Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
Phase: NA
Conditions: Persistent Atrial Fibrillation
Sponsor: Acutus Medical

CL-AF-002, Rev. 01 
***CONFIDENTIAL*** 
Page 1 of 51 
 
 
 
 
Utilizing Novel dipole density Capabilities to Objectively 
Visualize the Etiology of Rhythms in Atrial Fibrillation 
(UNCOVER-AF) 
 
Protocol: CL-AF-002, Revision 01 
Date: 10 May 2016 
 
Sponsor: 
Acutus Medical, Inc. 
2210 Faraday Ave, Suite 100 
Carlsbad, CA  92008 
NCT02825992 
 
 
 
CONFIDENTIALITY STATEMENT 
This document contains proprietary information that is privileged or confidential and subject to terms of the Non-
Disclosure Agreement.  No portion of this work may be reproduced in whole or in part without the express 
written permission of Acutus Medical.  Persons to whom the information is disclosed must be informed that this 
and future information is privileged or confidential. 
 
 

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PROTOCOL SIGNATURE PAGE 
CL-AF-002 Rev 1 
 
The signature below constitutes the approval of this Clinical Investigational Plan (CIP) and provides 
assurances that this clinical study will be conducted in accordance with all stipulations of the CIP including 
all statements regarding patient confidentiality. The CIP will be followed according to all national and 
local legal and regulatory requirements. 
 
 
 
 
 
 
Site Investigator Printed Name 
 
 
 
 
 
Site Investigator Signature 
 
Date 
dd-mmm-yyyy 
 
 
 
 
 
 
 

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Revision History 
Revision # 
Date 
Description 
01 
10 May 2016 
Initial release 
 
 
 

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1 CLINICAL STUDY SYNOPSIS 
 
 
STUDY TITLE 
Utilizing Novel dipole density Capabilities to Objectively Visualize 
the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF) 
DEVICE NAME 
AcQMap™ High Resolution Imaging and Mapping System 
DEVICE SHORT 
NAME 
AcQMap™ 
DEVICE 
COMPONENTS 
The AcQMap™ System consists of the following components: 
• 
The AcQMap™ 3D Imaging and Mapping Catheter 
(AcQMap™ Catheter) 
• 
The AcQGuide™ Steerable Delivery Sheath 
• 
The AcQMap™ Console 
• 
The AcQMap™ Workstation 
• 
The AcQMap™ Patient Electrode Kit 
INDICATION FOR USE  
(INTENDED USE) 
The AcQMap™ Imaging and Mapping System is intended for 
imaging and mapping of cardiac chambers, which will be utilized in 
the management of cardiac arrhythmias.  
SPONSOR 
Acutus Medical, Inc. 
2210 Faraday Ave., Suite 100 
Carlsbad, CA  92008 
STUDY OBJECTIVE 
To evaluate the incidence of device- and procedure-related safety, 
efficacy, and efficiency (6 and 12 month outcomes) when using the 
AcQMap™ as an imaging and mapping system for ablation of persistent 
atrial fibrillation (AF). 
STUDY DESIGN 
A prospective, single-arm, multi-center, multi-national, non-
randomized, post-market study designed to provide clinical data 
regarding the use of the AcQMap™ System in the ablation of 
persistent atrial fibrillation.   
Subject assessments will occur at screening, procedure, hospital 
discharge, 1, 3, 6, 9, and 12 months. 
Data may be published at 6 and 12 months 
PRIMARY 
MEASURABLE 
OBJECTIVE 
The primary measurable objective is an analysis of the proportion of 
subjects who are free from device/procedure related Major Adverse 
Events (MAEs) that occur within the first 24 hours post-procedure.  
MAEs include any of the following: 
• Death 
• Cardiac perforation/pericardial tamponade 
• Cerebral infarct, transient ischemic attack (TIA), or systemic 
embolism 

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• Major bleeding  
• Mitral or tricuspid valvular damage 
• Other serious adverse device effects (SADEs) adjudicated by 
an independent Clinical Events Committee (CEC) as 
“probably related” to the AcQMap 
SECONDARY 
MEASURABLE 
OBJECTIVES 
 
Secondary measurable objectives include the following: 
Safety Outcomes Measure 
• 
Recording and analysis of all identified adverse events (AEs) 
and adverse device effects (ADEs) through 12 months post-
procedure. Events will be adjudicated by an independent 
Clinical Events Committee (CEC) for severity and 
relationship to the AcQMap 
Procedural Outcome Measures 
• 
Analysis of the proportion of subjects with acute procedural 
(ablation) success defined as: 
- Conversion to sinus rhythm (with or without DC 
cardioversion) within 12 hours of the ablation procedure 
- Procedural conversion to atrial flutter, atrial tachycardia or 
other organized supraventricular rhythm 
Clinical Outcome Measures 
• 
Analysis at 3, 6, 9, and 12 months post ablation (with a 24 
hour continuous ECG monitor) of the proportion of subjects 
with freedom from documented episodes of AF lasting 
longer than 30 seconds.  Analysis will include: 
- 
Freedom from AF/AT/AFL without anti-arrhythmic 
drugs (AADs) 
- 
Freedom from AF/AT/AFL with AADs 
- 
Freedom from AF/AT/AFL with a single procedure 
- 
Freedom from AF/AT/AFL with multiple procedures 
SAMPLE SIZE 
Up to 125 subjects will be enrolled.  
Up to 15 clinical sites in Europe. 
STUDY CENTER AND 
LOCATION 
TBD 
PATIENT 
POPULATION 
The patient population will consist of men and women between the 
ages of 18 – 80 years of age scheduled for an endocardial ablation of 
persistent atrial fibrillation (AF). 
A potential study patient will be eligible for study enrollment only if 
all of the following inclusion and none of the exclusion criteria apply: 
Inclusion Criteria 
IC 1 
Male or female between the ages of 18 and 80 years  
IC 2 
Currently scheduled for an ablation of persistent atrial 
fibrillation defined as AF lasting at least 7 days but no more 

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than 12 months without electrical cardioversion 
IC 3 
Willingness, ability and commitment to participate in 
baseline and follow-up evaluations for the full length of the 
study  
IC 4 
Willing and able to give informed consent 
Exclusion Criteria 
EC 1 
In the opinion of the Investigator, any known 
contraindication to an AF ablation, TEE, or anticoagulation 
EC 2 
Any duration of continuous AF lasting longer than 12 
months 
EC 3 
History of previous left atrial ablation or surgical treatment 
for AF/AFL/AT  
EC 4 
Atrial fibrillation secondary to electrolyte imbalance, 
thyroid disease, or any other reversible or non-cardiac cause 
EC 5 
Structural heart disease as described below: 
a. Left ventricular ejection fraction (LVEF) < 40% based 
on TTE within 6 months of enrollment 
b. Left atrial size > 50 mm based on TTE within 6 
months of enrollment 
c. An implanted pacemaker or ICD 
d. Previous cardiac surgery, ventriculotomy, or atriotomy 
(excluding atriotomy for CABG (see EC 5, j)), 
e. Previous cardiac valvular surgical or percutaneous 
procedure, or prosthetic valve 
f. Interatrial baffle, closure device, patch, or PFO 
occluder 
g. Presence of a left atrial appendage occlusion device 
h. Coronary artery bypass graft (CABG) or PTCA 
procedure within the last 6 months 
i. Unstable angina or ongoing myocardial ischemia 
j. Myocardial infarction within the previous six (6) 
months 
EC 6 
History of blood clotting or bleeding disease 
EC 7 
ANY prior history of documented cerebral infarct, TIA or 
systemic embolism 
EC 8 
Pregnant or lactating (current or anticipated during study 
follow up) 
EC 9 
Current enrollment in any other study protocol where 
testing or results from that study may interfere with the 
procedure or outcome measurements for this study 
EC 10 Any other condition that, in the judgment of the 
investigator, makes the patient a poor candidate for this 
procedure, the study or compliance with the protocol 
(includes vulnerable patient population, mental illness, 
addictive disease, terminal illness with a life expectancy of 

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less than two years, extensive travel away from the research 
center) 
STUDY DURATION 
Enrollment is anticipated to take approximately six (6) to eight (8) 
months.  Post-procedure follow up will occur at hospital discharge, 
1, 3, 6, and 12 months.  The total study duration is anticipated to be 
approximately 18 months.     
STATISTICAL 
METHODS AND 
ANALYSIS SUMMARY 
The primary outcome measure for the study is the primary safety 
objective, defined as the proportion of subjects who are free from 
device/procedure related Major Adverse Events (MAEs) that occur 
within the first 24 hours post-procedure.  Subjects who remain free 
from such device/procedure related MAEs will be considered a 
success with respect to the primary safety objective, and subjects 
who experience at least one such MAE will be considered a 
primary safety failure.  
The analysis of the primary safety objective will be performed on 
the treatment population, which will include all enrolled subjects 
who complete a procedure up to the point the AcQMap catheter is 
deployed in the left atrium.  The number and proportion of 
subjects in the treatment population who are primary safety 
successes will be computed, along with a 95% exact binomial (i.e., 
Clopper-Pearson) confidence interval on the proportion.  
Descriptive statistics will be applied to all other outcome measures.  
FOLLOW-UP 
EVALUATIONS 
See Table Below 
 

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Table 1:  Schedule of Events 
 
Screening1 
& 
Baseline 
Procedure 
Discharge 
7 Days 
(± 3 days) 
Phone 
Contact 
1-month 
(± 7 days) 
3-month 
 (± 14 days) 
6-month 
 (± 30 days) 
9-month 
(± 30 days) 
12-month 
 (± 30 days) 
CIP Informed 
Consent 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
History & 
Physical Exam 
X 
X 
X 
 
X 
X 
X 
 
X 
Medications 
X 
X 
X 
 
X 
X 
X 
 
X 
Transthoracic 
Echo (TTE) 
X 
(within 6 
months) 
 
 
 
 
 
 
 
X 
Trans 
Esophageal Echo 
(TEE) 
 
X 
(within 72 
hours) 
 
 
 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
 
X 
12-lead ECG 
X 
X 
X 
 
X 
X 
X 
 
X 
Labs 
X 
 
 
 
 
 
 
 
 
HCG 
(female patients) 
X 
 
 
 
 
 
 
 
 
Patient Reported 
Outcome 
Measures 
(AFEQT) 
X 
 
 
 
X 
X 
X 
 
X 
24-hour 
Continuous 
ECG Monitor 
Recording 
 
 
 
 
 
 
X 
X 
X 

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2 TABLE OF CONTENTS 
 
1 
Clinical Study Synopsis ...................................................................................................4 
2 
Table of Contents .............................................................................................................9 
3 
Contact Information .......................................................................................................13 
3.1 
Name and Address of Sponsor ...................................................................................... 13 
4 
Abbreviations .................................................................................................................14 
5 
Introduction to the Clinical Investigational Plan ...........................................................16 
5.1 
Background ................................................................................................................... 16 
5.2 
Clinical Study Design Justification ............................................................................... 18 
5.2.1 
Patient Reported Outcomes (AFEQT) .................................................................... 19 
5.3 
Indication for Use Statement ........................................................................................ 20 
5.4 
Device Description........................................................................................................ 20 
5.4.1 
General System Description ................................................................................... 20 
5.4.2 
AcQMap System Hardware .................................................................................... 20 
5.4.3 
The AcQMap 3D Imaging and Mapping Catheter ................................................. 20 
5.4.4 
AcQGuide Steerable Sheath ................................................................................... 20 
6 
Clinical Study.................................................................................................................21 
6.1 
Clinical Study Objective ............................................................................................... 21 
6.2 
Clinical Study Design ................................................................................................... 21 
6.2.1 
Primary Measurable Objective ............................................................................... 21 
6.2.2 
Secondary Measurable Objectives .......................................................................... 21 
6.3 
Clinical Study Duration ................................................................................................ 22 
6.4 
Clinical Study Sample Size and Clinical Sites ............................................................. 22 
6.5 
Clinical Study Enrollment Definitions.......................................................................... 22 
6.6 
Clinical Study Population ............................................................................................. 23 
6.6.1 
Inclusion Criteria .................................................................................................... 23 
6.6.2 
Exclusion Criteria ................................................................................................... 23 
6.7 
Subject Withdrawal ....................................................................................................... 24 

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7 
Clinical Study Treatments and Follow-up Visits ...........................................................25 
7.1 
Informed Consent.......................................................................................................... 25 
7.2 
Patient Screening and Baseline ..................................................................................... 25 
7.3 
Ablation Procedure ....................................................................................................... 26 
7.3.1 
Mapping and Ablation ............................................................................................ 26 
7.3.2 
Procedure Data Collection ...................................................................................... 27 
7.4 
Follow-Up Procedures .................................................................................................. 27 
7.4.1 
Hospital Discharge .................................................................................................. 27 
7.4.2 
Seven Day Phone Follow-Up.................................................................................. 28 
7.4.3 
Visits at One, Three, Six, and Twelve Months ....................................................... 28 
7.4.4 
Unscheduled Visits ................................................................................................. 28 
7.5 
Recurrence of Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia (AF/AFL/AT) ..... 28 
8 
Statistical Methods .........................................................................................................33 
8.1 
Analysis Population ...................................................................................................... 33 
8.2 
Statistical Analysis for Primary Safety Outcome Measure........................................... 33 
8.3 
Statistical Analysis for Secondary Outcome Measures ................................................ 33 
8.4 
Study Size Justification ................................................................................................. 33 
9 
Adverse Events ..............................................................................................................33 
9.1 
Adverse Event Reporting .............................................................................................. 35 
9.2 
Event Relationship to the Device .................................................................................. 35 
9.3 
Death Notice ................................................................................................................. 36 
9.4 
Device Complaint and Malfunction .............................................................................. 37 
9.5 
Clinical Events Committee (CEC) ................................................................................ 37 
10 
Risk: Benefit Analysis ...................................................................................................37 
10.1 
Risks .............................................................................................................................. 37 
10.2 
Mitigation of Risks ....................................................................................................... 38 
11 
Data Quality Assurance .................................................................................................38 
11.1 
Data Management ......................................................................................................... 38 
11.2 
Subject Identification .................................................................................................... 39 

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11.3 
Screen Failure Subjects ................................................................................................. 39 
11.4 
Subject Study Completion and Withdrawal .................................................................. 39 
11.5 
Subjects Lost-to-Follow-Up.......................................................................................... 39 
11.6 
Confidentiality of Data ................................................................................................. 39 
11.7 
Source Documents ........................................................................................................ 40 
11.8 
Electronic Case Report Forms (eCRFs) ........................................................................ 41 
11.9 
Records Retention ......................................................................................................... 41 
11.10 
Clinical Monitor ......................................................................................................... 41 
11.11 
Clinical Data Monitoring Procedures ......................................................................... 42 
11.12 
Investigator Responsibilities....................................................................................... 42 
11.13 
Deviations from the Clinical Investigational Plan ...................................................... 43 
11.13.1 
Maintaining Records ........................................................................................... 43 
11.13.2 
Submitting Reports .............................................................................................. 44 
11.14 
Acutus Medical Responsibilities ................................................................................ 45 
11.14.1 
General Duties ..................................................................................................... 45 
11.14.2 
Selection of Investigators .................................................................................... 45 
11.15 
Training ...................................................................................................................... 46 
11.15.1 
Changes in the Clinical Investigational Plan....................................................... 46 
11.15.2 
Withdrawal of Regulatory Approval ................................................................... 47 
12 
Ethics and Regulatory Compliance ................................................................................47 
12.1 
Conduct of the Clinical Study ....................................................................................... 47 
12.2 
Ethics Committee Approval .......................................................................................... 47 
12.3 
Clinical Study Informed Consent Approval ................................................................. 47 
12.4 
Identification and Confidentiality ................................................................................. 48 
12.5 
Site Qualification Visits ................................................................................................ 48 
12.6 
Site Initiation Visits ...................................................................................................... 48 
12.7 
Insurance ....................................................................................................................... 49 
12.8 
Site Audit Plan .............................................................................................................. 49 
12.8.1 Site Data Audits by Acutus Medical ....................................................................... 49 

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12.8.2 External Audits ....................................................................................................... 49 
12.9 
Investigational Device Traceability .............................................................................. 49 
12.10 
Public Domain Access to the Clinical Study .............................................................. 50 
12.11 
Required Reports ........................................................................................................ 50 
13 
General Considerations ..................................................................................................50 
13.1 
Discontinuation of the Clinical Study ........................................................................... 50 
13.2 
Use of Information and Publications ............................................................................ 50 
14 
Appendix ........................................................................................................................51 
14.1 
Bibliography ................................................................................................................. 51 
  
 
 
 

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3 CONTACT INFORMATION 
3.1 
Name and Address of Sponsor 
Acutus Medical, Inc. 
2210 Faraday Ave., Suite 100 
Carlsbad, CA  92008 
 
 

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4 ABBREVIATIONS  
3D 
Three Dimensional 
AAD 
Anti-Arrhythmic Drug 
ACT 
Activated Clotting Time 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
AFEQT 
Atrial Fibrillation Effect on Quality of Life 
AFL 
Atrial Flutter 
AT 
Atrial Tachycardia 
CABG 
Coronary Artery Bypass Grafting 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigational Plan 
CMP 
Clinical Monitoring Plan 
CPM 
Clinical Project Manager 
CRA 
Clinical (or Contract) Research Associate 
CRO 
Contract Research Organization 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
DCCV 
Direct Current Cardioversion 
DCF 
Data Clarification Form 
DMP 
Data Management Plan 
EC 
Ethics Committee 
EU 
European Union 
eCRF 
Electronic Case Report Form 
ECG 
Electrocardiogram 
EGM 
Electrogram 
EMR 
Electronic Medical Record 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IA 
Investigator Agreement 
ICD 
Implantable Cardioverter Defibrillator 
IFU 
Instructions For Use 
IM 
Investigator Meeting 
IMV 
Interim Monitoring Visit 
ISF 
Investigator Site Files 
ISO 
International Organization for Standardization 

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LA 
Left Atrium 
LFU 
Lost to Follow-Up 
LVEF 
Left Ventricular Ejection Fraction 
MAE 
Major Adverse Event 
PAF 
Paroxysmal Atrial Fibrillation 
PFO 
Patent Foramen Ovale 
PI 
Principal Investigator 
PROs 
Patient Recorded Outcomes 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
PV 
Pulmonary Vein 
PVI 
Pulmonary Vein Isolation 
QAP 
Quality Assurance Procedure 
RMV 
Routine Monitoring Visit 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SD 
Standard Deviation 
SIV 
Site Initiation Visit 
SQV 
Site Qualification Visit 
SOP 
Standard Operating Procedure 
SVT 
Supraventricular Tachycardia 
TEE 
Transesophageal Echocardiogram 
TIA 
Transient Ischemic Attack 
TMF 
Trial Master File 
TS 
Trans-septal Puncture 
TTE 
Transthoracic Echocardiogram 
UADE 
Unanticipated Adverse Device Effect 
USFDA 
United States Food and Drug Administration 
WACA 
Wide Area Circumferential Ablation 
 
 
 

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5 INTRODUCTION TO THE CLINICAL INVESTIGATIONAL PLAN 
5.1 
Background 
Atrial fibrillation (AF) is among the most prevalent arrhythmias in the world today affecting 
approximately 1.5-2% of the general population.  The age of patients with AF is steadily rising 
and now averages between 75 and 85 years of age. AF is associated with a five-fold risk of 
stroke, a three-fold incidence of congestive heart failure, and higher mortality.1 
Symptoms arise from the rapid, irregular rhythm as well as the loss of cardiac pump function 
related to uncoordinated atrial contractions.  These uncoordinated contractions also allow 
blood to pool in the atria and may ultimately lead to thromboembolism and stroke. 
AF is characterized by a chaotic contraction of the atrium in which an electrocardiogram 
(ECG) recording is necessary to diagnose the arrhythmia. Any arrhythmia that has the ECG 
characteristics of AF and lasts sufficiently long for a 12-lead ECG to be recorded, or at least 
30 seconds on a rhythm strip, should be considered an AF episode.2,3 
The diagnosis requires an ECG or rhythm strip demonstrating: (1) Irregular RR intervals (in 
the absence of complete AV block), (2) no distinct P waves on the surface ECG, and (3) an 
atrial cycle length (when visible) that is usually variable and less than 200 milliseconds.3 
AF can be characterized into four classifications: 
• Paroxysmal AF (PAF) is defined as recurrent AF (≥two episodes) that 
terminates spontaneously within seven days.  
• Persistent AF is defined as recurrent AF that is sustained for seven days.  In 
addition, patients with continuous AF who undergo cardioversion within 
seven days should be classified as having paroxysmal AF if the cardioversion 
is performed within 48 hours of AF onset, and persistent AF if the 
cardioversion is performed more than 48 hours after AF onset.  
 
1  Camm AJ, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update 
of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the 
European Heart Rhythm Association. Europace, 2012 Oct; 14(10):1385-413 
2  Calkins H, Brugada J, Packer DL et al. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical 
ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the 
Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. Jun 
2007;4(6):816–861 
3 Camm AJ, Kirchhof P, Lip GY et al. Guidelines for the management of atrial fibrillation: the Task Force for the 
Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. Oct 
2010;31(19):2369–2429 
 

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• Long-standing persistent AF is defined as continuous AF of greater than one 
year’s duration.  
• Permanent AF is defined as AF in which the presence of the AF is accepted 
by the patient (and physician). Within the context of any rhythm control 
strategy, including catheter ablation, the term permanent AF is not 
meaningful. The term permanent AF represents a joint decision by the patient 
and a physician to cease further attempts to restore and/or maintain sinus 
rhythm at a particular point in time.3 
For many years, three major schools of thought competed to explain the mechanism(s) of AF: 
multiple random propagating wavelets, focal electrical discharges, and localized reentrant 
activity with fibrillatory conduction.4,5,6,7,8  Significant progress has been made in defining 
the mechanisms of initiation and perpetuation of AF.  One of the most important 
breakthroughs was the recognition that, in a subset of patients, AF was triggered by a rapidly 
firing focus and could be “cured” with a localized catheter ablation procedure.9,10  This 
landmark observation caused the EP community to refocus its attention on the pulmonary 
veins (PVs) and the posterior wall of the left atrium (LA), as well as the autonomic innervation 
in that region. It also reinforced the concept that the development of AF requires a “trigger” 
and an anatomic or functional substrate capable of both initiation and perpetuation of AF. 
Sustained high rates in the atrium and/or the presence of heart disease are associated with 
structural and electrophysiological remodeling of the atria and can alter the substrate even 
further and help to perpetuate AF.11  Atrial Fibrillation can also be the result of preexisting 
atrial disease. Although much has been learned about the mechanisms of AF, they are not 
 
4 Jalife J, Berenfeld O, Mansour M. Mother rotors and fibrillatory conduction: a mechanism of atrial fibrillation. 
Cardiovasc Res. May 2002;54(2):204–216. 
5 Nattel S. New ideas about atrial fibrillation 50 years on. Nature. Jan 10 2002; 415(6868):219–226. 
6 Dobrev D, Voigt N,Wehrens XH. The ryanodine receptor channel as a molecular motif in atrial fibrillation: 
pathophysiological and therapeutic implications. Cardiovasc Res. Mar 1 2011;89(4):734–743. 
7 Schotten U, Verheule S, Kirchhof P, Goette A. Pathophysiological mechanisms of atrial fibrillation: a translational 
appraisal. Physiol Rev. Jan 2011;91(1):265–325. 
8 Wakili R, Voigt N, Kaab S, Dobrev D, Nattel S. Recent advances in the molecular pathophysiology of atrial 
fibrillation. J Clinical Invest. Aug 1 2011;121(8):2955–2968 
9 Jais P, Haissaguerre M, Shah DC et al. A focal source of atrial fibrillation treated by discrete radiofrequency 
ablation. Circulation. Feb 4 1997;95(3):572–576. 
10 Haissaguerre M, Jais P, Shah DC et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in 
the pulmonary veins. N Engl J Med. Sep 3 1998; 339(10):659–666. 
11 Everett TH 4th, Wilson EE, Verheule S, Guerra JM, Foreman S, Olgin JE. Structural atrial remodeling alters the 
substrate and spatiotemporal organization of atrial fibrillation: a comparison in canine models of structural and 
electrical atrial remodeling. Am J Physiol Heart Circ Physiol. Dec 2006;291(6):H2911–2923 

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completely understood. Because of this, in the great majority of AF patients, it is not yet 
possible to precisely tailor an ablation strategy to a particular AF mechanism. 
3D Mapping 
Three-dimensional (3D) electroanatomical contact and noncontact mapping systems have 
been reported to facilitate ablation of AF by identifying anatomical structures and highlighting 
the location of ablated sites.  This can guide the initial ablation and help identify existing gaps 
in an incomplete lesion set.12  Additionally, electromagnetic navigation systems have been 
shown to substantially reduce the fluoroscopy time required for AF ablation.13,14,15 
The AcQMap System 
The AcQMap™ High Resolution Imaging and Mapping System (AcQMap System) has been 
designed to provide information on cardiac dipole densities as a function of time and project 
that information on an image of a cardiac chamber.  In this study, the AcQMap System will 
collect data from the AcQMap 3D Imaging and Mapping Catheter (AcQMap Catheter) to 
create anatomical reconstructions of the chamber(s) being mapped and to create Dipole 
Density maps on those reconstructions.  These maps will then be used to identify mechanisms 
of atrial fibrillation, which can be targeted for ablation. 
5.2 
Clinical Study Design Justification 
Previous clinical studies utilizing the AcQMap System in an ablation procedure for SVTs 
have initially demonstrated an acceptable safety profile when mapping and imaging cardiac 
chambers.  The UNCOVER-AF study is a multi-center, multi-national, non-randomized, post-
market study designed to provide clinical data regarding the use of the AcQMap™ System in 
the ablation of persistent atrial fibrillation.  The study objective is to evaluate the safety, 
efficacy and efficiency of using the AcQMap catheter exclusively in the atrial chambers 
during the ablation of persistent AF.  Recording of all Serious Adverse Events/Device Effects 
occurring during the first twenty-four (24) hours post-procedure will be used to assess the 
safety related to the AcQMap Catheter.  An independent Clinical Events Committee (CEC) 
 
12 Hindricks G, Willems S, Kautzner J, De Chillou C, Wiedemann M, Schepel S, Piorkowski C, Risius T, Kottkamp 
H; EuroFlutter Investigators. Effect of electroanatomically guided versus conventional catheter ablation of typical 
atrial flutter on the fluoroscopy time and resource use: a prospective randomized. J Cardiovasc Electrophysiol. 2009 
Jul;20(7):734-40.  
13 Sporton SC, Earley MJ, Nathan AW, Schilling RJ. Electroanatomic versus fluoroscopic mapping for catheter 
ablation procedures: a prospective randomized study. J Cardiovasc Electrophysiol. 2004 Mar;15(3):310-5.  
14 Kottkamp H, Hügl B, Krauss B, Wetzel U, Fleck A, Schuler G, Hindricks G. Electromagnetic versus fluoroscopic 
mapping of the inferior isthmus for ablation of typical atrial flutter: A prospective randomized study. Circulation. 
2000 Oct 24;102(17):2082-6.  
15 Smeets JL, Ben-Haim SA, Rodriguez LM, Timmermans C, Wellens HJ. New method for nonfluoroscopic 
endocardial mapping in humans: accuracy assessment and first clinical results. Circulation. 1998 Jun 
23;97(24):2426-32.  

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will adjudicate all reported events for relationship to the device/procedure.  A composite list 
of anticipated Serious Adverse Device Effects (SADEs) and Unanticipated Serious Adverse 
Device Effects (USADEs) are considered Major Adverse Events and will be used in a 
statistical analysis for the primary outcome measure.  All safety events reported throughout 
the follow-up period will also be evaluated for device relationship and utilized in developing 
a complete risk assessment. 
Since it is hypothesized the technology advances of dipole density mapping may better 
identify and more precisely direct lesion locations during AF ablation, the study is additionally 
designed to record longer term (six- and twelve-month) data on the effectiveness of the 
ablation procedure in the treatment of the arrhythmia.  An analysis of treatment success 
(defined as freedom from atrial fibrillation at 6 and 12 months), compared to literature based 
historical controls, may offer insight regarding the ability of the AcQMap System to 
effectively and accurately identify appropriate ablation targets.  However, since ablation 
techniques and catheter choices are not controlled during the study, clinical outcomes will not 
be used to imply the effective creation of lesion sets in the left atrium substrate.   
Automatic, instantaneous, and simultaneous 3D display of the left atrial surface with 
associated charge densities may potentially shorten AF ablation procedure time and provide 
an intuitive tool to rapidly identify and guide effective treatment.  To further assess these 
potential benefits of the AcQMap System during the study procedures, data will be collected 
for many other procedural and clinical outcomes. 
Data from this study will be combined with a nearly identical pre-market clinical study 
conducted in Canada and Australia.  Data are considered suitable for pooling based on 
identical patient inclusion and exclusion criteria, procedures, and measurement methods for 
outcomes data.  The patients in the general population of the countries conducting the study 
have similar demographics.  Analysis of primary safety data will be adjudicated by a common, 
independent CEC.  The pooled data will be utilized to statistically assess the safety and 
performance of the device when used in the ablation treatment of persistent AF. 
5.2.1 
Patient Reported Outcomes (AFEQT) 
The clinical study is designed to include reported changes in a patient’s quality of life 
following an ablation for atrial fibrillation.  The Atrial Fibrillation Effect on Quality of Life 
(AFEQT) Questionnaire is a “validated, comprehensive, disease-specific measure to quantify 
the impact of AF and its treatment on a full spectrum of a patient’s health”.16   By evaluating 
a subject’s perception of their symptoms and functional impairment at pre-procedure and all 
 
16 Spertus, J.,Dorian, P., Bubien, R., et al.  Development and validation of the Atrial Fibrillation Effect on Quality 
of Life (AFEQT) Questionnaire in Patients with Atrial Fibrillation.  Circ Arrhythm Electrophysiol. 2011;4:15-
25. 

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follow-up visits, the test will measure the impact of rhythm management on their health and 
wellbeing. 
5.3 
 Indication for Use Statement 
The AcQMap™ Imaging and Mapping System is intended for imaging and mapping of 
cardiac chambers, which will be utilized in the management of cardiac arrhythmias. 
5.4 
Device Description 
5.4.1 
General System Description 
The AcQMap™ System is designed to create a 3D image of a heart chamber’s endocardial 
surface in which catheters can be navigated and a chamber-wide electrical activation map 
can be overlaid for percutaneous procedures.  The AcQMap™ System should only be used 
by physicians thoroughly trained in electrophysiology procedures and trained on the use of 
the AcQMap™ System 
5.4.2 AcQMap System Hardware 
The AcQMap™ System hardware consists of the AcQMap™ Console, AcQMap™ 
Workstation and the AcQMap AIU/PIU.  The AcQMap Console contains all electronics for 
interfacing with patient-contacting devices such as the AcQMap™ Catheter and the Patient 
Electrode Kit.   
 
5.4.3 The AcQMap 3D Imaging and Mapping Catheter  
The AcQMap 3D Imaging and Mapping Catheter is a diagnostic, sterile, single-use device 
that has a polymeric catheter torque shaft, an integral handle and a flexible, metallic 
deployable/retractable array.   
 
5.4.4 
AcQGuide Steerable Sheath 
The AcQGuide Steerable Sheath is a single-use, sterile, delivery sheath consisting of a 
deflectable shaft with a lumen, integral handle with steering mechanism, hemostasis valve and 
flush port. The sheath is compatible with other Acutus Medical catheter products.  The sheath 
can be placed within the desired heart chamber thus allowing the AcQMap Catheter to be 
introduced, deployed and directed within the chamber as needed. 
 
 
  
 
 
 

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6 CLINICAL STUDY  
6.1 
Clinical Study Objective 
The objective of the clinical study is to evaluate the incidence of device- and procedure-related 
safety, efficacy, and efficiency (6- and 12-month outcomes) when using the AcQMap as an 
imaging and mapping system for ablation of persistent atrial fibrillation (AF). 
6.2 
Clinical Study Design 
The clinical study is a prospective, single-arm, multi-center, multi-national, non-randomized, 
post-market study designed to provide clinical data regarding the use of the AcQMap System 
during an ablation of persistent atrial fibrillation.  In parallel with this clinical study, a second 
study, identical in design, inclusion/exclusion criteria and reportable outcomes, will be 
conducted in geographical locations where regulatory approval has not been obtained.  The 
data from these collaborative studies will be pooled for analysis and eventual publication on 
the use of the AcQMap System for mapping and imaging during ablation of persistent AF. 
6.2.1 
Primary Measurable Objective 
The primary measurable objective is an analysis of the proportion of subjects who are free 
from device/procedure related Major Adverse Events (MAEs) that occur within the first 24 
hours post-procedure.  MAEs include any of the following: 
• Death 
• Cardiac perforation/tamponade 
• Cerebral infarct, transient ischemic attack (TIA), or systemic embolism 
• Major bleeding  
• Mitral or tricuspid valvular damage 
• Other serious adverse device effects (SADEs) adjudicated by an independent 
Clinical Events Committee (CEC) as “probably related” to the AcQMap 
System 
6.2.2 
Secondary Measurable Objectives 
Secondary measurable objectives include the following: 
Safety Outcome Measure 
• Recording and analysis of all identified adverse events (AEs) and adverse 
device effects (ADEs) through 12 months post-procedure.  Events will be 
adjudicated by an independent Clinical Events Committee (CEC) for severity 
and relationship to the AcQMap 
 

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Procedure Outcome Measure 
• Analysis of the proportion of subjects with acute procedural (ablation) success 
defined as: 
- 
Conversion to sinus rhythm (with or without DCCV) within 12 
hours of the procedure 
- 
Procedural conversion to atrial flutter, atrial tachycardia or other 
organized supraventricular rhythm 
Clinical Outcome Measures 
• Analysis at 3, 6, 9, and 12 months post ablation (with a 24 hour continuous 
ECG monitor) of the proportion of subjects with freedom from documented 
episodes of AF lasting longer than 30 seconds.  Analysis will include: 
- 
Freedom from AF/AT/AFL without AADs 
- 
Freedom from AF/AT/AFL with AADs 
- 
Freedom from AF/AT/AFL with a single procedure 
- 
Freedom from AF/AT/AFL with multiple procedures 
6.3 
Clinical Study Duration 
Enrollment is anticipated to take approximately six (6) to eight (8) months.  Post-procedure 
follow up will occur at hospital discharge, 1, 3, 6, and 12 months.  The total study duration is 
anticipated to be approximately 18 months.     
6.4 
Clinical Study Sample Size and Clinical Sites 
Up to one hundred and twenty-five (125) patients will be enrolled at up to fifteen (15) clinical 
sites in Europe.  No site may enroll more than 25 patients (20% of the study population).   
6.5 
Clinical Study Enrollment Definitions 
For the purposes of this clinical study, the following definitions regarding the status of a 
subject will apply: 
Screen Failure Subject – Any subject who has not met all of the inclusion and exclusion 
criteria.  This includes a subject who may be excluded based on the results of the pre-
procedure TEE.  Screen failure subjects should have the screening eCRF completed and the 
screening data entered in the database. 
Enrolled Subject – Any subject who has signed an informed consent form and is deemed study 
eligible by meeting all of the inclusion and exclusion criteria. 

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Pre-treatment Subject – Any enrolled subject who has the venous access portion of the 
ablation procedure initiated.  Pre-treatment patients that do not complete the AcQMap 
procedure will be followed for adverse events through hospital discharge.  In addition to the 
discharge eCRF, a study completion eCRF will be completed.  No follow-up beyond the 
hospital discharge will be required.   
Treatment Subject – Any pre-treatment subject who completes the ablation procedure to the 
point the AcQMap catheter and AcQGuide sheath has been deployed in the left atrium.  
Treatment subjects will be followed for all study outcome measures for the full duration of 
the clinical study.  The number of treatment subjects will be used for the study sample. 
6.6 
Clinical Study Population 
The patient population will consist of men and women between the ages of 18 – 80 years of 
age scheduled for an endocardial ablation of persistent atrial fibrillation (AF). 
A potential study subject will be eligible for study enrollment only if all of the following 
inclusion and none of the exclusion criteria apply: 
6.6.1 
Inclusion Criteria 
IC 1 
Male or female between the ages of 18 and 80 years of age 
IC 2 
Currently scheduled for an ablation of persistent atrial fibrillation 
defined as AF lasting at least 7 days but no more than 12 months 
without electrical or chemical cardioversion 
IC 3 
Willingness, ability and commitment to participate in baseline and 
follow-up evaluations for the full length of the study  
IC 4 
Willing and able to give informed consent 
6.6.2 
Exclusion Criteria 
EC 1 
In the opinion of the Investigator, any known contraindications to an AF 
ablation, TEE, or anticoagulation 
EC 2 
Any duration of continuous AF lasting longer than 12 months 
EC 3 
History of previous left atrial ablation or surgical treatment for 
AF/AFL/AT  
EC 4 
Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or 
any other reversible or non-cardiac cause 
EC 5 
Structural heart disease as described below: 
a. Left ventricular ejection fraction (LVEF) < 40% based on TTE 
within 6 months of enrollment 

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b. Left atrial size > 50 mm based on TTE within 6 months of 
enrollment 
c. An implanted pacemaker or ICD   
d. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding 
atriotomy for CABG (see EC 5, j)), 
e. Previous cardiac valvular surgical or percutaneous procedure, or 
prosthetic valve 
f. Interatrial baffle, closure device, patch, or PFO occluder 
g. Presence of a left atrial appendage occlusion device 
h. Coronary artery bypass graft (CABG) or PTCA procedure within 
the last 6 months 
i. Unstable angina or ongoing myocardial ischemia 
j. Myocardial infarction within the previous six (6) months 
EC 6 
History of blood clotting or bleeding disease 
EC 7 
ANY prior history of documented cerebral infarct, TIA or systemic 
embolism 
EC 8 
Pregnant or lactating (current or anticipated during study follow up) 
EC 9 
Current enrollment in any other study protocol in which testing or results 
from that study may interfere with the procedure or outcome 
measurements for this study 
EC 10 Any other condition that, in the judgment of the investigator, makes the 
patient a poor candidate for this procedure, the study or compliance with 
the protocol (includes vulnerable patient population, mental illness, 
addictive disease, terminal illness with a life expectancy of less than two 
years, or extensive travel away from the research center) 
6.7 
Subject Withdrawal 
Individual subjects may withdraw their consent to participate in the study at any time.  Also, 
an Investigator may discontinue a subject’s participation in the study at any time to protect 
the safety, rights, or welfare of the subjects.   
Subjects missing follow-up visits will not be considered lost to follow-up until adequate 
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7 CLINICAL STUDY TREATMENTS AND FOLLOW-UP VISITS 
7.1 
Informed Consent 
It is the responsibility of the Investigator to give each subject full and adequate verbal and 
written information regarding all aspects of the study procedure, device, and associated risks.  
A signed, informed consent must be obtained from the subject before any study procedures 
not considered standard of care for an AF ablation are undertaken.  The informed consent 
form must be signed by the subject and witnessed by the Investigator (or designee).  The 
original signed consent is filed in the patient’s study records with one copy placed in the 
patient’s medical notes and one copy provided to the patient. 
7.2 
Patient Screening and Baseline  
The following information must be acquired to verify eligibility in the clinical study: 
• Subject demographics 
• Medical history review including: 
- 
All history of AF and other arrhythmias, including onset, duration, 
previous testing, etc.   
- 
Prior and current AAD treatments for AF 
- 
Medication history including AADs, pertinent cardiovascular 
drugs, and anticoagulation 
- 
DCCV history 
- 
Information supportive of determining a CHADS2 and CHA2DS2-
VASc scores 
• Review of all inclusion/exclusion criteria to confirm patient eligibility 
• Physical exam 
• Transthoracic echocardiogram (TTE) within the previous six (6) months to 
document: 
- 
Left atrial size 
- 
Left ventricular ejection fraction 
- 
Severity of any valvular heart disease 
• Pregnancy test (if applicable) 
• Routine standard of care laboratory and X-ray tests for pre-ablation work-up 
• ECG or continuous ECG monitor tracing/report documenting AF 

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• Completion of a Patient Reported Outcome (AFQET) 
7.3 
Ablation Procedure 
7.3.1 
Mapping and Ablation 
The objective of this clinical study is to evaluate the safety and performance of the AcQMap 
System when mapping and imaging the left and right atria during persistent AF ablation.  
Therefore, the utilization of devices for 3D anatomic reconstruction, navigation and electrical 
mapping should be limited to the AcQMap System.  Furthermore, RF ablation catheters 
utilized during the procedure should be limited to those compatible with the AcQMap System. 
 
 
 
Figure 1:  Ablation Procedure Flow Diagram 
 
 

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7.3.2 
Procedure Data Collection 
Collection of data generated during the procedure should include: 
• Medications and any change in health prior to the ablation 
• Recording of 12 lead ECG at procedure start 
• Recording of 12 lead ECG at procedure completion  
• Total procedure time (from first venous access to study completion) 
• Total fluoroscopy time and times to complete segments of the ablation 
procedure 
• Ablation time to complete PVI (delineate RF vs Cryo) 
• Ablation time for additional LA lesions (separate AF from AT ablations) 
• Ablation times for right atrial ablations 
• Recording of all DCCV used during the procedure 
• EP recording of all atrial tachyarrhythmias noted during the procedure 
• EP recording of conversion to sinus rhythm (either spontaneous or DCCV) 
• EP recording demonstrating PV isolation of all treated veins 
• Recording of any right atrial arrhythmias mapped and/or treated 
• Recording of all AADs infused during the procedure 
• Recording of any medications administered for anticoagulation reversal 
7.4 
Follow-Up Procedures 
7.4.1 
Hospital Discharge 
The subjects should be monitored with telemetry prior to hospital discharge for the 
documentation of recurrence of atrial fibrillation or other atrial tachyarrhythmias. 
The following evaluations should be completed prior to discharge: 
• Physical exam (including neurological assessment) 
• Medication history 
• Evaluation of Adverse Events 
• 12-lead electrocardiogram 
Careful attention should be placed in the identification of potential cardiac effusions and post-
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shortness of breath require a post-procedure TTE and further evaluation and management as 
indicated. 
7.4.2 
Seven Day Phone Follow-Up 
Subjects should be contacted by phone at seven (7 ± 3) days following their discharge from 
the hospital.  Information regarding their groin access sites and sense of any irregular heart 
rate should be obtained.  The Study Coordinator should also review current medications, 
review the follow-up schedule, and answer any questions the subject might have. If any 
concerns arise that suggest adverse events, the subject may be asked to return to clinic for a 
thorough evaluation.  Any visits prior to the one-month visit should be captured on the 
Unscheduled Visit eCRFs. 
7.4.3 
Visits at One, Three, Six, and Twelve Months 
The following evaluations will be performed during each clinic follow-up visit.  Data will be 
recorded on the Follow-Up eCRFs. 
• History and Physical exam (including neurological assessment) 
• Medication history 
• Adverse events assessment 
• 12-lead electrocardiogram 
• Echocardiogram (TTE at 12 months only, for comparison to baseline) 
• AFEQT Questionnaire (completed prior to visit) 
• 24-hour continuous monitor (3, 6, 9, and 12 months) 
- 
Since the 24-hour continuous monitor at 9-months does not 
coincide with a follow-up visit, the subject will be instructed how 
and when to wear the recording device.  Once the recording is 
completed, the device will be returned to the study site and the 
results of the recording will be entered into an eCRF. 
7.4.4 
Unscheduled Visits 
Any visit outside of the scheduled follow-up visit windows will be considered an unscheduled 
visit.  All pertinent data will be recorded on the Follow-up Visit eCRF. 
7.5 
Recurrence of Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 
(AF/AFL/AT) 
Arrhythmia Recurrence during the Blanking Period 
Occurrences of symptomatic atrial fibrillation or other (tachyarrhythmias) during the first 90 
days post-ablation (blanking period) may be transient in nature and not associated with the 

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long-term effectiveness of the ablation treatment.  However, prolonged AF should be treated 
as soon as possible to maintain sinus rhythm during the remodeling period.  Treatment should 
follow the Investigator’s standard of care for AF recurrence, which may include a DCCV 
and/or AAD administration.  Repeat ablations may be considered during the blanking period; 
however, they are discouraged. 
Arrhythmia Recurrence beyond the Blanking Period 
Development of AF/AFL/AT beyond the blanking period should first be documented with an 
ECG or a24-hour continuous ECG monitor.  Recurrence of an arrhythmia will be recorded on 
the eCRF as part of the continued management process of the subject in follow-up.  These 
will be documented at unscheduled or routine (three-, six- and twelve-month) follow up visits.  
Treatment should follow the Investigator’s standard of care and may include DCCV, AAD 
administration or repeat ablation (retreatment procedure).  Use of a DCCV is recommended 
prior to an ablation as many of these arrhythmias may be self-limited. One retreatments is 
allowed and may only occur in the time range from day 91 through day 270 post-ablation. 
In a retreatment procedure, the AcQMap System should be used following the same protocol 
as the index procedure.  Documentation of the retreatment will be on the procedure retreatment 
eCRF form.  Follow-up visits will restart using the same schedule as with the index procedure 
(7-day call, 1, 3, 6 months); however, the study completion date (12 months from the index 
procedure) will not change.   
Hospital admissions and clinic visits to treat these arrhythmias (cardioversion, in-patient 
medication change and ablation) will not constitute an SAE but will be reported as an 
additional intervention to the management of the persistent AF.  In the event the subject 
suffers an untoward or unanticipated complication as a result of the arrhythmia (i.e. 
thrombotic event, pulmonary edema etc.), an adverse event reporting will occur and be 
adjudicated by the Clinical Events Committee in accordance with the CEC Charter. 
Screening, procedure and follow-up visits are outlined in Table 2 and a flow diagram of visits 
is pictured in Figure 10.  

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Table 2:  Schedule of Events 
 
Screening1 
& 
Baseline 
Procedure 
Discharge 
7 Days 
(± 3 days) 
Phone 
Contact 
1-month 
(± 7 days) 
3-month 
 (± 14 days) 
6-month 
 (± 30 days) 
9-month 
(± 30 days) 
12-month 
 (± 30 days) 
CIP Informed 
Consent 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
History & 
Physical Exam 
X 
X 
X 
 
X 
X 
X 
 
X 
Medications 
X 
X 
X 
 
X 
X 
X 
 
X 
Transthoracic 
Echo (TTE) 
X 
(within 6 
months) 
 
 
 
 
 
 
 
X 
Trans Esophageal 
Echo (TEE) 
 
X 
(within 72 
hours) 
 
 
 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
 
X 
12-lead ECG 
X 
X 
X 
 
X 
X 
X 
 
X 
Labs 
X 
 
 
 
 
 
 
 
 
HCG 
(female patients) 
X 
 
 
 
 
 
 
 
 

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Screening1 
& 
Baseline 
Procedure 
Discharge 
7 Days 
(± 3 days) 
Phone 
Contact 
1-month 
(± 7 days) 
3-month 
 (± 14 days) 
6-month 
 (± 30 days) 
9-month 
(± 30 days) 
12-month 
 (± 30 days) 
Patient Reported 
Outcome 
Measures 
(AFEQT) 
X 
 
 
 
X 
X 
X 
 
X 
24-hour 
Continuous ECG 
Monitor 
Recording 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 

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Figure 2:  Flow Diagram of Follow-Up and Retreatment Procedures 
 

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8 STATISTICAL METHODS  
8.1 
Analysis Population 
The following analysis populations will be defined for the study: 
Safety Population – The safety population will include all enrolled subjects who 
have the venous access portion of the ablation procedure initiated.   
Treatment Population – The treatment population will include all enrolled 
subjects who complete a procedure up to the point the AcQMap catheter is deployed 
in the left atrium. 
8.2 
Statistical Analysis for Primary Safety Outcome Measure 
The primary outcome measure for the study is the primary safety objective, defined as 
the proportion of subjects who are free from device/procedure related Major Adverse 
Events (MAEs), as adjudicated by the CEC, that occur within the first twenty-four (24) 
hours post-procedure.  Subjects who remain free from such device/procedure related 
MAEs will be considered a success with respect to the primary safety objective, and 
subjects who experience at least one such MAE will be considered a primary safety 
failure.  MAEs that occur during the first 24 hours will be reported and adjudicated by 
the CEC for any probable relationship to the device and/or procedure.  
8.3 
Statistical Analysis for Secondary Outcome Measures 
Descriptive statistics will be applied to the secondary outcome measures 
8.4 
Study Size Justification 
The total sample size for the combined studies was selected based on the primary 
safety objective of the study.  In order to estimate the primary safety objective within 
a margin of error of 3.89% (i.e., this is the 95% confidence interval half-width), 
assuming the observed proportion of subjects who are free from device/procedure 
related Major Adverse Events (MAEs) that occur within the first 24 hours post-
procedure is 96.0%, a total of 125 subjects is required.  These calculations assume the 
data are from a binomial distribution and that the confidence interval will be computed 
using the Clopper-Pearson exact approach. 
9 ADVERSE EVENTS 
For the purpose of this protocol, an adverse event is any untoward medical occurrence, 
unintended disease or injury, or any untoward clinical signs in subjects whether or not 
related to the AcQMap System, and includes events related to the procedures involved 

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in the clinical investigation plan.  Any adverse event (AE) that occurs in a subject once 
they are considered a “safety” population is considered an AE.  Any medical 
conditions, problems, signs, symptoms, and findings occurring prior to enrollment are 
to be reported as pre-existing conditions on the Medical History eCRF. 
Serious Adverse Events (SAEs) 
A Serious Adverse Event is any adverse event that:17 
• led to death, 
• led to serious deterioration in the health of the subject, that either 
resulted in: 
- a life-threatening illness or injury, or 
- a permanent impairment of a body structure or a body function, 
or 
- in-patient or prolonged hospitalization, or 
- medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
Reports relating to the subject’s subsequent medical course following an SAE must be 
submitted to the Sponsor and the reviewing EC until the event has subsided or, in the 
case of permanent impairment, until the event has stabilized and the overall clinical 
outcome has been ascertained. 
A planned, in-patient hospitalization, without a serious deterioration in health, is 
not considered to be a serious adverse event.   
Adverse Device Effects (ADEs) 
Adverse device effects (ADE) are a subset of adverse events. The ADEs are only those 
adverse events caused by, or related to, the device, including any adverse event 
resulting from insufficiencies or inadequacies in the instructions for use, the System 
components, or any product malfunction, including any event that is a result of a user 
error or intentional misuse.   
With any procedure or treatment, there are known possible risks and complications. A 
list of known or anticipated adverse events for the AcQMap™ System is found in the 
IFU.   
Unanticipated Adverse Device Effects (UADEs) 
 
17  ISO 14155: 2011 section 3.37 

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Investigators are required to submit a report to the Sponsor as soon as possible of any 
suspected Unanticipated Adverse Device Effect (UADE) occurring during an 
investigation, but in no event later than five (5) business days after the Investigator 
first learns of the effect.  
When an Investigator suspects an event meets the definition for a UADE, then the 
event, date of onset, seriousness, severity, duration, treatment, outcome and 
relationship to device will be recorded on the Adverse Event CRF.  Additionally, 
reports must be provided to the reviewing EC per national and local requirements.   
The Sponsor/manufacturer must then conduct an evaluation of the suspected UADE 
and report the results of the findings to the Notified Body and to all reviewing ECs 
and participating Investigators within five (5) business days after first receiving notice 
of the effect. Thereafter, the Sponsor shall submit such additional reports concerning 
the effect as the Notified Body requests. 
9.1 
Adverse Event Reporting 
The Investigator is responsible for reporting all adverse events that occur during the 
study.  Initial reporting will be with the Adverse Event eCRF; however, additional 
information may be required by the Sponsor, the CEC, the Ethics Committee, or any 
other regulatory authority.  The Investigator should report any serious adverse events 
(SAEs), serious adverse device effects, (SADEs), or unanticipated adverse device 
effects (UADEs) to the Sponsor as soon as possible after becoming aware of the event, 
but not later than five (5) business days after receiving knowledge of the event 
occurrence.  All SAEs, SADEs, and UADEs will be documented on the Adverse Event 
eCRF along with an explanation of any medical treatment administered.  
Documentation should include the time of onset, complete description of the event, 
severity, duration, actions taken and outcome.   
9.2 
Event Relationship to the Device 
The Investigator should provide information regarding the relationship of the event to 
the AcQMap™ System and the persistent AF ablation procedure.  The device 
relationships are defined in the table below: 
 
 
 

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Table 3:  AE Relationships 
Not Related 
The cause of the AE is known and is not related to any aspect of 
the mapping and imaging portion of the persistent AF ablation 
procedure. 
Possibly 
Related 
There is a reasonable possibility that the event may be related to 
the mapping and imaging portion of the persistent AF ablation 
procedure. The AE has a timely relationship to the study 
procedure(s); however, it follows no known pattern of 
response and an alternative cause seems more likely or there is 
significant uncertainty. 
Probably 
Related 
It is probable that the event was related to the mapping and 
imaging portion of the persistent AF ablation procedure. The AE 
has a timely relationship to the study procedure(s) and follows 
a known pattern of response, but a potential alternative cause 
may be present. 
Definitely 
Related 
The event was definitely related to the mapping and imaging 
portion of the persistent AF ablation procedure. A related event 
has a strong temporal relationship and an alternative cause is 
unlikely. 
9.3 
Death Notice 
When a site becomes aware of a subject’s death, it should be reported to the Sponsor.   
Notification should be made to the reviewing EC per local requirements.   
The materials to be submitted to the Sponsor for a death include the following:  
• Death narrative: A short description by the treating physician of record 
at the time of death regarding the circumstances of death. 
• An assessment by the Investigator as to whether the death is related to 
study interventions.  
• A copy of the patient’s death certificate. 
• When applicable, a copy of an autopsy report. 
For reported deaths, the Investigator or designee should supply the Sponsor and the 
presiding EC with any additional requested information, if available (i.e., hospital 
records). 

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9.4 
Device Complaint and Malfunction 
Each clinical procedure will be attended by Acutus Medical personnel responsible for 
the proper use of the technology.  In the event that a malfunction occurs, the Sponsor 
representative will report the findings to the Clinical and R & D departments.  
Evaluations of all complaints will follow Acutus Medical QAPs for complaint 
handling.  Any trends information for complaints may be evaluated by the CEC. 
9.5 
Clinical Events Committee (CEC) 
Acutus Medical (or designee) will coordinate the convening of meetings of a Clinical 
Events Committee (CEC) in accordance with the QAP and the CEC Charter specific 
to this study.  The CEC has the responsibility to independently review and comment 
on all data and safety aspects of the trial.  Based on their review, the committee may 
make recommendations regarding all aspects of the conduct of the study, including the 
termination of the study.  All recorded minutes of the meetings and actions will be 
kept on file and available for review as requested. 
10 RISK: BENEFIT ANALYSIS 
10.1 Risks 
The following adverse events are associated with electrophysiology mapping and 
ablation procedures: 
• Adult Respiratory Distress Syndrome 
• Obstruction, perforation or damage 
to the vascular system 
• Air embolism 
• Pericardial effusion 
• Anemia 
• Pericarditis 
• Anesthesia reaction 
• Phrenic nerve damage 
• Arrhythmias 
• Pleural effusion 
• AV fistula  
• Pneumonia 
• Atrial esophageal fistula 
• Pneumothorax 
• Cardiac perforation/tamponade 
• Pseudoaneurysm 
• Cardiac thromboembolism 
• Pulmonary edema 
• Cerebral infarct (hemorrhagic or 
thromboembolic) 
• Pulmonary embolism 
• Chest pain/discomfort 
• Radiation injury 
• Complete heart block  
• Respiratory depression 
• Congestive heart failure 
• Seizure 
• Coronary artery spasm 
• Skin burns 
• Death 
• Temporary complete heart block 
• Endocarditis 
• Thrombi 

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• Expressive aphasia  
• Thromboembolism 
• Heart failure  
• Transient ischemic attack 
• Hemothorax 
• Unintended (in)complete AV, sinus 
node block or other heart block or 
damage 
• Increased phosphokinase level 
• Valvular damage/insufficiency 
• Infections 
• Vascular bleeding 
• Laceration 
• Vasovagal reactions 
• Leakage of air or blood into the lungs 
or other organs due to perforation 
• Ventricular tachycardia 
• Local hematomas/ecchymosis 
• Worsening chronic obstructive 
pulmonary disease 
• Myocardial infarction 
 
10.2 Mitigation of Risks 
Pre-clinical research and current clinical studies have demonstrated that the system is 
safe for human use.  All potential risks have been evaluated and mitigation strategies 
have been implemented to reduce potential risks to acceptable levels.  Acutus Medical 
believes that the potential benefits of the system outweigh the potential risks.   
11 DATA QUALITY ASSURANCE 
Acutus Medical will oversee a database for this study in accordance with regulatory 
data integrity requirements, the Data Management Plan (DMP), and corporate QAPs.  
Data will be collected and entered on the eCRFs in the database.  Data will be reviewed 
for accuracy and completeness by Acutus Medical (or designees) during all onsite and 
remote monitoring visits, and throughout the data management process.  Any 
discrepancies will be resolved with the Investigator or designees, as appropriate.  In 
order to preserve data integrity and security of the database, access to the database will 
be controlled by Acutus Medical and shall be limited to appropriately trained 
personnel with assigned log-on credentials.   
11.1 
Data Management 
The standard procedures for handling and processing records will follow Acutus 
Medical (or designee) QAPs for data management.  All data collection will be in 
compliance with Good Clinical Practice (GCP).  A comprehensive Data Management 
Plan (DMP) will be developed prior to the start of the clinical study.   
For the duration of the study, the Investigator and their designees will maintain 
complete and accurate documentation, including but not limited to, medical records, 
study progress notes, laboratory reports, signed patient informed consent forms, device 
accountability logs, correspondence with the reviewing EC, correspondence with 

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Acutus Medical (or designees) and study monitors, adverse event reports, and 
information regarding subject discontinuation/withdrawal or completion of the study. 
The Investigator/Institution will permit direct access to source data and documents in 
order to complete study-related monitoring, audits, EC reviews, event adjudication and 
regulatory inspections that may be performed.  The Investigator will obtain, as part of 
the informed consent process, permission for authorized Sponsor employees, study 
monitors or regulatory authorities to review, in confidence, any records that identify 
subjects in this study. 
11.2 Subject Identification 
Subjects will be identified on all eCRFs and source documents by a unique 
identification reference, which will be issued once the Informed Consent has been 
signed.  An identification reference may not be reused for any reason.   
11.3 Screen Failure Subjects 
Subjects who are screened for the study but are not enrolled for any reason will not be 
followed and their data will not be used for any outcomes analysis. The screening 
eCRF should be completed for all screen failure subjects. 
11.4 Subject Study Completion and Withdrawal 
A subject will be considered completed when the twelve- (12) month visit is completed 
and all data collection is complete.  Subjects who withdraw for any reason will have 
all available data entered into the database.  Reasons for withdrawal will be entered on 
the Study Completion eCRF. 
11.5 Subjects Lost-to-Follow-Up 
A subject will be considered lost-to-follow-up from the last missed clinical evaluation 
if all reasonable efforts made to contact the subject and request their continued 
participation in the study have failed. All attempts to contact the subject will be 
documented.   
Whenever possible, subjects who have been withdrawn for reasons other than lost-to-
follow-up will be contacted and requested to participate in ongoing safety data 
assessments, which will be conducted by phone. 
11.6 
Confidentiality of Data 
Information regarding study subjects will be kept confidential and managed according 
to the requirements and regulations of the local and national governing bodies and 
QAPs of Acutus Medical or participating CROs. 

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All data and information collected during this study will be considered confidential by 
Acutus Medical and their delegates.  All data used in the analysis and summary of this 
study will be anonymous, and without reference to specific subject names.  Access to 
subject files will be limited to authorized personnel of Acutus Medical (including core 
labs), the Investigator, Clinical Site research staff and authorized Regulatory 
Authorities.  Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study. 
11.7 Source Documents 
Source data encompasses all information, original records of clinical findings, 
observations, or other activities, which are required in a clinical trial for the 
reconstruction and evaluation of the trial.  Examples of these original documents, and 
data records include, but are not limited to, hospital records, clinical and office charts, 
laboratory notes, memoranda, subject diaries or evaluation checklists, recorded data 
from automated instruments, copies or transcriptions certified after verification as 
being accurate and complete, copies of clinic and procedural site coding and billing 
records, microfiches, photographic negatives, microfilm or magnetic media, X-rays, 
patient files, and records kept at the pharmacy, and at the laboratories involved in the 
clinical trial. 
Regulations require that the Investigator maintain information in the patient’s medical 
records that corroborate data collected for the study.  In order to comply with these 
regulatory requirements, the following is a list of information that should be 
maintained, at a minimum:  
• Medical history/general physical condition of the subject before 
involvement in the study, which will be of a sufficient nature to verify 
the protocol eligibility criteria. 
• Study/progress notes, including the date of entry into the study, 
documenting the following: 
- 
The general health of the subject. 
- 
The discussion of the study risks and benefits with the 
patient. 
- 
Completion of the informed consent process. 
- 
A statement that the subject reviewed and signed the 
patient informed consent form. 
• Dated notes from each subject visit to support all data recorded on the 
eCRFs. 

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• Adverse Events reported and their continuation or resolution at each 
visit, including supporting documentation, such as discharge 
summaries, lab results, non-invasive testing reports, etc. 
• Notes regarding protocol-required and prescription medications taken 
during the study (including start and stop dates, dosage, and routes of 
administration, if known). 
• Subjects general health and medical condition upon completion of, or 
withdrawal from the study. 
11.8 Electronic Case Report Forms (eCRFs) 
This study will use an electronic Case Report Form (eCRF) as the primary data 
collection instrument and will record data by electronic capture.  All data requested on 
the eCRF must be entered in a timely manner.  All missing data must be explained.  If 
an entry on the eCRF is left blank because the procedure was not done or the question 
was not asked, a query will be generated for the site data entry staff.  If a data entry 
error has been made, the corrected information will be entered on the eCRF.  All such 
changes are recorded in the audit and queries report.   
Specific instructions to complete the eCRFs will be provided to the Investigator and 
other site personnel, as appropriate. The Investigators (and designees) are responsible 
for reporting clinical study-requested information in the eCRFs.   
11.9 Records Retention 
The Investigator will retain study essential documents for two (2) years after formal 
closure or discontinuation of the trial.  These documents must be retained for a longer 
period if required by an agreement with Acutus Medical or defined by local or national 
regulations.  Acutus Medical will inform the Investigator/Institution as to the date of 
formal closure or discontinuation of the trial and when these documents no longer need 
to be retained. 
11.10 Clinical Monitor 
A clinical research organization has been designated as the clinical monitor for this 
study.  Their personnel are qualified by training and experience to oversee the conduct 
of the study.  The Clinical Monitor's responsibilities include maintaining regular 
contact with each investigational site through telephone contact and on-site visits to 
ensure that: 1) the CIP is followed; 2) complete, timely, and accurate data are 
submitted; 3) problems with inconsistent and incomplete data are addressed; 4) 
complications and Unanticipated Adverse Device Effects are reported to the Sponsor; 
and 5) the site facilities continue to be adequate. 

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11.11 Clinical Data Monitoring Procedures 
Acutus Medical Clinical Trial Monitors (or designees) will conduct site visits at the 
study facilities to monitor the study, which will be in compliance with the CIP, QAPs, 
and the Clinical Monitoring Plan (CMP).  Monitoring visits will occur as defined in 
the CMP. The Investigational site agrees to allow these monitors and other authorized 
Acutus Medical personnel access to information and clinical supplies related to the 
study.  The Acutus Medical monitors will verify data entered into the eCRFs against 
hospital/clinic records or other source documents, in order to ensure accuracy and 
completeness of the eCRFs for each subject.  Clinical Investigators and their staff 
agree to assist the monitors in their activities. Requests may be made to review patient 
charts by Acutus Medical personnel and/or designee(s) so that protocol adherence and 
source documentation can be verified.   
Monitoring visits will be performed at regular intervals throughout the course of the 
study to ensure compliance with the protocol.  Monitoring activities may include, but 
are not limited to:  
• Evaluation of subject screening and selection methods 
• Verification of signed informed consent for each subject 
• Verification of source documentation against completed case report 
forms for each subject 
• Assurance that required study reports, including reports to the 
applicable EC, are generated in a timely manner 
• Monitoring of Safety Events, including device deficiencies that may 
have led to an SAE 
• Monitoring of device deficiencies, irrespective of associated safety 
events 
• Review of device accountability records and device reconciliation 
• Review of protocol deviations 
• Overall study compliance 
• Review of the Investigator Site File 
11.12 Investigator Responsibilities 
The investigator is responsible for ensuring that the clinical study is performed in 
accordance with the protocol, the Declaration of Helsinki, the principles of Good 

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Clinical Practice (GCP), ISO 14155: 2011, applicable regulatory requirements, and 
institutional procedures.  
11.13 Deviations from the Clinical Investigational Plan 
A protocol deviation is defined as an event in which the Investigator or site personnel 
deviates from the study protocol or study procedures.  It is the Investigator’s 
responsibility to ensure that there are no deviations from the protocol.  On a rare 
occasion, a waiver to a screening test, exclusion criteria, or protocol-specific procedure 
may be granted in advance by Acutus Medical and must be reported in full compliance 
with all established procedures and conditions of the reviewing EC.   
An Investigator may deviate from the protocol without prior written approval from 
Acutus Medical in cases of medical emergencies to protect the life or physical well-
being of a subject. In the event of an emergent deviation, the Investigator is required 
to notify Acutus Medical and the applicable EC as soon as possible, but in no event 
later than 5 business days from the occurrence of the deviation from the protocol.  
Except in such an emergency, prior approval by Acutus Medical is required for 
changes in, or deviations from, the protocol.  Additionally, if these changes or 
deviations affect the scientific soundness of the investigational plan or the rights, 
safety, or welfare of human subjects, EC notification is required. 
Prior approval is generally not expected in situations where unforeseen circumstances 
are beyond the Investigator’s control (e.g., the subject was not available for a 
scheduled follow-up office visit or has moved without providing a forwarding 
address).  These events, although outside the Investigators control, are still required to 
be reported on the appropriate Protocol Deviation eCRF in order to ensure that all 
deviations from the standard subject population are adequately documented and 
reported.  The Investigator will inform Acutus Medical and the reviewing EC of all 
protocol deviations as per the EC requirements established for this study.   
If Acutus Medical becomes aware that an Investigator is not complying with the any 
part of the Clinical Investigation Plan, including the signed Investigator Agreement, 
the protocol, or any conditions of approval imposed by the reviewing EC, Acutus 
Medical will immediately secure compliance, and may suspend the Investigator’s 
participation (including enrollment at the site).  Acutus Medical may terminate an 
Investigator’s participation in the study at its discretion.  
11.13.1 Maintaining Records 
The Investigator will maintain the following accurate, complete, and current records 
related to the Investigator's participation: 

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• Correspondence with another Investigator, an EC, Acutus Medical, a 
Sponsor monitor or designee, or any regulatory agency. 
• Records of each patient's case history and exposure to the device, 
including:  
- 
Documents evidencing informed consent and for 
participation in the clinical study without informed consent,  
- 
Any written concurrence of a licensed physician and a brief 
description of the circumstances justifying the failure to 
obtain informed consent 
- 
All relevant observations, including records concerning 
adverse device effects (whether anticipated or not), 
- 
Information and data on the condition of each subject upon 
entering, and during the course of the investigation, 
including information related to relevant previous medical 
history and the results of all diagnostic tests, 
- 
A record of the procedure involving treatment with the 
AcQMap for each subject, including the date and time of 
the procedure. 
• The protocol, with documents showing the dates of and reasons for 
each deviation from the protocol. 
11.13.2 Submitting Reports 
In compliance with local and national laws, each Investigator may be required to 
prepare and submit complete, accurate, and timely reports to Acutus Medical and/or 
ECs.  These reports may include: 
• Any unanticipated adverse device effect occurring during an 
investigation.  
• Any deviation from the investigational plan made to protect the life or 
physical well-being of a subject in an emergency.  
• A protocol deviation requiring prior written Acutus Medical approval 
(except in emergency situations). If the deviation affects the scientific 
soundness of the plan or the rights, safety, or welfare of subject, prior 
documentation of EC approval may be required. 
• Any further information requested by an EC about any aspect of the 
investigation. 

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The Investigator will provide, in writing, any withdrawal of EC approval of the study 
or an Investigator within five (5) business days of such action. 
11.14 Acutus Medical Responsibilities 
11.14.1 General Duties 
Acutus Medical has the overall responsibility for the conduct of the study, including 
assurance that the study satisfies the regulatory requirements of the appropriate 
regulatory agencies, ensuring EC approvals, selecting Investigators, ensuring proper 
monitoring and that informed consent is obtained.  Acutus Medical will provide all 
information necessary to conduct the study, including the Clinical Study Protocol, and 
any reports of prior investigations, as appropriate.  During the conduct of the clinical 
study, updates regarding information that may impact the clinical study will be made 
available to all appropriate national and local regulatory authorities. 
11.14.2 Selection of Investigators 
Acutus Medical will select Investigators (including Sub Investigators performing the 
procedure) qualified by training and experience.  Sites will be selected based on a site 
assessment, appropriate facilities, clinical experience and the qualifications of the 
Principal Investigator.  Investigators will be evaluated by Acutus Medical based on: 
• Curriculum vitae, or other statement of Investigator’s relevant training 
and experience, including type of experience with the intended 
procedure and clinical research, specifically  
• Education and experience in the ablation management of arrhythmias 
• Whether the Investigator has an adequate patient population to meet 
requirements of the study enrollment 
• Whether the Investigator has adequate time to be personally involved 
in the conduct of the study, and adequate research staff and resources 
to support the study 
• Whether the Investigator’s Study Center is associated with an EC that 
satisfies all applicable regulatory requirements 
• Whether an Investigator was involved in an investigation or other 
research that was terminated.  This may require an explanation of the 
circumstances that led to the termination.  
Prior to study initiation, each Investigator must also submit a:  
• Certificate of human patient’s protection training (if required by the 
reviewing EC), 

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• Signed Investigator’s Agreement, indicating an Investigator’s 
commitment to: 
- 
Conduct the investigation in accordance with the 
agreement, the Clinical Investigational Plan/protocol, GCP, 
and any conditions of approval imposed by the EC;  
- 
Supervise all testing of the device involving human 
subjects;  
- 
Ensure that the requirements for informed consent are met;  
- 
Conduct the study according to the Clinical Investigational 
Plan/protocol. 
The Sponsor reserves the right to apply additional criteria to site and/or Investigator 
selection. 
11.15 Training 
Acutus Medical will provide training on the AcQMap™ System prior to enrolling any 
subject.  Training may consist of a review of the IFU, hands-on training on the device 
and procedure, presentations, literature, etc.  The training program will be standardized 
and will be documented.  Additional training will include a review of the protocol, the 
regulations for medical device investigations and general study logistics required to 
complete the study. 
Training of appropriate clinical study personnel will be the responsibility of Acutus 
Medical.  To ensure uniform data collection and protocol compliance, Acutus Medical 
will review the Clinical Investigational Plan/protocol (including the ICF), techniques 
for identification of eligible subjects, instructions on data collection, methods for 
scheduling follow-up visits in the window, etc.  Detailed feedback regarding 
completion of the eCRFs, study requirements, and protocol compliance will be 
provided by Acutus Medical, its study monitors, and/or designees, functioning in a 
data management capacity. 
11.15.1 Changes in the Clinical Investigational Plan 
Acutus Medical will obtain appropriate regulatory approval for any change to the 
Clinical Investigational Plan/protocol that may affect the scientific soundness of the 
investigation or the rights, safety and/or welfare of the subjects.  
Acutus Medical will provide approved protocol amendments to the Investigators prior 
to implementing the amendment.  The Investigator will be responsible for notifying 
the reviewing ECs of the protocol amendment (administrative changes) or obtaining 

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EC approval of the protocol amendment (changes in subject care of safety), according 
to the instructions provided with the protocol amendment.  The EC 
acknowledgement/approval of the protocol amendment must be documented in 
writing prior to implementation of the protocol amendment.  Copies of this 
documentation must be provided to Acutus Medical and placed in the Trial Master 
File (TMF). 
11.15.2 Withdrawal of Regulatory Approval  
Acutus Medical will notify all reviewing ECs and participating Investigators of any 
withdrawal of regulatory approval to conduct the clinical study, and shall do so within 
five (5) business days after receipt of notice of the withdrawal of approval. 
12 ETHICS AND REGULATORY COMPLIANCE 
12.1 Conduct of the Clinical Study 
Conduct of the clinical study will follow QAPs from Acutus Medical, as well as the 
Declaration of Helsinki, Good Clinical Practices, ISO 14155: 2011, and other regional 
and local laws.  Each Investigator must sign and date the Investigator Agreement prior 
to the start of this study. With the signature, the Investigator agrees to perform all study 
procedures according to the governing local and national regulations and the Clinical 
Investigational Plan Protocol. 
12.2 
Ethics Committee Approval 
A properly constituted, valid Ethics Committee (EC) must review and approve the 
Clinical Investigational Plan (CIP), Informed Consent, and related patient information 
and recruitment materials prior to initiation of the study.  It is the responsibility of the 
Investigator to obtain protocol approval from the institution’s EC, and to keep the EC 
informed of any serious adverse events or serious adverse device effects and 
amendments to the protocol.  Additional requirements imposed by the EC or other 
regulatory authority shall be followed as appropriate.  All correspondence with the EC 
should be filed by the Investigator and copies sent to Acutus Medical (or designees). 
12.3 
Clinical Study Informed Consent Approval 
In accordance with the principles of Informed Consent, the Declaration of Helsinki, 
Good Clinical Practice (GCP), and ISO 14155: 2011, informed consent will be 
obtained and documented in writing before a patient is enrolled in the clinical study.  
It is the responsibility of the Investigator to ensure that a written informed consent is 
obtained from the patient (or legally acceptable representative) before any activity or 
procedure is undertaken that is not part of routine care. Information obtained during 

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the conduct of the clinical study that may impact the patient informed consent may 
require revisions to the informed consent.  If so, revisions and approvals of such 
changes by the appropriate regulatory authority is required.  Documentation of the 
current versions of the informed consent will be documented in the clinical study TMF. 
12.4 Identification and Confidentiality 
Patient identification and confidentiality will be ensured in accordance with all 
applicable regulatory and Ethics Committee governance.  This includes, but is not 
limited to, the following: 
• Subjects will be identified on all eCRFs and source documents by a 
unique identification reference  
• eCRFs are confidential documents and will only be made available to 
Acutus Medical (and appropriate designees), the Investigator, the 
biostatistician, the Clinical Events Committee (CEC), and, if 
requested, to advisory committees and regulatory authorities 
(including USFDA) 
• Data will be stored and analyzed by computer following national 
regulations for handling of computerized data 
Each Study Center will maintain (anonymous to Acutus Medical) a list identifying all 
patients entered into the trial.  The list will be maintained as part of the investigation 
file and monitored for completeness. 
12.5 Site Qualification Visits 
A site qualification visit will be performed to evaluate site facilities, Investigator 
qualifications, and site knowledge of Good Clinical Practice (GCP) guidelines.  
Acutus Medical’s QAP for site qualification visits will be followed and a report filed 
in the Trial Master File (TMF), which will be maintained by Acutus Medical.    
12.6 Site Initiation Visits 
All study personnel will be required to participate in a site initiation visit that follows 
Acutus Medical’s QAP.  Components of this initiation visit may include: 
• Introduction of the study design including the protocol-specific 
treatment and follow-up phase 
• Informed Consent process 
• Product training to all end-users  
• eCRF completion training 

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• Safety reporting instructions 
• Training on the regulations governing human research 
• Procedure training on the use of the device 
12.7 Insurance 
Acutus Medical shall maintain insurance coverage for this study.  Pertinent 
information regarding the coverage shall be made available to the site upon request. 
12.8 Site Audit Plan 
Participation as an Investigator in this study implies acceptance of potential inspection 
by government regulatory authorities and applicable compliance and quality assurance 
offices. The Investigator and/or designee must be available to respond to reasonable 
requests and queries made by authorized regulatory representatives during the audit 
process.  The Investigator must provide Acutus Medical with copies of all 
correspondence that may affect the review of the current study or their qualifications 
as an Investigator in this and future clinical studies conducted by Acutus Medical. 
12.8.1 Site Data Audits by Acutus Medical 
In accordance with local and national regulations and Acutus Medical’s operating 
procedures, an internal audit may be requested to access all study records, including 
source documents, for inspection and duplication.  The investigator will ensure the 
capability for inspections of applicable study-related functions. 
Site data quality assurance audits may be conducted at various sites during the clinical 
study.  Selection of sites to undergo auditing will be determined by the Acutus Medical 
as needed.  
12.8.2 External Audits 
Requests by regulatory agencies to inspect the study sites may be made as well. The 
Investigator and/or designee is required to report to Acutus Medical as soon as possible 
after receiving a request from a regulatory authority to perform an audit.  The clinical 
Investigator agrees to allow inspectors from regulatory agencies to review records, and 
to assist the inspectors in their duties, if requested. 
12.9 Investigational Device Traceability 
The AcQMap™ System components will be stored at each site.  All sites will maintain 
a device accountability log that will match patients to a particular device by a unique 
manufacturer number.  At the conclusion of the study all unused devices will be 
returned to Acutus Medical. 

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***CONFIDENTIAL*** 
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12.10 Public Domain Access to the Clinical Study 
A description of this clinical trial will be available on http//www.Clinicaltrials.gov.  
Information regarding the public access will be presented in the informed consent. 
12.11 Required Reports 
Acutus Medical will remain in compliance with all required and pre-specified reports 
during the enrollment and follow-up of the clinical study.  EC requirements for reports, 
including minutes from CEC meetings, will be provided as requested. 
13 GENERAL CONSIDERATIONS 
13.1 Discontinuation of the Clinical Study 
The Sponsor reserves the right to discontinue the study at any stage, with suitable 
written notice to the Investigator and the appropriate government regulatory agencies.  
Such decisions will be based on advice from the Scientific Advisory Board or Clinical 
Events Committee.  Similarly, Investigators may withdraw from the study, subject to 
providing written notification to the Sponsor within 30 days of their intent to withdraw.  
However, the Sponsor and Investigators will be bound by their obligation to complete 
the follow-up of subjects already enrolled into the study. 
Acutus Medical, as Sponsor, may terminate Investigator and site participation in the 
study if there is evidence of an Investigator’s failure to maintain adequate clinical 
standards or evidence of an Investigator’s or staff’s failure to comply with the Clinical 
Investigation Plan/protocol. 
Notification of suspension or termination will occur no later than five (5) business 
days after Acutus Medical makes the determination.  In the event of study suspension 
or termination, Acutus Medical or designee will send a report outlining the 
circumstances to the reviewing EC, the appropriate regulatory agencies, and to all 
participating Investigators.  Any suspension or termination may not be re-initiated 
without prior approval of the EC and Acutus Medical. 
13.2 Use of Information and Publications 
All information concerning Acutus Medical operations, patent applications, 
manufacturing processes, and basic scientific data supplied by Acutus Medical to the 
Investigator and not previously published, are considered confidential and remain the 
sole property of Acutus Medical This includes all study materials, CRF forms, 
worksheets and eCRFs. 

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The information developed in this study may be used by Acutus Medical as support 
for a regulatory filing and in connection with the continued development of the 
AcQMap™ System.  Any publication or other public presentation of the data resulting 
from this study will require prior review and written approval of Acutus Medical. 
At the conclusion of the study, it is expected that Acutus Medical and the Investigators 
will promptly prepare and submit a multi-center manuscript for publication in a 
reputable scientific journal. The publication of the principal results, including 
abstracts, from any single-site experience within the study is not allowed until the 
preparation and publication of the multi-center results. Exceptions to this rule require 
the prior written approval of Acutus Medical. 
Further analyses, beyond those presented in the initial multi-center publication may be 
proposed to Acutus Medical.  Many secondary manuscripts are anticipated.  For 
purposes of timely abstract presentation and publication, such secondary publications 
may be delegated to the appropriate principal authors; however, final analyses and 
manuscript review for all multi-center data will require the prior written approval of 
Acutus Medical. 
None of the results, in whole or part, of the study carried out under this protocol, nor 
any of the information provided by Acutus Medical for the purposes of performing the 
study, will be published or passed on to any third party without the consent of Acutus 
Medical.  Any Investigator involved with this study is obligated to provide Acutus 
Medical with complete test results and all data derived from the study. 
14 APPENDIX 
14.1 Bibliography 
A bibliography of pertinent publications identified or supportive of the clinical study 
will be maintained by Acutus Medical and available upon request. 
 

Statistical Analysis Plan 
 
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STATKING Clinical Services                                                                                              Acutus Medical 
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Statistical Analysis Plan (SAP) 
 
 
Utilizing Novel dipole density Capabilities to Objectively 
Visualize the Etiology of Rhythms in Atrial Fibrillation 
(UNCOVER-AF) 
 
Study Numbers: CL-AF-001 and CL-AF-002  
 
 
 
Version 2.0 
May 20, 2019 
 
NCT02825992 
 
 
Prepared for 
Acutus Medical, Inc. 
2210 Faraday Ave, Suite 100 
Carlsbad, CA 92008 
 
 
 
 
 
 
 
 
Prepared by 
STATKING Clinical Services 
759 Wessel Drive 
Fairfield, OH  45014 
513-858-2989 
www.statkingclinical.com 
 
 
 
 

Statistical Analysis Plan 
 
                           UNCOVER-AF Study 
 
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STATKING Clinical Services                                                                                              Acutus Medical 
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Revision History 
 
Version 1.1 to 2.0 
1. Listing 6 (AEs): modified to add columns specifying device relationship to AE for 
each device. 
2. Listing 15 (Catheter Data): Part 5 header corrected. Part 4 Sheath Model number 
and Lot number added. 
3. Listing 16 (PVI Data): Column added to identify visit and PVI count. 
4. Table 2 and Time-to-event specification: TTE defined as TTE = End-Date – Start-
Date rather than End-Date – Start-Date + 1.  
5. Tables 7 and 35: Footnote added to state data source as continuous monitor 
data with 12 lead imputation when continuous monitor data are unavailable. 
6. Table 16: Highest Relationship to Device expanded to summarize relationships 
to System, Catheter, Sheath, and PEK (in accord with added tables 20- 22). 
7. Tables 16, 17, 18, 19 (AEs): Table sources modified to use CEC adjudication 
only, titles changed to reflect this. Text of Section 4.2.2 changed to reflect these 
changes.  
8. Table 19 (AE Relationship to Device) – Changed to Relationship to AcQMap 
Catheter. 
9. Tables 20-22 – Added to summarize additional AE relationship assessments.  
 
Version 1.0 to Version 1.1 
1. In Appendix B, the shell for Table 6 modified to include Total Procedure Time. 
 
2. In Appendix B, the shell for Table 7 extensively modified to add AF only 
subtables. It is split into Table 7 (AF, AFl, and AT) and Table 32 (AF only). A 
complete list of the subtables is given below (italics represent current subtables): 
 
Table 32 (New) 
a. Freedom from AF with a single procedure. 
b. Freedom from AF with a single procedure without AADs. 
c. Freedom from AF with a single procedure with AADs. 
d. Freedom from AF with multiple procedures. 
e. Freedom from AF with multiple procedures without AADs. 
f. Freedom from AF with multiple procedures with AADs. 
 
Table 7 (Existing) 
g. Freedom from AF/AT/AFL with a single procedure. 
h. Freedom from AF/AT/AFL with a single procedure without AADs. 
i. Freedom from AF/AT/AFL with a single procedure with AADs. 
j. Freedom from AF/AT/AFL with multiple procedures. 
k. Freedom from AF/AT/AFL with multiple procedures without AADs. 
l. Freedom from AF/AT/AFL with multiple procedures with AADs. 
 

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3. Imputation of 12-Lead ECG rhythm for missing Holter data added to Appendix B. 
Table 22 divided into three parts to display 12-lead results at baseline, 1, 3, 6, 
and 12 months, Holter monitor data at 3, 6, 9, and 12 months, and results after 
imputation.  
 
4. Appendix B. Table 33 added to cover medical history co-morbidities. 
 
5. Treatment Population redefined in terms of atrial mapping rather than sensor 
deployment. 
 
6. Data Listing 2: Date-of-birth column removed, because it is not present in the 
data file. 
 
7. AFEQT questionnaire scoring algorithms added to text. 
 
8. Data Listing 15 divided across 5 pages (from 3) to reduce line breaks. 
 
 
 
 
 
 
 

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Table of Contents 
1.0  SYNOPSIS OF STUDY DESIGN PROCEDURES ................................................... 5 
1.1 Design and Treatment ........................................................................................................................................... 5 
1.2 Study Procedures ................................................................................................................................................... 5 
1.3 Sample Size ............................................................................................................................................................. 6 
2.0  DATA ANALYSIS CONSIDERATIONS ................................................................... 6 
2.1 Types of Analyses ................................................................................................................................................... 6 
2.2 Analysis Populations .............................................................................................................................................. 7 
2.3 Missing Data Conventions .................................................................................................................................... 7 
2.4 Interim Analyses .................................................................................................................................................... 7 
2.5 Study Center Considerations in the Data Analysis ............................................................................................. 8 
2.6 Documentation and Other Considerations .......................................................................................................... 8 
3.0  ANALYSIS OF BASELINE PATIENT CHARACTERISTICS ................................... 8 
4.0  ANALYSIS OF SAFETY .......................................................................................... 8 
4.1 Description of Safety Objectives ........................................................................................................................... 8 
4.2 Analysis of Safety Objectives ................................................................................................................................ 9 
5.0  ANALYSIS OF EFFECTIVENESS ......................................................................... 11 
5.1 Description of Effectiveness Objectives ............................................................................................................. 11 
5.2 Analysis of Effectiveness Objectives .................................................................................................................. 12 
6.0  OTHER RELEVANT DATA ANALYSES/SUMMARIES ........................................ 14 
6.1 Subject Completion ............................................................................................................................................. 14 
6.2 Prior and Concomitant Medications .................................................................................................................. 14 
7.0  REFERENCES ....................................................................................................... 14 
APPENDIX A – TABLES, FIGURES AND LISTING SPECIFICATIONS ..................... 15 

Statistical Analysis Plan 
 
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1.0  Synopsis of Study Design Procedures 
 
This Statistical Analysis Plan (SAP) describes the analysis of data from Acutus Medical 
Studies CL-AF-001 and CL-AF-002, both referred to by the acronym UNCOVER-AF. The 
CL-AF-001 study is being conducted in Canada as a pre-market study, and the CL-AF-
002 study is being conducted in Europe as a post-market study.  
 
Data from both studies are considered suitable for pooling based on identical patient 
inclusion and exclusion criteria, procedures, and measurement methods for outcomes 
data. Moreover, the patients in the general population of the countries conducting the 
study have similar demographics.  For the purposes of the analysis tables planned in this 
SAP, the data will be treated as data originating from a single study.  Data listings will 
report the study number in order to identify the protocol under which each individual 
subject was enrolled.    
 
Each study is a prospective, single-arm, multi-center, multi-national, non-randomized 
study designed to provide clinical data regarding the use of the AcQMap® System in the 
ablation of persistent atrial fibrillation (AF). 
 
The objective of the statistical analyses is to evaluate the incidence of device- and 
procedure-related safety, efficacy, and efficiency (six and 12 month outcomes) when 
using the AcQMap as an imaging and mapping system for ablation of persistent AF. 
 
1.1 Design and Treatment 
 
Subjects will be enrolled in the trial for approximately 12 months. All enrolled subjects will 
undergo an ablation procedure using the AcQMap Imaging and Mapping System as the 
only advanced 3D navigation system. The AcQMap Imaging and Mapping System is 
intended for imaging and mapping of cardiac chambers, which will be utilized in the 
management of cardiac arrhythmias.  
 
1.2 Study Procedures 
 
Subject assessments will occur at screening, procedure, hospital discharge, one, three, 
six, nine, and 12 months. A follow up phone call will also occur seven days post-
procedure. 
 
Inclusion and exclusion criteria will be assessed prior to enrollment and during the 
screening 
period 
up 
through 
the 
pre-procedure 
required 
transesophageal 
echocardiogram (TEE). Assessments performed during screening will include subject 
demographics, medical history, physical exam findings, transthoracic echo (TTE) results 
(within previous six months), clinical laboratory exams, electrocardiograms (ECGs), the 
Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire and the aforementioned 
TEE.     

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Subjects who meet all inclusion and exclusion criteria will be enrolled into the study and 
will proceed to receive an ablation procedure. Prior to hospital discharge, the following 
post-procedure evaluations will be completed: physical exam, 12-lead ECG, collection of 
concomitant medications and reporting of all adverse events. A phone call will occur 
seven days following hospital discharge to review concomitant medications, adverse 
events, and scheduled follow up visits. 
 
Follow up clinical visits will occur at one, three, six, and 12 months. The following 
evaluations will be performed: 
 
• History and physical exam (including neurological assessment) 
• Medication history 
• Adverse events assessment 
• Vital Signs 
• 12-lead electrocardiogram 
• Echocardiogram (TTE at 12 months only, for comparison to baseline) 
• AFEQT Questionnaire (completed prior to the clinic visit) 
• 24-hour continuous monitor (three, six, nine, and 12 months post ablation 
procedure) 
o Since the 24-hour continuous monitor at nine months does not coincide with 
a follow-up visit, the subject will be instructed how and when to wear the 
recording device. Once the recording is completed, the device will be 
returned to a core lab.  Results will be compiled and reported to the site and 
Sponsor. Results of the recording will be entered into an electronic case 
report form (eCRF).    
 
1.3 Sample Size 
 
The total sample size for the combined studies was selected based on the primary safety 
objective of the study. In order to estimate the primary safety objective within a margin of 
error of 3.89% (i.e., this is the 95% confidence interval half-width), assuming the observed 
proportion of subjects who are free from device/procedure related Major Adverse Events 
(MAEs) that occur within the first 24 hours post index procedure is 96.0%, a total of 125 
subjects is required. These calculations assume the data are from a binomial distribution 
and that the confidence interval will be computed using the Clopper-Pearson exact 
approach. 
 
2.0  Data Analysis Considerations 
 
2.1 Types of Analyses 
 
Data analyses will consist of descriptive statistics and confidence intervals.  Tests of 
hypotheses will not be conducted. 
 

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2.2 Analysis Populations 
 
The following analysis populations will be defined for the study: 
 
Safety Population – The safety population will include all enrolled subjects who 
have the venous access portion of the ablation procedure initiated. 
 
Treatment Population – The treatment population will include all enrolled 
subjects who complete a procedure up to the point the AcQMap catheter has 
completed mapping the atrial anatomy. 
 
The analysis of the primary safety objective of the study will be based on the safety 
population. The analysis of the secondary safety and effectiveness outcomes will be 
based on the safety population or the treatment population as indicated in Sections 4 and 
5 below. 
 
2.2.1 Subgroup Definitions 
 
There are no subgroup analyses planned for this study.      
 
2.3 Missing Data Conventions 
 
With the exceptions noted below, no missing value imputation will be used.  That is, all 
analyses will be based on the observed data (i.e., complete case analysis). 
 
Missing 24-hour Holter rhythm data will be imputed from 12-lead ECG results for the 
corresponding visit at 3, 6, and 12 months. Statistics will be computed for complete case 
analysis and with the imputed data present. 
 
In case of missing data for dates, January will be imputed for missing months and the first 
will be imputed for missing days for purposes of elapsed time computations. 
 
2.4 Interim Analyses 
     
No formal interim analysis is planned for this study.  However, data collected up through 
the first 24 hours post procedure may be analyzed prior to all subjects completing this 
time point.  This data may be used for publications and/or marketing purposes, but will 
not be used to change the study design or procedures.  The study will continue as planned 
until the required sample size has been enrolled. 
Additionally, once all subjects have completed the six month follow up visit, the data 
collected up through that visit may be analyzed.  Data from the 12 month follow up visit 
will not be analyzed until all subjects complete the study. 
Separate Interim Data Review Plan (IDRP) documents will be written to describe the 
procedures for performing the data reviews at 24 hours and six months post procedure. 

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2.5 Study Center Considerations in the Data Analysis 
 
A study center is defined as a treatment administration site or group of treatment 
administration sites under the control and supervision of the same Principal Investigator 
(PI).  There will be no selective pooling of study centers. 
 
2.6 Documentation and Other Considerations 
 
The data analyses will be conducted using SAS Software, version 9.4 or later. 
 
3.0  Analysis of Baseline Patient Characteristics 
 
Baseline and demographic characteristics, including a detailed arrhythmia history, will be 
summarized for all subjects in the safety population.  Continuous variables will be 
summarized via mean, standard deviation, median, range, and number of non-missing 
responses. Categorical variables will be summarized via counts and percentages.   
 
Time-to-event (e.g., Time since first documented AF diagnosis) will be computed as  
 
TTE = End-Date – Start-Date, 
 
where TTE represents the time to the event, End-Date the ending date for the event, and 
Start-Date the starting date for the event. 
 
4.0  Analysis of Safety  
 
4.1 Description of Safety Objectives  
 
4.1.1 Primary Safety Objective 
 
The primary measurable objective is an analysis of the proportion of subjects who are 
free from device/procedure related Major Adverse Events (MAEs), as adjudicated by the 
Clinical Events Committee (CEC), that occur within the first 24 hours post index 
procedure. MAEs include any of the following: 
 
• Death 
• Cardiac perforation/tamponade 
• Cerebral infarct, transient ischemic attack (TIA), or systemic embolism 
• Major bleeding 
• Mitral or tricuspid valvular damage 
• Other serious adverse device effects (SADEs) adjudicated by an independent CEC 
as “probably related” to the AcQMap System 

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4.1.2 Secondary Safety Objectives 
 
The secondary safety analysis measures are defined as follows: 
 
• All adverse events (AEs) reported through 12 months 
• 12-lead ECGs and Holter monitor results 
• Physical exam findings 
• Vital signs 
 
 
4.2 Analysis of Safety Objectives  
 
4.2.1 Analysis of Primary Safety Objective 
 
Subjects who remain free from device/procedure related MAEs, as adjudicated by the 
CEC, that occur within the first twenty-four (24) hours post index procedure will be 
considered a success with respect to the primary safety objective, and subjects who 
experience at least one such MAE will be considered a primary safety failure. MAEs that 
occur during the first 24 hours will be reported and adjudicated by the CEC for any 
probable relationship to the device and/or procedure. 
 
The analysis of the primary safety objective will be performed on the safety 
population. The number and proportion of subjects in the safety population who are 
primary safety successes will be computed, along with a 95% exact binomial (i.e., 
Clopper-Pearson) confidence interval on the proportion. 
 
4.2.2 Analysis of Secondary Safety Objectives 
 
With the exception of treatment emergent adverse events (TEAEs), all analysis of 
secondary safety objectives will be conducted on the treatment population. TEAE 
analyses will be conducted on the safety population. 
 
Adverse Events  
 
All treatment-emergent AEs (TEAEs) occurring during the study will be recorded and 
classified on the basis of the Medical Dictionary for Regulatory Activities (MedDRA®) 
terminology. Treatment-emergent AEs are those AEs with an onset on or after the start 
time of the ablation procedure (defined as the point the AcQMap catheter is deployed in 
the left atrium). All TEAEs will be categorized by the number of subjects reporting the 
TEAE, severity, device relationship as adjudicated by the CEC (not related, possibly 
related, probably related, and definitely related), procedure relationship as adjudicated by 
the CEC (not related, possibly related, probably related, and definitely related),  and 
seriousness. A separate relationship table will be provided for each device in the study 
(AcQMap System, AcQGuide Sheath, AcQMap Catheter, and Patient Electrode Kit).  
 

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A separate TEAE summary table will be constructed to display the number of TEAEs, the 
number of subjects with at least one TEAE, the maximum severity per subject, the 
maximum device relationship per subject, the maximum procedure relationship per 
subject, the number of subjects experiencing at least one serious TEAE, the number of 
withdrawals from the study due to a TEAE, and the number of deaths.  
 
The device and procedure relationships used in the analysis tables will be based on the 
CEC adjudicated results. However, the relationships assigned by the investigators will be 
listed. TEAE adjudicated as non-events by the CEC will not be analyzed.  
 
12-Lead ECGs   
 
12-Lead ECGs will be performed in screening, prior to procedure (baseline), at the 
completion of procedure, prior to hospital discharge, and at one, three, six, and 12 months 
post-procedure. The number and percent of subjects with each ECG rhythm will be 
reported by time point.  
 
24-Hour Holter Monitor 
 
A 24-Hour Holter monitor of heart rhythm will be completed at three, six, nine, and 12 
months. The number and percent of subjects with each heart rhythm will be reported by 
time point. The Holter data will be listed along with the 12-Lead ECG data. 
 
Physical Exam Findings   
 
Physical exams will be performed at screening (baseline), pre-procedure, discharge, and 
at the one, three, six, and 12 month follow up visits. A physical exam shift table will be 
constructed for each post-procedure time point in order to count the frequency of each 
shift for each body system. Shifts include normal/normal, normal/abnormal, 
abnormal/normal, and abnormal/abnormal. 
 
Vital Signs  
 
Vitals signs will include heart rate, blood pressure, and temperature.  Vital signs will be 
taken at screening (baseline), discharge, and at the one, three, six, and 12 month follow 
up visits.   For each vital sign, summary statistics (mean, standard deviation, median, 
range, n) on the raw as well as their changes from baseline will be presented by timepoint.  
If repeat vital signs are taken at a given time point, then the last measurement will be 
used for the analysis tables.  All vital signs will be listed. 
 

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5.0  Analysis of Effectiveness 
 
5.1 Description of Effectiveness Objectives 
 
5.1.1 Description of Primary Effectiveness Objective    
 
The primary objective of this study is categorized as a safety measure (see Section 4.1.1).  
All effectiveness objectives are considered to be secondary and are described in Section 
5.1.2. 
 
5.1.2 Description of Secondary Effectiveness Objectives     
 
Secondary measurable effectiveness objectives include the following, which are divided 
into procedure outcome measures and clinical outcome measures. 
 
The procedure outcome measures are: 
 
• Proportion of subjects with acute procedural (ablation) success defined as: 
o Conversion to sinus rhythm (with or without direct current cardioversion 
[DCCV]) within 12 hours of the procedure 
o Procedural conversion to atrial flutter, atrial tachycardia or other organized 
supraventricular rhythm 
• Procedure fluoroscopy time 
• Ablation time to complete PVI 
• Ablation time for non-PVI ablation 
• Ablation time for right atrial ablation 
• Number of DCCV completed during the procedure 
 
The clinical outcome measures are: 
 
• Proportion of subjects with freedom from documented episodes of AF/AT/AFL 
lasting longer than 30 seconds, based on the 24-hour continuous ECG monitor at 
three, six, nine, and 12 months post ablation. Analysis will include: 
o Freedom from AF/AT/AFL without AADs 
o Freedom from AF/AT/AFL with AADs 
o Freedom from AF/AT/AFL with a single procedure 
o Freedom from AF/AT/AFL with multiple procedures 
• Improvement of left atrial (LA) size at 12 months compared to baseline 
• Number of repeat ablation procedures in follow-up period from day 91-270 (i.e., 
from three months to nine months) 
• Number of DCCV in first 90 days post-ablation 
• Number of DCCV from day 91-365 (i.e., from three months to 12 months) 
• Changes in patient reported outcomes (PROs) in the follow-up period, based on 
the AFEQT questionnaire 
 

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STATKING Clinical Services                                                                                              Acutus Medical 
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5.2 Analysis of Effectiveness Objectives 
 
5.2.1 Analysis of Primary Effectiveness Objective 
 
N/A 
 
5.2.2 Analysis of Secondary Effectiveness Objectives 
 
All secondary effectiveness analyses will be conducted on the treatment population.   
 
Procedure Outcome Measures 
 
The continuous procedure outcome measures, which include procedure fluoroscopy time, 
ablation time to complete PVI, ablation time for non-PVI ablation, ablation time for right 
atrial ablation, and the number of DCCV completed during the procedure will be 
summarized via mean, standard deviation, median, range, and number of non-missing 
responses.  Ninety-five percent (95%) confidence intervals (CIs) on the mean will also be 
provided.  
 
The categorical procedure outcome measure of acute procedural success will be 
summarized by the number of successful subjects and the proportion of successful 
subjects. An exact binomial 95% CI on the proportion will also be provided.      
 
Clinical Outcome Measures 
 
The number and proportion of subjects with freedom from documented episodes of 
AF/AT/AFL lasting longer than 30 seconds, based on the 24-hour continuous ECG 
monitor at three, six, nine, and 12 months post ablation will be displayed, along with exact 
binomial 95% CI’s for each proportion.  Separate proportions and confidence intervals will 
be calculated for: 
o Freedom from AF/AT/AFL with a single procedure 
o Freedom from AF/AT/AFL with a single procedure without AADs 
o Freedom from AF/AT/AFL with a single procedure with AADs 
o Freedom from AF/AT/AFL with multiple procedures 
o Freedom from AF/AT/AFL with multiple procedures without AADs 
o Freedom from AF/AT/AFL with multiple procedures with AADs. 
o Freedom from AF with a single procedure 
o Freedom from AF with a single procedure without AADs 
o Freedom from AF with a single procedure with AADs 
o Freedom from AF with multiple procedures 
o Freedom from AF with multiple procedures without AADs 
o Freedom from AF with multiple procedures with AADs. 
 
Descriptive statistics (mean, standard deviation, median, range, and number of non-
missing responses) on the raw and change from baseline (CFB) LA size will be reported 

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at 12 months, along with a separate set of descriptive statistics for the raw baseline data.  
A 95% CI on the mean will also be provided.     
 
The number of repeat ablation procedures in follow-up period from day 91-270 (i.e., from 
three months to nine months) will be summarized via mean, standard deviation, median, 
range, and number of non-missing responses.  A 95% CI on the mean will also be 
provided. 
    
The number of DCCV in first 90 days post-ablation and the number of DCCV from day 
91-365 (i.e., from three months to 12 months) will be summarized via mean, standard 
deviation, median, range, and number of non-missing responses.  A 95% CI on the mean 
will also be provided. 
 
Raw and CFB scores for the AFEQT questionnaire will be computed and summarized 
with descriptive statistics (mean, standard deviation, median, range, and number of non-
missing responses) by time point (one, three, six, and 12 months post ablation).  The 
overall AFEAQT score is calculated according the following formula: 
𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴Overall = 100 × ቆ1 −
∑𝐴𝐴𝑗𝑗−𝑛𝑛
6𝑛𝑛
ቇ, 
where the summation extends over all items with a response, excluding questions 19 and 
20, and n represents the number items with responses. Items lacking responses are 
dropped from the analysis. If all items are missing, then the overall score is also missing. 
 
This analysis will be performed for the overall score and its three subscales (symptoms, 
daily activities, and treatment concern) and for the separate treatment satisfaction score.  
The subscale scores are computed similarly on the following subsets of questionnaire 
items: 
 
 
Subscale 
 
 
Questionnaire items included 
 
Symptoms 
 
 
1, 2, 3, 4 
 
Daily Activities 
 
5, 6, 7, 8, 9, 10, 11, 12 
 
Treatment Concerns 
13, 14, 15, 16, 17, 18 
 
As in the overall score, missing items are dropped from the analysis. If all items in a 
subscale are missing, the subscale score is also missing. 
 
As noted above, items 19 and 20 are not included in the overall AFEQT score. These 
items form a separate scale for treatment satisfaction: 
 
𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴Treatment Satisfaction = 100 × ൬1 −𝐴𝐴19 + 𝐴𝐴20 −𝑛𝑛
6𝑛𝑛
൰, 
 
where n is the number of items answered. 
 

Statistical Analysis Plan 
 
                           UNCOVER-AF Study 
 
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STATKING Clinical Services                                                                                              Acutus Medical 
Version 2.0 
                                                                                                            May 20, 2019 
6.0  Other Relevant Data Analyses/Summaries 
 
6.1 Subject Completion  
 
A table will be constructed with counts and percentages of subjects who completed the 
study and subjects who withdrew from the study. Of the subjects who withdrew from the 
study, the number and percent of subjects with each withdrawal reason will be reported.         
 
6.2 Prior and Concomitant Medications 
 
All prior/concomitant medications taken by or administered to a subject will be collected 
according to the time intervals described in the clinical study protocols.  All 
prior/concomitant medications will be coded the WHO Drug Dictionary prior to analysis.  
 
A table of the WHO-coded medications will be constructed with medications summarized 
by anatomical therapeutic chemical (ATC) code levels. The number and percent of 
subjects on each drug will be summarized. A separate table summarizing antiarrhythmic 
medications (AADs) will also be constructed.   
 
The analysis of concomitant medications and AADs will be performed for the safety 
population and for the treatment population.  
 
7.0  References 
 
N/A 
 
 

Statistical Analysis Plan 
 
                           UNCOVER-AF Study 
 
Page 15 of 16 
STATKING Clinical Services                                                                                              Acutus Medical 
Version 2.0 
                                                                                                            May 20, 2019 
Appendix A – Tables, Figures and Listing Specifications 
 
Orientation 
 
Tables and figures will be displayed in landscape.  
 
Margins  
 
Margins will be 1 inch on all sides.  Table and listing boundaries will not extend into the 
margins. 
 
Font 
 
Courier New, 8 point. 
 
Headers 
 
The table number will be on the first line of the title.  The title area will contain the 
Sponsor name, the study number, and the name of the table.  The title area will contain 
the page number (Page x of y) on the far right, one line above the name of the table. 
 
Footers 
 
- The first line will be a solid line. 
- Next will be any footnotes regarding information displayed in the table. 
- Below these footnotes will be displayed “STATKING Clinical Services (Date)” on the 
far left. 
- The last line will display the name of the SAS program that generated the table and (if 
applicable) the source data reference. 
 
Table Disclaimer 
 
The format of the mock tables shown in the appendix of this Statistical Analysis Plan 
(SAP) will be the format of the deliverable tables to the extent that Word document 
constructed tables can match production tables produced by SAS.  This formatting 
includes the content and format of the header and footer areas of the tables.  The 
Sponsor agrees to the format of the tables as shown in the appendix. 
 
Further programming charges will be applicable for changes in the format of tables 
(including title statements, notes, data dependent footnotes, etc.) made after the 
approval of the SAP. 
 
 
 
 
 

Statistical Analysis Plan 
 
                           UNCOVER-AF Study 
 
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STATKING Clinical Services                                                                                              Acutus Medical 
Version 2.0 
                                                                                                            May 20, 2019 
Missing Values 
 
All missing values will be displayed on the output tables/listings as blanks. 
 
Display of Study Dates 
 
The date format to be used is yyyy-mm-dd.  Missing parts of dates are not shown (i.e., 
for a missing day value, the value displayed is in yyyy-mm format).