Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia
Phase: NA
Conditions: Ventricular Tachycardia
Sponsor: Srinivas Dukkipati

Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia 
PI: Dr. Srinivas Dukkipati
NCT02374476
Document Date: August 24, 2016

VERSION 7.0 - August 2016 
 
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Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related 
Ventricular Arrhythmia 
 
 
 
 
Dr. Srinivas Dukkipati 
Department of Cardiac Electrophysiology 
Icahn School of Medicine at Mount Sinai 
New York City 
 
Version 7.0 
AUGUST, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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. 
VT 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 
14.1. 
MAINTAINING RECORDS (21 CFR 812.140 (B)) 
14.2. 
INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) INFORMATION 

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15. CLINICAL CENTERS 
 
16. DATA HANDLING 
 
17. DATA ANALYSIS 
 
REFERENCES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Bipolar Catheter Ablation for the Treatment of Refractory Scar-
Related Ventricular Arrhythmia 
 
Objective: 
This study will examine the safety and efficacy of irrigated bipolar 
radiofrequency (RF) ablation in the treatment of intramural ventricular 
tachycardia (VT) in patients for whom standard VT unipolar RF 
ablation has been unsuccessful. We hypothesize that the increased 
current density and improved rates of transmural lesion creation seen 
with bipolar RF ablation will lead to successful arrhythmia termination 
with minimal or no increased risk of complication.  
 
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  VT ablation. Patients are considered eligible to undergo 
bipolar ablation if they meet the following criteria 1.) evidence of 
ischemic or non-ischemic VT; 2.) intramural VT not terminable with 
unipolar ablation once enrolled in the Bipolar study, OR 3.) failed 
unipolar VT ablation within the past 6 months prior to enrollment. 
Patients will be excluded from the trial if:1.) history of MI or CABG 
within 6 weeks; 2.) Class IV HF; 3.) pregnant; 4.) unable to sign 
consent; 5.) projected lifespan of < 1 year;  Patients are considered 
enrolled once consented.  Patients who do not undergo VT ablation 
within 90 days of enrolling will be considered to be screen failures. 
Patients successfully terminated with unipolar ablation once enrolled 
will be followed in a registry for 6 months, (adhering to the same post-
procedure schedule as the patients that underwent bipolar ablation).. 
Two hundred subjects are expected to be enrolled in the study. 
 
Clinical Sites: 
1. Mount Sinai Hospital, New York, NY 
2. Loyola University Health System, Maywood, IL 
3. Brigham and Women‘s Hospital, Boston, MA 
4. University of Pennsylvania, Philadelphia, PA 
5. Texas Cardiac Arrhythmia Research Foundation 
6. Beth Israel Hospital, Boston, MA 
7. Homolka Hospital, Prague, Czech Republic 
 
Time Course: 
Expected duration of patient enrollment is approximately 2 years. 
 
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 VT. 
 
1. Freedom from recurrent VT at 6 months 
2. Procedural complications (death, stroke, myocardial infarction, 
heart failure, conduction abnormalities, pericardial effusion 
requiring drainage, hematoma, pseudoaneurysm) 

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Secondary Endpoints: 
 
1. Post-ablation inducibility 
2. Time to termination 
3. Total duration of bipolar ablation 
4. All-cause mortality 
 
Primary Analytical Analysis: 
N/A 
 
Secondary Analytical Analysis: 
N/A 
Principal Investigator: 
Srinivas Dukkipati, 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 
Events Adjudication 
Committee: 
TBD 
Data Safety and Monitoring 
Board: 
 
Dr. Jonathan Halperin 
Icahn School of Medicine at Mount Sinai 
New York, NY 
Cardiologist 
 
Dr. Arash Aryana 
Regional Cardiology Associates Medical Group 
Sacramento, Ca. 
Electrophysiologist 
 
Dr. Shephal Doshi 
Pacific Heart Institute 
Santa Monica, Ca. 
Electrophysiologist 
 

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1   CONTACT INFORMATION 
 
 
PRINCIPAL INVESTIGATOR: 
 
 SRINIVAS DUKKIPATI 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: SRINIVAS.DUKKIPATI@MOUNTSINAI.ORG 
 
1.1 STUDY SITES & INVESTIGATORS  
 
Site 
Principal Investigator 
1. Mount Sinai Hospital  
Srinivas Dukkipati, MD 
2. Loyola University Health System 
David Wilber, MD 
3. Brigham and Women‘s Hospital 
Usha B. Tedrow, MD, M.Sc. 
4. Penn Cardiovascular Institute 
Pasquale Santangeli,MD 
5. Texas 
Cardiac 
Arrhythmia 
Research 
Foundation 
Andrea Natale, MD 
6. Beth Israel Hospital 
Elad Anter, MD 
7. Homolka Hospital 
Petr Neuzil, MD 
 
 
2 
STUDY  OBJECTIVE 
 
This prospective, multicenter observational study will examine the role of irrigated bipolar 
radiofrequency (RF) ablation for the treatment of intramural ventricular tachycardia in patients who have 
failed standard unipolar RF ablation. We hypothesize that the increased current density and improved 
rates of transmural lesion creation seen with bipolar RF ablation will lead to successful arrhythmia 
termination with minimal or no increased risk of complication. 
 
 
3 
INTRODUCTION, RATIONALE 
 
Radiofrequency (RF) ablation is the most commonly employed method for the catheter treatment of 
cardiac arrhythmias. Myocardial scar serves as the most frequent substrate for the genesis of both atrial 
and ventricular arrhythmia. Such scar frequently contains surviving myocyte bundles interspersed with 
fibrotic tissue, which leads to slow conduction. Areas of denser fibrosis cause conduction block. When 
appropriately arranged, conduction through or around these scars leads to the creation of a ―reentry‖ 
circuit through which an arrhythmia is generated and maintained.1 Each reentry circuit contains within it 
an area called the isthmus, a portion of the circuit located in a position intimately related to the scar 
border zone. Electrical activation travels slowly through the isthmus before breaking out into normal 
myocardium. Ablation at the site of an isthmus will terminate a reentrant tachycardia.2  
 
A variety of techniques, including electroanatomic mapping and activation, entrainment, and substrate 
mapping, are employed during electrophysiologic (EP) study to identify areas of myocardial scar and 
potential isthmus sites. Points or lines of ablation using RF energy are then created in an attempt to 
interrupt the reentry circuit. Typically, unipolar RF energy is applied via a catheter tip electrode to the 

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endocardial or epicardial surface of the heart and grounded via an electrode pad placed on the patient‘s 
skin. RF energy in this setting is dispersed through the entirety of the tissue between catheter tip and 
grounding pad. The standard 7-French, 4-mm tip catheters are highly successful at ablating circuits 
located within a few millimeters of the catheter tip. A focal, 1mm area of resistive heating occurs within 
the myocardium immediately in contact with the catheter tip; myocardial cell death occurs several 
millimeters more deeply through passive, conductive heating, which spreads outward from the contact 
point.3 
 
While the standard catheter is effective at the ablation of superficial arrhythmias, it has proven more 
problematic when used for deep myocardial sites or for creating transmural lesions. A number of 
alternatives have been developed in an attempt to access these sites. 8-mm or 10-mm catheter tips are able 
to create larger zones of resistive heating, delivering direct RF energy to a larger area of myocardium. A 
larger interface between catheter tip and blood improves cooling and allows for the delivery of more 
power without a rise in impedence.4 The clinical use of these larger catheters can, however, be limited by 
rapid temperature rises at the catheter-tissue interface, resulting in thrombus formation, char, and ―steam 
pop‖ rupture of the endocardial surface.5 The use of irrigated ablation catheters have improved upon the 
ability to deliver RF energy without a sustained rise in impedance. Both open irrigated- and closed-loop 
irrigated catheters circulate saline along the catheter tip-myocardial interface, allowing for continued 
delivery of RF current without thrombus formation at the endocardial surface. Intramyocardial 
temperature rises accordingly without a concomitant endocardial temperature surge, creating larger and 
deeper myocardial ablation zones.6-10 Catheters featuring a retractable needle tipped electrode with 
intramyocardial saline infusion have also shown promise as a means of accessing deep myocardial 
circuits in ventricular tachycardia ablation, but are not currently available in the US.11-13 Transcoronary 
ethanol ablation has also been employed with moderate success in patients with arrhythmias resistant to 
endocardial catheter ablation.14 This technology, however, grants only limited control over the size of the 
resulting infarct and is restricted by the need for perfusion of the scar zone by an accessible coronary 
artery. 
 
Nevertheless, there remain occasions in which an arrhythmia cannot be eliminated by standard unipolar 
ablation technique. This is seen most frequently due to deep intramural ventricular tachycardia, 
sometimes encountered following myocardial infarction. Both standard and alternative ablation strategies 
are frequently either unavailable or inadequate for termination of these arrhythmias. 
 
Recently, several centers have employed irrigated bipolar ablation (BA) to target arrhythmias not 
amenable to unipolar ablation. During BA, two catheters are connected to either pole of an RF generator, 
allowing either catheter to function as the ―active‖ catheter and the other the ―return‖ catheter. Rather 
than being dispersed between the catheter tip and a distant grounding pad, BA concentrates energy 
between two catheter tips positioned on opposing sides of a target scar.  BA may thus improve lesion 
transmurality through synergistic, simultaneous heating and increased current density leading to 
concentrated thermal injury.15-17 
 
Initial experience in the use of BA technology in mammalian hearts demonstrated that it could 
successfully be applied to create discrete areas of myocardial necrosis with minimal risk of complication. 
When compared to unipolar ablation, several studies suggested that BA could create larger areas of 
necrosis and transmural lesions with only rare episodes of perforation.15-27 Subsequent experience in 
human hearts was predominantly surgical: a large number of observational studies and reviews 
demonstrated the effectiveness and safety of BA in patients undergoing pulmonary vein isolation and 
Cox-Maze surgery as either isolated procedures or as adjuncts to valve replacement or coronary artery 
bypass surgery.24, 28-50 
 

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Despite its broad use during surgical ablation, the application of BA during catheter-based therapies is 
limited.  Recently, our group demonstrated the utility of BA in both an in vitro model and in a series of 
patients with arrhythmia resistant to unipolar ablation.51 When compared to unipolar RF ablation, BA was 
found to be more likely to achieve transmural lesions in a porcine heart model (33% vs 82%, respectively, 
p = 0.001) and could do so in tissue up to 25 mm thickness. Clinically, all septal atrial flutters, 5 of 6 
septal VTs, and 2 of 4 free-wall VTs were successfully acutely terminated. 
 
The proposed study will further examine the role of BA in patients with ventricular tachycardia resistant 
to standard ablation techniques. 
 
 
4    DEVICES AND PROCEDURES 
        
       4.1   HARDWARE / SOFTWARE / CATHETERS  
 
The product consists of the CARTO V3 system (Biosense Webster, Inc.) preserving all existing 
functionalities with small software and hardware changes to allow the connection of an additional 
ablation catheter as an indifferent electrode for use of a bipolar ablation mode. 
  
Hardware: 
The bipolar ablation mode objective is to enable the performance of bipolar ablation between two 
therapeutic catheters. This mode is enabled by a special cable solution that allows the connection of a 
second therapeutic catheter to the Stockert 70 radiofrequency generator through the PIU ‗REF/DECA‘ 
port. The cable is based on the regular ablation catheter, modified to allow ablation while maintaining the 
magnetic location and all other existing capabilities. 
 
Software: 
The system displays the distance (tip to tip) between the Map and Ref/Decca catheters in the map viewer 
in order to simplify the position of the two catheters when ablating. The distance indication includes a 
connecting line between the two catheters, numerical value (in mm) and color change according to a user-
defined threshold. The conventional ‗ablation tag‘ on the ablation catheter is replaced by new ―bipolar 
ablation mode tag‖ that is displayed for each of the ablation catheters (dual point). The ―ablation mode‖ 
can be activated/deactivated by the user and has additional safety protections. 
 
Catheters: 
 Two of four types of Biosense Webster Thermocool catheters will be used during bipolar ablation in the 
following configuration:  
 
1. THERMOCOOL®SMARTTOUCH® Catheter, NAVISTAR® THERMOCOOL® Catheter, 
Or THERMOCOOL® SF or SF NAV Catheter, connected to the MAP socket of the PIU 
 
2. THERMOCOOL® SF Catheter (D-1313-XX or D-1315-XX), connected to the 
REF/DECA socket of the PIU 
 
 
The Diagnostic/Ablation Deflectable Tip Catheters are 7.5 F luminal catheters with deflectable tips 
designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to 
the catheter tip electrode for ablation purposes. For ablation, the catheters are used in conjunction with a 
radiofrequency generator (Stockert 70, described above) and a dispersive pad (reference electrode). The 
catheters have a high-torque shaft with a deflectable tip section containing an array of platinum 
electrodes. All of the electrodes may be used for recording and stimulation purposes. The tip electrode 

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serves to deliver radiofrequency current from the radiofrequency generator to the desired ablation site. 
The tip electrode and ring electrodes are made from platinum-iridium. The catheters incorporate either a 
thermocouple or thermistor temperature sensor that is embedded in the 3.5 mm tip electrode.  
 
The Thermocool Navistar and SmartTouch catheters are currently FDA-approved for ventricular 
tachycardia ablation. The Thermocool SF catheters are currently FDA-approved only for ablation of atrial 
arrhythmias.  
 
      4.2   ABLATION PROCEDURES 
 
Unipolar Ventricular Tachycardia Ablation 
Hemodynamic support to allow for entrainment mapping will be employed with either an intra-aortic 
balloon pump or with a percutaneous left ventricular assist device (Impella 2.5, Abiomed, Inc, Danvers, 
MA). All mapping will be performed with a hybrid magnetic/impedance-based mapping system (Carto, 
Biosense Webster, Diamond Bar, CA). LV endocardial and epicardial mapping was performed by 
utilizing a transseptal and subxiphoid puncture approach, respectively. Prolonged, split, or isolated late 
potentials will be tagged. For unipolar RF, power will be set to 30–50 W at 30-cm3 irrigation, targeting an 
impedance drop of >10 . In the epicardium, power will be set to 15–30 W with 5-ml/min irrigation. The 
use of the percutaneous left ventricular assist device in patients with VT allows for prolonged mapping 
during VT. Termination during VT was therefore the preferred initial strategy for these patients, followed 
by substrate modification. The procedural end point was the non-inducibility of VT.  
 
Bipolar Ventricular Tachycardia Ablation 
BA will be performed across two 3.5-mm externally irrigated catheters (Thermocool). Catheters will be 
positioned at locations determined on the basis of activation or entrainment mapping. The catheter on the 
left side of the heart (in the left ventricle) will connect to the ablation catheter connection on the RF 
generator (Stockert, Biosense Webster, Diamond Bar, CA). The second catheter, located in the right heart 
(right ventricle) or epicardium will be connected to the indifferent electrode connection via a custom 
cable, which allows visualization of electrograms from 4 poles of the second catheter while 
simultaneously allowing the distal electrode to be the indifferent electrode. Ablation will be initiated with 
a power of 30 W in the ventricle (limiting catheter tip temperatures to < 42-45oC) and then titrated to a 
maximum of 35 W over 60-90 seconds for an impedance drop of up to 30-40 . Ablation will be 
terminated or the power down-titrated if a sudden rise in temperature or a rapid fall or rise in impedance 
is seen. 
 
 

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5    SCHEDULE OF TREATMENT AND TESTS 
 
TABLE 1: SCHEDULE OF TREATMENTS AND TESTS: 
 
Baseline 
Procedure 
Discharge 
Telephone 
Follow-up (2 
weeks +/- 3 
days) 
Follow-up 
Visit (6mo, +/- 
2 weeks) 
 
Type of visit 
 
 
Office 
 
Hospital 
N/A 
 
Office 
 
Informed 
Consent 
 
 
X 
 
 
 
 
 
Brief History & 
Physical 
 
 
X 
 
 
 
 
 
X 
Blood 
Laboratory 
Testing: CBC, 
Electrolytes, 
BUN/Creatinine, 
BNP, INR, LFTs 
X 
 
 
 
X 
(as indicated) 
 
 
TTE 
 
 
X 
 
 
 
 
CT/MRI 
X 
 
 
 
 
 
 
ICD 
Interrogation 
 
 
X 
 
 
 
 
 
 
 
X 
 
EKG 
 
 
X 
 
 
 
 
 
 
X 
 
 
Medications 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
Adverse Events 
 
 
 
X 
 
X 
 
X 
 
X 
* Patients who screen fail will be placed in a registry and will continue to be followed throughout the 
study, adhering to the same post-procedure schedule as the patients who underwent bipolar ablation.  

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6    ENDPOINTS 
      6.1   Primary Endpoint 
 
1. 
Freedom from recurrent VT at 6 months, defined as sustained ventricular tachycardia lasting 
longer than 30 seconds and identified due to clinical symptoms or during device interrogation. 
2. 
Procedural complications (death, stroke, myocardial infarction, heart failure, conduction 
abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm) 
 
 
      6.2   Secondary Endpoints  
 
1. 
Post-ablation inducibility 
2. 
Time to termination 
3. 
Total duration of bipolar ablation 
4. 
All-cause mortality 
 
 
7    STUDY SUBJECTS 
 
7.1 
INCLUSION CRITERIA 
 
1. 
≥ 18 years of age. 
2. 
The study will include all forms of scar VT--both ischemic (post-myocardial infarction) and non-
ischemic (e.g. sarcoid, amyloid, dilated)--as determined by cardiac MRI and/or voltage mapping 
at the time of VT ablation.  
3. 
Intramural VT not terminable with unipolar ablation once enrolled in the Bipolar study or 
previous failed unipolar ablation within 6 months prior to enrollment. 
4. 
Ability to understand the requirements of the study and sign the informed consent form. 
5. 
Willingness to adhere to study restrictions and comply with all post- procedural follow-up 
requirements 
6. 
Projected lifespan greater than 1 year. 
 
      7.2     EXCLUSION CRITERIA  
 
1. 
Tissue Thickness less than 5 mm as assessed by electroanatomic mapping, CT, or MRI. 
2. 
MI or CABG within 6 weeks. 
3. 
NYHA Class IV CHF. 
4. 
Women known to be pregnant or to have positive beta-HCG. 
5. 
Participation in another study that would interfere with this study. 
 
 
8    SAMPLE SIZE 
 
This safety and efficacy study will enroll 200 patients across 6 US centers and 1 OUS center. This 
number has been determined on the basis of study feasibility and not by statistical means. 
 
 
9    PATIENT ENROLLMENT AND WITHDRAWAL 
 

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Patients meeting the study inclusion criteria will be identified in the outpatient or inpatient setting by one 
of the study sites‘ primary or co-investigators. Patients will be followed by one of the study site primary 
or co-investigators. Approximately 100  patients are expected to participate each year, with an expected 
total enrollment of 200 patients. 
 
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 (see 
Appendix 1 for informed consent form.)  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, 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 VT ablation. Patients 
are considered eligible to undergo bipolar ablation if they meet the following criteria 1.) evidence of 
ischemic or non-ischemic VT; 2.) intramural VT not terminable with unipolar ablation once enrolled in 
the Bipolar study, OR 3.) failed unipolar VT ablation within the past 6 months prior to enrollment.  
Patients are considered enrolled once consented.  Patients who do not undergo VT ablation within 90 days 
of enrolling will be considered to be screen failures. Patients successfully terminated with unipolar 
ablation once enrolled will be followed in a registry for 6 months (adhering to the same post-procedure 
schedule as the patients that underwent bipolar ablation). 
 
              

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10   STUDY PROCEDURES 
 
10.1.    PRE-PROCEDURE EVALUATION 
 
Patients will be consented for the study in either the inpatient or outpatient setting. The consent 
will detail the use of unipolar RF energy as part of standard of care in all patients undergoing VT 
ablation, and bipolar ablation as an experimental procedure employed only if patient had an 
unsuccessful unipolar ablation within six months prior to enrollment or if the index unipolar 
ablation procedure proves unsuccessful. Unsuccessful unipolar ablation is defined as the inability 
to terminate VT or VT that is still inducible following unipolar ablation. 
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 VT both clinical/ICD) 
 
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 
 
If performed for any reason, review and collect any pre-procedural imaging: MRI/CT, 
echocardiograms 
 
Baseline laboratory, including complete blood count, standard electrolyte panel, renal 
function, and brain natriuretic peptide levels. 
 
Consent must be obtained before the VT ablation procedure. 
 
10.2   PRE-PROCEDURE MEDICATION MANAGEMENT 
 
Management of pre-procedural anti-platelet and anti-thrombotic medications will be at the 
discretion of the primary operator. Typically, however, these medications will be continued 
through the procedure. Every effort will be made to maximize beta-blocker, ACE-i/ARB, and 
aldosterone antagonist therapy per current guidelines. 
 
10.3    VT ABLATION PROCEDURAL DETAILS  
 
 
Patients will be brought to the electrophysiology laboratory in a fasting state. 
 
General anesthesia will be used for sedation. 
 
Patients will undergo electrophysiology study and VT ablation as per standard practice. 
 
If a patient‘s arrhythmia cannot be eliminated with standard unipolar ablation or if the 
patient has failed unipolar ablation within the previous six months the patient will 
undergo a bipolar ablation. The bipolar hardware/software will be employed as described 
above. 
 
Therapeutic anticoagulation will be administered with intravenous heparin with a target 
ACT of 300 seconds or greater.  
 
Esophageal temperature monitoring is required when ablation is performed in the 
coronary sinus or epicardium irrespective of whether unipolar or bipolar ablation is 
performed.  Ablation should be stopped when esophageal temperature is 38.5oC. 
 
10.4    POST-PROCEDURE 

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10.4.1    POST-PROCEDURE FOLLOW UP 
 
 
All patients will be monitored to verify vascular hemostasis prior to discharge from 
the hospital.   
 
The majority of patients will receive either warfarin or a novel oral anti-coagulant 
(dabigatran, rivaroxaban, or apixaban) for 4-6 weeks post-procedure. Those patients 
with less extensive ablations may receive oral aspirin (81-325 mg daily) or 
clopidogrel (75 mg daily). These decisions will be made at the discretion of the 
primary operator per current guidelines. 
 
A proton pump inhibitor is recommended for any significant esophageal temperature 
rises noted during the procedure as determined by the treating physician.  However, if 
the esophageal temperature is noted to have been 41.0oC, a proton pump inhibitor is 
required for a minimum of 4 weeks following the ablation procedure.   
 
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 total number of episodes of VT, ATP, and shocks will be documented at all 
visits. 
 
The follow-up includes: 
o 2 weeks: Telephone follow up 
 
Assessment for adverse events or recurrent arrhythmia. 
o 6 months: In-office follow up 
 
History and Physical 
 
Electrocardiogram 
 
ICD interrogation (may be trans-telephonic) 
 
Review of medications and adverse events 
 
10.4.2    POST-PROCEDURE MEDICATION MANAGEMENT 
 
 
Standard cardiovascular medications are left up to the discretion of the investigator.  
Beta-blockers, ACE-i/ARBs, and aldosterone antagonist use is recommended as per 
standard guidelines. 
 
Therapeutic anticoagulation beyond the requisite 4-6 week post-procedure time point 
will be at the discretion of the patient‘s physician.  
 
      10.4.3    REPEAT VT ABLATION PROCEDURES 
 
  
 
 
A repeat bipolar VT ablation may be performed within 90 days post procedure at the 
discretion of the physician and will  be deemed a treatment  failure.   
 
 
11    SAFETY 
 
We anticipate no significant increase in adverse events as compared to the standard VT or AT ablation 
procedures. The local site primary investigator will oversee the safety of the study at his/her site.  All 
adverse events will be reported to the DSMB. The DSMB will consist of one Cardiologist and two 
electrophysiologists.  The PI will also be present at the meetings to relate any pertinent trial information.  
However, recommendations are solely up to the discretion of the DSMB. 

VERSION 7.0 - August 2016 
 
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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.  
 
Unanticipated Serious Adverse Event 
 
An unanticipated (unexpected) serious adverse event is any serious adverse event that is not protocol-
defined or documented in the patient consent form.  Expedited reporting is required for serious adverse 
events that are unexpected.  
 
Unanticipated Adverse Device Effects 
 
An unanticipated adverse device effects (UADE) is any serious adverse effect on health or safety or any 
life-threatening problem caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan, or any other 
unanticipated serious problem associated with the device that relates to the rights, safety, or welfare of 
subjects. 
 
Event Recording 
 
The following adverse events will be captured throughout the period of trial participation: 
 
 
Protocol-defined (as described below) 
 
Serious unanticipated events (serious “Other” adverse events) 
 
Causality 
 
The investigator will assess the relationship of an adverse event to the intervention. Causality will be 
defined as follows:  
 
Probable 
Adverse events that, after careful medical evaluation, are considered with a high degree of 
certainty to be related to the ablation procedure. The following characteristics will apply: 
o A reasonable temporal relationship exists between the event and the intervention, and  
o The event is a known reaction to the intervention, and cannot be explained by an 
alternative etiology commonly occurring in the population/individual. 

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17 
 
Possible 
Adverse events that, after careful medical evaluation, do not meet the criteria for a probable 
relationship to the intervention, but for which a connection cannot be ruled out with certainty. 
The following characteristics will apply: 
 
o The event occurs after intervention, and 
o The event is not a known reaction to intervention, but cannot be explained by a 
commonly occurring alternative etiology 
Unlikely 
 
Adverse events that, after careful medical evaluation, do not meet the criteria for a possible or 
probable relationship to intervention and for which a connection is unlikely. The following 
characteristics will apply: 
o The event does not follow a reasonable temporal sequence from administration of the 
intervention, or 
o May have been produced by environmental factors, and there is no apparent pattern of 
response to the intervention. 
Reporting of Serious Adverse Events and Unanticipated Adverse Device Effects  
 
All investigators must report both expected (protocol-defined) and unexpected SAEs. All protocol defined 
SAEs must be reported directly to the clinical center‘s IRB and the DCC within 5  business days of 
knowledge of the event, or as dictated by the specific IRB policy, whichever is sooner.  All deaths, 
UADEs, and unexpected SAEs that are possibly or probably related to the BIPOLAR VT ablation must 
be reported to the DCC and the clinical center‘s IRB within 24 hours of knowledge of the event, or as 
dictated by the specific IRB policy, whichever is sooner.  All unexpected SAEs that are unlikely related to 
the study intervention must be reported to the DCC and the clinical center‘s IRB within 5 business days of 
knowledge of the event, or as dictated by the specific IRB policy, whichever is sooner.  
 
The DCC will report these events to the DSMB chair within 72 hours of notification.  All SAEs will be 
reported to the DSMB at least semi-annually, at the discretion of the DCC medical monitor.   
 
Reporting of Unanticipated Problems 
 
All UPs that are also SAEs, which are at least possibly related to the study intervention, must be reported 
to the DCC within 24 hours of knowledge of the event.  All UPs that are not SAEs must be reported to the 
DCC within 5 calendar days of knowledge of the event, or as dictated by the specific IRB policy, 
whichever is sooner.  
 
DCC Reporting to FDA  
 
The DCC will report unexpected SAEs that are possibly or probably related to the investigational device 
or UADEs to FDA as appropriate. The DCC will send an initial IDE safety report communication to the 
FDA within 2 business days of notification from the site. The DCC will submit a follow-up safety 
communication to the FDA, based on source documentation or PI Report from the site, within 10 business 
days from notification of a UADE for this IDE trial. 
 
Data and Safety Monitoring Board 
 

VERSION 7.0 - August 2016 
 
18 
 
To meet the study's ethical responsibility to its subjects, an independent data safety monitoring board 
(DSMB) will monitor results during the study.  The DSMB will act in a senior advisory capacity to the 
DCC regarding data and safety matters throughout the duration of the study. In addition, the DSMB will 
review interim summary results of the accumulating data from the Event Adjudication Committee every 6 
months.  These 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 DSMB to the study sponsor related to safety concerns within 10 days. 
FDA will also be notified within 10 days if the DSMB requires changes to the study protocol, procedures 
or informed consent document.  The DSMB 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 DSMB regarding this trial and 
no voting member of the committee may participate in the study as an investigator.  Non-DSMB members 
will not be allowed during DSMB closed meetings.  
 
Event Adjudication Committee 
 
The charge of the Event Adjudication Committee (EAC) is to review source documents and adjudicate all 
adverse events and causes of mortality. The individuals who will serve on the committee are unaffiliated 
with the clinical sites and the DCC, and will be appointed by the DCC. The committee will consist, at 
least, of a statistician, a cardiologist, and an electrophysiologist. The EAC will meet every 6 months or as 
needed to review outcomes data for each subject enrolled. 
 
Interim and Futility Analyses 
 
An interim or futility analyses will be performed after the enrollment of 20 subjects. This analysis will be 
presented to the DSMB, who has the authority to terminate the study prematurely if an increase in adverse 
events is encountered. If the DSMB determines the trial should be stopped early either because of efficacy 
or safety concerns, or otherwise modified, the DSMB will prepare formal written recommendations to the 
PI to consider final action. Moreover, any pressing safety concerns that the DSMB identifies will be 
verbally communicated to the PI as soon as possible, prior to written documentation. The trial will be 
terminated early if severe procedure-related adverse events occur in more than 15% of patients. 
 
 
12   RISKS 
 
Patient confidentiality risks associated with any research study are minimal and include: breach of 
confidentiality and loss of personal data. 
 
As the protocol includes a standard of care VT ablation procedure, the risks of the procedure are generic 
to a standard VT procedure, and include the following:  
 
Potential Risks Associated with VT Ablation 
 
 
Death: End of Life (1%).  
 
Cardiogenic shock: when the heart has been damaged so much that it is unable to supply enough 
blood to the organs of the body (<1%).  
 
Complete Heart Block: complete absence of conduction from the atria to the ventricles during a 
stable supraventricular rhythm (2%).  
 
New incessant VT/VF: new arrhythmias may occur as a result of damage to the heart‘s electrical 
system. It may be necessary to shock your heart to stop the rhythm (<1%).  

VERSION 7.0 - August 2016 
 
19 
 
 
Acute Myocardial Infarction (MI): blocked blood supply to the heart that may cause damage to 
the heart muscle and affect how you feel and how well your heart can pump blood. This is often 
treated with drugs or may require surgical repair (1.5%).  
 
Stroke (also called Cardiovascular Accident or CVA): may cause an interruption in the blood 
supply to a part of the brain (~2-4%).  
 
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 (1.5%).  
 
Adverse effects on implantable pacemakers, cardioverters, and defibrillators. An example is 
dislodgement of ICD leads: (<1%).  
 
Coronary artery occlusion: a partial or complete block of blood flow in a coronary (heart) artery 
(<1%).  
 
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%).  
 
Esophageal injury:  the esophagus is located in close proximity to the left atrium and ventricles.  
Esophageal injury may occur from radiofrequency ablation and most often heals on its own.  In 
rare situations, a communication may develop between a cardiac chamber and the esophagus.  
This may present as fever, hematemesis, gastrointestinal bleeding, or stroke.  This complication 
requires emergency surgical repair and is associated with a high mortality.  The incidence of a 
fistula forming between a cardiac chamber and the esophagus following ventricular tachycardia 
ablation is very rare (<0.1%).  
 
Hemo-pneumothorax: bleeding in the chest (also called hemothorax); blood may leak into the 
chest cavity putting pressure on internal organs like your lungs (also called hemo-pneumothorax). 
This may be treated by using a needle or suction to remove the excess blood or it may require 
surgical repair. Pneumothorax may also occur when gas or air is present in the pleural (chest) 
cavity (<1%). 
 
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%). 

VERSION 7.0 - August 2016 
 
20 
 
 
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%). 
 
There are risks associated with an epicardial ablation if this is performed 
 
 
RV puncture with no clinical consequence: a rupture or hole (perforation) in the right ventricular 
heart of no clinical significance (15%). 
 
Pericardial bleeding: blood in the pericardial sac (~7%). 
 
Hemoperitoneum: blood in the peritoneal cavity due to damage to abdominal vessel / organ 
(<1%). 
 
Coronary Artery Damage: see definition for Coronary Artery Occlusion above (~0.6%). 
 
Phrenic Nerve Damage: see definition for Phrenic Nerve Damage above (~0.6%). 
 
Pleural damage: see definition for Hemo-pneumothorax above (~1.5%). 
 
MI: see definition for acute myocardial infarction above (~0.6%). 
 
Tamponade: see definition for Cardiac Perforation above (~4%). 
 
Abdominal bleeding: uncontrolled bleeding in the abdomen (~ 0.5%). 
 
Pericarditis: see definition of Pericarditis above (~21%). 
 
Esophageal injury:  the esophagus is located in close proximity to the left atrium and ventricles.  
Esophageal injury may occur from radiofrequency ablation, particularly in the epicardium and the 
coronary sinus.  This most often heals on its own.  In rare situations, a fistula may develop 
between a cardiac chamber and the esophagus.  This may present as fever, hematemesis, 
gastrointestinal bleeding, or stroke.  This complication requires emergency surgical repair and is 
associated with a high mortality.  The incidence of a fistula forming between a cardiac chamber 
and the esophagus following ventricular tachycardia ablation is very rare (<0.1%).  
 
 
 
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 

VERSION 7.0 - August 2016 
 
21 
 
(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 01-10) 
 
_2_ _3__4_: patient screening/enrollment # (001 – 500)—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   Deviations from Protocol 
 
The investigator will not deviate from the protocol except in medical emergencies or in unforeseen, 
isolated instances where minor changes are made that will not increase the patient‘s risk or affect the 
validity of the trial.  In medical emergencies, prior approval for protocol deviations will not be 
required, but the IRB/EC must be notified within five days of the incident. 
 
13.4   Role of the Coordinating Center 
 
As principal investigator and study sponsor of this clinical study, Srinivas Dukkipati, 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, Srinivas Dukkipati, MD will have certain 
direct responsibilities and will delegate other responsibilities to his staff at the Coordinating Center, 
the Icahn School of Medicine at Mount Sinai. The coordinating center 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. 
 
13.5 Withdrawal of Subjects 
 

VERSION 7.0 - August 2016 
 
22 
 
A subject may withdraw from the study at any time should they 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 
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 6 sites in the United States and 1 in Europe.  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. 
 
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 
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. 
 
Qualifications and Training 
 

VERSION 7.0 - August 2016 
 
23 
 
Clinical investigators will be electrophysiologists with expertise in VT 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 
 
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. All 
continuous variables will be performed as the mean  standard deviation, and all categorical variables as a 
percentage of the total study population.  
 
The co-primary endpoints of safety and efficacy will display events as a percentage of the total study 
population. Bar charts may be employed to demonstrate such data. 
 
Secondary data analysis will display continuous variables as the mean  standard deviation, and all 
categorical variables as a percentage of the total study population. 
 
 
 

VERSION 7.0 - August 2016 
 
24 
 
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