AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Phase: NA
Conditions: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Sponsor: AtriCure, Inc.

ABLATE Post-Approval Study 
AtriCure Inc. 
Page 1 of 46 
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ABLATE POST APPROVAL STUDY 
 
ATRICURE SYNERGY ABLATION LESIONS FOR NON-PAROXYSMAL FORMS OF 
ATRIAL FIBRILLATION TREATMENT DURING CONCOMITANT ON-PUMP 
ENDO/EPICARDIAL CARDIAC SURGERY 
 
Protocol Number: 
CP2011-1 
 
Sponsor: 
AtriCure, Inc. 
6217 Centre Park Drive 
West Chester, OH 45069 
 
Shana Zink, Vice President Clinical Affairs 
Email: szink@atricure.com 
 
Data Management, 
Boston Biomedical Associates 
Statistics and Safety 
386 West Main Street – Suite 7 
Northborough, Massachusetts 01532 
 
PAS Steering Committee 
Patrick McCarthy, MD – Chairperson 
 
 
Study Centers: 
To be maintained in study files 
Core Lab: 
Agility Centralized Research Services, Inc. 
A CardioNet Company 
2275 Half Day Road Suite # 133 
Bannockburn, IL 60015 
 
Issue Date/Version: 
11 April 2014 / Version L 
 
Amendment Date /Version:  23 June 2014 / Version M 
 
Confidential Material: 
This document is the property of AtriCure, Inc. and is confidential and proprietary. The 
information contained herein is believed to be accurate and complete as of the date of 
preparation. The contents of this document may not be reproduced without prior expressed 
consent by AtriCure, Inc. 

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Protocol Signature Page 
 
 
 
The signature below constitutes the Investigator has reviewed the protocol and the attachments, 
and agrees to provide the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according to 
local legal and regulatory requirements and applicable regulations and ICH/GCP guidelines. 
 
 
 
 
Investigational Site Name:   
 
Investigator Designation (please select as appropriate) : 
 Principal Investigator 
 Physician Sub-Investigator 
 Non-Physician Sub-Investi 
Investigator Name (Print):   
 
Investigator Signature:   
 
Date of Signature (DD-Month-YYYY):   
 

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TABLE OF CONTENTS 
1.0 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .................................. 10 
1.1 
BACKGROUND CLINICAL INFORMATION ................................................................................................ 10 
2.0 
ATRICURE SYSTEM ........................................................................................................................... 10 
3.0 
ATRICURE SYNERGY ABLATION SYSTEM LABELING .......................................................................... 11 
3.1 
INDICATIONS FOR USE ....................................................................................................................... 11 
3.2 
CONTRAINDICATIONS ........................................................................................................................ 11 
3.3 
WARNINGS AND PRECAUTIONS ........................................................................................................... 11 
4.0 
ATRIAL FIBRILLATION CLASSIFICATION ............................................................................................ 11 
5.0 
STUDY OBJECTIVE ............................................................................................................................ 11 
6.0 
STUDY DESIGN ................................................................................................................................. 12 
6.1 
SITE SELECTION ............................................................................................................................... 12 
6.2 
STUDY CENTER INITIATION/START UP .................................................................................................. 13 
6.3 
ENROLLMENT PROCEDURES ............................................................................................................... 15 
6.4 
INFORMED CONSENT PROCEDURES ..................................................................................................... 16 
6.5 
PAS TIMELINE ................................................................................................................................. 16 
7.0 
STUDY OUTCOMES .......................................................................................................................... 17 
7.1 
PRIMARY EFFICACY OUTCOME ............................................................................................................ 17 
7.2 
SECONDARY EFFICACY OUTCOME ........................................................................................................ 17 
7.3 
PRIMARY SAFETY OUTCOME .............................................................................................................. 17 
7.4 
SECONDARY SAFETY OUTCOMES ......................................................................................................... 18 
8.0 
DEVICE DESCRIPTION, POTENTIAL RISK BENEFITS & STUDY JUSTIFICATION ..................................... 18 
8.1 
POTENTIAL RISKS AND BENEFITS ......................................................................................................... 18 
9.0 
ELIGIBILITY CRITERIA ........................................................................................................................ 19 
9.1 
SUBJECT INCLUSION CRITERIA ............................................................................................................. 19 
9.2 
SUBJECT EXCLUSION CRITERIA ............................................................................................................ 19 
10.0 
REASONS FOR WITHDRAWAL .......................................................................................................... 19 
11.0 
TREATMENT OF SUBJECTS ................................................................................................................ 20 
12.0 
CLINICAL ASSESSMENTS .................................................................................................................. 23 

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12.1 
REPEAT ABLATION AND/OR CARDIOVERSION PROCEDURES ...................................................................... 24 
12.2 
PERMANENT PACEMAKER IMPLANTATIONS (PPM) ................................................................................. 24 
12.3 
STANDARDIZATION OF ANTI-ARRHYTHMIC DRUG USE DURING FOLLOW-UP PERIOD ...................................... 24 
13.0 
ASSESSMENT OF SAFETY .................................................................................................................. 25 
13.1 
ADVERSE EVENTS ............................................................................................................................. 25 
13.2 
ANTICIPATED ADVERSE EVENTS .......................................................................................................... 25 
13.3 
EVENTS THAT DO NOT REQUIRE REPORTING TO THE SPONSOR .................................................................... 26 
13.4 
SERIOUS ADVERSE EVENTS ................................................................................................................. 27 
14.0 
CLINICAL EVENTS COMMITTEE (CEC) ................................................................................................ 27 
15.0 
MEDICAL DEVICE REPORTING .......................................................................................................... 28 
15.1 
MANUFACTURER REPORTING REQUIREMENTS ....................................................................................... 28 
16.0 
STATISTICAL CONSIDERATIONS ........................................................................................................ 28 
16.1 
STATISTICAL OVERVIEW ..................................................................................................................... 28 
16.2 
ANALYSIS POPULATIONS .................................................................................................................... 28 
16.3 
SAMPLE SIZE CALCULATIONS AND ASSUMPTIONS ................................................................................... 29 
16.4 
SAFETY .......................................................................................................................................... 29 
16.5 
EFFICACY ........................................................................................................................................ 30 
16.6 
STATISTICAL ANALYSES ...................................................................................................................... 30 
17.0 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................................ 31 
17.1 
PROTOCOL DEVIATIONS .................................................................................................................... 31 
17.2 
INVESTIGATOR / INVESTIGATIONAL SITE TRAINING .................................................................................. 32 
17.3 
MONITOR TRAINING ......................................................................................................................... 32 
17.4 
STUDY MONITORING ........................................................................................................................ 32 
17.5 
SITE MONITORING ........................................................................................................................... 32 
17.6 
REGULATORY AGENCY INSPECTION ...................................................................................................... 32 
18.0 
ETHICS/PROTECTION OF HUMAN SUBJECTS .................................................................................... 33 
18.1 
ETHICAL STANDARD .......................................................................................................................... 33 
18.2 
INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE .............................................................................. 33 

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18.3 
INFORMED CONSENT PROCESS ........................................................................................................... 33 
18.4 
SUBJECT CONFIDENTIALITY ................................................................................................................. 33 
19.0 
DATA HANDLING AND RECORD KEEPING ......................................................................................... 34 
19.1 
INVESTIGATOR RECORDS ................................................................................................................... 34 
19.2 
INVESTIGATOR REPORTS .................................................................................................................... 35 
19.3 
DATA MANAGEMENT RESPONSIBILITIES ............................................................................................... 36 
19.4 
STUDY RECORDS RETENTION .............................................................................................................. 36 
20.0 
PROTOCOL AMENDMENTS .............................................................................................................. 36 
21.0 
TERMINATION OF STUDY OR STUDY SITE PARTICIPCATION ............................................................. 36 
22.0 
LITERATURE REFERENCES ................................................................................................................. 38 
APPENDIX A:   ADVERSE EVENT DEFINITIONS .................................................................................................... 39 

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PROTOCOL SUMMARY 
 
 
Title: 
AtriCure Synergy RF Energy Lesions For Non-Paroxysmal Forms Of 
Atrial Fibrillation Treatment During Concomitant On-Pump Cardiac 
Surgery Post-Approval Study (or “ABLATE PAS”) 
Device: 
The AtriCure Synergy Ablation System devices included in post 
approval study are: 
• 
Ablation and Sensing Unit – ASU – RF Generator 
• 
Source Switch – ASB – allows user to connect multiple AtriCure 
devices to ASU 
• 
Surgical Clamps (Handpieces) – AtriCure Isolator Synergy 
Handpieces - Product Codes:  OLL2, OSL2 
Objective: 
The primary objective of this post-approval study is to evaluate 
clinical outcomes in a cohort of patients treated during commercial 
use of the AtriCure Synergy Ablation System by physicians 
performing the Maze IV procedure. 
Design: 
This prospective, open label, multi-center, observational, single arm 
registry is designed to monitor the AtriCure Synergy Ablation System 
continued safety and efficacy during the peri-procedural and long 
term phase during commercial use in patients being treated for non- 
paroxysmal forms of atrial fibrillation (AF) who are undergoing a 
concomitant open, on-pump cardiac surgical procedure. 
Primary Efficacy 
Outcome: 
The proportion of patients free from AF (i.e. no episodes lasting > 30 
continuous seconds duration of either Atrial Fibrillation, Atrial 
Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic 
drugs for at least 4 weeks (except amiodarone which must be 12 
weeks prior to assessment), as determined by an independent core 
lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation 
recording performed at a minimum of 12, 24 and 36 months 
postoperatively (hypothesis test at 36 months). 
Primary Safety 
Outcome: 
• 
The proportion of patients with any serious device or ablation 
procedure-related adverse events (excluding pacemaker 
implantation) within 30 days post-procedure or hospital 
discharge (whichever is later) as adjudicated by a Clinical Events 
Committee. 

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Secondary Efficacy 
Outcome: 
• 
The proportion of patients free from AF, regardless of AAD 
usage (i.e. no episodes lasting > 30 continuous seconds duration 
of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), 
as determined by an independent core lab assessment of 48 
hour Holter, Zio™ Patch or PPM interrogation recording 
performed at a minimum of 12, 24 and 36 months 
postoperatively. 
Secondary Safety 
Outcomes: 
• 
Composite major adverse event: Serious adverse events 
occurring post-operatively within 30 days post-procedure or 
hospital discharge (whichever is later) including: 
o 
Death (includes deaths after 30 days or hospital 
discharge if death is procedure related). 
o 
Stroke (resulting in significant permanent disability) 
o 
TIA 
o 
Myocardial infarction, and 
o 
Excessive bleeding (requiring >2 units of blood 
replacement and surgical intervention). 
• 
All adverse events that are reported in the study shall be 
summarized and reported. The events shall be summarized at 
each follow up interval based upon level of seriousness (serious 
vs. non-serious) and attribution (device, ablation procedure, 
primary cardiac surgical procedure or co-morbid condition, etc.) 
• 
A separate report of device and ablation procedure-related 
serious adverse events summarized and reported by type of 
primary cardiac surgical procedure (i.e. surgical procedure to 
address structural heart disease) shall also be performed. 
• 
Pacemaker implantation (PPM) within 30 days post procedure 
will be summarized and reported by reason for PPM (i.e., sinus 
node dysfunction, AV-node, etc.). 
Planned Enrollment: 
Up to 390 subjects. 
Population: 
Subjects who have non-paroxysmal forms of AF and are scheduled to 
undergo a primary open cardiac surgical procedure requiring 
cardiopulmonary bypass including valve surgery and/or CABG. 

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Follow-up Schedule: 
All patients will undergo clinical follow-up in hospital and at 30 days, 
4, 12, 24 and 36 months post procedure. 
Number of Sites: 
50 study centers located in North America 
Study Duration 
(Estimated): 
Study Start: Q3/2012 
Enrollment Completion: Q4/2014 
Follow Up Completion: Q4/2017 
Final Report: Q2/2018 
(See detail in section 6.5) 
Inclusion Criteria: 
• 
Age ≥ 18 years. 
 
Subjects with Persistent or Longstanding Persistent Atrial 
Fibrillation defined in accordance to HRS AF expert consensus 
statement (2012) 1 
• 
Persistent AF is defined as continuous AF that is sustained 
beyond seven days. Episodes of AF in which a decision is 
made to electrically or pharmacologically cardiovert the 
patient after > 48 hours of AF, but prior to 7 days, should 
also be classified as persistent AF episodes. 
• 
Longstanding persistent AF is defined as continuous AF of 
greater than 12 months duration. 
o The performance of a successful cardioversion (sinus 
rhythm >30 seconds) within 12 months of an 
ablation procedure with documented early 
recurrence of AF within 30 days should not alter the 
classification of AF as long-standing persistent 
 Subject is scheduled to undergo elective open cardiac surgical 
procedure(s) to be performed on cardiopulmonary bypass for 
one or more of the following: Coronary Artery Bypass Grafting 
(CABG), Mitral valve repair or replacement, Aortic valve repair or 
replacement, Tricuspid valve repair or replacement. In 
conjunction with these procedures Patent Foramen Ovale (PFO) 
or A Septal Defect (ASD) repair are allowed. 
 
The patient (or their legally authorized representative) agrees to 
participate in this study by signing the IRB approved informed 
consent form. 
 
Willing and able to return for scheduled follow-up visits. 

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Exclusion Criteria: 
• 
Stand alone AF without indication(s) for concomitant 
cardiac surgery. 
• 
Need for emergent cardiac surgery (i.e. cardiogenic 
shock). 
• 
Preoperative need for an intra-aortic balloon pump or 
intravenous inotropes 
• 
Pregnancy or desire to get pregnant for the duration of 
the study (concomitant surgical procedure through the 
thirty six (36) month follow-up period). 
• 
Enrolled in another clinical trial that could confound the 
results of this study. 
Sample Size: 
The study will enroll up to 390 subjects at 50 North 
American sites. The 390 patient sample size for this study 
was derived to establish that the rates for the primary 
outcomes of 30-day serious device and ablation procedure 
related AE and 3-year efficacy success rates are within the 
pre-established reference rate bounds. This number of 
subjects shall provide an adequate sample to fully assess 
the outcome of the procedure within a broad population 
and should supply a sufficient number of subjects for both 
30 day safety evaluation (>333 subjects at 30 days) and 
long term efficacy evaluation (>275 subjects at 3 years 
Steering Committee: 
Patrick McCarthy, MD – Committee Chairperson 
Sponsor/Manufacturer, 
Study Coordination and 
Monitoring: 
Data Management, 
Safety & Biostatistics: 
AtriCure, Inc. 
6217 Centre Park Drive 
West Chester, OH 45069 
Office Number: (513) 755-4100 
Boston Biomedical Associates 
386 West Main Street – Suite 7 
Northboro, Massachusetts 01532 
USA 
Office Number: (508) 351-8632 
Fax Number: (508) 351-8637 
Core Lab: 
Agility Centralized Research Services, Inc. 
A CardioNet Company 
2275 Half Day Road Suite # 133 
Bannockburn, IL 60015 

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1.0 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
1.1 
Background Clinical Information 
Atrial fibrillation (AF) is the most common sustained tachyarrhythmia seen in clinical practice, 
particularly in the elderly, and is an important risk factor for stroke. AF accounts for 34% of arrhythmias 
as the principal diagnosis.1 
 
AF is a condition in which there are highly asynchronous atrial depolarization without effective atrial 
contraction. AF is also characterized by the presence of rapid, irregularly timed impulses reaching the AV 
node from the atrium and is associated with irregularly timed ventricular response. The atrial rate can 
be between 350 to 600 beats per minute. Due to the low pass filtering properties of atrio-ventricular 
(AV) node, the ventricular response is much slower. 
 
It is estimated that 2.2 to 5.1 million people in the U.S. have AF.2,3 The prevalence of AF increases with 
age. The condition affects fewer than 1% of people under age 60, with nearly 4% of people 60 years and 
older and 9% of people 80 years and older having been diagnosed with AF.4 In 85-95% of cases, the 
presence of AF is related to the presence of underlying heart disease, left atrial enlargement, or 
abnormal atrial electrophysiology. 
 
AF can lead to thromboembolism and stroke in approximately 5 -10% of high-risk patients.5 Risk 
increases with age and with the coexistence of structural heart disease, such as mitral regurgitation, 
which is common in these patients. Because there are no effective atrial contractions, areas of blood 
stasis are set up in the atria (particularly in the appendages) and clot sometimes forms. In about 5% of 
patients with AF, clotted blood dislodges from the atria and causes stroke. The American Heart 
Association estimates that in the United States, AF is responsible for over 70,000 strokes each year. In 
just the United States, it is estimated that AF accounts for 1.4 million outpatient visits and over 227,000 
hospitalizations per year.2,3 
 
2.0   AtriCure System 
 
The trial is designed as a Post Approval Study to investigate the acute and long-term outcomes of the 
AtriCure Synergy Ablation System. The product has been used in previously clinical IDE trials (RESTORE 
and ABLATE) that were used to support market approval of the system. The clinical results were 
presented to the FDA Advisory Panel in October of 2011. This group recommended approval this 
product. FDA accepted their recommendation and the Synergy Ablation System received approval in 
December 2011. A condition of this approval is to conduct this Post Approval Study aimed at collecting 
information on the acute and longer term outcomes on the product when used to complete the MAZE 
IV procedure in a commercial setting. 

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3.0 
ATRICURE SYNERGY ABLATION SYSTEM LABELING 
 
3.1 
Indications for Use 
The AtriCure Synergy Ablation System is intended to ablate cardiac tissue for the treatment of persistent 
atrial fibrillation (sustained beyond seven days, or lasting less than seven days but necessitating 
pharmacologic or electrical cardioversion) or longstanding persistent atrial fibrillation (continuous atrial 
fibrillation of greater than 12 months duration) in patients who are undergoing open concomitant 
coronary artery bypass grafting and/or valve replacement or repair. 
 
3.2 
Contraindications 
The AtriCure Synergy Ablation System should not be used for contraceptive coagulation of fallopian 
tubes.  The device is not designed for safe and effective use for that purpose. 
 
3.3 
Warnings and Precautions 
The warnings and precautions can be found in the AtriCure Synergy Ablation System Instructions for 
Use. 
 
4.0 ATRIAL FIBRILLATION CLASSIFICATION 
In an effort to bring uniformity to the various nomenclature being used in the medical community, the 
Heart Rhythm Society Task Force on Catheter and Surgical Ablation (HRS/EHRA/ECAS) have 
recommended the following AF classification scheme based upon the patterns of duration and mode of 
termination1. 
• 
Paroxysmal AF is defined as recurrent AF (>2 episodes) that terminates spontaneously within 7 
days. Episode of AF <48 hours duration that are terminated with electrical or pharmacologic 
cardioversion should also be classified as paroxysmal AF episodes. 
 
• 
Persistent AF is defined as continuous AF that is sustained beyond seven days. Episodes of AF in 
which a decision is made to electrically or pharmacologically cardiovert the patient after >48 
hours of AF, but prior to 7 days, should also be classified as persistent AF episodes. 
 
• 
Longstanding persistent AF is defined as continuous AF of greater than 12 months duration. The 
performance of a successful cardioversion (sinus rhythm >30 seconds) within 12 months of an 
ablation procedure with documented early recurrence of AF with30 days should not alter the 
classification of AF as long-standing persistent. 
 
The ABLATE Post Approval Study (ABLATE PAS) will focus on those patients with non-paroxysmal 
forms of AF who meet the inclusion/exclusion criteria defined in Section 9 of this protocol. 
• 
5.0   STUDY OBJECTIVE 
The primary objective of this ABLATE Post-Approval Study (or “ABLATE PAS”) is to evaluate clinical 
outcomes in a cohort of patients receiving treatment with the AtriCure Synergy Ablation System in 
performing the Maze IV procedure. The efficacy of the device will be demonstrated by establishing that 
the device effectively eliminates non-paroxysmal forms of atrial fibrillation. Elimination of non- 
paroxysmal forms of atrial fibrillation will be assessed by a 48 hour Holter Monitor,  Zio™ Patch, or PPM 

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interrogation performed at 12, 24, and 36 months after the procedure that demonstrates no signs of 
atrial fibrillation/atrial flutter/ atrial tachycardia longer than 30 seconds as assessed by an independent 
core laboratory. 
 
Safety shall be assessed in the study using the incidence of serious device or ablation procedure related 
adverse events which occur within 30 days post-procedure or hospital discharge (whichever is longer). 
 
6.0 STUDY DESIGN 
 
The ABLATE PAS is a multi-center, prospective, observational study designed to evaluate the AtriCure 
Synergy Ablation System for continued safety and efficacy during commercial use in a real world settings 
in patients with non-paroxysmal forms of AF. One of the goals of a post approval study is to assure that 
the provider and subject population are representative of the general population. 
To that end, the following process is being implemented for site selection and enrollment procedures. 
 
6.1 
Site Selection 
The ABLATE PAS protocol will be conducted at 50 North American centers. Participating sites will be 
split into three categories, ABLATE AF Registry Subjects, New Users and Existing users. All participating 
sites will have successfully participated in AtriCure’s training/certification program. 
 
ABLATE AF Registry Centers (N = 20 sites): 
The intent of the ABLATE AF Registry protocol was to provide further supportive data on the 
concomitant MAZE procedure with the AtriCure Synergy Ablation System. To continue the collection of 
this supportive data, the FDA has approved the transfer of the ABLATE AF Registry subjects into the 
ABLATE PAS protocol. On the date of FDA approval of the ABLATE PAS approval, the ABLATE PAS 
database will be released and the former ABLATE AF subjects will move into the ABLATE PAS database. 
These subjects will be followed from that date forward per the ABLATE PAS protocol (follow up visits, 
safety endpoints, adjudication through 30 days, and efficacy endpoints). At the time of transition from 
the ABLATE AF Registry study to ABLATE PAS, 19 sites had been initiated with 18 centers enrolling. 

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Existing/ Current Users (currently uses the AtriCure Synergy Ablation System, but did not participate 
in the ABLATE AF Registry; (N=20): 
A total of 20 additional existing/current user centers will be qualified to participate in the ABLATE PAS. 
To identify these potential  current user centers, AtriCure developed a list of all cardiac surgery centers 
in the United States from their marketing database. Potential centers have been identified from this list 
based on the known data from the database against the following criteria: 
a) Performs the MAZE IV procedure using the AtriCure Synergy ablation system 
b) Performs at least 40 concomitant MAZE surgeries per year 
c) Has the capability of conducting clinical research 
d) Capable of performing a three year follow up on the patient population 
 
A total of thirty US centers were identified as potential CURRENT user centers for the ABLATE PAS study. 
A computer generated randomization number will be assigned by the study statistician to each study 
center on the list and this number will then be utilized to order the study centers.  Study centers will 
then be approached in the randomly assigned order and qualified based on the criteria for conducting 
this clinical study in accordance with Standard Operating Procedures for site qualification.  Study 
Centers will continue to be qualified from the randomly ordered list until a total of 20 US centers are 
identified. 
 
New User Centers (N=10): 
 
“New Users” are defined as centers that are either hospital that have not performed the MAZE IV 
procedure or have not performed the procedure with the AtriCure Synergy Ablation System. The 
ABLATE PAS protocol will include ten “new user” centers which were identified through the same list of 
cardiac surgery centers in the United States. However, the filtering process excluded the first bullet 
point “Performs the MAZE IV procedure using the AtriCure RF ablation system.” 
 
 
6.2 
Study Center Initiation/Start Up 
The ABLATE PAS will utilize the existing subjects and sites currently involved in the ABLATE AF Registry. 
It is anticipated that at the initiation of ABLATE PAS a total of 75 subjects will be enrolled at the 20 
ABLATE AF sites. It is anticipated that 2-5 centers will be initiated each month starting in August 2012 
with all sites being active for enrollment by June 2013. Table 1 and Figure 1 represents the anticipated 
site start up. 

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Post Approval Study 
Projected Site Start Up 
50 
 
40 
 
30 
 
20 
 
10 
 
 
 
 
Table 1:  Projected US Site Start-Up—PAS 
 
Month 
Site Approved 
Initiated 
Cumulative Sites 
August 2012 
20 from Ablate AF 
20 
Sept. 2012 
2 
22 
Oct 2012 
2 
24 
Nov 2012 
3 
27 
Dec 2012 
3 
30 
Jan 2013 
3 
33 
Feb 2013 
3 
36 
Mar 2013 
4 
40 
April 2013 
4 
44 
May 2013 
4 
48 
June 2013 
2 
50 
 
Figure 1:  ABLATE PAS Projected US Site Start Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sites 

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6.3 
Enrollment Procedures 
All patients presenting with non paroxysmal (AF) and who are scheduled to undergo a primary open 
cardiac surgical procedure requiring cardiopulmonary bypass including valve surgery and/or CABG are 
potential study candidates for the ABLATE PAS. Potential patients will be pre-screened to confirm AF 
classification (persistent or longstanding persistent) for eligibility and offered the chance to participate 
in the study. Patients will not undergo any protocol specific assessments that are not considered to be 
standard of care prior to signing the informed consent form for the study.  A Patient Screening Log will 
be provided to the study sites, in order to maintain a cumulative log of all screened patients. The reason 
for ineligibility will be documented on the study screening log including patients who refuse to 
participate in the study. 
 
Each investigator will recruit subjects equitably in an effort to ensure to the best extent possible that the 
subject pool is representative in gender, race, ethnicity, and age of the population affected by the 
condition being studied. 
 
The projected enrollment estimates for the ABLATE PAS is provided in Table 2 and Figure 2. It is 
anticipated that the study will be fully enrolled by the fourth quarter of 2014. 
 
Table 2:  ABLATE PAS US Enrollment Projections 
 
ABLATE 
AF 
Q3/ 
2012 
Q4/ 
2012 
Q1/ 
2013 
Q2/ 
2013 
Q3/ 
2013 
Q4/ 
2013 
Q1/ 
2014 
Q2/ 
2014 
Q3/ 
2014 
Q4/ 
2014 
Quarterly 
Enrollment 
20 
20 
25 
25 
30 
30 
30 
30 
35 
30 
Cumulative 
Enrollment 
75 
95 
115 
140 
165 
195 
225 
270 
310 
350 
390 

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Figure 2:  ABLATE PAS US Enrollment Estimates 
 
 
6.4 
Informed Consent Procedures 
Informed consent must be obtained from a potential patient or their legally authorized representative 
prior to conducting any preoperative assessments that are not part of the routine preparation and 
evaluation of a patient for their scheduled open-heart procedure or evaluation of atrial fibrillation, even 
though the patient’s eligibility has not yet been fully established. If during the course of the pre- 
operative evaluations, a treatment patient is found not to be eligible for inclusion in the study, the 
patient or their representative should be notified and the reason for ineligibility documented on the 
screening log. 
 
6.5 
PAS Timeline 
Table 3 outlines the projected timeline for the PAS. Based on these enrollment projects, the last subject 
enrolled will be in Q4/2014 and the last three year (36 month) follow up visit would be completed in 
Q4/2017.  The final study report would be submitted in Q1/2018. 
Post Approval Study Enrollment Estimates 
450 
400 
350 
300 
250 
200 
150 
100 
50 
0 
390 
350 
310 
270 
225 
195 
165 
115 
140 
75 
95 
20 
20 
25 
25 
30 
30 
30 
30 
35 
30 
ABLATE    Q3/ 
 Q4/ 
 Q1/ 
 Q2/ 
 Q3/ 
 Q4/ 
 Q1/ 
 Q2/ 
 Q3/ 
 Q4/ 
AF 
2012 
2012 
2013 
2013 
2013 
2013 
2014 
2014 
2014 
2014 
Quarterly Enrollment 
Cumulative Enrollment 

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Table 3:  PAS Timeline 
 
ABLATE 
AF 
Q3/ 
2012 
Q4/ 
2012 
Q1/ 
2013 
Q2/ 
2013 
Q3/ 
2013 
Q4/ 
2013 
Q1/ 
2014 
Q2/ 
2014 
Q3/ 
2014 
Q4/ 
2014 
Q4/ 
2017 
Q1/ 
2018 
Quarterl
y Enroll- 
ment 
20 
20 
25 
25 
30 
30 
30 
30 
35 
30 
Cumula- 
tive 
Enroll- 
ment 
75 
95 
115 
140 
165 
195 
225 
270 
310 
350 
390 
Follow 
up Com- 
plete 
390 
Final 
Report 
Sub- 
mitted 
 
 
7.0 STUDY OUTCOMES 
The ABLATE PAS will utilize a 48 hour Holter, Zio™ Patch or PPM interrogation performed at follow up 
(12, 24 and 36 month post-procedure interval) to assess efficacy (i.e. freedom from AF). Additionally, 
secondary efficacy outcomes will be reported through 36 months post-operatively. The Holter Monitor, 
Zio™ Patch or PPM interrogation data shall be reviewed by an independent Core Laboratory (see Study 
Reference Manual  for Holter Monitor Core Lab Procedures). 
The following are the primary and secondary efficacy outcomes for this ABLATE Post-Approval Study: 
 
7.1 
Primary Efficacy Outcome 
The proportion of patients free from AF (i.e. no episodes lasting > 30 continuous seconds duration of 
either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic drugs 
for at least 4 weeks (except amiodarone which must be 12 weeks) prior to assessment), as determined by 
an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation recording 
performed at a minimum of 12, 24 and 36 months postoperatively. 
 
7.2 
Secondary Efficacy Outcome 
The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting > 30 
continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as 
determined by an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation 
recording performed at a minimum of 12, 24 and 36 months postoperatively. 
 
7.3 
Primary Safety Outcome 
The proportion of patients with any serious device or ablation procedure-related adverse event within 
30 days post-procedure or hospital discharge (whichever is later). 

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7.4 
Secondary Safety Outcomes 
In addition to the primary safety outcome discussed above the following safety outcomes will be 
evaluated: 
• 
Composite major adverse event: Serious adverse events occurring post-operatively within 30 
days of procedure or hospital discharge (whichever is later) including: 
o Death (includes deaths after 30 days or hospital discharge if death is procedure related). 
o Stroke (resulting in significant permanent disability) 
o TIA 
o Myocardial infarction, and 
o Excessive bleeding (requiring >2 units of blood replacement and surgical intervention). 
 
All serious adverse events that are reported in the study shall be summarized and reported. The events 
shall be summarized at each follow up interval based upon level of seriousness (serious vs. non-serious) 
and attribution (device, ablation procedure, procedure to address structural heart disease, co-morbid 
condition, etc.) to provide a complete profile of the acute and long-term safety of the device and 
procedure. 
 
• 
Device and ablation procedure-related serious adverse events summarized and reported by type 
of surgical procedure (i.e. surgical procedure to address structural heart disease). 
• 
Permanent Pacemaker Implantation (PPM) occurring within 30 days post procedure will be 
summarized and reported by reason for PPM implantation (i.e., sinus node dysfunction, AV 
node, etc.). 
 
8.0 DEVICE DESCRIPTION, POTENTIAL RISK BENEFITS & STUDY JUSTIFICATION 
 
The approved AtriCure Synergy Ablation System devices included in the ABLATE Post-Approval Study 
are: 
• 
Ablation and Sensing Unit – ASU – RF Generator 
• 
Source Switch – ASB – allows user to connect multiple AtriCure devices to ASU 
• 
Surgical Clamps (Handpieces) – AtriCure Isolator Synergy Handpieces - Product Codes: OLL2, 
OSL2 
Refer to the Instructions for Use (IFU) for descriptions, indications for use, contraindications, system 
preparation, precautions and warnings. 
 
8.1 
Potential Risks and Benefits 
A summary of the risks and benefits of the AtriCure system are outlined in the product Instructions for 
Use (IFU) which is available in the Study Reference Manual (SRM). Also included in the SRM is a copy of 
the product summary of safety and effectiveness document which provides a complete overview of the 
clinical trial results used to support product approval. 

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9.0 ELIGIBILITY CRITERIA 
 
9.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 
• 
Age ≥ 18 years 
 
History of a non-paroxysmal form of atrial fibrillation as defined by the HRS/EHRA/ECAS Consensus 
Statement. 
 
• 
Persistent AF shall be defined as continuous AF that is sustained beyond seven days. Episodes of 
AF in which a decision is made to electrically or pharmacologically cardiovert the patient after > 
48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes. 
• 
Longstanding persistent AF shall be defined as continuous AF of greater than 12 months 
duration. The performance of a successful cardioversion (sinus rhythm >30 seconds) within 12 
months of an ablation procedure with documented early recurrence of AF with30 days should 
not alter the classification of AF as long-standing persistent. 
 
Note: For both types of AF, two (2) electrocardiograms (e.g. 12-lead ECG, Holter, event monitor, 
Implantable Loop Recorder (ILR), Pacemaker, Zio™ Patch, etc.) documenting AF, with 
electrocardiograms taken at least 7 days apart, for subjects with sustained AF ≥7 days. Holter, 
event monitor, ILR, Zio™ Patch or pacemaker recordings need to show continuous AF. 
 Subject is scheduled to undergo elective open cardiac surgical procedure(s) to be performed on 
cardiopulmonary bypass for one or more of the following: Coronary Artery Bypass Grafting, Mitral 
valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or 
replacement. In conjunction with these procedures patent foramen ovale (PFO) or atrial septal 
defect (ASD) repair are allowed. 
 
The patient (or their legally authorized representative) agrees to participate in this study by signing 
the IRB approved informed consent form. 
 
Willing and able to return for scheduled follow-up visits. 
 
9.2 
Subject Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participation in this 
study: 
 
Stand alone AF without indication(s) for concomitant cardiac surgery. 
 
Need for emergent cardiac surgery (i.e. cardiogenic shock). 
 
Preoperative need for an intra-aortic balloon pump or intravenous inotropes. 
 
Pregnancy or desire to get pregnant for the duration of the study (concomitant surgical procedure 
through the thirty six (36) month follow-up period). 
 
Enrolled in another clinical trial that could confound the results of this study. 
 
10.0 REASONS FOR WITHDRAWAL 
A study subject will be discontinued from participation in the study if: 

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• The investigator feels that the subject can no longer fully comply with the requirements of 
the study or if any of the study procedures would not be in the best interest of the subject. 
Non-compliance will be clearly documented in the subject’s source documentation (i.e., progress 
notes, medical records, etc.) 
• 
The subject is lost to follow up. A subject will be considered “lost to follow-up” and 
terminated from the study when all of the following criteria have been met: 
• 
Failure to complete the remainder of the scheduled study visits without due cause; and 
• 
Documentation of three unsuccessful attempts to contact the subject via telephone and 
by  certified mail. 
• 
The subject wishes to withdrawn their consent for participation in the study. 
 
11.0 
TREATMENT OF SUBJECTS 
The aim of all AF treatment is a complete bi-atrial MAZE IV procedure. This technique includes 
Pulmonary Vein Isolation (PVI) coupled with lesions made on both the left and right atria. In addition, 
the exclusion/excision of the left atrial appendage is recommended. All procedures must be 
documented on the Procedural Case Report Form. The detailed lesions procedure are summarized in 
Figure 3 and Table 4. For all lesions performed, the energy source utilized and number of ablations 
required for each lesion will be recorded. 
 
Based on the type of concomitant surgery or patient presentation, it is recognized that there may be 
situations in which some lesions are not able to be performed safely. The requirements for each lesion 
are as follows and further described in Figure 3 and Table 4. 
 
Mandatory Lesions - A protocol deviation will be documented for any mandatory left sided lesion that 
is either not performed or performed without utilizing the energy source(s) as described in Table 4. 
 
Recommended and Optional Lesions - - A clinical justification must be provided for any recommended 
or optional lesions that are either not performed or performed using an energy source that is different 
than the energy source(s) as described in Table 4. Protocol deviations will be required if a clinical 
justification is not provided. . Note:  Surgeon’s preference is not considered to be a clinical justification. 
 
 
The investigator should refer to the IFU for details on the product, preparation and usage. 

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Figure 3:  Lesion Set Diagram 
 
Table 4:  Lesion Set List and Energy Source 
Pulmonary Veins (Mandatory): 
Lesion 
Energy Source 
1 
Left PV Isolation (left PVI) 
AtriCure Synergy OLL2 or OSL2 Clamp 
2 
Right PV Isolation (Right PVI) 
AtriCure Synergy OLL2 or OSL2 Clamp 
 
Left side lesions (Mandatory): 
Lesion # 
Lesion 
Energy Source 
3 
Box lesion – “ROOF” line 
AtriCure Synergy OLL2 or OSL2 Clamp 
4 
Box lesion – “FLOOR” line 
AtriCure Synergy OLL2 or OSL2 Clamp 
5 
Mitral valve annulus 
Initiate lesion with AtriCure Synergy OLL2 or OSL2 Clamp 
(mandatory); completion lesion at level of annulus with AtriCure 
Transpolar Pen or Cryo 
6 
Connecting lesion from left atrial 
appendage to the left PVI lesion 
AtriCure Synergy OLL2 or OSL2 Clamp 
Right Atrial Lesions(Recommended; if not performed must provide clinical justification*) 
7 
Lesion from atriotomy to tricuspid 
valve annulus 
AtriCure Synergy OLLS or OSL2 Clamp; complete lesion at level of 
annulus with AtriCure Transpolar Pen or Cryo 
8 
Ablation of SVC 
AtriCure Synergy OLL2 or OSL2 Clamp 
8 
Ablation of IVC 
AtriCure Synergy OLL2 or OSL2 Clamp 
*If a recommended lesion is not done or an alternate energy source is used, a clinical justification must be provided. Protocol 
deviations will be required if a clinical justification is not provided. Note: Surgeon’s preference is not considered to be a clinical 
justification. 
 

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OPTIONAL LESIONS#: 
Right side lesions: 
9 
Right anterior freewall appendage 
lesion 
AtriCure Synergy OLL2 or OSL2 Clamp OR Clamp and AtriCure 
Transpolar Pen/Cryo; OR Cryo 
10 
Right atrialappendage to annulus 
lesion 
AtriCure Synergy OLL2 or OSL2 Clamp OR Clamp and AtriCure 
Transpolar Pen/Cryo; OR Cryo 
Left side lesions: 
11 
Left atrial appendage lesion 
AtriCure Synergy OLL2 or OSL2 Clamp 
If a recommended lesion is not done or an alternate energy source is used, a clinical justification must be provided. Protocol 
deviations will be required if a clinical justification is not provided. Note: Surgeon’s preference is not considered to be a clinical 
justification. 

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12.0 CLINICAL ASSESSMENTS 
Subjects shall be evaluated from the time of the surgical procedure through hospital discharge and at a 
variety of timepoints through the 36 months of follow up (Table 5). 
Table 5: Overall Schedule of Events 
Assessment 
Pre-        
Procedure/Baseline 
(within 14 days prior 
to procedure) 
Procedure 
Pre- 
Discharge 
(within 48 
hours prior 
to     
discharge) 
30 days 
(+7 days) 
4 month 
(+/- 30 days) 
12 month 
(+/- 60 days) 
24 month 
(+/- 60 days) 
36 month 
(+/- 60 days) 
Informed Consent 
X 
Medical History 
X 
Adverse Event 
Evaluation 
X 
X 
X 
X 
X 
X 
X 
Physical 
Assessment 
X 
X 
X 
X 
X 
X 
X 
NYHA Class 
X 
X 
X 
Medications 
X 
X 
X 
X 
X 
X 
X 
12 lead ECG1 
X 
X 
X 
X 
Holter Monitor 48 
hr, Zio™ Patch/PPM 
Interrogation2,3 
X 
X 
X 
RBC, WBC, HGB, 
HCT, Platelets 
X 
X 
INR4 
X 
X 
X 
X 
X 
X 
X 
Pregnancy Test5 
X 
Lesion set 
X 
Pacing Procedure 
X 
(optional) 
Concomitant 
Surgical Procedure 
X 
Cardioversion6 
X 
X 
X 
X 
X 
X 
X 
 
1 Per HRS/EHRA/ECAS Consensus, two ECGs are required prior to baseline to document the type of AF. 
2 Zio™ Patch or Permanent Pacemaker interrogations can be performed in lieu of 48 hour Holter 
3If patient is deemed a failure by EKG, a Holter, Zio™ Patch or Permanent Pacemaker Interrogation is not required 
4 For anticoagulated patients only 
5 Females of childbearing potential defined as females who have not reached menopause and have not been surgically 
sterilized 
6 At physician discretion per standard of care at institution 

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It is important that this schedule be maintained as closely as possible for all patients. AtriCure 
recognizes that patients may not be able to return for all scheduled visits at precisely the date required, 
and therefore, a period of time in which each visit is allowed. Table 6 describes the schedule of follow 
up visits along with the acceptable visit window. Assessments and/or visits not completed will be 
considered missed visits and a protocol deviation will need to be completed. Assessments and/or visits 
completed outside these windows will be considered late visits and therefore a protocol deviation. 
Study visits should be scheduled as close to the early part of the visit time period as possible so that if it 
is necessary to cancel and reschedule the visit, the visit could still be conducted in the required time 
period. 
 
Table 6: Schedule of Follow-up Visits and Time Periods 
 
Visit 
Follow-up Window 
Pre-procedure/Baseline 
Within 14 days prior to procedure 
Pre-Discharge 
No more than 48 hours prior to hospital discharge 
30 days 
30 days +7 days 
4 months 
120 days +/- 30 days 
12 months 
365 days +/- 60 days 
24 months 
730 days +/- 60 days 
36 months 
1095 days +/- 60 days 
 
12.1 Repeat Ablation and/or Cardioversion Procedures 
All information regarding any repeat catheter ablations (reason for the re-do as well as location) or any 
cardioversions will be collected and documented in the CRF. The most prevalent post-procedure rhythm 
will also be documented and recorded in the CRF. 
12.2 
Permanent Pacemaker Implantations (PPM) 
Information regarding PPM implantation within 30 days of the procedure will be collected and 
documented in the CRF, including time of implant and reason. 
 
12.3 
Standardization of Anti-arrhythmic Drug Use during Follow-up Period 
Postoperative use of anti-arrhythmic drugs (AAD) following atrial fibrillation surgery varies significantly 
among sites and among clinicians at individual sites. In addition, regulation of the medical regimen may 
be under the direction of the surgeon, the referring clinical cardiologist or both in collaboration. Since 
no specific data are available to prove efficacy of any given approach, this shall be left up to the 
discretion and ordinary practice of the investigators. This will not influence the primary efficacy 
outcomes analysis, since efficacy will be evaluated after AAD washout. 
The presence or absence of atrial fibrillation shall be assessed in each treatment subject pre-discharge 
(not more than 48 hours prior to discharge) and at the 30 day, 4 month, 12 month, 24 and 36 months 
post-operative visits. Between discharge and the 4 month visits, the investigator or their referring 
cardiologist should see patients who are continuing in AF.  Effective communication between the 

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investigator and the referring cardiologist is essential to ensure protocol procedures and required are 
followed when medically possible. An email will be sent to the site prior to each subject’s follow up visit 
as a reminder to contact the referring cardiologist for an update on the subject’s medications, any 
cardioversions/repeat ablations, rhythm status, etc. 
 
In addition, some subjects may present for medical care between or at scheduled visits, at which time 
AF may be discovered. If a patient is in AF during the follow-up course, additional attempts at medical 
management and cardioversion/catheter ablation can be undertaken as medically indicated. However, 
every effort should be made to discontinue AADs at least 4 weeks (except amiodarone which must be 
discontinued 12 weeks prior to assessment) prior to the Holter, Zio™ Patch or PPM interrogation 
evaluations at 12, 24, and 36 month follow-up visits. If AADs cannot be discontinued at least four (4) 
weeks (12 weeks for amiodarone) before the 12 month visit the subject will, by definition not be 
considered a primary efficacy outcome success. 
 
13.0 
ASSESSMENT OF SAFETY 
 
13.1 Adverse Events 
During each clinical follow-up, the investigator or designee will determine adverse event (AE) 
occurrences. An adverse event is any untoward medical occurrence (signs, symptoms, abnormal 
laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse 
event is considered to be either anticipated or unanticipated as described below. The site is required to 
report all adverse events that occur in the study. 
 
13.2 Anticipated Adverse Events 
A variety of complications are expected to occur in subjects undergoing treatment for atrial fibrillation 
with the AtriCure Synergy Ablation System concomitant with an open-heart procedure requiring 
cardiopulmonary bypass.   These anticipated adverse events are provided in Appendix A. 
 
These events shall also be classified according to the suspected causality by the study investigator. 
Causality can be attributed to the device, the surgical procedure or to the subject’s underlying disease 
according to the definitions below. 
Device Related Adverse Event: An adverse event, which in the judgment of the Investigator, results 
from use of the AtriCure Synergy Ablation System. 
Ablation Procedure Related Adverse Event: An adverse event which, in the judgment of the 
Investigator, results as a consequence of the ablation procedure and is not specifically related to use of 
the AtriCure Synergy Ablation System. 
Surgical Procedure Related Adverse Event: An adverse event which, in the judgment of the 
Investigator, results as a consequence of the surgical procedure to address underlying structural heart 
disease and is not specifically related to use of the AtriCure Synergy Ablation System or the ablation 
procedure. 

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Underlying Disease Related Adverse Event: An adverse event which, in the judgment of the 
Investigator, results as a consequence of the subject’s underlying medical condition and is related to 
neither the ablation nor structural heart disease surgical procedures nor to use of the AtriCure Synergy 
Ablation System. 
 
If the Investigator cannot determine the cause of the event, it should be classified as unknown. 
 
13.3 Events that do not require reporting to the sponsor 
For purposes of this study, the following events will not be required to be reported as adverse events to 
the sponsor, because they are normally expected to occur in conjunction with surgical treatment for 
non-paroxysmal forms of atrial fibrillation procedures (Maze IV) or are associated with customary, 
standard care of patients undergoing cardiac surgery: 
• 
Chest pain without associated ECG changes 
• 
Post-operative pain 
• 
Post-anesthesia emesis, nausea, or headache (within 24 hours of procedure) 
• 
Electrolyte imbalance without clinical sequelae following procedure, even if requiring correction 
• 
Pre - planned future surgical procedures 
• 
Low grade temperature increase (101°F or 38.5°C) 
• 
Dizziness: Imprecise term commonly used to describe various symptoms such as faintness, 
giddiness, imbalance, lightheadedness, unsteadiness or vertigo. 
• 
Elevated white blood count, outside the standard laboratory normal value, without signs and 
symptoms of infection 
• 
Post-operative hematocrit decrease from baseline measured in the OR, prior to the first incision, 
not associated with hemodynamic changes, remaining above 25% and requiring < 3 units PRBC’s 
• 
Minor, localized tenderness, swelling, induration, oozing, etc. at surgical site. 
• 
Sinus bradycardia/tachycardia that does not require treatment or intervention 
• 
Systolic or diastolic blood pressure changes that do not require treatment or intervention. 
• 
Any blood transfusions during preplanned operative procedures and unrelated to an adverse 
event. 
• 
Thrombocytopenia: does not become an AE until treatment is administered. 
• 
Atelectasis - collapse of lung tissue affecting part or all of one lung; the alveoli are deflated. This 
is not considered to be an AE unless treatment other than chest PT is required or it prolongs 
hospitalization. 
• 
Hyperglycemia - The use of insulin in the post-operative period does not constitute 
hyperglycemia if during the same hospitalization. An elevated blood sugar of less than 250 
mg/dl during the first 48 hours post-operative does not constitute hyperglycemia. 
• 
Pleural effusion is not an event unless treatment with thoracentesis or chest tube insertion is 
required 
• 
Pericardial effusion without hemodynamic compromise or treatment 

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• 
Atrial Fibrillation /Atrial Flutter/Atrial Tachycardia with or without cardioversion. Note: the 
occurrence of AF is reported as an outcome in the study and documented on a follow up visit 
CRF. 
 
13.4 Serious Adverse Events 
All SAEs must be reported to AtriCure or designee within 24 hours of investigational site knowledge of 
the event. The event shall be reported through the EDC system. In the event that the EDC system is not 
in service, a paper copy of the AE CRF must be faxed to Boston Biomedical Associates at (508) 351-8637 
within 24 hours of knowledge of the event. 
 
A serious adverse event (SAE) is any untoward medical occurrence that: 
 
• 
Results in death 
• 
Is life-threatening 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in persistent or significant disability/incapacity, or 
• 
Is an important medical event which may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the above outcomes 
 
The Investigator at each participating center is ultimately responsible for reporting adverse events 
(complications) to AtriCure or its designated CRO. Investigators must report SAEs within 24 hours of 
investigational site knowledge of event occurrence by entering data into the Case Report Form in the 
electronic database. The Investigator is required to complete the adverse event Case Report Forms at 
each study visit, if an adverse event occurs. One adverse event CRF must be completed for each adverse 
event. 
All adverse events will be reported to FDA at least annually. 
 
14.0 Clinical Events Committee (CEC) 
An independent group of physicians that are not involved in the clinical investigations will act as the 
Clinical Events Committee (CEC) under the direction of Boston Biomedical Associates. The CEC will be 
responsible for the review and validation of reported potential ENDPOINT adverse events (i.e.: all 
device/procedure related SAEs) that occur within 30 days post procedure per the CEC Charter. The CEC 
shall classify each of these adverse events based on severity and association to the device and/or 
procedure. During the review of the events, the CEC will be blinded to the clinical site as much as 
possible. The CEC Charter will be developed prior to the start of study enrollment. This charter shall 
include consistent definitions for each type of event and shall outline the review process. 

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15.0 MEDICAL DEVICE REPORTING 
 
15.1 Manufacturer Reporting Requirements 
The AtriCure Synergy Ablation System is commercially available and subject to FDA Medical Device 
Reporting (MDR) regulations.  These regulations require manufacturers who receive complaints of 
device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the 
incident. AtriCure will comply with the MDR requirements for devices used in this study through the 
information gathered on the case report forms and source documents obtained from the site. If there is 
a device malfunction or other observation, the Device Observation CRF requires the Investigator to 
notify AtriCure immediately and indicate if the observation resulted in an adverse events and indicate if 
complications are related to the device, procedure or underlying disease. The collective information 
required on AtriCure MDR procedure forms are designed to comply with time sensitive reporting 
requirements.  AtriCure will submit MDR reports according to 21 CRF parts 803.50 through 803.58. 
In the event of an MDR, the site should contact: 
AtriCure, Inc. 
Complaints/MDR Reporting 
6217 Centre Park Drive 
West Chester, OH 45069 
Telephone: 
513-755-4570 
Fax Number: 
513-644-1379 
 
16.0 STATISTICAL CONSIDERATIONS 
 
16.1 Statistical Overview 
The purpose of this study is to evaluate continued safety and efficacy of the AtriCure Synergy Ablation 
System during commercial use in real world settings for surgical ablation of non-paroxysmal atrial 
fibrillation during concomitant cardiac surgical procedures. 
16.2 Analysis Populations 
The primary analysis population will consist of patients who received the AtriCure Synergy Ablation 
System for treatment of non-paroxysmal atrial fibrillation in the setting of a concomitant cardiac surgical 
procedure.  Other sub-populations will be detailed in the statistical analysis plan. 
The primary study outcomes will also be stratified according to primary cardiac surgical procedure type, 
e.g.: 
(1) CABG 
 
(2) Aortic Valve 
 
(3) Mitral Valve 
 
(4) Tricuspid Valve, and 

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(5) Multiple procedures 
 
We will stratify enrolled subjects by type of primary cardiac surgical procedure to assure a reasonable 
precision of the estimate for serious device or procedure related SAEs within each specified stratum. 
In addition, primary study outcomes will be stratified by “new users” versus “existing users”. A “new 
user” is defined as a site that has not performed the Maze IV procedure in the past, or has not 
performed the procedure with the AtriCure Synergy Ablation System. An “existing user” is defined as a 
site that performs the MAZE IV procedure using the AtriCure Synergy Ablation System. 
 
16.3 Sample Size Calculations and Assumptions 
The study will enroll up to 390 subjects at 50 North American centers. This number of subjects shall 
provide an adequate sample to fully assess the outcome of the procedure within a broad population. 
The patient sample size for this study was derived to establish that the rates for the primary outcomes 
of 30-day serious device and ablation procedure related AE and 3-year efficacy success rates are within 
the pre-established reference rate bounds. This number of subjects shall provide an adequate sample to 
fully assess the outcome of the procedure within a broad population and should supply a sufficient 
number of subjects for both 30 day safety evaluation (>333 subjects at 30 days) and long term efficacy 
evaluation (>275 subjects at 3 years). Should the statistical power be sufficient with fewer than 390 
subjects (at least 333 subjects at 30 days), PAS will stop recruitment early and continue to follow those 
subjects currently enrolled. 
 
 
16.4 Safety 
The primary safety objective of the ABLATE Post Approval Study (ABLATE PAS) is to demonstrate that 
the serious device and ablation procedure related AE rate (excluding pacemaker implantation) within 30 
days or prior to discharge (whichever is later) of the AtriCure Synergy Ablation System is no worse than a 
performance goal derived from the non-paroxysmal AF subject cohort of the combined AtriCure IDE 
ABLATE and ABLATE AF clinical trials. 
The rate of serious device or ablation procedure related adverse events (excluding pacemaker 
implantation) within 30 days or prior to discharge (whichever is later) in the non-paroxysmal AF subject 
cohort of the combined AtriCure IDE ABLATE and ABLATE AF clinical trials was 6.25% (4/64). 
 
The acceptable upper limit of the serious device and ablation procedure related AE rate for the ABLATE 
PAS trial (i.e. the performance goal) is established at 10%. 
The primary safety hypotheses for this study are stated as follows: 
H0 : πPAS_SAFETY ≥ 10% 
H1 : πPAS_SAFETY < 10% 
Using a one-sided exact binomial test for proportions at the 0.05 overall level of significance, a total of 
333 subjects are required to demonstrate that the 30 day serious device or procedure related AErate 

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(excluding pacemaker implantation) in subjects treated with the AtriCure Synergy Ablation System is < 
10% (the performance goal) with 80% power. This calculation was completed using PASS 2008 Power 
and Sample Size Software by NCSS. 
A maximum of 15% Loss to Follow-Up (LTFU) is anticipated through 30 days, as such the sample size for 
enrollment is increased to 390 subjects to ensure a minimum of 333 subjects are available for 
assessment of the primary safety endpoint through 30 days. Should LTFU be less than 15%, enrollment 
will stop early given the safety endpoint is powered to at least 80%. 
16.5 Efficacy 
Based on data collected from the non-paroxysmal AF subject cohort of the AtriCure IDE ABLATE clinical 
trial it is estimated that approximately 55-60% of patients treated with the AtriCure Synergy Ablation 
System will be free of AF while off AADs at 2-3 years follow-up, where free of AF is defined as no episode 
of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds. This estimate is 
based on the 57.8% success rate (26/45) seen at an average follow-up time of 20 months in the subset 
of non-paroxysmal AF subjects treated under the AtriCure IDE ABLATE trial. 
 
The goal of the ABLATE PAS will be to show that the efficacy success rate in patients treated with the 
AtriCure Synergy Ablation System is no lower than a performance goal of 47.8%. This bound of 47.8% is 
established based on the 57.8% success rate (26/45) seen at an average follow-up time of 20 months in 
the subset of non-paroxysmal AF subjects treated under the AtriCure IDE ABLATE trial. 
 
An additional pre-specified margin of 10% is utilized, consistent with the pre-specified margin used in 
the ABLATE clinical trial to establish efficacy. This 10% margin is added to the target rate for purposes of 
defining the acceptable lower limit of the serious device and ablation procedure related AE rate for the 
trial (i.e. the performance goal), resulting in an acceptable one-sided lower 95% confidence interval limit 
of 47.8% for the AF free and off AADs at 3 years post-procedure success rate in the ABLATE PAS trial. 
The primary efficacy hypotheses for this study are stated as follows: 
H0 : πPAS_EF   ≤ 0.478 
H1 : πPAS_EF  > 0.478 
 
Assuming a success rate of 57.8% and a loss to follow-up that only leaves 250 of the initial 390 patients 
evaluable at 3 years, this test of efficacy superiority with a significance level of 0.05 can be shown with 
94% power. Since this is even greater than 90% power, the ABLATE PAS sample size is driven by the 
safety primary endpoint. 
 
16.6 Statistical Analyses 
Primary Analysis 
Serious device and ablation procedure related AE rates and confidence intervals will be summarized at 
discharge, 30 days, and 1-year with a hypothesis test performed on the cumulative 30 day serious device 

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and ablation procedure related AE rate. The primary safety hypothesis test will be conducted using a 
one-sided exact binomial test for proportions at the 0.05 overall level of significance. 
The efficacy outcome rate of freedom from AF, off antiarrhythmic drugs along with confidence intervals 
will be summarized at 1, 2 and 3 years (i.e. 12. 24, 36 month follow-up), with a hypothesis test 
performed on the 3-year success outcome. The primary efficacy hypothesis test will be conducted using 
a one-sided exact binomial test for proportions at the 0.05 overall level of significance. 
Secondary Analysis 
 
Secondary outcomes will be summarized for the analysis population and certain sub-populations. Two- 
sided 95% confidence intervals will be calculated for all presented rates. Descriptive analyses will be 
provided for patient demographics, clinical device/procedural success, medical histories, and co- 
morbidities. Logistic regression analyses may be used to screen a wide range of parameters for their 
association with some outcomes. 
Procedures to Account for Missing Data 
 
Reasonable efforts will be made to obtain complete data for all patients; however, missing observations 
will occur due to patients lost to follow-up or noncompliance with required assessments. The reasons 
for missing data will be evaluated (e.g. patient is deceased, lost to follow up, missed visit, etc.). In 
addition, the distribution of prognostic factors between patients with data and those without data will 
be examined to evaluate any potential sources of bias. 
Any missing observations will be described in detail and evaluated for assessment of possible bias. For 
the primary analysis of safety and efficacy outcomes, missing data will be imputed using multiple 
imputation methods (e.g. SAS PROC MI). Additional sensitivity analyses of missing data including 1) 
considering everyone who was a failure at last visit also a failure at 3 years and multiple imputation on 
everyone who was a success at last visit, 2) including everyone LTFU as a failure and 3) a tipping point 
analysis  will also be performed. 
 
 
17.0 QUALITY CONTROL AND QUALITY ASSURANCE 
 
17.1 Protocol Deviations 
A protocol deviation is a failure to comply with the requirements specified within this clinical study 
protocol. Examples of protocol deviations may include enrollment of a study patient who does not meet 
all of the inclusion/exclusion criteria specified in the protocol and missed study visits without 
documentation. Each investigator shall conduct this clinical study in accordance with this clinical study 
protocol, regulatory body regulations, ISO guidelines, Good Clinical Practices, and any conditions of 
approval imposed by their IRB. 
 
All deviations are reviewed and assessed for their impact on patient safety by AtriCure or designee. The 
site PI and study staff is responsible for knowing and adhering to their IRB/EC reporting requirements. 

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The protocol deviations for this protocol consist of, but not limited to the following: 
• 
Failure to obtain patient’s informed consent prior to any study-related activities and the index 
procedure 
• 
Use of other approved devices for the ablation procedure or MAZE IV procedure, or lesion set 
deviations. 
• 
Failure to conduct protocol required clinical follow-ups 
• 
Failure to conduct protocol required clinical follow-ups within time windows 
• 
Failure to report serious adverse events according to protocol requirements. 
 
In the event of any deviation from the protocol, the Investigator will be notified of the site’s non- 
compliance. Corrective actions will be required, if necessary. Continued protocol deviations despite re- 
education of the study site personnel or persistent protocol deviation may result in termination of the 
site’s study participation. Patients already enrolled at these sites will continue to be follow per the 
clinical protocol. 
 
17.2 Investigator / Investigational Site Training 
AtriCure and/or designated CRO will be responsible for providing training to the investigator and 
appropriate clinical site personnel. 
 
17.3 Monitor Training 
AtriCure and/or designated monitors will be trained appropriately to monitor study progress including 
but not limited to the protocol and CRFs. 
 
17.4 Study Monitoring 
A study specific monitoring plan will be conducted to ensure protocol compliance and applicable 
regulatory requirements. 
 
Clinical monitors will verify patient data and ensure compliance with GCP, clinical protocol and other 
study requirements, according to the guidelines set forth in the monitoring Standard Operating 
Procedures (SOP) and ISO 14155 guidelines to be utilized for the study. 
 
17.5 Site Monitoring 
AtriCure or designee may conduct periodic compliance assessments at various study sites. AtriCure or 
designee may request access to all trial records including source documentation for inspection and 
photocopying during a compliance assessment. The Investigator and research coordinator must be 
available to respond to reasonable requests and queries made during the compliance assessment 
process. 
 
17.6 Regulatory Agency Inspection 
In the event that an investigator is contacted by a regulatory agency regarding this trial, the investigator 
will notify AtriCure or its designee immediately. The investigator and research coordinator must be 
available to respond to reasonable requests and queries made during the inspection process. The 

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investigator must provide AtriCure or designee with copies of all correspondence that may affect review 
of the current trial (e.g., Form FDA 483, Inspectional Observations and Warning Letters). AtriCure may 
provide needed assistance in responding to regulatory audits. 
 
18.0 ETHICS/PROTECTION OF HUMAN SUBJECTS 
 
18.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set forth in 
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 
as drafted by the US National Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6; 62 Federal 
Regulations 25691 (1997), the Declaration of Helsinki, CIOMS, and the International Ethical Guidelines 
for Biomedical Research Involving Human Subjects (2002). 
 
18.2 Institutional Review Board/Ethics Committee 
Each participating institution must provide for the review and approval of this protocol and the 
associated informed consent documents and recruitment material by an appropriate Ethics 
Committee(EC)/Institutional Review Board (IRB). Any amendments to the protocol or consent materials 
must also be approved before they are placed into use. 
 
18.3 Informed Consent Process 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks and 
possible benefits of this therapy will be provided to the subjects and their families. Consent forms 
describing in detail the study interventions/products, study procedures, and risks are given to the 
subject and written documentation of informed consent is required prior to starting intervention/ 
administering study product. Consent forms will be IRB-approved and the subject will be asked to read 
and review the document. Upon reviewing the document, the investigator will explain the research 
study to the subject and answer any questions that may arise.  The subject will sign the informed 
consent document prior to any procedures being done specifically for the study. The subjects should 
have the opportunity to discuss the study with their surrogates or think about it prior to agreeing to 
participate.  The subjects may withdraw consent at any time throughout the course of the trial.  A copy 
of the informed consent document will be given to the subjects for their records. The rights and welfare 
of the subjects will be protected by emphasizing to them that the quality of their medical care will not 
be adversely affected if they decline to participate in this study. 
 
18.4 Subject Confidentiality 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and AtriCure 
and their agents. This confidentiality is extended to cover testing of biological samples and genetic tests 
in addition to the clinical information relating to participating subjects. 

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The study protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the sponsor. 
 
The study monitor or other authorized representatives of the AtriCure may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the subjects in this study. The clinical study site will 
permit access to such records. 
 
19.0 DATA HANDLING AND RECORD KEEPING 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of subjects. As part of participating in a manufacturer-sponsored study, each site will 
permit authorized representatives of the sponsor(s), BBA, and regulatory agencies to examine (and 
when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety and progress. 
 
Source data are all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial. 
 
The investigator is responsible to ensure the accuracy, completeness, legibility, and timeliness of the 
data reported. All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data. Dark ink is required to ensure clarity of reproduced copies. When making 
changes or corrections, cross out the original entry with a single line, and initial and date the change. 
DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
19.1 Investigator Records 
Investigators will maintain complete, accurate and current study records. Records shall be maintained 
during the clinical study and for two years after the later of the date on which the study is terminated or 
completed, or the date the records are no longer required to support FDA approval of the device. 
Investigator records shall include the following materials: 
o Correspondence: Documentation of all verbal and written correspondence with FDA, AtriCure, 
the Clinical Monitor, the Clinical Events Committee (CEC), and other investigators regarding this 
clinical study or any patient enrolled therein. 
o Subject records: Signed informed consent forms, copies of all completed Case Report Forms and 
supporting documents (laboratory reports, reports of diagnostic tests, medical records, etc.) and 
records of exposure of each subject to the device. Informed consent must comply with FDA 
regulations (21 CFR, part 50). 
 
 

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o Investigational Plan (Clinical Study Protocol): A current copy of the Clinical Study Protocol 
including Instructions for Use of the AtriCure Synergy Ablation System and blank case report 
forms. 
o Institutional Review Board (IRB)/Ethics Committee (EC) Information: All information pertaining 
to IRB/EC review and approval of this clinical study including a copy of the IRB/EC letter 
approving the clinical study, a blank informed consent form approved by the IRB/EC, and 
certification from the IRB/EC Chairman that the IRB/EC complies with FDA regulations (21CFR, 
Part 56)/regulatory body regulations, and that the IRB/EC approved the clinical study protocol 
based on the Report of Prior Investigations. 
o Investigator Agreements: Copies of signed Investigator, Co-investigator and Sub-Investigator 
Agreements with accompanying curriculum vitae. 
o Other: Any other records that may be required by applicable state or federal laws. 
 
19.2 Investigator Reports 
The Investigator will prepare and submit the following reports: 
o MDR: Medical Device Reporting of all events related to the device or device malfunctions. 
o Withdrawal of IRB Approval: Withdrawal of approval shall be reported to AtriCure or designee 
within five working days. The Investigator will provide a written report of the reason(s) approval 
was withdrawn. 
o Progress Reports: The Investigator will submit progress reports to AtriCure or designee in the 
form of completed Case Report Forms. The same forms will be used at all Investigative Centers 
for the recording of data on the findings of follow-up evaluations and complications. In 
addition, the Investigator may be asked to submit progress reports to AtriCure or designee and 
the reviewing IRB that include the number of study subjects, a summary of follow-up data and 
complications and a general description the study progress. 
o Final Report: The investigator shall submit a final report within three months of termination or 
completion of the study or that Investigator’s participation in the study, to AtriCure or designee 
and the IRB. 
o Other Reports: Upon the request of FDA, the reviewing IRB, or AtriCure or designee, the 
Investigator will provide accurate and timely information about any aspect of the clinical study. 
o Deviations from the Study Protocol: The Investigator shall notify AtriCure or designee and the 
reviewing IRB of any deviation from the Clinical study protocol intended to protect the life or 
physical well being of a patient in an emergency. Such notice shall be given as soon as possible, 
but in no event later than five working days after the emergency occurred. Except in such an 
emergency, prior approval of AtriCure is required for any deviation from the Clinical study 
protocol. Approval from the FDA and the reviewing IRB is also required if these changes or 
deviations are expected to affect the rights, safety or welfare of human subjects. 

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19.3 Data Management Responsibilities 
Electronic Case Report Forms are used for the collection and recording of data at all Investigative 
Centers. Investigators are responsible for the timely completion and updating the electronic case report 
form database (enrollment form should be completed within 24 hours of the concomitant surgical 
procedure; follow up visits should be completed within 5 working days of the corresponding study visit. 
SAEs to be reported within 24 hours of knowledge of the event). 
 
Incoming data are reviewed to identify inconsistent or missing data and adverse events. Data issues will 
be addressed within the EDC system with the investigative Centers and/or during site visits. All hard 
copy forms and data files will be secured to ensure confidentiality. 
 
19.4 Study Records Retention 
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications in an 
ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical development 
of the product. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is 
the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
20.0 
PROTOCOL AMENDMENTS 
Approved protocol amendments were provided to investigators by AtriCure or its designee prior to 
implementation. The site Investigator was responsible for notifying the IRB of the protocol amendment 
with administrative changes or obtaining IRB approval of the protocol amendment with changes in 
patient care or safety, according to instructions provided by AtriCure or its designee with the protocol 
amendment. Institutional Review Board acknowledgements and approvals must be documented in 
writing prior to implementing protocol amendments.  Copies of this documentation must also be 
provided to AtriCure or its designee. 
 
21.0 
TERMINATION OF STUDY OR STUDY SITE PARTICIPCATION 
AtriCure may terminate the study at any time. If the study is terminated prior to the completion of 
expected enrollment for any reason, all participating centers will be notified within five working days. 
All patients already enrolled will continue to be followed for the planned course of study described in 
this protocol. The study shall be terminated following the final follow-up visit of the last enrolled 
patient. 
 
AtriCure reserves the right to terminate study site participation and remove appropriate study materials 
at any time. Specific instances that may precipitate such termination include but are not limited to the 
following: 
 
 
Failure to meet minimum patient enrollment requirements 

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Failure to comply with protocol specified procedures and documentation 
 
 
Failure to comply with Good Clinical Practice 
 
The site Investigator may also discontinue study participation with suitable written notice to AtriCure. 

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22.0 
LITERATURE REFERENCES 
1. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial 
Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient 
Management and Follow-up, Definitions, Endpoints and Research Trial Design. 2012 Heart 
Rhythm Society 
2. Peters NS et al., Atrial Fibrillation: strategies to control, combat and cure.  Lancet; 2002:359:593-603 
3. American Heart Association. Heart Disease and Stroke Statistics – 2006 Update. Circulation. 2006; 
113:e85-e151. 
4. Secular Trends in Incidence of Atrial Fibrillation in Olmsted County, Minnesota, 1980 to 2000, and 
Implications on the Projections for Future Prevalence, Yoko Miyasaka, Marion E. Barnes, 
Bernard J. Gersh, Stephen S. Cha, Kent R. Bailey, Walter P. Abhayaratna, James B. Seward and 
Teresa S.M. Tsang. Circulation 2006; 114; 119-125. 
5. Brown, DL et al “Projected costs of ischemic stroke in the United States” Neurology. 2006; 67:1-1. 
6. Di Tullio MR, Homma S. Mechanisms of cardioembolic stroke. Curr Cardiol Rep. 2002;4:141-148 

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Appendix A:   Adverse Event Definitions 
 
Acute Coronary Syndrome (ACS): Any constellation of clinical signs or symptoms suggestive of AMI 
(acute myocardial ischemia) or UA (unstable angina). This syndrome includes patients with AMI, STEMI 
(ST-Segment Elevation Myocardial Infarction), NSTEMI (non-ST-elevation myocardial infarction), 
enzyme-diagnosed MI, biomarker-diagnosed MI, late ECG-diagnosed MI, and UA. This term is useful to 
generically refer to patients who ultimately prove to have 1 of these diagnoses to describe management 
alternatives at a time before the diagnosis is ultimately confirmed. 
 
Acute respiratory distress syndrome (ARDS): A failure of the respiratory system characterized by fluid 
accumulation within the lung that causes the lung to stiffen. This condition must be confirmed by 
radiological evidence, or lung biopsy, or the need for prolonged positive pressure ventilation. 
Air Embolism: An inadvertent introduction of air or gas to the vasculature which requires medical 
treatment. 
Allergic Reaction: An allergic reaction characterized by rash, nausea, vomiting, upper respiratory 
congestion, urticaria, shortness-of-breath, vasovagal reaction, or general collapse (anaphylaxis). 
Anemia: Decrease from baseline in red blood cells, hemoglobin, or total blood volume that is associated 
with hemodynamic changes or requires transfusion, or a drop in hematocrit to <21 or Hgb < 7. 5%. Any 
documented anemia event requiring ≥ 3 units PRBCs will be considered an SAE. 
 
Angina: Chest pain or discomfort due to myocardial ischemia. Typical angina is uncomfortable pressure, 
fullness, squeezing or pain in the center of the chest. The discomfort also may be felt in the neck, jaw, 
shoulder, back or arm. Angina should be confirmed by evidence of coronary artery blockage such as 
electrocardiographic changes, positive imaging study (radioisotope scanning), coronary angiography or 
cardiac MRI. 
 
Arrhythmia (other than AFIB) 
 
• 
Bradycardia: 
• 
Significant Bradycardia is symptomatic bradycardia (with heart rate less than 60 and symptoms 
attributed to the slow rate) or extreme bradycardia (persistent rates less than 40 bpm). 
• 
Supraventricular tachycardia (SVT): Supraventricular rhythm > 100 bpm for > 30 seconds 
Ventricular tachycardia (VT): A regular heart rhythm originating from the ventricle > 120 bpm 
and clinically significant. Sustained VT is > 30 seconds or requires intervention. 
• 
Ventricular fibrillation (VF):. An extremely rapid polymorphic ventricular rhythm with essentially 
no cardiac output. 
 
Arterial embolism: Angiographic evidence of embolic occlusion in any vascular distribution. 
 
Atelectasis (post surgical): Is a collapse of lung tissue affecting part or all of one lung; the alveoli are 
deflated. This is not considered to be an AE unless treatment other than Chest PT is required or it 
prolongs hospitalization. 

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Atrial Fibrillation: A heart rhythm disorder in which the upper chambers of the heart (the atria) contract 
very rapidly in a disorganized manner without effective atrial contraction. AF is characterized by the 
presence of this chaotic uncoordinated electric activity from the atria to the AV node and is associated 
with irregular ventricular response.  The atrial rate can be between 300 to 600 beats per minute. 
 
Atrial Tear/Perforation/Rupture/ Bruise: Any evidence of a tear or damage to one of the atria. 
 
Atrial thrombus: Thrombus formation or detection within the atrium. 
 
Atypical Chest Pain: Located under the sternum, left chest, abdomen, back, or arm and is fleeting or 
sharp. It is unrelated to exercise, not relieved by rest or the administration of nitroglycerin. 
Bacteremia: Presence of viable bacteria in the circulating blood. May be associated with clinical 
signs/symptoms such as fever but not hemodynamic compromise. Must be confirmed by having one 
positive blood culture and no subsequent negative cultures. 
 
Bleeding complications: 
 
Bleeding: 
 
Major bleeding  Is defines as  3 units of blood transfused in a 24 period 
Minor Bleeding  Is  defined as < 3 units of blood transfused within a 24 hour period 
 
Procedural Bleeding: Bleeding occurring during the procedure requiring 3 or more units of blood 
transfused. 
Major Bleeding: Any bleeding which results in a drop in hematocrit from pre-procedure level which is 
associated with hemodynamic compromise or which results in a hematocrit of ≤ 25% or blood loss that 
requires transfusion of 3 or more units of blood. 
 
Coagulopathy: Documented inappropriate coagulation, which leads to the consumption of clotting 
factors, resulting in the failure of the clotting mechanism at the site of bleeding. 
 
Disseminated intravascular coagulation (DIC): Also known as consumptive coagulopathy, which leads 
to the activation of coagulation (blood clotting) mechanisms. This leads to the formation of small blood 
clots inside the blood vessels throughout the body. 
Hematoma: Development of a collection of blood > 5 cm’s under the skin requiring transfusion or 
surgical intervention to resolve. 
Intracranial Hemorrhage: Includes all bleeding within the cranium either subarachnoid, intra- 
parenchymal, or intracerebral. 

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GI Bleed: Detection of frank blood or hemoglobin in the stool which requires medical intervention 
including but not limited to transfusion, medication, surgical intervention, prolongation of hospital stay, 
or re-hospitalization. 
Cardiac Arrest: Cardiac arrest is the sudden, abrupt loss of heart function. Often related to malignant 
arrhythmia.  Results in sudden death unless acutely successfully resuscitated. 
Cardiac Tamponade: The compression of the heart caused by blood or fluid accumulation in the space 
between the myocardium and the pericardium. Cardiac tamponade (also referred to as pericardial 
tamponade or tamponade) is associated with a hemodynamic profile characterized by equalization of 
right and left heart diastolic pressures and/or pulsus paradoxicus (a > 15cm drop in blood pressure 
during inspiration). 
 
Coronary Artery Injury:  Damage to the artery caused during surgery requiring repair. 
 
Cardiac Valve Injury: Damage to any cardiac valve resulting from the index surgical procedure. 
 
Cardiogenic Shock: Patient presents with SBP < 80 mm Hg for more than 30 minutes unresponsive to 
fluids and / or requiring intravenous pressor agent or an intraortic balloon pump (IABP). 
 
Congestive Heart Failure (CHF): A clinical syndrome caused by heart disease, characterized by 
breathlessness and abnormal sodium and water retention, and resulting in edema. This term is used 
when there is congestion of pulmonary or systemic vascular beds. 
 
Death: All cause mortality. Death is not an adverse event, it is an outcome. The Adverse Event is what 
caused the death. Death (within the first 30 days postoperative or >30 days if procedure related). 
 
Sudden Death: Cardiac arrest which is unexpected and occurs within minutes of the onset of symptoms. 
 
Damage to intra-thoracic structures other than the heart (e.g., lungs, trachea, esophagus, 
aorta/arteries, vena cava/veins, etc.): Any evidence of puncture/dissection/perforation or damage to 
any non-cardiac structure within the thoracic cavity requiring intervention. 
Deep Vein Thrombosis (DVT): Unilateral lower extremity swelling, redness, pain with confirmation by 
Doppler tests of obstructed venous flow in that extremity. DVT occurring within 30 days of the surgical 
procedure shall be considered procedure related. 
Diaphragmatic paralysis: May be unilateral or bilateral. May be caused by injury to the phrenic nerve as 
a result of trauma to the thoracic cage. 
Drug Reaction: Adverse event related to a drug reaction to the anesthesia or intercostal blocks (pain 
medications) used during the surgical procedure. 

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Endocarditis: An infection associated with classic signs of endocarditis (positive blood cultures, fever, 
red blood cell casts in urine, splinter hemorrhages in finger nails, roof of mouth, lesions on retina, etc) 
associated with a vegetation inside the atrium or on a valve which may be confirmed on echo 
cardiography. 
Esophageal Fistula: Abnormal passage communicating with the esophagus (for the purposes of this 
protocol- likely resulting from an esophageal rupture). 
Esophageal rupture: Any evidence of puncture/dissection/perforation or damage to the esophagus. 
 
Fever: A temperature > 101°F / 38.5°C  not related to a culture positive infection. 
 
General Discomfort: Physical or psychosocial signs or symptoms commonly associated with 
hospitalization that are investigated and determined to require minor (i.e. aspirin, non-narcotic 
medication) or no, treatment. 
 
Headache: Aching or pain that occurs in one or more areas of the head, face, mouth, or neck. Headache 
can be chronic, recurrent, or occasional. The pain can be mild or severe enough to disrupt daily 
activities. 
 
Hemoptysis: A cough that produces bloody sputum. 
 
Hemolysis: The breakdown of red blood cells. 
 
Heparin-Induced Thrombocytopenia (HIT): A 50% or greater fall in the platelet count from the 
postoperative peak1 which may be confirmed with + antiplatelet antibodies. 
 
Hepatic Failure: A clinical condition that results from severe and extensive damage of liver cells leading 
to failure of the liver to function normally and can induce mental confusion of various degrees. Liver 
failure is described as the combination of hyperbilirubinemia (Total Bilirubin >2), Coagulopathy with INR 
level greater than the upper limits of normal (in the absence of Coumadin treatment) and 
Hypoalbuminemia, with an albumin <3. 
 
Hyperglycemia: The use of insulin in the post op period does not constitute hyperglycemia if during the 
same hospitalization. An Elevated blood sugar of less than 250 during the first 48 hours post op does not 
constitute hyperglycemia. 
 
Hypertension: Systolic BP > 140 mmHg, or diastolic > 90 mmHg requiring specific medical therapy. 
 
 
 
 
1 Warkentin TE, et al. An improved definition of immune heparin-induced thrombocytopenia in postoperative 
orthopedic patients.  Arch Intern Med. 2003 Nov 10;163(20):2518-24. 

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Hypotension: Low blood pressure requiring medical intervention or treatment with medication. 
 
Infection: The following are the categories for infections: 
 
• 
Deep Sternal: Involving muscle, bone, and/or mediastinum. 
• 
Thoracotomy Site: Involving a thoracotomy or parasternal site. 
• 
Lung: Involving airways associated with intubation or other respiratory causes. 
• 
Leg: Involving a leg vein harvest site. 
• 
Chest tube: Involving the chest tube insertion site 
• 
UTI: Involving the urinary tract. 
• 
Pacemaker site: Involving the incision line created for pacemaker placement 
• 
Or Systemic Infection: Bloodstream infection caused by bacteria. 
 
Each type of infection should be classified as either Major or Minor as outlined 
below: 
• 
Infection Major: Life threatening or requiring surgical intervention. 
• 
Infection Minor: Temperature > 101°F / 38.5°C or higher and a positive culture (e.g., tissue, 
urine, etc.). Easily eradicated requiring a brief course of antibiotics. 
 
 
Leukopenia:  Leukopenia is defined as leukocyte count of <3.5 x109/liter for more than 3 days. 
 
Limb ischemia: Limb ischemia is manifested by pain in an extremity at rest, associated with non-healing 
wounds and gangrene. Limb ischemia should be confirmed by diagnostic imaging studies. 
Medication Reaction: An unwanted or harmful side effect experienced following the administration of a 
drug or combination of drugs and is suspected to be related to the drug. 
 
Multi-organ failure: Failure of more than one organ due to shock or sepsis. This requires volume and 
inotropic support and has a high incidence of death. 
Myocardial infarction: Myocardial damage detected either by electrocardiographic changes including ST 
segment elevation, laboratory evaluation (e.g., elevated levels of serum CPK-MB, troponin-I) or cardiac 
imaging studies (echocardiographic images showing reduction in ejection fraction from the pre- 
operative level). 
 
Nausea: The unsettling feeling in the stomach that accompanies the urge to vomit. 
 
Neutropenia:  Neutropenia is defined as ANC <1000 per mm3 for more than 3 days. 
 
Ogilvie Syndrome/Acute Colonic Pseudo-Obstruction (ACPO): Clinical disorder with the signs, symptoms 
and radiographic appearance of an acute large bowel dilatation with no evidence of distal colonic 
obstruction. 

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Pain: An unpleasant sensation occurring in varying degrees of severity as a consequence of injury, disease, 
or emotional disorder. 
Pain (Persistent Chest Pain): Post discharge surgical incisional pain, not angina. 
 
Pericardial Tamponade:  See Cardiac Tamponade. 
 
Pericarditis: Infection of the pericardium which may or may not require re-operation. 
 
Peripheral Edema: The swelling of tissues, usually in the lower limbs, due the accumulation of fluids. 
 
Pleural Effusion: Accumulation of fluid in the pleural space evidenced by x-ray, echocardiography, CT 
Scan or other appropriate diagnostic technique and which requires drainage. 
Pneumothorax: Air in the thoracic cavity associated with partial collapse of a lung with chest tube 
drainage. 
 
Pneumonia: An inflammation of the lungs caused by an infection. This condition must be confirmed by 
radiological evidence, positive sputum culture, or significant improvement of the condition following 
antibiotic treatment. 
Pulmonary edema: Pulmonary edema is present if there is fluid accumulation in the lungs caused by 
backpressure in the lung veins. This condition must be confirmed by radiological evidence or lung water 
measurements. 
Pulmonary embolism: an obstruction of a blood vessel in the lungs, usually due to a blood clot, which 
blocks a pulmonary artery. 
Pulmonary hypertension: Patient has mean pulmonary artery pressure that is greater than 25 mmHg at 
rest and/or greater than 30 mmHg during exercise as measured by right heart catheterization. 
Pulmonary vein stenosis: Defined 70% stenosis of one pulmonary vein or 50% stenosis of more than 
one vessel. PV stenosis is manifest as dyspnea at rest, may be associated with hemoptysis and must be 
confirmed by imaging studies of the pulmonary veins (using CT or MRI). 
Pulmonary vein stenosis, suspected: Any patients exhibiting mild or suspected pulmonary vein stenosis 
(defined as >40% stenosis of one vein or >30% in more than one vein) shall undergo additional imaging 
studies at 12 months or as needed. 
Pseudo-aneurysm: Disruption of the arterial wall characterized by an outpouching or pocket with 
swirling, flowing blood outside of the confines of the arterial lumen. 
Respiratory failure: Need for mechanical ventilation beyond 48 hours of completion of surgical 
procedure(s), or the need for re-intubation and ventilator support occurring at any time within 30 days 
of the surgical procedure, outside the setting of an additional operation. 

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Renal failure: a.) Increase of > 2.0 mg/dl in serum creatinine from any previous value or, b.)  50% 
increase over baseline to a level that is  the upper limit of normal which may require dialysis. . 
Reoperation: A repeat operation for the same condition in the same patient or to resolve an adverse 
event resulting from the initial operation. Reoperation is not an adverse event – it is an outcome – the 
reason for reoperation is the adverse event. 
Restrictive (constrictive) pericarditis: A chronic form of pericarditis in which the pericardium is rigid, 
thickened, scarred, and less elastic than normal. The pericardium cannot stretch as the heart beats, 
which prevents the chambers of the heart from filling. 
 
Retroperitoneal bleeding: Documented collection of blood in the retroperitoneum or by CT/MR. 
 
Sepsis: Positive blood cultures associated with cardiovascular collapse and signs and symptoms of 
multiorgan failure. 
Septicemia: Positive blood cultures. 
 
Seizures: Sudden, uncontrolled muscle spasms with or without loss of consciousness resulting from 
brain electrical activity. 
Sick sinus syndrome: Also called sinus node dysfunction, is a group of abnormal heart rhythms 
(arrhythmia) presumably caused by a malfunction of the sinus node, the heart's primary pacemaker, 
often resulting in the combination of sinus bradycardia alternating with rapid supraventricular rhythms 
such as afib with rapid ventricular response, as tachycardia-bradycardia syndrome 
 
Stroke (permanent disability): A loss of brain function that occurs when the blood supply to any part of 
the brain is interrupted, resulting in tissue death or that which occurs with cerebral hemorrhage with 
clinical sequelae lasting more than 24 hours. Clinical signs/symptoms of neurological deficit as 
determined by standard comprehensive neurological examination, neurological imaging (CT scan or 
MRI) or autopsy. 
May be further categorized as: 
 
• 
Ischemic Stroke: Neurologic deficit attributed to thromboembolic event. 
• 
Hemorrhagic Stroke: Neurologic deficit meeting the study definition for Stroke that is attributed 
to bleeding into brain tissue, epidural, subdural, or subarachnoid space; or a combination of 
these sites. 
 
Thrombocytopenia: A persistent decrease in the number of blood platelets to subnormal levels. 
 
Thromboembolism: Formation of a thrombus (masses composed of insoluble fibrin, deposited platelets, 
accumulating WBCs, and entrapped RBCs) that obstructs vascular blood flow locally and detaches and 
embolizes to occlude blood flow downstream.  Diagnostic confirmation should be made with 
angiography or ultrasound. 

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Thrombus: Blood clot that obstructs a blood vessel. 
 
Transient Ischemic Attack (TIA): A neurological deficit lasting less than 24 hours and if an imaging study 
is performed showing no evidence of infarction. 
Unstable Angina: Angina which increases in frequency, intensity, or duration, which occurs at rest, or 
which is new in onset. Unstable angina is a syndrome that is intermediate between stable angina and 
myocardial infarction: it is characterized by an accelerating or "crescendo" pattern of chest pain that 
lasts longer than stable angina, occurs at rest or with less exertion than stable angina, or is less 
responsive to medication. Unstable angina and myocardial infarction are considered acute coronary 
syndromes. 
Vasovagal Reaction: Reflex stimulation of the vagus nerve causing slowing of the heartbeat, decreased 
blood pressure, lightheadedness or syncope, etc. and requires treatment consisting of any of the 
following: (a) > 1 liter of IV fluids; (b) postural changes; (c) pacing intervention; or (d) administration of 
atropine. 
 
Ventricular tear / perforation / bruise /rupture: Any evidence of puncture/dissection/ perforation or 
damage to the ventricle. The AtriCure Bipolar System is not intended to be used in the ventricle. Care 
should be taken during introduction of the device on the left side of the heart so that the clamps and 
shaft of the device do not come in contact with the ventricle and cause disruption of the ventricular 
tissue. 
 
Wound dehiscence/delayed wound healing:  Not associated with infection.