Subject Withdrawal ..................................................................................................................................... 18 
 
Study Committees ...................................................................................................................................... 18 
6.9.1 
Publication Committee (PC) ................................................................................................................... 18 
7 
Statistical Considerations ..................................................................................................................................... 18 
 
Endpoints ................................................................................................................................................... 18 
7.1.1 
Analysis Methodology ............................................................................................................................ 19 
7.1.2 
Sample Size Determination .................................................................................................................... 21 
7.1.3 
Analysis Populations .............................................................................................................................. 21 
7.1.4 
Subgroup Analysis ................................................................................................................................. 21 
7.1.5 
Missing Data .......................................................................................................................................... 21 
 
Justification of Clinical Study Design .......................................................................................................... 21 
 
Overall Sample Size ................................................................................................................................... 22 
 
Timing of Analysis ...................................................................................................................................... 22 
 
Success Criteria ......................................................................................................................................... 22 
 
Interim Analysis .......................................................................................................................................... 22 
 
Statistical Criteria for Termination .............................................................................................................. 22 
 
Deviations from Statistical Plan .................................................................................................................. 22 
8 
Risks and Benefits ............................................................................................................................................... 22 
 
Risks Associated with the Clinical Study Device ........................................................................................ 22 
8.1.1 
Anticipated Adverse Device Effects ....................................................................................................... 22 
8.1.2 
Risks Associated with Clinical Study Assessments................................................................................ 22 
 
Risk Control Measures ............................................................................................................................... 23 
 
Possible interactions with concomitant treatments ..................................................................................... 23 
 
Anticipated Benefits .................................................................................................................................... 23 
 
Risk-to-Benefit Rationale ............................................................................................................................ 23 
 
History of Device Modifications or Recall ................................................................................................... 23 
9 
Requirements for Investigator Records and Reports ........................................................................................... 23 
 
Deviations from CIP.................................................................................................................................... 23 
 
Safety Reporting ......................................................................................................................................... 24 
9.2.1 
Subject Death......................................................................................................................................... 24 
9.2.2 
Complaints ............................................................................................................................................. 24 
 
Source Records .......................................................................................................................................... 24 
 
Records Retention ...................................................................................................................................... 24 
10 
Clinical Data Handling..................................................................................................................................... 25 
 
Protection of Personally Identifiable Information ........................................................................................ 25 
 
Data Management Plan .............................................................................................................................. 25 
 
Document and Data Control ....................................................................................................................... 25 

 
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10.3.1 
Traceability of Documents and Data .................................................................................................. 25 
10.3.2 
Recording Data .................................................................................................................................. 25 
11 
Monitoring ....................................................................................................................................................... 25 
12 
Compliance Statement.................................................................................................................................... 26 
 
Statement of Compliance ........................................................................................................................... 26 
 
Quality Assurance Audits and Regulatory Inspections ............................................................................... 26 
 
Repeated and Serious Non-Compliance .................................................................................................... 26 
13 
Suspension or Premature Termination of the Clinical Study ........................................................................... 27 
14 
Clinical Study Conclusion ............................................................................................................................... 27 
15 
Publication Policy ............................................................................................................................................ 27 
16 
Reporting Results on ClincalTrials.gov Website ............................................................................................. 27 
Appendix A: CIP Revisions .......................................................................................................................................... 28 
Appendix B: Bibliography ............................................................................................................................................. 29 
Appendix C: Definitions ................................................................................................................................................ 30 
Appendix D: Abbreviations ........................................................................................................................................... 32 
Appendix E: Case Report Form ................................................................................................................................... 33 
Appendix F: Informed Consent Form ........................................................................................................................... 34 
Appendix G: Percentage by Arrhythmia type ............................................................................................................... 42 
Appendix H: EQ-5D Questionnaire .............................................................................................................................. 44 
 
 
 

 
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o 
Atrioventricular Reentrant Tachycardia (AVRT) 
- 
Planned cryoablation procedure 
- 
Implanted with a neurostimulator 
- 
Contraindication to anticoagulation 
- 
Known presence of cardiac thrombus 
- 
Recent (<3 months) myocardial infarction or unstable angina or coronary artery by-pass 
- 
Currently enrolled in a clinical study/investigation evaluating another device or drug that would 
confound the results of this study 
- 
Pregnant or nursing 
- 
Individuals whose willingness to volunteer in a study, in the judgement of investigator or public 
authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or 
mental disability, or adverse personal circumstances, or hierarchical influence 
 
 
Enrollment 
 
A subject is considered enrolled in the clinical study from the moment the subject has provided a written 
Informed Consent.   
 
 
 
Study Assessments 
Refer to Section 6, Procedures for the Clinical Study Procedures Table 
 
 

 
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2 
Introduction 
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study.  
This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac 
Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be 
conducted in patients who are indicated for a cardiac EP mapping and RF ablation procedure using a 3D 
system.  
 
This document describes the rationale and procedures used for a prospective, multicenter, observational 
study. The clinical study is sponsored by St. Jude Medical / Abbott. 
 
The clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the 
clinical study will be qualified by education, training, or experience to perform their tasks and this training 
will be documented appropriately. 
3 
Background and Justification for Clinical Study 
Atrial fibrillation (AF) is a common cardiac rhythm disturbance and increases in prevalence with 
advancing age. Approximately 1% of patients with AF are <60 years of age, whereas up to 12% of 
patients are 75 to 84 years of age. More than one third of patients with AF are >80 years of age. In the 
United States, the percentage of Medicare Fee-for-Service beneficiaries with AF in 2010 was reported as 
2% for those <65 years of age and 9% for those ≥ 65 years of age. 
 
The mechanisms causing and sustaining AF are multifactorial, and can be complex and difficult for 
clinicians to manage (January, et al., 2014). Ablation is increasingly used for AF and is superior to 
pharmacological therapy for patients with early (paroxysmal) to advanced (persistent) AF (Wright & 
Narayan, 2015). 
 
Sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) are typically a manifestation of 
significant structural heart disease and often associated with a high risk of sudden cardiac death. 
Implantable cardioverter defibrillators (ICDs) remain the mainstay of therapy for prevention of sudden 
cardiac death associated with these arrhythmias. However, ICDs treat the arrhythmia after it occurs and 
does not prevent the arrhythmia. Recurrent ventricular arrhythmias can lead to multiple ICD shocks that 
are painful, decrease quality of life and cause post-traumatic stress disorder. Spontaneous VT and ICD 
shocks are also associated with an increased risk of death and progressive heart failure. Antiarrhythmic 
drugs, notably amiodarone, reduce arrhythmias for some patients, but have limited efficacy for long-term 
management, particularly for scar-related re-entrant arrhythmias. In addition, antiarrhythmic drugs have  
the potential for significant adverse effects that includes negative inotropy, pro-arrhythmia and non-
cardiac organ toxicities that limit their long-term use. Catheter ablation offers an alternative therapy for 
preventing arrhythmias, and can be life-saving when frequent episodes (VT storm) threaten survival. (Nof, 
Stevenson, & John, 2013) (Pedersen, et al., 2014) 
 
The incidence and treatment complexity of these arrhythmias represent an opportunity for the EnSite™ 
Velocity Cardiac Mapping System due to the increased case complexity and duration, as mapping system 
precision is a key requirement to maximize the success of these challenging procedures. As a result, the 
EnSite Precision™ System was developed to introduce features such as Delayed Enhancement Magnetic 
Resonance Imaging (DE-MRI) image integration, lesion marking automaticity, automatic mapping, and 
workflow flexibility to aid in the success of complex ablation procedures.  This clinical study is intended to 
understand how the EnSite Precision™ System is utilized in the treatment of complex ablation 
procedures.   

 
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5.4.1 
Inclusion Criteria 
To participate in this clinical study, the subject must meet all of the following inclusion criteria: 
 
- 
Indicated for a cardiac EP mapping and RF ablation procedure using a 3D mapping system per 
IFU 
- 
Over 18 years of age   
- 
Able to provide informed consent for study participation and willing and able to comply with the 
protocol described evaluations and follow up schedule 
5.4.2 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria must be excluded from the clinical study: 
 
- 
Patients who are only presenting with: 
o 
Atrioventricular Nodal Reentrant Tachycardia (AVNRT) 
o 
Atrioventricular Reentrant Tachycardia (AVRT) 
- 
Planned cryoablation procedure 
- 
Implanted with a neurostimulator 
- 
Contraindication to anticoagulation 
- 
Known presence of cardiac thrombus 
- 
Recent (<3 months) myocardial infarction or unstable angina or coronary artery by-pass 
- 
Currently enrolled in a clinical study/investigation evaluating another device or drug that would 
confound the results of this study 
- 
Pregnant or nursing 
- 
Individuals whose willingness to volunteer in a study, in the judgement of investigator or public 
authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or 
mental disability, or adverse personal circumstances, or hierarchical influence 
 
6 
Procedures 
Approval from the Sponsor must be received prior to initiating study related activities. 
 
Subjects will undergo a cardiac mapping and RF ablation procedure using the EnSite Precision™ Cardiac 
Mapping System per the IFUs of all devices used during the procedure. After the post-procedure hospital 
discharge, the subject will have 3 in-clinic visits: at 1 month, 6 months and 12 months post-procedure. 
Upon completion of the 12-month follow-up visit, the subject will be considered to have completed the 
follow-up requirements of this clinical study. The Principal Investigator should arrange for appropriate 
care of subjects following study completion.  
 
The following sections provide a detailed description of procedures required by this CIP. 
 
Informed Consent Process 
The Principal Investigator or his/her authorized designee will conduct the informed consent process, as 
required by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion 
with the subject on all aspects of the clinical study that are relevant to the subject’s decision to participate, 
such as details of clinical study procedures, anticipated benefits, and potential risks of clinical study 
participation. During the discussion, the Principal Investigator or his/her authorized designee will avoid 
any improper influence on the subject and will respect subject’s legal rights. The subject shall be provided 
with the informed consent form (refer to Appendix F) written in a language that is understandable to the 
subject and has been approved by the center’s IRB/EC. The subject shall have adequate time to review, 
ask questions and consider participation. 
 

 
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If the subject agrees to participate, the informed consent form must be signed and dated by the subject 
and by the person obtaining the consent. The signed original will be filed in the subject’s hospital or 
research charts, and a copy will be provided to the subject. 
 
The Principal Investigator or his/her authorized designee will document the informed consent process in 
the subject’s hospital and/or research charts. The date of signature will be entered on an applicable Case 
Report Form (CRF). 
 
Failure to obtain informed consent from a subject prior to a study specific procedure should be reported to 
Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the IRB’s/ EC’s 
reporting requirements. 
 
If, during the clinical study, new information becomes available that can significantly affect a subject's 
future health and medical care, the Principal Investigator or his/her authorized designee will provide this 
information to the subject. If relevant, the subject will be asked to confirm their continuing informed 
consent in writing. 
 
Point of Enrollment 
A subject is considered enrolled in the clinical study from the moment the subject has provided a written 
Informed Consent.   
 
 
Scheduled Procedures 
The Principal Investigator is responsible for ensuring all clinical study data is collected as required per 
CIP scheduled procedures. 
 
6.3.1 
Baseline Visit (within 10 days from Informed Consent) 
The following assessments and information will be collected at the baseline visit:  
 
- 
Demographics - include subject’s age and gender 
- 
Physical information - include subject’s height, weight (measurements taken during visit) 
- 
Cardiac History (most recent value prior to baseline visit) 
- 
Arrhythmia History 
- 
12 Lead ECG information (most recent information prior to baseline visit) 
- 
Antiarrhythmic medication - indicate both the medication that failed and the medication (if any) 
the patient is currently taking 
- 
Current anticoagulant medication 
- 
Completion of the EQ-5D questionnaire (refer to Appendix H for additional information)  
 
Record the required information on the Baseline form. 
6.3.2 
Procedure Visit (within 14 days from Baseline) 
The procedure should be performed according to the IFU of the EnSite Precision™ Cardiac Mapping 
System, the IFUs of the AutoMark and EnSite™ AutoMap modules and any other medical devices used 
during the procedure.  
 
Subjects will be prepared according to the standard ablation procedures and standard practice of the 
center.  
 
 
 

 
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The following information will be collected during the Procedure Visit: 
 
- 
Mapping and ablation tools used during the procedure 
- 
Procedural characteristics (set up and timing) 
- 
AutoMap settings used (if applicable) 
- 
AutoMark setting used (if applicable) 
- 
Field Scaling used 
 
Sponsor representatives can be involved in providing support during the procedure. 
 
The entire case (procedure) should be recorded and stored on a study-specific USB (password-
protected), provided by the Sponsor, and returned within reasonable timelines to the Sponsor.  
 
A User Experience form should be completed once by every physician performing a procedure for this 
study, preferably after the first study related procedure performed by that physician. 
 
Protocol deviations (refer to section 9.1 for details) that were observed during the procedure will also be 
recorded at this time. 
 
NOTE: A separate guideline for additional information on supplementary data collection will be available. 
This guideline is not mandatory, however, it may assist in increasing knowledge and understanding of the 
treatment options for patient with arrhythmias. 
 
6.3.3 
Scheduled Follow-ups 
In-clinic follow-up visits are scheduled at 1 month, 6 months and 12 months after procedure. The 
scheduled visit windows are calculated from the index procedure.  
 
6.3.3.1 
1-Month Visit (within 30 days from procedure) 
The 1-month visit needs to be performed within 30 days post procedure, depending on the hospital’s 
standard practice for 1st follow-up post procedure.  
 
The following information is collected: 
- 
Arrhythmia recurrence 
o 
For the purpose of this clinical study, recurrence of arrhythmia is deemed to have occurred only 
when the arrhythmia is documented on ECG or during a period of monitoring e.g. holter-monitoring 
or implantable cardiac monitor.  Atrial arrhythmias 30 seconds or longer will be collected. 
Ventricular arrhythmias treated by an ICD, or lasting 20 seconds or longer will be collected.  
- 
Antiarrhythmic / Anticoagulant medication  
- 
Healthcare Utilization information when applicable 
- 
Protocol deviation, when applicable 
 
6.3.3.2 
6- and 12-Month Visit (± 30 days) 
At each visit, the following information is collected: 
- 
Arrhythmia recurrence 
o 
For the purpose of this clinical study, recurrence of arrhythmia is deemed to have occurred only 
when the arrhythmia is documented on ECG or during a period of monitoring e.g. Holter-monitoring 
or implantable cardiac monitor.  Atrial arrhythmias 30 seconds or longer will be collected. 
Ventricular arrhythmias treated by an ICD, or lasting 20 seconds or longer will be collected.  
- 
Antiarrhythmic / Anticoagulant medication  
- 
Completion of the EQ-5D questionnaire  

 
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- 
Holter monitoring* at 12-Month visit (for patients treated for AF) 
- 
Healthcare Utilization information when applicable 
- 
Protocol  deviation, when applicable 
 
*Holter Monitoring (AF only) 
Subjects with AF will be issued a holter monitor at the 12-month visit and instructed to obtain a 48-hour 
recording. A core laboratory will review each recording and report findings to the Sponsor. 
 
NOTE: The Sponsor may request access to other patient data during the required protocol follow up visits 
or throughout the follow up period, which may include, but is not limited to, data from implanted device(s). 
 
Record the required information on the appropriate CRF(s). Documentation of arrhythmia (e.g. ECG 
printouts, holter printouts, session records), where applicable, should be retrieved and submitted 
electronically through EDC to the Sponsor.  
 
Sponsor representatives can be involved in providing support during the follow-up procedures. 
 
 
Unscheduled Visits 
An unscheduled visit is defined as any healthcare visit (e.g. office visit, outpatient visit, urgent care, 
observational visit, ER visit, hospitalization) between scheduled follow-ups, due to a cardiovascular event.  
 
Such visits need to be documented by completing the Health Care Utilization form. 
 
 
 

 
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Subject Study Completion 
Subject participation in the clinical study will conclude upon completion of the 12-Month visit and 48-hour 
holter monitoring (if applicable). Upon completion of subject participation in the clinical study, the subject 
will return to standard of care. 
 
Subject Withdrawal 
Subjects must be informed about their right to withdraw from the clinical study at any time and for any 
reason without sanction, penalty or loss of benefits to which the subject is otherwise entitled. Withdrawal 
from the clinical study will not jeopardize their future medical care or relationship with the investigator. 
Subjects will be requested to specify the reason for the request to withdraw. The investigator must make 
all reasonable efforts to retain the subject in the clinical study until completion of the clinical study. 
 
A subject will be considered ‘Lost to Follow-up’ after one missed visit and a minimum of two unsuccessful 
phone calls from study site personnel to the subject or subject’s contact to schedule the next follow-up 
visit. These two phone calls must be documented in the subject’s hospital records. If the subject is 
deemed lost to follow-up, a letter should be sent to the subject’s last known address or to the subject’s 
general practitioner (GP) and a copy of the letter must be maintained in the subject’s hospital records. 
 
Study Committees 
6.9.1 
Publication Committee (PC) 
A Publication Committee shall be established to oversee study publications. Publication Committee 
membership may include Principal Investigators, a representative of the Sponsor and a statistician. The 
Publication Committee will be responsible for identifying, selecting and approving publication proposals 
and determining authorship according to a Publication Plan.  A Publication Committee charter will define 
membership of the committee and outline the roles and responsibilities of the committee, as well as rules 
to define authorship. 
7 
Statistical Considerations 
The following section describes the statistical methods for the observational study and justification of the 
design.  
 
Endpoints 
 
The endpoints for evaluating the objectives are as following: 
 
- 
Summary of subjects that used EnSite™ AutoMap and AutoMark module 
- 
Summary of EnSite™ Automap and AutoMark module software settings used per arrhythmia  
- 
Assessment of EnSite™ AutoMap Module including: 
o 
Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type 
used in a single subject  
o 
Used Points per Minute per catheter type stratified by arrhythmia type and mapping type 
- 
Rate of acute success based on pre-defined procedural endpoints 
- 
Freedom from arrhythmia recurrence through 12 months 
- 
Number of repeat ablations up to 12 months  
- 
Summary of NavX patch placement locations used 
- 
Number of gaps in lesions identified requiring touch-up ablation  
- 
Changes in EQ-5D quality of life score at 6 and 12 months 
- 
Number of unscheduled visits and hospitalizations due to arrhythmia 
- 
Overall procedure time 

 
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- 
Overall system stability 
 
7.1.1 
Analysis Methodology  
 
The endpoints will be summarized descriptively based on available data or measurements in the analysis 
population.  No hypothesis testing will be performed.   
 
Summary of subjects that used EnSite™ AutoMap and AutoMark module: 
 
- 
Overall usage of EnSite™ AutoMap Module: 
This will be summarized by the number and proportion of subjects with a procedure that use 
EnSite™ AutoMap.  
- 
Overall usage of AutoMark module: 
This will be summarized by the number and proportion of subjects with a procedure that use 
AutoMark.  
 
Summary of EnSite™ Automap and AutoMark Module software settings used per arrhythmia: 
 
- 
Usage of EnSite™ AutoMap Module features: 
Among the subjects with EnSite™ AutoMap module features used during the procedure, the 
initial settings of EnSite™ AutoMap features listed below will be summarized descriptively by 
each arrhythmia, as number and proportion or mean and standard deviation as appropriate.  
 
AutoMap Settings: 
- Score Threshold (%) 
- Cycle length tolerance (ms) 
- Speed limit (mm/s) 
- Distance threshold (mm) 
- Signal-to-Noise ratio (number) 
- Force lower limit (grams) 
- Force upper limit (grams) 
- Enhanced Noise rejection enabled? (Y/N) 
- Independent Scoring Interval enabled? (Y/N) 
 
- 
Usage of AutoMark Module features: 
Among the subjects with AutoMark features used during the procedure, the AutoMark features 
listed below will be summarized descriptively as number and proportion or mean and standard 
deviation as appropriate.   
 
AutoMark Parameters (values and diameters of Lesion Color and Lesion Size Metrics): 
- Energy (Joules) 
- Time (Seconds)  
- Impedance Drop (Ohms) 
- Impedance Drop (%) 
- Average Power (Watts) 
- Maximum Power (Watts) 
- Average Temperature (Degrees Celsius) 
- Max. Temperature (Degrees Celsius) 
- Average Force (Grams)  
- Max. Force (Grams)  
- LSI (number)  OUS only 
- FTI (gr/s)  OUS only 
 

 
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AutoMark placement settings: 
- AutoMark Spacing (mm) 
- Min AutoMark Time (s) 
- Away Time (s) 
 
Mapping time associated with (re-)mapping one or multiple arrhythmias per catheter type used in a single 
subject:   
- 
Mapping time will be summarized (e.g. as mean, median, standard deviation, minimum and 
maximum) across arrhythmia types and for each type of arrhythmia per catheter, as appropriate 
for the following map types:   
o 
Manual 
o 
AutoMap 
o 
Combination Manual Map / AutoMap 
o 
TurboMap™ 
 
Used Points per Minute per catheter type stratified by arrhythmia type and mapping type:   
- 
Mapping points per minute used will be summarized (e.g. as mean, median, standard deviation, 
minimum and/or maximum) across arrhythmia types and for each type of arrhythmia per catheter 
as appropriate, with following map types:  
o 
Manual mapping 
o 
AutoMap 
o 
Combination Manual Map / AutoMap 
o 
TurboMap™ 
 
Rate of acute success based on pre-defined procedural endpoints (refer to Appendix C):  
- 
The number and proportion of subjects with acute success will be summarized.    
 
Freedom from arrhythmia recurrence: Arrhythmia recurrence is defined as documented atrial arrhythmia 
for 30 seconds or longer or documented ventricular arrhythmia either treated by ICD or lasting 20 
seconds or longer throughout the follow-up period. 
- 
This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date 
of the index procedure. For subjects who do not experience an event, their follow up duration will 
be defined from the start date to the date of death, withdrawal, or last follow-up, whichever 
occurred later. 
- 
Time to arrhythmia recurrence is defined as time from index procedure to the date of the first 
recurrence. For subjects with AF, events occurring within the blanking period (defined as the first 
90 days after the index procedure) will be excluded from the analysis.  
 
Number of repeat ablations up to 12 months. This will be summarized as: 
- 
Total count of repeat ablations up to 12 months among all subjects in the analysis population 
defined in section 7.1.3 
- 
Total number of subjects who experience at least one repeat ablation up to 12 months among all 
subjects in analysis population defined in section 7.1.3 
 
Summary of NavX Patch placement locations used 
- 
The number and proportion of subjects with NavX patches (Surface Electrode Patches) placed by 
location 
 
Number of gaps in lesions identified during the procedure that require touch-up ablation: 
- 
The number and proportion of subjects with gaps in lesions identified will be summarized and 
reported. 
- 
The summary of number of gaps identified will be reported. 
- 
The number and proportion of subjects where the AutoMark Module assisted in identifying these 
gaps will be summarized and reported. 

 
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For those procedures where the physician applies sedation or anesthesia, the standard risks of 
anesthesia also exist and include allergic reactions, pneumonia, aspiration pneumonitis, atelectasis, 
prolonged sedation, other medical complications and in very rare cases, death.  
 
Risk Control Measures 
Every possible effort will be taken to minimize the risks, including: 
• 
Careful selection of experienced Investigators for the study  
• 
Training of Investigators/study nurses on the CIP 
• 
Conducting the clinical study in accordance with the CIP, all applicable laws and regulations and 
any conditions of approval imposed by the appropriate IRB/EC or applicable regulatory 
authorities where the clinical study is performed 
• 
Conducting the ablation procedures in accordance with the IFU of corresponding devices 
 
Possible interactions with concomitant treatments 
There are no interactions with concomitant medical treatments and/or concurrent medical interventions 
compared to standard practice. 
 
Anticipated Benefits 
The aim of this clinical study is to collect information on the use and the performance of the EnSite 
Precision™ Cardiac Mapping System.  
The information collected in this clinical study will be added to the current knowledge and understanding 
of treatment options for patients with arrhythmias. Subjects participating in this clinical study are not 
expected to experience any additional benefit or harm compared to patients who are not participating in 
this clinical study as the clinical study will follow local standard practice.  
 
Risk-to-Benefit Rationale 
Catheter ablation is a recognized safe and effective treatment of cardiac arrhythmias. The EnSite 
Precision™ Cardiac Mapping System is believed to not introduce any unanticipated risks compared to 
current practice 
 
History of Device Modifications or Recall 
There have been no modifications or recalls in relation to safety and clinical performance of the EnSite 
Precision™ Cardiac Mapping System. 
 
9 
Requirements for Investigator Records and Reports 
 
Deviations from CIP 
A deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the CIP. The investigator should not deviate from the CIP. 
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects; such non-compliance exposes subjects to unreasonable risks, e.g. failure to 
adhere to the inclusion/exclusion criteria. Investigators should seek to minimize such risks by adhering to 
the CIP. 
 
The PI must maintain accurate, complete, and current records, including documents showing the date of 
and reason for each deviation from the CIP. Relevant information for each deviation will be documented 
as soon as possible on the applicable CRF. The site will submit the CRF to the Sponsor. 
 

 
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The PI is required to adhere to local regulatory requirements for reporting deviations to IRB/EC. 
 
 
Safety Reporting 
The devices used in this clinical study are market released and should be used according to IFU. As there 
are no safety driven endpoints, adverse events will not be collected during this clinical study.  
Complaints will be managed via the sponsor’s standard Postmarket Surveillance process. 
9.2.1 
Subject Death 
Subject deaths shall be reported to the IRB/EC as per local regulations and shall be reported on a 
Withdrawal form. 
9.2.2 
Complaints 
The investigator will be responsible for reporting all complaints they became aware of during the study. A 
complaint is defined as any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is 
released for distribution. 
 
The investigator must notify the Post Market Surveillance Department by submitting the information on 
the device via email to 
 as soon as 
possible after becoming aware of the complaint. This information will not be collected on a CRF for the 
study. 
 
 
Source Records 
Source documents will be created and maintained by the investigational site team throughout the clinical 
study. The data reported on the CRFs will be derived from, and be consistent with, these source 
documents, and any discrepancies will be explained in writing. 
 
To facilitate data collection during the EP procedure, worksheets may be provided to the site where 
source data can be collected. 
 
 
Records Retention 
The Sponsor and the Principal Investigators will maintain the clinical study documents as required. 
Measures will be taken to prevent accidental or premature destruction of these documents. The Principal 
Investigator or the Sponsor may transfer custody of records to another person/party and document the 
transfer at the investigational site or the Sponsor’s facility, as appropriate. 
 
These documents must be retained by the investigational site for a period of 2 years (or longer if required 
by local regulations) after the conclusion of the clinical study and made available for monitoring or 
auditing by the Sponsor’s representative or representatives of the applicable regulatory agencies. 
 
All original source documents must be stored for the maximum time required by the regulations at the 
hospital, research institute, or practice in question. If original source documents can no longer be 
maintained at the site, the investigator will notify the Sponsor.  
 

 
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10 Clinical Data Handling 
The Sponsor will be responsible for the data handling. The Sponsor and/or its affiliates will be responsible 
for compiling and submitting all required reports to governmental agencies. Data will be analyzed by the 
Sponsor and may be transferred to the Sponsor’s locations worldwide and/or any other worldwide 
regulatory authority in support of a market-approval application. 
 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical study. The privacy of each subject and confidentiality of his/her information will be preserved in 
reports and when publishing any data. Confidentiality of data will be observed by all parties involved at all 
times throughout the clinical study. All data will be secured against unauthorized access. 
 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, database cleaning, and 
issuing and resolving data queries. If appropriate, the DMP may be updated throughout the clinical study 
duration. All revisions will be tracked and document controlled. 
 
Subject data will be captured in a validated electronic data capture (EDC) system hosted by the Sponsor. 
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed 
by the Sponsor. An electronic audit trail will be used to track any subsequent changes of the entered 
data. 
 Document and Data Control 
10.3.1 Traceability of Documents and Data 
The investigator will ensure accuracy, completeness legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. 
10.3.2 Recording Data 
The CRF will be reviewed by the authorized site personnel. An appropriate comment will be provided to 
explain changes to data reported on the CRF. 
 
11 Monitoring 
It is the responsibility of the Sponsor to ensure the clinical study is conducted, recorded and reported 
according to the approved CIP, subsequent amendment(s), applicable regulations and guidance 
documents. 
 
Centralized monitoring will occur through routine internal data review. This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential CIP deviations that may be indicative of 
site non-compliance. On-site monitoring may occur at the discretion of the Sponsor. 
 
 

 
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12 Compliance Statement 
 Statement of Compliance 
This clinical study will be conducted in compliance with the most current regional and local laws and 
regulations. Principles of Good Clinical Practice will be followed as based on the most current version of 
the World Medical Association (WMA) Declaration of Helsinki. 
 
The investigator will sign a Clinical Trial Agreement and agrees to be compliant with it. The investigator 
will not start enrolling subjects or requesting informed consent from any subject prior to obtaining IRB/EC 
approval and relevant Regulatory Authority approval, if applicable, and authorization from the Sponsor in 
writing for the clinical study. If additional requirements are imposed by the IRB/EC or relevant Regulatory 
Authority, those requirements will be followed. If any action is taken by an IRB/EC or a relevant 
Regulatory Authority with respect to the clinical study, that information will be forwarded to the Sponsor. 
 
The Sponsor has taken up general liability insurance in accordance with the requirements of the 
applicable local laws. An appropriate Sponsor country representative will be utilized to understand the 
requirements for the type of insurance that will be provided for subjects, and such information will be 
incorporated into the site informed consent, as applicable. If required, additional subject coverage or a 
clinical study specific insurance will be provided by the Sponsor. 
 Quality Assurance Audits and Regulatory Inspections 
The investigator and/or delegate should contact the Sponsor immediately upon notification of a regulatory 
authority inspection at the site. A monitor or designee will assist the investigator and/or delegate in 
preparing for the audit. The Sponsor may perform quality assurance audits, as required. 
 
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical study for monitoring, audits, IRB/EC review and regulatory authority inspections, as required. The 
Principal Investigator or institution will obtain permission for direct access to source documents from the 
subject, hospital administration and national regulatory authorities before starting the clinical study. 
 Repeated and Serious Non-Compliance 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by the 
Sponsor, a monitor or designee will attempt to secure compliance by one or more of the following actions: 
• 
Visiting the investigator, 
• 
Contacting the investigator by telephone, 
• 
Contacting the investigator in writing, 
• 
Retraining of the investigator. 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any other 
conditions of the clinical study, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical study. In case of termination, the Sponsor will 
inform the responsible regulatory authority, as required, and ensure that the IRB/EC is notified, either by 
the Principal Investigator or by the Sponsor. 
 
 

 
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13 Suspension or Premature Termination of the Clinical Study 
The Sponsor reserves the right to terminate the clinical study at any stage, with appropriate written notice 
to the investigators, IRB/ECs and relevant Regulatory authorities, if required.  
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical study at the investigational sites for which they are responsible. The investigators 
will follow the requirements specified in the Clinical Trial Agreement.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so instructed by 
the IRB/EC or regulatory authority, the Sponsor may suspend the clinical study while the risk is assessed. 
The Sponsor will terminate the clinical study if an unacceptable risk is confirmed. If the Sponsor 
completes an analysis of the reasons for the suspension, implements the necessary corrective actions, 
and decides to lift the temporary suspension, the Sponsor will inform the Principal Investigators, IRB/EC, 
or regulatory authority, where appropriate, of the rationale, providing them with the relevant data 
supporting this decision. Approval from the IRB/EC or regulatory authority, where appropriate, will be 
obtained before the clinical study resumes. If subjects have been informed of the suspension, the 
Principal Investigator or authorized designee will inform them of the reasons for resumption. 
 
If the Sponsor suspends or prematurely terminates the clinical study at an individual investigational site in 
the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the subjects 
enrolled in the clinical study, and the Principal Investigator or authorized designee will promptly inform the 
enrolled subjects at his/her investigational site, if appropriate. 
 
14 Clinical Study Conclusion 
The clinical study will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical study closure. 
 
15 Publication Policy 
Publications or presentations of clinical study methods or results will adhere to Sponsor’s publication 
policy, which is based on Good Publication Practices and International Committee of Medical Journal 
Editors (ICMJE) guidelines. A copy of the policy will be provided upon request of the investigator. 
Publication planning and authorship determinations will be overseen by Publications Committee (see 
section 6.9.1), and investigators will be notified via email about the dissemination of study data and 
opportunities for involvement as authors on publications/presentations.  
 
16 Reporting Results on ClincalTrials.gov Website 
This clinical study will be registered on ClinicalTrials.gov and results will be posted on ClinicalTrials.gov 
as required. 
 
 

 
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Appendix B: Bibliography 
 
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H., Cleveland, J. C., Cigarro, J. E., . . . M, N. (2014). 
2014 AHA/ACC/HRS Guideline 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 Heart Rhythm Society. Circulation, e-199 - e267. 
Nof, E., Stevenson, W. G., & John, R. M. (2013). Catheter Ablation for Ventricular Arrhythmias. 
Arrhythmia & Electrophysiology Review, 45 - 52. 
Pedersen, C. T., Kay, G. N., Kalman, J., Borggrefe, M., Della-Bella, P., Dickfeld, T., . . . Kirchhof, P. 
(2014). EHRA/HRS/APHRS Expert Consensus on Ventricular Arrhythmias. Heart Rhythm, e166 - 
e196. 
Wright, M., & Narayan, S. M. (2015). Ablation of Atrial Fibrillation. Trends Cardiovasc Med., 409-419. 
 
 
 

 
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Appendix C: Definitions 
 
Non-study Specific Definitions 
Vulnerable Subject 
Vulnerable subject is defined as individual whose willingness to volunteer in a clinical investigation could 
be unduly influenced by the expectation, whether justified or not, of benefits associated with participation 
or of retaliatory response from senior members of a hierarchy in case of refusal to participate. 
EXAMPLE Individuals with lack of or loss of autonomy due to immaturity or through mental disability, 
persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic 
minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. 
Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as 
university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members 
of the armed forces, and persons kept in detention. 
 
Complaint  
Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, 
durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. 
 
 
Study Specific Definitions 
Arrhythmia recurrence 
For the purpose of this clinical study, recurrence of arrhythmia is deemed to have occurred only when the 
arrhythmia is documented on ECG or during a period of monitoring e.g. Holter-monitoring, implantable 
cardiac monitor, ICD, CRT… Atrial arrhythmias must be 30 seconds or longer. Ventricular arrhythmias 
are any treated by ICD or 20 seconds or longer.  
 
Blanking period (AF only)  
The 3-month (90 days) period of time following a procedure in which AF episodes can occur as part of the 
body’s healing response. Any arrhythmia activity during that blanking period is not counted in the study’s 
results and is not used in determining success or failure of the procedure. 
 
Acute success 
For the purpose of this study, acute success is attained when one (or multiple) predefined procedural 
endpoints, have been realized. These predefined procedural endpoints include, but are not limited to:  
 
- 
Abolition of all clinical ventricular ectopies and unstable ventricular arrhythmias 
- 
Bidirectional block across CTI 
- 
Block across mitral isthmus 
- 
Confirmation of vagal reflexes 
- 
CS isolation 
- 
Documentation of block at a critical isthmus of conduction 
- 
Elimination and noninducibility of tachycardia following ablation 
o 
With burst pacing 
o 
With Isoproterenol 
o 
With programmed atrial and ventricular stimulation 
- 
Elimination of dormant conduction 
- 
Elimination of LAVA 
- 
Elimination of local Purkinje potentials 
- 
Lines connecting scar to anatomic conduction barrier 
- 
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- 
Pulmonary Vein capture with exit block 
- 
Pulmonary Vein electrical isolation 
- 
Scar homogenization 
- 
Superior Vena Cava isolation 
- 
Termination of tachycardia during RF energy application 
 
 
 

 
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Appendix D: Abbreviations 
 
3D 
Three-Dimensional 
AF 
Atrial Fibrillation 
AVNRT 
Atrioventricular Nodal Reentry Tachycardia 
AVRT 
Atrioventricular Reentrant Tachycardia 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Forms 
CRT 
Cardiac Resynchronization Therapy 
DE-MRI 
Delayed Enhancement Magnetic Resonance Imaging 
DMP 
Data Management Plan 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EP 
Electrophysiological Procedure 
ER 
Emergency Room 
ICD 
Implantable Cardioverter Defibrillator 
ICMJE 
International Committee of Medical Journal Editors 
IFU 
Instructions For Use 
IRB 
Institutional Review Board 
OUS 
Outside the United States 
PVC 
Premature Ventricular Contractions 
RF 
Radiofrequency 
SVT 
Supraventricular Tachycardia 
US 
United States 
USB 
Universal Serial Bus 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
WMA 
Word Medical Association 
 
 
 

 
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Appendix E: Case Report Form 
The Final CRFs will be kept under a separate cover and are available upon request. 

 
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Appendix H: EQ-5D Questionnaire 
 
 
 
 
 
 
The subject should be asked to indicate 
his/her health state by ticking or placing a 
cross in the box against the most 
appropriate statement in each of the 5 
dimensions.  
This decision results in a 1-digit number 
expressing the level selected for that 
dimension. The digits for 5 dimensions can 
be combined in a 5-digit number describing 
the subject’s health state. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The EQ VAS records the subject’s self-rated 
health on a 20 cm vertical, visual analogue 
scale with endpoints labelled ‘the best health 
you can imagine’ and ‘the worst health you can 
imagine’. This information can be used as a 
quantitative measure of health as judged by the 
individual respondents.