A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
Phase: NA
Conditions: Atrial Fibrillation
Sponsor: Inova Health Care Services

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/23 
 
i 
 
A PRAGMATIC RANDOMIZED CLINICAL TRIAL COMPARING RECTILINEAR 
BIPHASIC WAVEFORM AND BIPHASIC TRUNCATED EXPONENTIAL WAVEFORM 
SHOCKS FOR CARDIOVERSION OF ATRIAL FIBRILLATION (ZOLL VS LIFEPAK-RCT) 
 
 
NCT05992623 
 
 
Document Date 5/22/2023 
 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/23 
 
ii 
 
A PRAGMATIC RANDOMIZED CLINICAL TRIAL COMPARING RECTILINEAR 
BIPHASIC WAVEFORM AND BIPHASIC TRUNCATED EXPONENTIAL WAVEFORM 
SHOCKS FOR CARDIOVERSION OF ATRIAL FIBRILLATION (ZOLL VS LIFEPAK-RCT)  
 
Inova Protocol #: 
U23-04-5042 
External IRB Protocol #: 
NA 
Funding Source: 
N/A 
Drug or Device Name(s): 
Zoll Series R Defibrillator 
Physiocontrol Lifepak Series 15/20 Defibrillator 
FDA IND/IDE #: 
N/A 
Protocol Date: 
 
3/2/23 
Sponsor-Investigator: 
Inova Heart and Vascular Institute 
Study Principal Investigator: 
Brett Atwater 
Inova Health System 
3300 Gallows Road 
Falls Church, Virginia 22042 
919 239 0127 
Brett.Atwater@inova.org 
Site Principal Investigator(s) (PI): 
Brett Atwater 
Inova Health System 
3300 Gallows Road 
Falls Church, Virginia 22042 
9192390127 
Brett.Atwater@inova.org 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
  
 
 
Statistician: 
Study Coordinator: 
Not applicable  
Tracy Plummer 
Inova Health System 
3300 Gallows Road 
Falls Church, Virginia 22042 
Tracy.Plummer@inova.org 
Responsible Research Nurse: 
Responsible Data Manager: 
Not applicable 
Brett D. Atwater 
Inova Health System 
3300 Gallows Road 
Falls Church, Virginia 22042 
9192390127 
brett.atwater@inova.org 
Supplied Agent(s): 
Commercial 
Study Exempt from IND Requirements per 21 CFR 312.2(b) as determined by FDA.   
Protocol Type / Version # / Version Date: 
Original / Version # 1 / Version Date 03/02/2023 
 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
i 
SUMMARY OF CHANGES 
Inova Study #: 
U23-04-5042 
External IRB Protocol #: 
 
 
n/a 
Protocol Date:  
 
 
 
03/02/2023 
Protocol Modification #: 
 
 
1 
REVISION HISTORY 
# 
Section 
Page(s) 
Summary of Changes 
Consent 
Change 
(Y/N) 
1. 
 
 
 
 
2. 
 
 
 
 
3. 
 
 
 
 
4. 
 
 
 
 
5. 
 
 
 
 
 
 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
ii 
ABSTRACT 
Atrial fibrillation (AF) is a major cause of cardiovascular morbidity and mortality, 
affecting more than 46 million people worldwide.1 Direct current cardioversion 
(DCCV) is used to terminate an episode of symptomatic or hemodynamically 
unstable AF.  The success rate for DCCV is 90-95% and is dependent on patient and 
procedural characteristics including obesity, use of antiarrhythmic drugs, pad 
placement, type of shock waveform and shock energy.  Biphasic defibrillation 
waveform shocks improve DCCV success rates for AF to normal sinus rhythm (NSR) 
compared to monophasic shocks. Various biphasic shock waveforms are available: 
The Rectilinear Biphasic Waveform (RBW) is used by the Zoll series R defibrillator 
while the Biphasic Truncated Waveform (BTW) is used in the FDA approved 
Lifepak model 15 and 20 defibrillators. Despite their routine use in clinical 
practice, no adequately powered prospective head-to-head randomized controlled 
trials (RCT) have compared the safety or efficacy of the two biphasic waveforms 
for DCCV of AF to NSR. 
The primary objectives for this pragmatic prospective randomized controlled trial 
are to 1) compare the efficacy of first shock DCCV from AF to NSR using 
anterolateral pad placement and a full-output 200J RBW synchronized shock from 
a Zoll series R defibrillator or a full output 360J BTW synchronized shock from a 
Lifepak 15 or 20 defibrillator; 2) compare the DCCV efficacy of first or second full 
output shock 3) compare the DCCV efficacy of third or fourth full output shock 
after treatment group cross over after first failing 2 consecutive full output shocks 
from the originally assigned treatment group. The secondary objective is to 
compare the frequency of skin irritation or damage after first or second shock 
cardioversion from either defibrillator. 
Data will be derived from approximately 560 patients arriving to Inova sites of care 
in AF scheduled to undergo either AF ablation with expected DCCV or elective 
stand-alone AF DCCV. Patients will be included if they are in AF prior to their 
procedure and are willing to sign the consent form and comply with the research 
procedures. Participants will be excluded if they are in a rhythm other than AF on 
arrival to IHVI, have not been appropriately anticoagulated with warfarin or direct 
oral anticoagulant, or have known left atrial appendage thrombus prior to their 
procedure. 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
iii 
 
ABBREVIATIONS AND DEFINITIONS 
Abbreviation 
Definition of Terms 
  DCCV 
Direct Current Cardioverison 
RBW 
Rectilinear Biphasic Waveform 
BTW 
Biphasic Truncated Waveform 
J 
Joules 
AF 
Atrial Fibrillation 
IHVI 
Inova Heart and Vascular Institute 
NSR 
Normal Sinus Rhythm 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
iv 
PROTOCOL SYNOPSIS 
 
Study Title: 
A Pragmatic Randomized Clinical Trial Comparing 
Rectilinear Biphasic Waveform and Biphasic Truncated 
Exponential Waveform Shocks for Cardioversion of Atrial 
Fibrillation (Zoll vs Lifepak-RCT) 
Source of Funding: 
N/A 
Clinical Phase: 
N/A 
Study Rationale: 
Atrial fibrillation (AF) is a major cause of cardiovascular 
morbidity and mortality, affecting more than 46 million 
people worldwide.1 Direct current cardioversion (DCCV) is 
used to terminate an episode of symptomatic or 
hemodynamically unstable AF.  The success rate for DCCV 
is 90-95% and is dependent on patient and procedural 
characteristics including obesity, use of antiarrhythmic 
drugs, pad placement, type of shock waveform and shock 
energy.  Biphasic defibrillation waveform shocks improve 
DCCV success rates for AF to normal sinus rhythm (NSR) 
compared to monophasic shocks. Various biphasic shock 
waveforms are available: The Rectilinear Biphasic 
Waveform (RBW) is used by the Zoll series R defibrillator 
while the Biphasic Truncated Exponential Waveform 
(BTE) is used in the FDA approved Lifepak 15 or 20 
defibrillator. Despite their routine use in clinical practice, 
no adequately powered prospective head-to-head 
randomized controlled trials (RCT) have compared the 
safety or efficacy of the two biphasic waveforms for DCCV 
of AF to NSR. 
The primary objectives for this pragmatic prospective 
randomized controlled trial are to 1) compare the efficacy 
of first shock DCCV from AF to NSR using an anterolateral 
pad placement and full-output 200J RBW synchronized 
shock from a Zoll series R defibrillator and a full output 
360J BTW synchronized shock from a Lifepak 15 or 20 
defibrillator; 2) compare the DCCV efficacy of first or 
second full output shock 3) compare the DCCV efficacy of 
first or second crossover full output shock after first 
failing 2 consecutive full output shocks from the other 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
v 
defibrillator. The secondary objective is to compare the 
frequency of skin irritation or damage after first or 
second shock cardioversion from either defibrillator. 
Study Objective(s): 
Primary: 
1. To compare the efficacy of a single 200J RBW shock 
and a single 360J BTE shock  
2. To compare the efficacy of one or two consecutive 
200J RBW or 360J BTE shocks  
3. To measure the efficacy of cross over from RBW to 
BTE or BTE to RBW after failing 2 consecutive full 
output shocks with the first waveform  
Secondary:  
1. To compare the frequency of adverse events after 
one or two 200J RBW or 360J BTE shocks 
Test 
Product(s)/Agent(s): 
1. Zoll Series R Defibrillator (RBW shock waveform, 
maximum output 200J) 
2. Physiocontrol Lifepak 15 or 20 Defibrillator (BTE 
shock waveform, maximum output 360J) 
Study Design: 
Single center, investigator-initiated, open label 
prospective randomized controlled trial 
Participant Population 
Key Criteria for 
Inclusion and 
Exclusion: 
Inclusion Criteria: 
 Adults aged ≥18 years of age in AF scheduled to 
undergo DCCV or catheter ablation with expected 
DCCV 
Exclusion Criteria: 
 Patients with arrhythmias other than AF, 
hemodynamically unstable AF, untreated 
hyperthyroidism, known or suspected pregnancy, 
those in another trial. Patients will be required to 
have received sufficient anticoagulation or computed 
tomography angiography scan or transesophageal 
echocardiogram documenting the absence of 
intracardiac thrombi. 
Number of 
Participants: 
A total of 560 unique study subjects will be enrolled.  

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
vi 
Study Duration: 
Each subject’s participation will last from screening until 1 
minute after the final DCCV shock is delivered.  
Study Phases: 
1. Screening: Patients arriving in AF scheduled to 
undergo DCCV or AF ablation with possible DCCV at an 
Inova site of care will be screened in the peri-
procedure holding area.  
2. Intervention: Patients will be randomized to a Zoll or 
Lifepak defibrillator to perform the DCCV.  All shocks 
will be full output (200J for Zoll shocks and 360J for 
Lifepak shocks). Follow up will be assessment and 
documentation of rhythm 1 minute after the last 
shock is delivered.   
Efficacy Evaluations: 
1. Proportion of patients in NSR by ECG or monitor 1 
minute after the first DCCV shock. 
2. Proportion of patients in NSR by ECG or monitor 1 
minute after the first or second DCCV shock. 
3. Proportion of patients in NSR by ECG or monitor 1 
minute after a third or fourth crossover treatment 
assignment shock after failing first and second shock 
on original treatment assignment. 
Safety Evaluations: 
1. Number of patients with skin redness, pain or 
discomfort under the shock electrodes (excluding 
those with cross-over) 
2. Number of patients with arrhythmic events (asystole, 
atrioventricular block, transient bradycardia or 
ventricular arrhythmia) within 10 minutes of the last 
DCCV shock  
3. Frequency of pacemaker or ICD dysfunction after 
shock among patients with prior pacemaker or 
defibrillator implant 
Statistical and 
Analytical Plan: 
Based on the best available literature we expect the first 
shock DCCV success rate to be 93% in our population.  A 
total sample size of 538 subjects (269 in each group) will 
be needed to provide 80% power to reject the null 
hypothesis (a difference of efficacy < 5%). The analysis 
will be performed on the intention-to-treat population.  
The proportions will be compared using both risk 
difference and risk ratio with corresponding 95% CI. 
Effects of treatment will be estimated by modified 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
vii 
Poisson regression using generalized estimating 
equations. Outcomes will be compared across pre-
specified subgroups and testing will be performed for 
interactions (sex, body mass index, first or > 1 AF episode, 
AF type, DCCV location).  
Data and Safety 
Monitoring Plan: 
The study PI will be responsible for study safety.  One 
interval analysis will be performed after 50% trial 
enrollment. No DSMB will be assembled. 
 
 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
viii 
TABLE OF CONTENTS 
STUDY TITLE ....................................................................................... Error! Bookmark not defined. 
SUMMARY OF CHANGES ................................................................................................................... i 
ABSTRACT ......................................................................................................................................... ii 
ABBREVIATIONS AND DEFINITIONS ................................................................................................. iii 
PROTOCOL SYNOPSIS ...................................................................................................................... iv 
TABLE OF CONTENTS ..................................................................................................................... viii 
SCHEMA EXAMPLES ........................................................................... Error! Bookmark not defined. 
 
BACKGROUND .............................................................................................................. 2 
1.1 
Study Disease(s) or Condition(s) .......................................................................... 2 
1.2 
Product(s) / Agent(s) ............................................................................................ 2 
1.3 
Rationale .............................................................................................................. 3 
1.4 
Relevant Literature and Data ............................................................................... 3 
1.5 
Correlative Studies Background ........................................................................... 5 
1.6 
Compliance Statement ......................................................................................... 5 
 
OBJECTIVES .................................................................................................................. 5 
2.1 
Primary Objectives ............................................................................................... 5 
2.2 
Secondary Objectives ........................................................................................... 5 
 
SETTINGS ...................................................................................................................... 5 
3.1 
Study Sites ............................................................................................................ 5 
3.2 
Community Involvement ...................................................................................... 6 
3.3 
Outside of Organization ....................................................................................... 6 
 
RESOURCES AVAILABLE ............................................................................................... 6 
4.1 
Conducting Research ............................................................................................ 6 
4.2 
Medical and/or Psychological Resources ............................................................. 6 
 
INVESTIGATIONAL PLAN .............................................................................................. 6 
5.1 
General Schema of Study Design ......................................................................... 6 
5.2 
Product(s) / Agent(s) ............................................................................................ 7 
5.3 
Allocation to Treatment Groups and Blinding/Randomization ........................... 7 
 
STUDY TIMELINE .......................................................................................................... 7 
6.1 
Individual Participation ........................................................................................ 7 
6.2 
Study Timeline ...................................................................................................... 8 
 
PARTICIPANT SELECTION ............................................................................................. 8 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
ix 
7.1 
Eligibility Criteria ................................................... Error! Bookmark not defined. 
7.2 
Exclusion Criteria .................................................................................................. 8 
7.3 
Lifestyle Considerations ....................................................................................... 8 
7.4 
Vulnerable Populations ........................................................................................ 8 
 
RECRUITMENT METHODS ............................................................................................ 9 
8.1 
Methods ............................................................................................................... 9 
8.2 
Materials .............................................................................................................. 9 
8.3 
Underrepresented Populations ............................................................................ 9 
 
STUDY PROCEDURES .................................................................................................... 9 
9.1 
Screening Visit ...................................................................................................... 9 
9.2 
Study Intervention Visit(s) .................................................................................. 10 
9.3 
Follow-Up ........................................................................................................... 10 
9.4 
Unscheduled Visits ............................................................................................. 10 
9.5 
Lost to Follow-Up ............................................................................................... 10 
 STUDY ADMINISTRATION .......................................................................................... 10 
10.1 
Study Intervention(s) Administration ............................................................. 10 
10.2 
Measures to Minimize Bias: Randomization / Blinding.................................. 11 
 DATA AND SPECIMEN COLLECTION AND MANAGEMENT......................................... 11 
11.1 
Data Collection and Management .................................................................. 11 
11.2 
Specimen Collection and Management ......................................................... 12 
11.3 
Security ........................................................................................................... 12 
11.4 
Release of Locally Banked Data ...................................................................... 12 
11.5 
Confidentiality ................................................................................................ 12 
 DATA ANALYTICS ....................................................................................................... 13 
12.1 
Study Endpoints .............................................................................................. 13 
12.2 
Analytics .......................................................................................................... 14 
 SAFETY MANAGEMENT ............................................................................................. 14 
13.1 
Regulatory and Ethical Considerations ........................................................... 14 
13.2 
Clinical Adverse Events ................................................................................... 15 
13.3 
Reporting of Deviations, Adverse Events, and Unanticipated Problems .. Error! 
Bookmark not defined. 
 Participant compensation and reports ...................................................................... 16 
14.1 
Participant Compensation .............................................................................. 16 
14.2 
Reporting Events to Participants .................................................................... 16 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
x 
14.3 
Study Results and Incidental Findings ............................................................ 16 
 ECONOMIC BURDENS AND COMPENSATION / INCENTIVE ....................................... 16 
15.1 
Foreseeable Costs ........................................................................................... 16 
15.2 
Payments / Reimbursements ......................................................................... 16 
 CONSENT PROCESS .................................................................................................... 16 
16.1 
Informed Consent ........................................................................................... 16 
16.2 
HIPAA Research Authorization(s) ................................................................... 16 
16.3 
Safeguards for Vulnerable Populations .......................................................... 17 
16.4 
Documentation of Consent ............................................................................ 17 
 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION / 
WITHDRAWAL ............................................................................................................ 17 
17.1 
Discontinuation of Study Intervention ........................................................... 17 
17.2 
Participant Discontinuation/Withdrawal from the Study .............................. 17 
17.3 
Early Termination Study Visit ............................ Error! Bookmark not defined. 
 RECORDINGS .............................................................................................................. 18 
 IRB REVIEW HISTORY ................................................................................................. 18 
 COORDINATING CENTER for MULTI-Site Studies ...................................................... 18 
20.1 
Participating Sites ........................................................................................... 18 
20.2 
Description of Collecting Sites ........................................................................ 18 
20.3 
Study-Wide Number of Participants............................................................... 18 
20.4 
Communication to Participating Sites ............................................................ 18 
 REFERENCES / BIBLIOGRAPHY ................................................................................... 18 
 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
xi 
 
 
 
 
 
 
 
Screening 
Randomization 
Zoll 200J Shock 
Zoll 200J Shock 
Zoll 200J Shock 
Zoll 200J Shock 
Lifepak 360J Shock 
Lifepak 360J Shock 
Lifepak 360J Shock 
Lifepak 360J Shock 
Crossover 
Study Exit 
DCCV Success 
DCCV Success 
DCCV Fail 
DCCV Fail 
DCCV Fail 
DCCV Fail 
DCCV Fail 
DCCV Fail 
DCCV Fail 
DCCV Fail 
Skin Assessment > 10 
minutes after last shock 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
1 
 
Study Phase 
Screening (Pre-Op) 
Treatment/Intervention (EP Lab or CDU Procedure 
Suite) 
Informed 
Consent/Assent 
X 
 
Review 
Inclusion/Exclusion 
Criteria 
X 
 
Duration of AF 
Assessment (< 7 
days, 7 days-365 
days, > 365 days 
X 
 
Months since AF 
diagnosis 
X 
 
Prior DCCV? 
X 
 
CHA2DS2VASC score 
X 
 
Moderate or Severe 
Valvular Disease? 
X 
 
Heart Failure with 
Reduced Ejection 
Fraction? 
X 
 
Body Mass Index 
X 
 
Date of Birth 
X 
 
Sex 
X 
 
Pregnancy Test 
X 
 
Amiodarone 
(yes/no) 
X 
 
Flecainide (yes/no)  
X 
 
Beta blockers 
(yes/no) 
X 
 
Ace Inhibitor or ARB 
(yes/no) 
X 
 
Randomization  
X 
 
DCCV 
 
X 
ECG or Monitor 1 
minute after 1st 
shock 
 
X 
Adverse Event 
Assessment 10 
minutes after shock 
or at conclusion of 
procedure 
 
X 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
2 
 BACKGROUND 
Direct current cardioversion (DCCV) is widely used for restoring normal sinus rhythm 
(NSR) in patients with atrial fibrillation (AF)1,2. More than 1500 DCCV procedures were 
performed in the Inova health system in 2022.  Identifying the safest and most 
efficacious method is important.  Despite decades of clinical use, the ideal shock 
waveform and energy for DCCV from AF to NSR are still unknown. Two FDA approved 
external defibrillation devices (Zoll series R and Lifepak 15/20) are used to deliver DCCV 
shocks in clinical practice in the Inova Health System.  These devices differ in shock 
waveform and maximum energy delivery. The Zoll Series R device uses a Rectilinear 
Biphasic Waveform (RBW) with a maximum energy of 200 Joules while the 
Physiocontrol Lifepak Series 15/20 devices use a Biphasic Truncated Exponential (BTE) 
Waveform with a maximum energy of 360 Joules. Four small studies (n=50-101 patients 
per group) have compared the efficacy of RBW and BTE waveforms for DCCV of AF to 
NSR3,4,5,6. None of the studies were adequately powered to detect clinically meaningful 
differences in efficacy or safety of the waveforms. All 4 studies used a protocol starting 
with low energy shocks (50-100J) and escalating the output over multiple shocks.  Since 
these studies have been published, maximum energy shocks were found to be more 
effective and safer than escalating low-energy shocks for DCCV7 and maximum energy 
first shocks are now recommended in European guidelines8. We therefore propose an 
adequately powered randomized controlled trial (RCT) evaluating the efficacy and safety 
of maximum energy RBW and BTE shock waveforms delivered by the Zoll series R and 
Physiocontrol Lifepak Series 15/20 devices respectively.  
1.1 
Study Disease(s) or Condition(s) 
AF is the most common cardiac arrhythmia affecting more than 46 million people worldwide.  
More than 86,000 patients have been diagnosed with AF in the Inova health system in the past 
year.  AF is frequently associated with symptoms of fatigue, shortness of breath and 
palpitations.  DCCV is a commonly performed procedure to temporarily restore NSR in patients 
with symptomatic AF or in those with hemodynamically intolerable AF.   
1.2 
Product(s) / Agent(s) 
The Zoll series R defibrillator is an FDA approved device with indications for defibrillation of 
cardiac arrest where there is an apparent lack of circulation and for synchronized DCCV of 
certain atrial and ventricular arrhythmias. It is indicated for adult and pediatric patients. The 
device is connected to the patient through the one-step cable and the manufacturer 
recommends also connecting a separate ECG cable.  The Zoll series R defibrillator has been 
deployed across the Inova health system and is currently available for clinical use in all clinical 
areas performing DCCV.  For this study the device will be used on label and according to 
manufacturer recommendations.  All shocks will be synchronized and delivered in the manual 
mode at 200J through the one touch hands-free pads.  No shocks will be delivered through 
paddles. The Physiocontrol Lifepak 15 and 20 monitor/defibrillators are FDA approved devices 
with indications for termination of certain fatal arrhythmias such as ventricular fibrillation and 
symptomatic ventricular tachycardia.  Delivery of energy in synchronized mode is a method for 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
3 
treating AF, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable 
patients with ventricular tachycardia.  The Lifepak 15 and 20 defibrillators have been deployed 
across the Inova health system and are currently available for clinical use in all clinical areas 
performing DCCV. For this study all shocks will be delivered in the manual mode at 360J 
synchronized through hands-free pads.  No shocks will be delivered through paddles. 
 
1.3 
Rationale 
Four small studies (n=50-101 patients per group) have compared the efficacy of RBW 
and BTE waveforms for DCCV of AF to NSR3,4,5,6. None of the studies were adequately 
powered to detect clinically meaningful differences in efficacy or safety of the 
waveforms and all used escalating low-energy shocks.  Since these studies have been 
published, maximum fixed energy shocks were found to be more effective than 
escalating low-energy shocks for DCCV and maximum energy first shocks are now 
suggested in European guidelines8. We therefore propose an adequately powered 
randomized controlled trial (RCT) evaluating the efficacy and safety of maximum energy 
RBW and BTE shock waveforms delivered by the Zoll series R and Lifepak 15 and 20 
devices respectively.  
 
1.4 
Relevant Literature and Data 
In 1959 Lown developed a direct current waveform to improve efficacy and reduce 
adverse events associated with defibrillation performed with alternating current.  The 
monophasic waveform he developed was in use until the 1980s when biphasic 
waveforms were shown to further improve defibrillation success.  Several biphasic 
waveforms have been developed including the BTE and RBW waveforms.  These 
waveforms have been incorporated into competing FDA approved devices 
manufactured by Zoll, Phillips, and Physiocontrol/Medtronic.   
 
• 
The first comparative study of biphasic DCCV shock waveforms was published in 
20033. Investigators randomized 101 patients with AF to DCCV using escalating 
RBW shocks from a Zoll M series defibrillator (50, 100, 200, 200J) or escalating 
BTE shocks from a Physiocontrol Lifepak-12 defibrillator (50, 100, 200, 200J). If 
the fourth shock at 200J failed in either arm a single 360J shock was delivered 
from the BTE device. Patches were placed in an antero-posterior location. The 
overall efficacy was 97.9% in the BTE group and 100% in the RBW group 
(p=0.29).  The study was underpowered to detect a clinically significant 
difference between groups.  Enrollment would have allowed the study to detect 
an efficacy difference of 20% or more. 
• 
The second observational study was published in 20044. Patients with AF 
underwent DCCV with a series of escalating RBW shocks from a Zoll series M 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
4 
defibrillator (50,100,150, 200J) or a BTE shock (50,100,150, 300, 360J) from a 
Medtronic Physiocontrol Lifepak 12 defibrillator.  If DCCV was unsuccessful at 
the maximum deliverable energy patients were crossed over to the other device.  
Patches were placed in an antero-posterior location. 145 patients were enrolled 
but treatment allocation was not randomized because of patient refusal or 
physician refusal to participate in the study.  The success rate was 97% in both 
groups (p=1.0).  2/71 patients in the RBW group failed maximum energy shock 
(200J) and crossed over to the 360J RBW shock and were successfully converted.  
2/71 patients in the BTE group failed maximum energy shock (360J) and crossed 
over to the RBW group.  Both also failed the RBW shock. 
• 
The third comparative study of the RBW and BTE waveforms was published in 
20055.The investigators randomized 188 subjects with AF in a 1:1 fashion to 
receive escalating low energy RBW shocks (50, 75, 100, 120, 150, 200 J) or BTE 
shocks (50, 70, 100, 125, 150, 200, 300, 360 J). The shock strength was escalated 
until success or maximum energy was delivered.  If maximum energy shock 
failed, the patient crossed over to the opposite waveform.  47 patients were 
excluded leaving a total of 141 patients (71 in RBW and 70 with BTE shocks).  The 
authors found a maximum energy success rate of 93% in patients receiving a 
RBW shock and 97% in patients receiving a BTE shock (p=0.44). Unfortunately, 
the small study sample size would have allowed the authors to detect a 
minimum difference in success rate of 14% or more, while a clinically relevant 
efficacy difference of 5% or more was impossible to detect. 
• 
The fourth comparative study of commercially available biphasic waveforms was 
published in 20136. The investigators randomized 199 patients to receive DCCV 
using either a RBW from a Zoll series R defibrillator or BTE from a Phillips 
Heartstart XL defibrillator using 50, 100, 150, 200, 200 J. The shock strength was 
escalated until success or maximum energy was delivered.  95% of patients in 
the RBW and 90.9% of patients in the BTE arms successfully converted to NSR 
(P=0.838).  Unfortunately, the small study sample size allowed the study to 
detect differences in efficacy of 20% or more and they did not deliver maximal 
energy (360J) shocks using the BTE waveform, limiting the clinical applicability of 
the findings. 
• 
Since the 4 comparative studies were published, a randomized controlled study 
in 2021 showed anterolateral patch placement improved DCCV success rate 
compared to anteroposterior placement9. Further, a DCCV protocol using fixed 
maximum energy shocks was found to be more effective than escalating low-
energy shocks7. No adequately powered studies have compared a first maximum 
shock efficacy of RBW (200J) to BTE (360J) waveforms incorporating these 
recommendations and an anterolateral patch location.   

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Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
5 
Correlative Studies Background 
1.4.1 NA 
1.5 
Compliance Statement 
This study will be conducted in full accordance with all applicable Inova Health 
System’s Federalwide Assurance (FWA), Research Policies and Procedures, and all 
applicable Federal and State laws. These regulations include, but are not limited to 
45 CFR 46, 21 CFR Parts 50, 54, 56, 312, 812, and the Good Clinical Practice: 
Consolidated Guideline approved by the International Conference on 
Harmonisation (ICH).  
The investigators will perform the study in accordance with this protocol, will 
obtain consent and/or assent (unless waived by the IRB of record), and will report 
unanticipated problems involving risk to participants or others and potential 
serious or continuing non-compliance in accordance with the Inova Health 
System’s Office of Research Policies and Procedures and all federal requirements. 
Collection, recording, and reporting of data will be accurate and will ensure the 
privacy, health, and welfare of research participants during and after the study. 
 OBJECTIVES 
2.1 
Primary Objectives 
2.1.1 To compare the efficacy of a single 200J RBW shock and a single 360J BTE 
shock  
2.1.2 To compare the efficacy of one or two consecutive 200J RBW or 360J BTE 
shocks  
2.1.3 To measure the efficacy of cross over from RBW to BTE or BTE to RBW 
after failing 2 consecutive full output shocks with the first waveform  
2.2 
Secondary Objectives 
2.2.1 To compare the frequency of adverse events after one or two 200J RBW 
or 360J BTE shocks.  Patients undergoing cross-over will be excluded from 
this analysis. 
 SETTINGS 
3.1 
Study Sites 
The study will be conducted at one investigative site in the United States. 
The following investigative sites will be conducting this study: 
 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
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PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
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Inova Heart and Vascular 
Institute 
3300 Gallows Rd. 
Falls Church, VA 22042 
Inova Alexandria 
Hospital Heart and 
Vascular Center 4320 
Seminary Road, 
Alexandria VA 22304 
Inova Loudoun Hospital 
Heart and Vascular 
Center 44045 Riverside 
Pkwy, Leesburg, VA 
20176 
 
3.2 
Community Involvement 
Not applicable 
3.3 
Outside of Organization 
Not applicable 
 RESOURCES AVAILABLE 
4.1 
Conducting Research 
30-35 unique patients undergo DCCV for AF in the cardiac diagnostic unit or 
electrophysiology labs at IHVI each week (1560/year). Assuming 50% of these subjects 
meet eligibility criteria, we expect to be able to complete enrollment of the 560 patients 
in approximately 6 months. 
 
The PI will dedicate 5% of his time to conducting and completing the research. Both the 
Zoll series R and Lifepak 15/20 defibrillators, connector cables, and pads are available in 
the EP labs and the CDU at IHVI, IAH, and ILH hospitals. 
4.2 
Medical and/or Psychological Resources 
Not Applicable 
 INVESTIGATIONAL PLAN 
5.1 
General Schema of Study Design 
5.1.1 Hypothesis 
We hypothesize that the maximal output first shock efficacy of RBW and BTE shocks 
differs by more than 5%. 
5.1.2 Phase of the Trial 
This is a single center, investigator-initiated, open-label, pragmatic randomized 
controlled assessment trial.  
5.1.3 Study Treatment 
Patients with AF will be randomized to receive either a full output synchronized 200J 
shock using a RBW waveform from a Zoll R series defibrillator or a full output 
synchronized 360J shock using a BTE waveform from a Lifepak Series 15/20 defibrillator.  

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PROTOCOL VERSION DATE: 03/02/2023  
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Success will be defined as NSR 1 minute after the shock.  Patients who do not have first 
shock success will have a second full output shock ≥1 minute after the first shock.  
Patients who do not have success after a second full output shock will be crossed over 
to the other defibrillator waveform and receive up to 2 full output shocks with a 
minimum of 1 minute between each shock to ascertain the outcome of the immediately 
prior shock.  
5.2 
Product(s) / Agent(s) 
5.2.1 Handling, Storage, Accountability, and Preparation 
Both the Zoll Series R defibrillator and the Lifepak 15 and 20 defibrillators and 
the necessary cables and pads are stored in the cardioversion procedure rooms 
and the Electrophysiology labs in IHVI, IAH, and ILH hospitals.   
5.2.1.1 Acquisition and Accountability 
Both defibrillators are already available for clinical use in both the cardioversion 
procedure rooms and Electrophysiology labs in IHVI, IAH, and ILH hospitals.   
5.2.1.2 Storage and Stability 
Not applicable 
5.2.1.3 Preparation 
Not applicable 
 
5.3 
Allocation to Treatment Groups and Blinding/Randomization 
Patients will be randomly allocated to either treatment group in a 1:1 fashion.  
Randomization will be blocked by treatment location (Electrophysiology labs versus 
other environments due to the differing pad locations in these two environments). A 
randomization sequence will be created in the RedCAP file. Randomization envelopes 
will be created and stored in the pre-procedure electrophysiology holding areas or 
electrophysiology labs or the DCCV procedure areas.  In the envelope will be the case 
report form with the treatment assignment listed on it. Prior to the DCCV procedure 
staff will open an envelope to learn the treatment assignment and then use the 
assigned defibrillator.  Patients, staff, and investigators will be unblinded. The clinical 
staff will complete the CRF. They will attach the rhythm strip or ECG acquired 1 minute 
after the shock and place it back in the envelope.  They will seal the envelope and place 
it in a secure location to be gathered by the study team.  
 STUDY TIMELINE 
6.1 
Individual Participation 
The study duration per participant will be up to 1 day.  Screening, treatment and the 10 
minute follow up will all occur at the time of the planned DCCV procedure. 

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PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
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6.2 
Study Timeline 
6.2.1 Treatment: 1 day 
6.2.2 Follow-up: same day 
6.2.3 Estimated Closure: 9-12 months after initiation. 
 PARTICIPANT SELECTION 
Participants that do not meet all the inclusion criteria may not be enrolled, unless a 
prior exception request is approved by the sponsor and submitted for IRB review and 
approval. Any violations of these criteria must be reported in accordance with IRB 
Policies and Procedures. 
7.1.1 Index/Case Participant Eligibility Criteria 
7.1.1.1 Age ≥ 18 years 
7.1.1.2 In AF on presentation with plan for DCCV in either the 
Electrophysiology lab or DCCV procedure area. 
7.2 
Exclusion Criteria 
7.2.1 Index/Case Participant Exclusion Criteria 
7.2.1.1 Participants who are receiving any other investigational agents. 
7.2.1.2 Parents/guardians or participants who, in the opinion of the 
Investigator, may be non-compliant with study schedules or 
procedures. 
7.2.1.3 Patients with arrhythmias other than AF 
7.2.1.4 Patients with hemodynamically unstable AF 
7.2.1.5 Patients with untreated hyperthyroidism 
7.2.1.6 Patients with known or suspected pregnancy 
7.2.1.7 Patients without sufficient anticoagulation or a transesophageal 
echocardiogram or computed tomography scan documenting 
the absence of intracardiac thrombi 
 
7.3 
Lifestyle Considerations 
7.3.1 Not Applicable 
7.4 
Vulnerable Populations 
Vulnerable populations will not be enrolled in this study. Both men and women of 
all races and ethnic groups are eligible for this trial.  

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PROTOCOL VERSION DATE: 03/02/2023  
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 RECRUITMENT METHODS 
8.1 
Methods 
8.1.1 Recruitment 
Patients in AF presenting to the pre-procedure holding areas prior to DCCV or catheter 
ablation of AF at Inova care sites will be screened for possible enrollment. Patients will 
be provided an opt-out information sheet before being enrolled in the study.  
8.1.2 Screening 
Screening will occur immediately before the patient undergoes a DCCV procedure.  
Screening will be performed by the performing physician investigator.  Because the 
inclusion criteria and exclusion criteria are identical to those for DCCV of AF, no 
additional chart review will be needed by the physician investigator for study screening. 
Prior to a DCCV procedure the chart is reviewed and a face to face discussion is had with 
the patient. These processes will be used to also screen for study inclusion since the 
same data will be used to determine if they are a candidate for DCCV AND whether they 
can be included in the study. Screening will occur on site just prior to scheduled DCCV 
procedures by the investigators performing the procedure. Screening will occur without 
prior consent/assent/HIPPA authorization under a HIPPA and/or Informed Consent 
Waiver.  
Projected Participants 
Recruitment will stop when approximately 560 participants are 
screened/consented. It is expected that approximately 560 participants 
will be enrolled to produce 544 evaluable participants. 
8.2 
Materials 
Not applicable 
8.3 
Underrepresented Populations 
Patients of all races, ethnicities, and sexes will be enrolled.  
 STUDY PROCEDURES 
9.1 
Screening Visit 
9.1.1 Informed Consent/Assent/HIPAA Authorization 
We will seek an alteration of consent, a waiver of documentation of consent, and 
an alteration of HIPPA for this study.  
9.1.2 Physical Exam 
Not Applicable 
9.1.3 Vital Signs 
Heart rate and blood pressure before and after DCCV will be obtained.  Patients 

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PROTOCOL VERSION DATE: 03/02/2023  
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with hypotension and tachycardia will be deemed to have hemodynamically 
unstable AF and will be excluded. 
9.1.4 Laboratory Tests 
Not applicable 
9.1.5 Medical Record Review 
This will be performed as part of the screening procedure prior to providing the 
information sheet. 
9.2 
Study Intervention Visit 
9.2.1 At the study visit the patient will be connected to the randomly allocated 
defibrillator, connector cable, and pads.  Pads will be placed in an 
anterolateral location unless this is impossible, in which case pads will be 
applied in alternative locations.  After sedation is provided the patient 
will undergo DCCV at full output (200J for the Zoll Series R device and 
360J for the Lifepak Series 15/20 device). After the procedure is complete 
the pads will be removed and the site assessed for erythema or burns 10 
minutes or more after the last administered shock.   
9.3 
Follow-Up 
Not applicable 
9.4 
Unscheduled Visits 
Not applicable 
9.5 
Lost to Follow-Up 
Not applicable 
 STUDY ADMINISTRATION 
10.1 Study Intervention(s) Administration 
10.1.1 Study Intervention Description 
The study will compare safety and efficacy of full output shocks from two 
commercially available FDA approved defibrillators.   
 
The Zoll R series defibrillator was approved with the following indications 
on 12/27/2017 (downloaded from www.accessdata.fda.gov on 
3/3/2023.) 
 
The R Series System Is Indicated For Defibrillation On Victims Of Cardiac 
Arrest Where There Is Apparent Lack Of Circulation As Indicated By:1) 
Unconsciousness;2) Absence Of Breathing; And 3) Absence Of Pulse. The 
R Series System In The Manual Mode Is Indicated For Synchronized 

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PROTOCOL VERSION DATE: 03/02/2023  
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Cardioversion Of Certain Atrial Or Ventricular Arrhythmias. A Qualified 
Physician Must Decide When Synchronized Cardioversion Is Appropriate. 
The R Series System Semiautomatic And Manual Mode Is Indicated For 
Use In Early Defibrillation Programs Where The Delivery Of A Defibrillator 
Shock During Resuscitation Involving CPR, Transportation, And Definitive 
Care Are Incorporated Into A Medically-Approved Patient Care Protocol. 
The R Series System Semiautomatic And Manual Mode Is Indicated For 
Adult And Pediatric Patients.  
 
The Lifepak model 15 and 20 Monitor/Defibrillator was approved with 
the following indications on 8/22/2018 (downloaded from 
www.accessdata.fda.gov on 3/3/2023.)  Manual defibrillation is indicated 
for the termination of certain potentially fatal arrhythmias, such as 
ventricular fibrillation and symptomatic ventricular tachycardia. Delivery 
of this energy in the synchronized mode is a method for treating atrial 
fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in 
relatively stable patients, ventricular tachycardia. 
 
10.1.2 Dosing and Administration 
The dose of energy for all shocks delivered from the Zoll series R defibrillator will 
be 200J.  The dose of energy for all shocks administered from the Lifepak series 
15/20 will be 360J.  A patient may receive a second shock at the same output if 
the first shock is unsuccessful.  If the second shock is unsuccessful the original 
defibrillator and pads will be removed, and the alternate defibrillator applied. 
10.2 Measures to Minimize Bias: Randomization  
10.2.1 Randomization 
Patients will be randomly allocated in a 1:1 fashion to RBW or BTE waveforms 
and their associated maximal outputs.  Randomization codes will not be broken. 
10.2.2 Blinding 
Neither the investigators nor patients will be blinded to their treatment 
allocation. 
10.2.3 Unblinding 
Not applicable 
 DATA AND SPECIMEN COLLECTION AND MANAGEMENT 
11.1 Data Collection and Management 
Data will be collected by study staff on case report forms.  The CRF will be completed by 
the physician investigator at the conclusion of the procedure.  The CRFs will be placed in 
a sealed envelope and stored in a locked file cabinet in the EP lab or CDU care area. The 

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Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
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PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
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study staff will collect the completed forms weekly.The study staff will not need to be 
present during enrollment or CRF completion. These forms will be scanned and the 
associated file stored in REDCAP as source documents.  Pre and post DCCV monitoring 
strips or ECGs to document pre DCCV AF and post DCCV rhythm will be stored in PDF 
format or printed on paper and scanned as source documents into the CRF. 
11.1.1 Storage and Future Use-  
All data will be stored in a REDCAP database.  Source documents including paper 
CRF forms will be scanned and files attached to the REDCAP database then 
shredded. 
11.1.2 Retention/Access 
Data will be stored in REDCAP according to Inova ORI policy.  No specimens will 
be collected.  The study PI and study coordinators will have access to the 
REDCAP database. Paper case report forms will be stored in a secure location in 
the procedure area and will be picked up weekly by the study coordinator for 
entry into the REDCAP database. Records will be retained in the REDCAP registry 
according to Inova’s record retention policy, currently a minimum of 3 years 
after study completion.  
11.1.3 Data Fields 
Please see the case report form for exact data collected.  Identifiers collected will 
include name, Inova medical record number, date of birth, and date of DCCV 
procedure. 
11.2 Specimen Collection and Management 
Not Applicable 
11.3 Security 
All data will be stored in a REDCAP database and access will be provided only to 
the PI and CRC.  All paper source documents will be scanned and then the originals 
will be shredded. 
11.3.1 Anonymization, De-Identification and/or Destruction 
Data will remain in the REDCAP registry and all analyses will be performed either 
within the REDCAP registry or on an Inova provisioned computer behind the 
Inova firewall. No data will be stored outside of REDCAP. 
11.4 Release of Locally Banked Data 
Not applicable 
11.5 Confidentiality 
All data and records generated during this study will be kept confidential in 
accordance with Inova Health System institutional policies and HIPAA on 
participant privacy. The Investigator and other site personnel will not use such 

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data and records for any purpose other than conducting the study. 
No identifiable data will be used for future use without first obtaining IRB approval 
or determination of exemption.  
11.5.1 Certificate of Confidentiality 
Not applicable 
 DATA ANALYTICS 
12.1 Study Endpoints 
Efficacy assessments for the primary endpoints will occur using data obtained at 
screening and the DCCV study visit.  Specifically, the endpoint of NSR will be acquired by 
monitoring strip or 12 lead ECG 1 minute after each DCCV shock is delivered.   
 
Primary Endpoints 
12.1.1 The frequency of NSR one minute after a single full output DCCV shock is 
delivered by a Zoll Series R RBW waveform defibrillator and a Lifepak 
Series 15/20 BTE waveform defibrillator. 
12.1.2 The frequency of NSR one minute after the first or second full output 
DCCV shock is delivered by a Zoll Series R RBW waveform defibrillator 
and a Lifepak Series15/20 BTE waveform defibrillator. 
12.1.3 The frequency of NSR one minute after the first or second full output 
DCCV shock is delivered by a Zoll Series R RBW waveform defibrillator 
and a Lifepak Series 15/20 BTE waveform defibrillator after crossing over 
from the alternative defibrillator after failing 2 consecutive full output 
shocks at maximum output. 
Secondary Endpoints 
12.1.4 The frequency of adverse events including skin irritation, pain, or 
burning; arrhythmic events including asystole, atrioventricular block, 
transient bradycardia or ventricular arrhythmia within 10 minutes of the 
last DCCV shock; and the frequency of pacemaker or ICD dysfunction 
after shock among patients with prior pacemaker or defibrillator implant.  
Transient bradycardia will be defined as symptomatic bradycardia 
requiring the use of temporary pacing, atropine, isuprel, or epinephrine 
for rate support. The secondary safety endpoint will be assessed only 
among patients who do not cross-over from one defibrillator to the 
other. 
12.1.5 End of Study Definition 
A participant is considered to have completed the study If he or she has 
completed all phases of the study including screening, enrollment, 

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procedure and the 10 minute skin assessment after pad removal. 
 
The end of the study is defined as completion of the last visit shown in 
the Schedule of Activities.  
12.2 Analytics 
All analyses will be performed on an intention to treat basis.  We calculated the 
sample size on the basis of the 3 prior randomized studies that compared RBW 
and BTE shocks for DCCV of AF.  In these studies, the mean overall shock success 
was 90-97% and the first shock success varied from 54%-90% albeit the first shock 
was delivered at a lower energy than maximum output. We therefore estimate 
that the mean first shock success rate will be 93%.  A clinically meaningful 
difference in first full output shock efficacy is 5%. A total study sample size of 544 
patients (272 in each group) is needed to provide a power of 80% to reject the null 
hypothesis (a difference in efficacy of < 5%). 
 
 SAFETY MANAGEMENT 
13.1 Regulatory and Ethical Considerations 
13.1.1 Data and Safety Monitoring Plan 
The Inova PI will monitor and review the study progress, participant 
safety, and the accuracy and security of the data. This will be a minimal 
risk study. The risks of participation are limited to unexpected loss of 
confidential PHI.   
13.1.1.1 Communication Plan 
This is a single center study.  There are no collaborating institutions. 
 
13.1.2 Risk Assessment 
The research interventions include on-label use of two FDA approved 
defibrillators for DCCV of AF.  These procedures include the risks of 
asystole, arrhythmia, stroke and skin burn or irritation. These risks are 
present whether or not these procedures are performed as part of a 
research study. The only risk associated with participation in the study is 
accidental loss of PHI.  This risk will be minimized by temporarily storing 
the paper case report forms in secure locations and long-term storage of 
all data in a REDCAP database with shredding of the paper case report 
forms. 
13.1.3 Potential Benefits of Trial Participation 
There is no benefit to individual participants in the research study, 

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however, the study results will inform IHVI and all other hospitals if there 
are clinical differences in efficacy or safety of the two commercially 
available defibrillators.  These findings may improve the likelihood of 
successful and safe DCCV for our future patients as well as patients cared 
for in hospitals around the world. The results will be reported on 
clinicaltrials.gov where they will be available to the device manufacturers 
and the FDA.  The results will also be published in a peer reviewed 
manuscript and presented at a major society meeting. 
13.1.4 Risk-Benefit Assessment 
Overall risks to research participants are minimal and limited to potential 
loss of PHI.  The benefit of participation is improvement in our knowledge 
of the mechanism of cardioversion and improvement in the safety and 
efficacy of this commonly performed procedure.  Because the benefits of 
the study far outweigh the minimal risks, we are justified in pursuing the 
study. 
13.2 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study. 
13.2.1 Adverse Events Reporting 
Since the study procedures are not greater than minimal risk, significant 
adverse events (SAEs) are not expected. If any unanticipated problems 
related to the research involving risks to participants or others happen 
during this study (including SAEs), they will be reported to the IRB in 
accordance with Policy – Reporting of Adverse Events, Unanticipated 
Problems and Protocol Violations, ORI 11.16. AEs that do not meet 
prompt reporting requirements will be summarized in the narrative or 
other format and will be tracked and documented internally by the study 
team but not submitted to the IRB. 
The investigator will comply with the requirements of ORI policy and of the 
reviewing IRB of record for the reporting of protocol deviations, adverse events, 
and unanticipated problems presenting risk to participants or others (UPIRSOs) to 
the IRB. If the Inova IRB is not the IRB of record, the Investigator must still submit 
prompt reports of any potential serious or continuing non-compliance or UPIRSOs 
to the Inova IRB via the electronic submission system consistent with ORI policy. 
13.2.2 Follow-Up Report to and from IRB 
The investigator is responsible for ensuring that all SAEs are followed 
until either resolved or stable 

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 PARTICIPANT COMPENSATION AND REPORTS 
14.1 Participant Compensation: Not Applicable 
14.2 Reporting Events to Participants 
14.2.1 Adverse Events Not Applicable 
14.3 Study Results and Incidental Findings 
14.3.1 Study Results- Study results will be published in peer reviewed 
manuscripts, society meetings, and on clinicaltrials.gov where they can 
be seen by study participants. 
14.3.2 Incidental Findings Not applicable 
 ECONOMIC BURDENS AND COMPENSATION / INCENTIVE 
15.1 Foreseeable Costs 
15.1.1 Economic Burden to Participants 
We expect no financial or economic burden for the participants 
15.2 Payments / Reimbursements 
Not applicable 
15.2.1 Reimbursement for Travel, Parking and Meals Not applicable 
15.2.2 Payments to Parent/LAR for the Time and Inconvenience (i.e. 
compensation) Not applicable 
15.2.3 Payments to Participants for Time, Effort and Inconvenience (i.e. 
compensation Not applicable 
15.2.4 Gifts Not applicable 
 CONSENT PROCESS 
16.1 Informed Consent- We have applied for a waiver of documentation of informed 
consent and alteration of HIPPA 
16.1.1 Waiver of documentation of Informed Consent- Please see the completed 
request within the electronic submission system. Patients will be 
provided an opt-out information sheet about the study but will not be 
asked to sign an informed consent form. 
16.2 HIPAA Research Authorization(s) 
The Inova Health System uses a stand-alone HIPAA Research Authorization that is 
compliant with federal, state and institutional Privacy rules and regulations. 
16.2.1 Alteration of HIPAA Authorization- We have submitted an alteration of 

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Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
17 
HIPPA authorization.  Please see the request for alteration of HIPPA 
authorization within the electronic submission system. Patients will be 
given an information sheet discussing this alteration of HIPPA 
authorization with the ability to opt-out of participation if desired. 
16.3 Safeguards for Vulnerable Populations 
16.3.1 Cognitively Impaired Individuals- Will not be enrolled in the study. 
16.3.2 Pediatric Participants- Children will not participate in the study 
16.3.3 Individuals with Limited English Proficiency- Will be enrolled in the study 
using a translated information sheet. This will be submitted as an 
amendment and patients with limited English proficiency will not be 
enrolled until this is approved. 
16.3.4 Adults Unable to Consent- Since consent will not be required, adults 
unable to consent will be enrolled. 
16.4 Documentation of Consent:A waiver of documentation of consent has been 
submitted. 
16.5 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION / WITHDRAWAL  
Participants may withdraw from the study at any time without prejudice to their care. 
They may also be discontinued from the study at the discretion of the Investigator for 
lack of adherence to study treatment or visit schedules, AEs, or due to reasons listed 
below. The Investigator or Sponsor may also withdraw participants who violate the 
study plan, or to protect the participant for reasons of safety or for administrative 
reasons. It will be documented whether each participant completes the study. If the 
Investigator becomes aware of any serious, related adverse events after the 
participant completes or withdraws from the study, the participants will be 
communicated based on the IRB’s directions.  
16.6 Discontinuation of Study Intervention 
Discontinuation from study intervention does not mean discontinuation from the 
study, and remaining study procedures should be completed as indicated by the 
study protocol. If a clinically significant finding is identified (including, but not 
limited to changes from baseline) after enrollment, the investigator or qualified 
designee will determine if any change in participant management is needed. Any 
new clinically relevant finding will be reported as an adverse event (AE). 
16.7 Participant Discontinuation/Withdrawal from the Study 
Participant may voluntarily withdraw from the study or discontinue the study 
intervention at any time.  
Participants may discontinue the study intervention, but remain in the study for 
follow-up, especially for safety and efficacy of study endpoints 

A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
18 
An Investigator may discontinue or withdraw a participant from the study for the 
following reasons: 
16.7.1 Significant study intervention non-compliance. 
16.7.2 Any Clinical Adverse Event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the 
study would not be in the best interest of the participant. 
16.7.3 Disease progression which requires discontinuation of the study 
intervention. 
16.7.4 If the participation meets an exclusion criterion (either newly developed 
or not previously recognized) that precludes further study participation. 
16.7.5 Participant unable to receive DCCV on the scheduled date/time. 
The reason for participant discontinuation or withdrawal from the study will be 
recorded on the paper Case Report Form (CRF).  
 RECORDINGS 
NA 
 IRB REVIEW HISTORY 
NA 
 COORDINATING CENTER FOR MULTI-SITE STUDIES 
19.1 Participating Sites 
NA 
19.2 Description of Collecting Sites 
NA 
19.3 Study-Wide Number of Participants 
560 
19.4 Communication to Participating Sites 
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A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
19 
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A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic 
Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs 
Lifepak-RCT) |  
PI: Brett D. Atwater, MD 
PROTOCOL VERSION DATE: 03/02/2023  
20 
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