Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)
Phase: NA
Conditions: Persistent Atrial Fibrillation
Sponsor: Vivek Reddy

Real-time electrogram Analysis for Drivers of AtRial fibrillation (RADAR)
Dr. Vivek Reddy
NCT003263702
Document Date: Dec 13, 2017

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Table of Contents: 
1.
CONTACT INFORMATION
1.1. STUDY SITES & INVESTIGATORS
2.
STUDY OBJECTIVE
3.
INTRODUCTION, RATIONALE
4.
DEVICES AND PROCEDURES
4.1. HARDWARE / SOFTWARE / CATHETERS
4.2. ABLATION PROCEDURES
5.
SCHEDULE OF TREATMENTS AND TESTS
6.
ENDPOINTS
6.1. PRIMARY CLINICAL ENDPOINTS
6.2. SECONDARY CLINICAL ENDPOINTS
7.
STUDY SUBJECTS
7.1. INCLUSION CRITERIA
7.2. EXCLUSION CRITERIA
8.
SAMPLE SIZE
9.
PATIENT ENROLLMENT AND WITHDRAWAL
10. STUDY PROCEDURES
10.1. 
PRE-PROCEDURE 
10.1.1.  
EVALUATION 
10.1.2.  
MEDICATION MANAGEMENT 
10.2. 
ABLATION PROCEDURAL DETAILS 
10.3. 
POST-PROCEDURE 
10.3.1.  
FOLLOW UP 
10.3.2.  
MEDICATION MANAGEMENT 
11. SAFETY
12. RISKS
13. STUDY MANAGEMENT
13.1. 
STUDY DATA COLLECTION AND PROCESSING 
13.2. 
CONFIDENTIALITY 
13.3. 
DEVIATIONS FROM PROTOCOL 
13.4. 
ROLE OF THE COORDINATING CENTER 
13.5. 
WITHDRAWAL OF SUBJECTS 
14. ETHICAL AND REGULATORY CONSIDERATIONS

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3 
14.1. 
MAINTAINING RECORDS (21 CFR 812.140 (B)) 
14.2. 
INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) INFORMATION 
15. CLINICAL CENTERS
16. DATA HANDLING
17. DATA ANALYSIS
REFERENCES 
APPENDICES 

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4 
PROTOCOL SUMMARY 
Title: 
Real-time electrogram Analysis for Drivers of AtRial fibrillation 
(RADAR) 
Objective: 
This study will assess the ability of real time electrogram processing to 
identify driver domains to target for ablation in persistent AF patients 
Design: 
This is a prospective, multi-center, non-randomized, un-blinded, 
observational trial.  
Enrollment: 
Eligible subjects will be consented for participation in the trial prior to 
undergoing AF ablation. Patients are considered eligible if they have 
1. ≥ 18 years of age.
2. Symptomatic or drug-refractory patients who are planned to undergo a
catheter ablation procedure for persistent AF (ether a first procedure or a redo 
procedure). Patients may have either persistent AF (AF > 7 days) or long-
standing persistent AF (AF > 1 year’s duration). 
3. Ability to understand the requirements of the study and sign the informed
consent form. 
4.Willingness to adhere to study restrictions and comply with all post-
procedural follow-up requirements 
5. Projected lifespan greater than 1 year.
Patients will be excluded from the trial if: 
1. Rheumatic heart disease,
2. Current intra-cardiac thrombus,
3. History of MI or CABG within 6 weeks
4. Unstable angina
5. CVA or TIA within 3 months
6. Contraindication to anticoagulation
7. Class IV HF;
8. Unable to sign consent
9. Projected lifespan of < 1 year
10. Women known to be pregnant or to have positive beta-HCG.
11. Participation in another study that would interfere with this study.
Patients are considered enrolled once consented.  Patients who do not 
undergo AF ablation within 90 days of enrolling will be considered to be 
screen failures. 
Sixty-five subjects are expected to be enrolled in the study. 
Clinical Sites: 
1.
Mount Sinai Hospital, New York, NY
2.
University of Colorado Hospital, Denver, CO
3.
University of Kansas Medical Center, Kansas City, KS
4.
Seton Medical Center, Austin, TX
5.
Porter Adventist Hospital, Denver, CO
6.
Massachusetts General Hospital, Boston, MA
Time Course: 
Expected duration of patient enrollment is approximately 8 months to 1 year. 
Subject Description: 
Primary Endpoints: 
Subjects will only be eligible for this study if they are ≥ 18 years of age and 
have a history or suspected history of AF 
1.
Acute Procedural Outcome Analysis: after performing procedures on the
65 patients
2.
Clinical Outcome Analysis - Freedom from recurrent AF after one

VERSION 2.3, - December 2017 
5 
procedure at 12 months. 
3.
Clinical Outcome Analysis – Freedom of recurrent AF after two
procedures at 12 months. 
Additional Endpoints: 
1.
Clinical Outcome Analysis – Freedom from recurrent AT after one
procedure at 12 months.
2.
Clinical Outcome Analysis – Freedom from recurrent AT after two
procedures at 12 months.
3.
Total duration of RF ablation/Fluoro time/exposure/ procedure time
4.
Procedure-related adverse events
5.
Major Adverse Cardiac Events (MACE)
6.
Serious Adverse Events
Follow-Up 
1.
Post-Ablation blanking period = 3 months
2.
AAD use during blanking:  Any AAD is permitted, but should be
stopped by 8 weeks post-procedure. 
3.
Any documented post-blanking AF episode > 30 seconds would be
considered as a failure 
4.
Patients will undergo continuous 7-14 day ambulatory monitoring at 3, 6
and 12 months 
5.
A second ablation procedure using the CMA software is allowed should
a patient have recurrence of AF at any time during the 1 year follow-
up period.   
Principal Investigator: 
Vivek Reddy , M.D. 
Icahn School of Medicine at Mount Sinai 
One Gustave L Levy Place, Box 1030 
New York, NY 10029, USA 
Site, Monitoring, and Data 
Management Center 
Electrophysiology Clinical Research Group 
Icahn School of Medicine at Mount Sinai 
One Gustave L Levy Place, Box 1030 
New York, NY 10029, USA 

VERSION 2.3, - December 2017 
6 
1   CONTACT INFORMATION 
PRINCIPAL INVESTIGATOR: 
 
 VIVEK REDDY MD 
 
 ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI  
 
 HELMSLEY TRUST ELECTROPHYSIOLOGY CENTER 
 
 ONE GUSTAVE L. LEVY PLACE, BOX 1030 
 
 NEW YORK, NY 10029 
 
 TEL: (212) 241-7114 
 
 FAX: (646) 537-9691 
 
 EMAIL: VIVEK.REDDY@MOUNTSINAI.ORG 
1.1 STUDY SITES & INVESTIGATORS 
Site
Principal Investigator
1.
Mount Sinai Hospital
Vivek Reddy, MD 
2.
University of Colorado Hospital
Duy Nguyen, MD 
3.
University of Kansas Medical Center
Dhanunjay Lakkireddy, MD 
4.
Seton Medical Center
Kristopher Heinzmann, MD 
5.
South Denver Cardiology
Sri Sunduram, MD 
6.
Massachusetts General Hospital
Moussa Mansour, MD 
2 
STUDY  OBJECTIVE 
This prospective, multicenter observational study will examine the ability of real time electrogram 
processing mapping to identify driver domains to target for ablation in persistent AF patients.  
3 
INTRODUCTION, RATIONALE 
Catheter ablation targeting the PVs and/or PV antrum has been recognized as the cornerstone of AF 
catheter ablation.  But for non-PV sources of AF, ablation strategies remain controversial although 
several types of targets have been proposed: non-PV triggers, continuous fragmented atrial 
electrograms, ganglionated plexi, and linear lesions.  Of note, in a recent multicenter trial, STAR AF-
2, PV isolation (PVI) alone resulted in successful maintenance of SR in only 59% of patients with 
persistent AF.1  This clearly reveals the need for establishing strategies to address non-PV sources of 
AF in non-paroxysmal AF.  However, extensive atrial ablation lesion sets, such as ablation of CFAE 
sites or linear lesions, have not proven effective.  In the STAR AF-2 trial, after 18 months, the 
freedom from recurrent AF in patients assigned to PVI alone (59%) was not improved by the addition 
of either CFAE ablation (49%) or linear ablation (46%), p=0.15.1  Accordingly, PV isolation is now 
the most commonly performed procedure for not only paroxysmal AF, but also for persistent AF.  
However, there is little consensus as to what one should do beyond PV isolation. 
Localized driver domains perpetuating AF have been difficult to detect with conventional techniques 
because of the limits of sequential temporospatial mapping, intermittent firing, and, presumably, 
spatial meandering of rotor-like activity. Accordingly, we propose to use a new software 
Computational Mapping Algorithm (CMA) that enables high resolution temporospatial mapping of 
atria for the identification of drivers of AF.  CMA receives data from standard of care, commercially 
available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a 
unique way.  Electrogram and anatomy data are fed from the commercially available 3D Mapping 

VERSION 2.3, - December 2017 
7 
System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. 
Commercially available 3D Mapping Systems track the position (X,Y,Z) of catheters and each 
electrode on the catheters in a 3D coordinate system.  Further, these 3D Mapping Systems measure 
the electrical activity (electrograms) of the heart tissue with which each electrode comes in contact, 
much like an oscilloscope.  These 3D Mapping Systems draw the position of the catheters in 3D on a 
computer screen to allow the physician to see their position without the use of ionizing radiation (x-
ray).  These 3D Mapping Systems then facilitate a process of “painting” the inside of a heart chamber 
with a catheter to create a cloud of X-Y-Z points that is used to create a 3D geometry (anatomic 
image) of the heart chamber.  Concurrently, the 3D Mapping System is continuously displaying on 
the computer screen the electrograms measured on the electrodes, enabling the physician to see and 
diagnose arrhythmia within the context of the 3D geometry and the position of all the catheters. 
The electrogram data and the 3D geometry data gathered by the 3D mapping system are passed to the 
laptop running CMA via an established communication protocol and an Ethernet cable.  CMA then 
processes the electrogram data and generates a map of where the potential AF driver domains are 
located and superimposes those potential AF driver domain targets onto the 3D geometry of the 
anatomy (provided by the 3D mapping system).  This AF driver domain map is displayed on the 
laptop computer that sits next to the 3D mapping system.  This process is referred to as AF Mapping 
throughout the rest of this document.  CMA employs a unique pattern recognition technology on 
electrograms recorded by a standard coronary sinus catheter to sequence and synchronize 
electrograms recorded throughout a particular atrial chamber of the heart with a standard spiral or 
loop catheter.  CMA then stitches together electrograms panoramically throughout a particular atrial 
chamber, enabling the operator physician to visualize all the electrical activity of a particular chamber 
and thus identify drivers of AF.  Further, CMA amalgamates and overlays physiologic data gathered 
by the standard catheters such as tissue voltage, enabling the physician operator to integrate 
information and holistically interrogate the patient’s condition to decide on a catheter ablation 
treatment strategy.  This approach using CMA has the potential to reduce the amount of catheter 
ablation performed in a particular patient while focusing and targeting ablation on removing and/or 
isolating drivers of AF.  This approach using CMA also has the potential to provide meaningful 
therapy options for patients with persistent AF that have undergone standard of care pulmonary vein 
isolation and still suffer from AF. 
Extensive retrospective evaluation of CMA has been performed and published3,4.  A total of 70 
patients have been mapped using CMA at Mercy Hospital in St. Louis, MO, University of Kansas 
Medical Center in Kansas City, KS, and Mount Sinai Hospital in New York, NY.  No adverse events 
were associated with the mapping process.  Fifty-five of the 70 mapped patients produced analysis 
that was usable.  The unusable patient data can be attributed to initial tuning of the signal processing 
algorithms.  In this 55 patient series of data, patients were mapped using CMA and subsequently 
ablated with standard of care ablation at the operator’s discretion, without the benefit of the CMA 
generated maps. Ablation techniques included Wide Area Circumferential Ablation (WACA), 
empiric Complex Fractionated Atrial Electrogram (CFAE) Ablation and empiric linear lesion 
Ablation.  Retrospectively, the data was analyzed to see the effects of incidental ablation of CMA 
identified AF Driver domains.  Ultimately, the use of CMA generated maps of AF driver domains 
may serve to reduce the amount of empiric CFAE and linear lesion ablation and improve outcomes in 
persistent AF patients. 
The Abstract and Conclusion sections from the journal article entitled “Characterization of Drivers 
in Patients with Persistent Atrial Fibrillation to Identify Substrate Based Rotor Ablation Targets” 
serve as a good overview of CMA and associated retrospective clinical findings: 

VERSION 2.3, - December 2017 
8 
ABSTRACT:  Recent clinical trials have shown that targeting rotors and focal impulses (FIs) 
during atrial fibrillation (AF) ablation improves outcomes.  This study evaluated whether a novel 
computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors 
when incidental ablation resulted in rhythm changes.  Three-dimensional (3D) left atrial 
electroanatomic maps were created from signals recorded from multipolar circular mapping 
catheters in 61 patients undergoing persistent AF ablation.  Forty of 61acquired patient datasets 
were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, 
creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure.  
Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of 
rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms 
(CFAEs).  Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated 
for rhythm changes.  A total of 172 drivers were identified in 40 patients (4.3 2.2 
drivers/patient).  Seventy percent were rotors (120/172) and 30% were FIs (52/172).  Sixty-seven 
percent of rotors were classified as SBR vs 33% as NSBR.  Incidental ablation of SBRs resulted 
in rhythm change 91% of the time versus only 24% of the time for NSBR (p<0.0001).   
CONCLUSIONS:  Incidental ablation of SBRs resulted in rhythm change significantly more 
frequently than ablation of NSBRs.  Identification of drivers and classification of rotors based on 
substrate properties may allow a more tailored ablation approach in patients with persistent AF. 
The following is a description of what each Mapping System will perform during Persistent Atrial 
Fibrillation cases: 
St. Jude Ensite System: 
1. Tracking the position of the catheters as they travel through the heart and displaying them on a
screen in 3D so that X-Ray is not needed (or reduced). 
2. Create a shell of the heart chamber and display on a screen so that the physician knows where the
catheters are in relation to the anatomy (shell of heart chamber). 
3. Display electrogram signals from all the electrodes on the different catheters in the heart.
These three features will be used for the entire case to determine where to ablate tissue. 
AFTx System: 
1. Receive the heart chamber shell from St Jude Ensite.
2. Receive the electrogram signals from St Jude Ensite.
3. Use proprietary software algorithms to create a map of where the potential sources causing AF are
within the chamber and highlight them on the heart chamber shell. 
The physician will then navigate a catheter to those highlighted areas (using St Jude Ensite) and 
further interrogate the areas for suspicious electrograms and decide if it is appropriate to ablate the 
tissue.  Ultimately, St. Jude Ensite is the final tool used to decide whether to ablate or not. 

VERSION 2.3, - December 2017 
9 
5    SCHEDULE OF TREATMENT AND TESTS 
TABLE 1: SCHEDULE OF TREATMENTS AND TESTS: 
Baseline 
Procedure 
Discharge
Event 
monitor  
3 months 
Event 
monitor 
6 months 
Event 
monitor  
12 months 
Type of visit 
Office
Hospital
Office 
Office 
Office
Informed 
Consent 
X
Brief History & 
Physical 
X
X
X
X
TTE 
X
EKG 
X 
X
X
X
X
1-wk 
Ambulatory 
Monitoring 
X
X
X
Medications 
X
X
X
X
X 
X 
Adverse Events 
X
X
X
X
X

VERSION 2.3, - December 2017 
10 
6    ENDPOINTS 
      6.1   Primary Endpoint 
Primary Endpoints: 
1.
Acute Procedural Outcomes as defined by termination of
Atrial Fibrillation into NSR or AT > 5min.
2.
Clinical Outcome Analysis - Freedom from recurrent AF after
one procedure at 12 months.
3.
Clinical outcome Analysis – Freedom from recurrent AF after
two procedures at 12 months.
Additional Endpoints: 
1.
Clinical outcome Analysis – Freedom from recurrent AT after
one procedure at 12 months.
2.
Clinical outcome Analysis – Freedom from recurrent AT after
two procedures at 12 months.
3.
 Total 
duration 
of 
RF 
ablation/Fluoro 
time/exposure/
procedure time
4.
Procedure-related adverse events
5.
Major Adverse Cardiac Events (MACE)
6.
Serious Adverse Events
7    STUDY SUBJECTS 
7.1 
INCLUSION CRITERIA 
1.
≥ 18 years of age.
2.
Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned
to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo
procedure). Patients may have either persistent AF (AF > 7 days) or long-standing persistent AF
(AF > 1 year’s duration).
3.
Ability to understand the requirements of the study and sign the informed consent form.
4.
Willingness to adhere to study restrictions and comply with all post-procedural follow-up
requirements
5.
Projected lifespan greater than 1 year.
      7.2     EXCLUSION CRITERIA  
1.
Rheumatic heart disease
2.
Current intra-cardiac thrombus
3.
History of MI or CABG within 6 weeks
4.
Unstable angina
5.
CVA or TIA within 3 months
6.
Contraindication to anticoagulation
7.
Class IV HF
8.
Unable to sign consent
9.
Projected lifespan of < 1 year
10. Women known to be pregnant or to have positive beta-HCG.
11. Participation in another study that would interfere with this study.

VERSION 2.3, - December 2017 
11 
8    SAMPLE SIZE 
This safety and efficacy study will enroll 65 patients across 1-5 US centers and 1-2 OUS centers. This 
number has been determined on the basis of study feasibility and not by statistical means. This is a 
feasibility study of the mapping system performance in which the sample size of the clinical investigation 
is intended to provide preliminary estimates of safety and performance.   
The study will involve two cohorts.  The first cohort will be composed of patients with persistent AF > 7 
days but < 1 year’s duration.  The second cohort will be composed of up to 15 patients with long-standing 
persistent AF (AF > 1 year’s duration). 
9    PATIENT ENROLLMENT AND WITHDRAWAL 
Patients meeting the study inclusion criteria will be identified in the outpatient or inpatient setting by 
investigators. Patients will be followed by one of the study site principal or co-investigators.  
The study will typically be described (including the risks and benefits) during the initial clinic or hospital 
visit.  Consent will typically be obtained at the time of the initial assessment if it is clear that the patient 
truly understands the nature of the study.  Alternatively, the patient will be encouraged to take a copy of 
the consent form home to contemplate whether he/she would like to be enrolled in the study.  Only 
patients who voluntarily provide consent will be included in this study.  Consent will be obtained prior to 
undergoing the ablation procedure. Patients will be able to withdraw from the study at any point without 
compromising their medical care. All data will be de-identified and protected in accordance with 
institutional and HIPAA guidelines, including 1) de-identification of all geographic subdivisions smaller 
than a state; 2) all elements of dates related to the individual; 3) telephone and fax numbers; 4) email 
addresses; 5) social security number, medical record, health plan beneficiary, account, and 
certificate/license numbers; 6) vehicle identifiers; 7) device identifiers; 8) URLs and IP addresses; 9) 
biometric identifiers; and 10) photographic images.  
Eligible subjects will be consented for participation in the trial prior to undergoing AF ablation. Patients 
are considered enrolled once consented.  Patients will be followed for 12 months.  Patients who do not 
undergo an ablation procedure within 90 days of enrolling will be considered to be screen failures. 
Additionally, if a patient does not have any ablation performed that is a result of the mapping completed 
by the CMA software, the patient will be considered a screen failure.    Patients who are deemed to be 
screen failures may be considered for re-enrollment should they require a later AF ablation procedure. 
9.1 
MAPPING COHORTS 
In the first cohort of up to 15 patients, AF mapping (utilizing CMA) will be performed but will not be 
utilized to guide the ablation procedure.  That is, ablation will be based on standard approaches only.  
The purpose of this initial cohort is to validate the software and mapping procedure.  Brief operator 
learning curve relating to the mapping procedure is expected.  Proper sampling is necessary in order 
to achieve full spatial coverage of an entire chamber. The benefit of the technology includes infinite 
spatial resolution with unlimited multiple synchronized sample locations throughout the atria, but that 
unlimited sampling must be balanced with time added to the procedure for sampling and software 
computation.  The first cohort of patients is designed to allow for this learning curve to be normalized 
between the catheter operators and the software operators.  Performing the mapping alone, Kurian T, 
et al. have seen no procedure related adverse events in over 61 patients. As such, it is safe and 
worthwhile to take an initial cohort of patients to normalize the mapping process in persistent AF 
patients where the chambers are often diseased, complex and dilated requiring operator skill to 

VERSION 2.3, - December 2017 
12 
sample an entire chamber appropriately.  The consistent convergence of the CMA software within 
five minutes signifies that a balance has been struck between the amount of sampling data supplied to 
the software and the operator’s satisfaction in adequate sampling of the patient’s anatomy.  Over the 
course of these cases, if the software algorithm is converging to a solution consistently within five 
minutes of processing time, the size of this validation cohort may be reduced to less than 15.  
In the second cohort of patients (potentially patients 16-65), AF mapping (utilizing CMA) will be 
performed and used to point the operator to regions within a heart chamber that should be 
interrogated further for suspicious electrogram activity, as measured by the St. Jude Ensite System, 
and ablated if the suspicious electrogram activity persists.   

VERSION 2.3, - December 2017 
13 
 
 
Empiric ablation (CFAE or linear ablation) is not permitted
Screening 
Inclusion/Exclusion Informed Consent 
Assess patient’s rhythm 
IV isuprel infusion and or induction of AF.  
Perform AF driver mapping utilizing CMA. 
(right and left atria) 
Procedure complete 
Sinus rhythm achieved 
If still in AF- DCCV to SR 
If sinus rhythm  
If AF, perform AF driver mapping utilizing 
CMA. (right and left atria) 
In patients 16-65, review AF driver maps utilizing 
CMA. Use standard 3D Mapping System (St Jude 
Ensite) to navigate to AF Driver domains to 
further interrogate electrograms and deliver 
therapy to patient.  Perform Pulmonary Vein 
Isolation if veins not already isolated.   
In first 15 patients (or less), proceed with standard 
of care catheter ablation with no ablation based on 
AF driver mapping.   Use standard 3D Mapping 
System (St Jude Ensite) and instrumentation to 
navigate in heart, assess electrograms and deliver 
therapy. 
If the rhythm organizes to an atrial 
tachycardia, it should be targeted 
for ablation
Follow-Up: 3, 6, 12 Months, Office
If AF recurrence occurs, 
one ablation using the 
CMA software is allowed.

VERSION 2.3, - December 2017 
14 
10   STUDY PROCEDURES 
10.1.    PRE-PROCEDURE EVALUATION 
Patients will be consented for the study in either the inpatient or outpatient setting. The following 
tests and procedures will occur before the ablation as a routine part of pre-procedural medical 
assessment: 

Recording of patient medical history (including details of previous ablation)

Recording of patient AF/AT recurrences

Recording medication history (including all anti-arrhythmic drugs used and duration of use)

Obtain β-HCG in females of child bearing age the morning of the procedure as per usual
clinical practice

Baseline assessment of arrhythmia burden and type: Office/inpatient records, ICD
interrogation report

Collect any pre-procedural echocardiograms

Baseline laboratory, including complete blood count, standard electrolyte panel, renal
function

Baseline TTE to assess any adverse conditions.

Consent must be obtained before the procedure.
10.2   PRE-PROCEDURE MEDICATION MANAGEMENT 
It will be recommended that all subjects take therapeutic doses of anticoagulation for at least 3 
weeks prior to their catheter ablation procedure. For those who are not taking anticoagulation for 
this length of time prior to their procedure, a pre-procedural transesophageal echocardiogram will 
be recommended if the subject presents in atrial fibrillation and has CHA2DS2-VASc score ≥1.  
For subjects who are taking warfarin at the time of the ablation, it will be continued uninterrupted 
through the procedure. For subjects who are taking novel oral anticoagulants (NOACs) with twice 
daily dosing (dabigatran, apixaban), the morning dose on the day of the ablation will be held, and 
the NOAC will be resumed the evening after the procedure at the primary operator’s discretion. 
For subjects who are taking NOACs with once daily dosing (rivaroxaban), the last dose will be 
the night prior to the procedure, and the NOAC will be resumed the evening after the procedure at 
the primary operator’s discretion. 
Every effort will be made to discontinue AADs prior to ablation. 
10.3    PROCEDURAL DETAILS 

Patients will be brought to the electrophysiology laboratory in a fasting state

Patients will under ECG to determine rhythm – i.e. Sinus rhythm v Atrial fibrillation

Patients will undergo electrophysiology study using a mapping system and ablation as per
standard practice. Placement of trimmed patches will be placed in standardized locations.

The AF ablation procedure will be performed using any of the following marketed catheters:
(Note: the first 3 catheters listed below are FDA approved for the treatment of paroxysmal

VERSION 2.3, - December 2017 
15 
atrial fibrillation but not persistent The FlexAbility is only approved for treatment of typical 
atrial flutter.)  
o
Biosense-Webster Smart Touch SF
o
Biosense-Webster Thermocool SF
o
St. Jude Medical TactiCath Quartz
o
St. Jude Therapy FlexAbility

Intraprocedural anticoagulation will be administered with intravenous heparin, with target
ACT levels ≥350 sec during any period in which catheters are positioned in the left atrium.

For all patients, the initial ablation lesion set will consist of pulmonary vein isolation,
assessed by entrance block during electrode recordings in the PV and by exit block during
pacing from the PV.

It will be suggested to operators that energy and duration of any RF lesions delivered either
during PV isolation or subsequent ablation of drivers should be titrated to a goal tissue
impedance drop ≥10 ohms from baseline during each lesion. Additionally, acute elimination
of all local electrograms at ablation sites will be encouraged.
Presenting rhythm - Sinus 

AF is induced by pacing

Electro anatomic maps of right and left atria are created and PV isolation is assessed with
multielectrode mapping catheter.

Once this occurs - Map inducedAF   is obtained using the CMA software running on the laptop
adjacent to the 3D Mapping System.

Ablation of drivers can be initiated in chamber with faster CL or with greater number of
identified drivers

Drivers can be addressed in order of importance as suggested by maps.

Periodic reassessment of TCL in LAA and RAA to be done to help direct operator to
chamber of interest- e.g. if there is significant gradient between RAA and LAA such that
RAA is faster then drivers can be pursued in RAA prior to completion of all driver regions of
LA

All drivers are to be sequentially ablated or isolated using the St Jude Ensite system to
navigate ablation catheter to the anatomic region identified by the AF mapping as a potential
driver domain, assessing the local electrograms via St. Jude Ensite system and delivering
ablation via St. Jude ablation catheter.  If rhythm is still not organized then ablation sites are
visited again to ensure adequate ablation.

Then, Re-assess rhythm

If AF persists, Real time electrogram processing mapping should be repeated (MapRe1,2….)
and additional driver regions targeted.

If the rhythm organizes to an atrial tachycardia, it should be targeted for ablation

If  rhythm is still is in AF despite elimination of all drivers based on repeated Maps or if no
drivers are localized- the patient will be cardioverted to sinus rhythm (Number of remaps is at
the discretion of operator)

VERSION 2.3, - December 2017 
16 

If during AF or AT ablation- the patient reverts to sinus rhythm- ablation is complete at that
site as per operator definition of sufficient ablation. Additional drivers localized during
mapping will also be targeted despite sinus rhythm

Empiric ablation (CFAE or linear ablation) is not permitted
Presenting rhythm - Atrial fibrillation 

Electro anatomic maps of right and left atria are created and PV isolation is assessed with
multielectrode mapping catheter.

Map spontAF will be acquired CMA software running on the laptop adjacent to the 3D
Mapping System.

Prior to ablation- LAA and RAA cycle length are to be measured over 10 beats.

Ablation of drivers can be initiated in chamber with faster CL or with greater number of
identified drivers

Drivers can be addressed in order of importance as suggested by maps.

Periodic reassessment of TCL in LAA and RAA to be done to help direct operator to
chamber of interest- e.g. if there is significant gradient between RAA and LAA such that
RAA is faster then drivers can be pursued in RAA prior to completion of all driver regions of
LA

All drivers are to be sequentially ablated or isolated using the St Jude Ensite system to
navigate ablation catheter to the anatomic region identified by the AF mapping as a potential
driver domain, assessing the local electrograms via St. Jude Ensite system and delivering
ablation via St. Jude ablation catheter.  If rhythm is still not organized then ablation sites are
visited again to ensure adequate ablation.

Then, re-assess rhythm

If AF persists, real time electrogram processing mapping should be repeated (MapRe1,2….) and
additional driver regions targeted. (previous driver regions may be revisited to ensure
elimination of complex EGMs)

If the rhythm organizes to atrial tachycardia this will be ablated and if rhythm converts to
sinus – then procedure is deemed complete. Additional drivers are to be targeted based on
Map Re1,2

If presenting rhythm is AF- and Map spontAF   has been acquired; induced AF map based driver
ablation is not required unless this occurs spontaneously

Empiric ablation (CFAE or linear ablation) is not permitted
10.4    POST-PROCEDURE 
10.4.1    POST-PROCEDURE FOLLOW UP 

Discharge criteria decisions will be made at the discretion of the primary operator per
current guidelines.

Medication and adverse event review will be performed prior to discharge.

Complications including vascular, stroke, heart failure, pericardial effusion,
tamponade, bleeding, and death will be documented.

The post ablation blanking period will last 3 months only - any AAD is permitted but
should be stopped by 8 weeks after the study procedure

The total number of episodes of post-blanking AT or AF episode > 30 seconds will
be recorded

VERSION 2.3, - December 2017 
17 

Patients will undergo continuous 7 day ambulatory monitoring at 3, 6 and 12 months

Review of medications and adverse events will be performed at the 3, 6 and 12
month follow up

At any time during the follow-up period, patients will be allowed a second ablation
procedure using the CMA software should recurrence of AF occur.  Data from the
second procedure will be recorded.
10.4.2    POST-PROCEDURE MEDICATION MANAGEMENT 

Standard cardiovascular medications are left up to the discretion of the investigator.

Therapeutic anticoagulation beyond the requisite 2 month post-procedure time point
will be at the discretion of the patient’s physician.

The post ablation blanking period will last 3 months only - any AAD is permitted but
should be stopped by 8 weeks after the study procedure
11    SAFETY 
The local site Principal Investigator will oversee the safety of the study at his/her site.  The Data 
Coordinating Center will provide on-site and remote monitoring to assess safety issues at each site. 
Additionally, a Data Monitoring Committee will review safety data on a 6 month basis or as needed.  A 
detailed tally of adverse events will be kept and are defined below.   
Adverse Events 
An adverse event is any undesirable clinical occurrence in a study patient, whether or not it is related to 
the study intervention.  Any condition that was recorded as pre-existing is not an adverse event unless 
there is a change in the nature, severity or degree of the condition.   
Serious Adverse Event 
Serious adverse events are defined by FDA regulation as any experience that results in a fatality or is life 
threatening; results in significant or persistent disability; requires or prolongs a hospitalization; results in 
a congenital anomaly/birth defect; or represents other significant hazards or potentially serious harm to 
research subjects or others, in the opinion of the investigators. Important medical events that may not 
result in death, be life-threatening, or require hospitalization may be considered a serious adverse event 
when, based upon appropriate medical judgment, they may jeopardize the patient and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition.  Examples of such 
medical events include bronchospasm requiring intensive treatment in an emergency room or at home, 
blood dyscrasias, or convulsions that do not result in inpatient hospitalization.  
12   RISKS 
Patient confidentiality risks associated with any research study are minimal and include: breach of 
confidentiality and loss of personal data. 
Potential Risks Associated with AF Ablation 

VERSION 2.3, - December 2017 
18 

Death: End of Life

Stroke (also called Cardiovascular Accident or CVA): may cause an interruption in the blood
supply to a part of the brain

Pericarditis: inflammation may occur in the outer lining of the heart (<1%).

Cardiac perforation causing pleural effusion or tamponade: fluid build-up around the heart. A
hole in your heart wall (perforation) could result in bleeding into the sac, called the pericardium,
which surrounds your heart (cardiac tamponade). This may be treated by insertion of a needle,
through your chest wall, into the sac and removal of the blood. This type of hole sometimes
requires surgical repair

Heart Valve injury (also called Valvular Damage/Insufficiency): an injury to a valve structure
resulting in a loss and/or worsening of function (e.g., worsening of regurgitation score or
prolapse) (<1%).

Acute Pulmonary edema: fluid accumulation (build-up) in the lungs (<1%).

Pulmonary embolism: blockage of a pulmonary artery; a blood clot from a vein may get stuck in
the lungs. This is usually treated with drugs (<1%).

Vascular access complications: an obstruction or perforation or damage to the vascular (blood
vessel) system (2%).

Arterial/venous thrombus: clot formation in the artery or vein (1.5%).

AV fistula: an abnormal passageway (such as a hole) between an artery and a vein; this may
allow blood to go between the arteries and veins and not through the entire body. This may cause
some part of the body to not receive the usual amount of blood. This may heal on its own, but
may require surgical repair (1.5%).

Catheter insertion site hematoma: bleeding or bruising from the site of catheter placement. This
may go away without treatment, but may require manual compression or surgical repair. If
excessive bleeding at the site of the catheter placement continues, this could result in anemia
requiring medical intervention (2%).

Hypoxia: reduced oxygen supply to tissue (<1%).

Infection, Localized or systemic: an infection may occur anywhere an incision or cut is made
during the procedure (<1%).

Peripheral venous thrombosis: blood clots in the vein (<1%).

Phrenic nerve damage: damage to the nerve that controls the diaphragm and may affect your
breathing. Symptoms may be temporary but in some cases can be permanent (respiratory arrest)
(<1%).

Pneumonia: infection of lungs or gathering of fluid in the lungs (<1%).

Pseudoaneurysm: development of a false pouch in the vessel wall. This can be caused by
movement of catheters in the blood vessels. This may heal on its own, but sometimes need
surgical repair (<1%).

Radiation injury resulting in dermatitis (skin burns): (<1%).

Respiratory failure: damage to breathing that can be permanent (respiratory arrest) (<1%).

Radiation exposure during the fluoroscopic imaging of the catheters during ablation: this may
slightly increase the lifetime risk of developing a fatal malignancy or a genetic defect in offspring
(<1%).

Fluid overload: excessive fluid built up could result in pulmonary (lung) edema; congestive heart
failure (CHF) may occur or may be exacerbated (worsened) due to delivery of sterile salt water
(saline) during the procedure (these risks are specific to open irrigated ablation catheters) (1.5%).
Potential Risks Associated with investigational mapping system: 

The additional investigational mapping done for this study may cause patients to have a
prolonged procedure time.  The patients may be exposed to additional anesthesia as a

VERSION 2.3, - December 2017 
19 
result of this prolonged procedure time.  

Potential harms of a more extensive bi-atrial lesion set over PV isolation include prolonged
procedure time and atrial stunning. 
13   STUDY MANAGEMENT 
13.1 Study Data Collection and Processing 
The Case Report Form (CRF) is an integral part of the study and subsequent reports.  The CRF must 
be used to capture all study data recorded in the patient’s medical record.  The CRF must be kept 
current to reflect patient status during the course of the study.  Patients will be identified by a 5-digit 
number and their initials.  The investigator must keep a separate log of patient names and medical 
record numbers (or other personal identifiers) for their own reference. All study-related documents 
(CRFs, source medical records, regulatory binder) must be kept in a secure, locked environment with 
access limited to study personnel only. 
The PI is responsible for ensuring the following: 1) adherence to the protocol; 2) verifying adherence 
to local regulations on the conduct of clinical research; and 3) ensuring completeness, accuracy, and 
consistency of the data entered in the CRF. 
Final CRFs in human readable format must be reviewed and verified for accuracy by the study site 
Principal Investigator and signed-off.  A copy of the final CRF will remain at the investigator’s site at 
the completion of the study. 
The CRF numbering convention is as follows: 
_01_-_2_ _3__4_ A -B -A 
_01_: Site # must be 2 digits (use leading zero) --- (sites 01-05) 
_2_ _3__4_: patient screening/enrollment # (001 – 065)—must be 3 digits 
A-B-A: Patient initials (if no middle initial, use dash)  
Total 5 digits and initials for enrolled patients. 
13.2 Confidentiality 
Patient information will be kept confidential and managed according to the 1996 HIPAA guidelines. 
Each patient will be given a unique subject number and will be identified by this number and their 
initials. All data used in the analysis and reporting of this evaluation will be without identifiable 
reference to the patient. Data relating to the study might be made available to third parties (for example 
in case of an audit performed by regulatory authorities) provided the data are treated confidential and 
that the patient’s privacy is protected.   
13.3 Role of the Data Coordinating Center 
As Principal Investigator and study sponsor of this clinical study, Vivek Reddy, MD assumes the 
overall responsibility for the conduct of the study, including assurance that the study meets national 
and institutional guidelines for study conduct.  In this study, Vivek Reddy, MD will have certain direct 

VERSION 2.3, - December 2017 
20 
responsibilities and will delegate other responsibilities to his staff at the Data Coordinating Center at 
the Electrophysiology Clinical Research Group at the Icahn School of Medicine at Mount Sinai. The 
Data Coordinating Center (DCC) will: 1) ensure adherence to the national and institutional regulations; 
2) develop and distribute protocols and case report forms; 3) coordinate data organization; 4) perform
statistical analyses; 5) provide on-site and remote monitoring. 
13.4 Withdrawal of Subjects 
A subject may withdraw from the study at any time should he/she choose to do so.  Additionally, 
subjects may be withdrawn by the investigator if deemed appropriate due to safety or compliance 
issues. 
13.6 Economic Impact on Subjects 
There are no additional costs related to involvement in this study. Since the cost of the procedure will 
be included within the Disease Related Group (DRG) charge, neither patient nor insurance provider 
will incur additional cost. 
14   ETHICAL AND REGULATORY CONSIDERATIONS 
14.1 Maintaining Records (21 CFR 812. 140 (B)) 
All clinical sites will maintain study records for two years after research termination. The Data 
Coordinating Center will maintain copies of correspondence, data, shipment of devices, adverse device 
effects and other records related to the clinical trial.   
14.2 Institutional Review Board (IRB) / Ethics Committee (EC) Information 
This protocol and the informed consent must be reviewed and approved by the appropriate IRB/EC 
where the trial is to be conducted before enrollment of patients.  Changes to the protocol that may 
increase the risk or present new risks to the patient, or may adversely affect the validity of the trial, 
must be approved in writing by the IRB/EC before the change is made. 
The study site Principal Investigator(s) is responsible for submitting and obtaining initial and 
continuing review (at intervals not greater than once a year) of the trial by their IRB/EC. 
15   CLINICAL CENTERS  
The study will be conducted in up to 5 sites in the United States and 1-2 OUS sites.  Each clinical center 
will be required to obtain IRB/EC approval for the protocol and consent (and their revisions) in a timely 
fashion, to recruit patients, to collect data and enter it accurately in the electronic data capture (EDC) 
system, to faithfully follow the protocol and adhere to the standards of Good Clinical Practice (GCP).  In 
addition, centers will be required to provide the DCC with the information necessary for interim, annual, 
and final reports, to provide source documents, data and regulatory documents for study monitors, 
provide prompt responses to DCC inquiries, and to participate in analyses and reporting of study results. 
15.1 Investigator Profile 
All cardiologists, coordinators and other investigators in the study must complete the Investigator 
Profile form, including hospital affiliation, address, telephone, fax, beeper and email information. The 

VERSION 2.3, - December 2017 
21 
cardiologist and coordinator must email or fax their CV, Conflict of Interest Statement and Financial 
Disclosure Certification, and Institutional Health Insurance Portability and Accountability Act 
(HIPAA) Certificates to the DCC. 
15.2 Qualifications and Training 
Clinical investigators will be electrophysiologists with expertise in AF ablation.  The certified 
operator will either perform the ablation on their own patient, or participate in the ablation of an 
enrolled patient. The clinical site Principal Investigator will be responsible for overseeing the ongoing 
performance of the other participating investigators at that site over the course of the study.   
All clinical site investigators and coordinators will be trained by the DCC in the specifics of the 
protocol at a site initiation visit in advance of patient enrollment.  In addition, the investigators and 
coordinators will undergo a separate training session to gain familiarity with the electronic data 
capture system. 
16    DATA HANDLING 
Information about patients will be kept confidential and managed according to the requirements of the 
United States of American Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those 
regulations require a signed patient authorization informing the patient of the following:  
1. What protected health information (PHI) will be collected from patients.
2. Who will have access to that information and why.
3. Who will use or disclose that information.
4. The rights of a research patient to revoke their authorization for use of their PHI.
In order to ensure patient confidentiality, all case report forms and patient information (CT/MRI, if 
reviewed), fluoroscopic and endoscopic images, ECGs) will be de-identified and replaced with a unique 
patient identifier.  Information will be stored in the office of the local study coordinator, which will be 
kept in a secure, locked location. The research study coordinators, principal investigator and co-
investigators will be the only personnel with access to this data. All data will be stored without any 
patient information apart from the unique three digit patient identifier. Electronic data will be encrypted 
and password-protected.  
17    DATA ANALYSIS 
This clinical study is a proof of concept study intended to assess the feasibility of the study mapping 
system. Baseline clinical characteristics (e.g. age, gender, renal function) and procedural characteristics 
(e.g. surface intracardiac electrogram and imaging findings) of the patients will be collected and analyzed. 
Descriptive statistical data will be used to draw up the characteristics of subjects at the time of enrollment 
(demographics, baseline data).  Quantitative parameters will be described using the following summary 
descriptive statistics: mean, standard deviation, median, and minimum and maximum values. Qualitative 
parameters will be described overall using frequencies and percentages. Percentages will be calculated on 
the number of non-missing observations. In all cases, the number of missing values will be specified. 
Wilcoxon’s test or Student’s test for pairwise comparisons will be used, depending on the normality of 
the distribution, to study evolution in time. 
17.1 Data Monitoring Committee 

VERSION 2.3, - December 2017 
22 
To meet the study's ethical responsibility to its subjects, an independent Data Monitoring 
Committee (DMC) will monitor results during the study. The committee will consist of a 
cardiologist who has no formal involvement or conflict of interest with the subjects, the 
investigators, the sponsor or the DCC. The DMC will act in a senior advisory capacity to the 
DCC regarding data and safety matters throughout the duration of the study. In addition, the 
DMC will review interim safety and endpoint data every 6 months or on an as needed basis 
depending on enrollment figures. These safety data include adverse events (e.g., infection, 
bleeding, right heart failure) and mortality. They will communicate their findings directly 
with the DCC. The FDA will be provided a copy of any written communication from the 
DMC to the study sponsor related to safety concerns, or changes to the study protocol, 
procedures or informed consent document. The DMC will be provided a copy of any letter 
from the FDA to the study sponsor related to safety concerns, or changes to the study 
protocol, procedures or informed consent document. The clinical centers will have no contact 
with the members of DMC regarding this trial and no voting member of the committee may 
participate in the study as an investigator. Non-DMC members will not be allowed during 
DMC closed meetings.  
DMC membership: 
David Park, MD - Electrophysiologist 
NYU Medical Center 
New York, NY 

VERSION 2.3, - December 2017 
23 
18    REFERENCES 
1 Approaches to catheter ablation for persistent atrial fibrillation: Verma A, Jiang CY, Betts TR, Chen 
J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, 
Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. 
2 Driver domains in persistent atrial fibrillation. Haissaguerre M, Hocini M, Denis A, Shah AJ, 
Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux 
S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois 
R. 
3 Characterization of Drivers in Patients with Persistent Atrial Fibrillation to Identify Substrate Based 
Rotor Ablation Targets:  Kurian T, Janardhan A, Doshi A, Kessman P, Nguyen B, Atkinson J, Edwards 
J, Efimov I, Sanchez M; The Journal of Innovations in Cardiac Rhythm Management, 6 (2015), 2153-
2161. 
4 Rotors in Patients with Persistent Atrial Fibrillation; Case Report of a Left Atrial Appendage Rotor 
Identified by a Novel Computational Mapping Algorithm Integrated into 3-Dimensional Mapping and 
Termination of Atrial Fibrillation with Ablation:  Kurian T, Doshi A, Kessman P, Nguy 
en B, Edwards J, Pieper S, Efimov I, Janardhan A, Sanchez M;  Cardiac Electrophysiology Clinics 7 
(2015) 157-163. 
5 Identification of Drivers in Patients with Persistent Atrial Fibrillation Using a Novel Spatiotemporal 
Computational Algorithm Integrated with Electroanatomic Mapping:  Kurian T, Sanchez M, Doshi A, 
Kessman B, Edwards J, Pieper S, Efimov I, Janardhan A;  2014 Atrial Fibrillation Symposium 
Scientific Abstract Poster. 
6 Characterization Rotors in Patients with Persistent Atrial Fibrillation to Guide substrate Based Rotor 
Ablation Therapy; Kurian T, Doshi A, Kessman P, Nguyen B, Edwards J, Pieper S, Efimov I, 
Janardhan A, Sanchez M; 2014 Heart Rhythm Society Congress Scientific Abstract Poster. 
7 Acute Termination of Atrial Fibrillation is Highly Correlated with Incidental Modification of Drivers 
Identified by Probabilistic AF Driver Analysis (PADA) Mapping:  Kurian T, Janardhan A, Edwards J, 
Nguyen B, Kessman P, Doshi A, Pieper S, Efimov I, Sanchez M; 2015 Atrial Fibrillation Symposium 
Scientific Abstract Poster. 
8 Rotor Probability Index Predicts Rhythm Changes After Incidental Ablation of Identified Rotors in 
Persistent AF Patients; Kurian T, Janardhan A, Edwards J, Nguyen B, Kessman P, Doshi A, Pieper S, 
Efimov I, Sanchez M; 2015 Heart Rhythm Society Congress Scientific Abstract Poster. 
9 Outcomes after Incidental Ablation of Identified Rotors using Novel 3D Computational Mapping 
Algorithm in Persistent AF Patients; Kurian T, Janardhan A, Edwards J, Nguyen B, Kessman P, Doshi 
A, Lakkireddy DJ, Sanchez M; 2016 Atrial Fibrillation Symposium Published Scientific Abstract 
Poster. 
10 Incidence of Left Atrial Appendage Rotors in patients with Persistent Atrial Fibrillation using a 
Novel Computational Mapping Algorithm; Kurian T, Janardhan A, Edwards J, Nguyen B, Kessman P, 
Doshi A, Lakkireddy DJ, Sanchez M; 2016 Heart Rhythm Society Congress Scientific Abstract Poster. 

VERSIO
 
AP
 
ON 2.3, - Dec
PPENDIX 1A
cember 2017
:   2014 Atrial
7 
l Fibrillation Symposium Poster 
24 

VERSIO
 
APPENDI
ON 2.3, - Dec
IX 1B:   2014 
cember 2017
Heart Rhythm
7 
m Society Poster 
25 
 

VERSIO
 
 
APPENDI
ON 2.3, - Dec
IX 1C:   2015 
cember 2017
Atrial Fibrilla
7 
ation Symposium Poster 
 
26 

VERSIO
 
 
APPENDI
ON 2.3, - Dec
IX 1D:   2015 
cember 2017
Heart Rhythm
7 
m Society Poster
27 

VERSIO
 
APPENDI
ON 2.3, - Dec
IX 1E:   2016 
cember 2017
Atrial Fibrilla
7 
ation Symposium Poster 
28 

VERSIO
 
 
APPENDI
ON 2.3, - Dec
IX 1F:   2016 
cember 2017
Heart Rhythm
7 
m Society Poster 
 
29