Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF)
Phase: NA
Conditions: Recurrent Atrial Fibrillation
Sponsor: Acutus Medical

CLP-AF-004, Rev. 02 
***CONFIDENTIAL*** 
Page 1 of 42 
 
 
 
 
 
Utilizing Novel Dipole Density Capabilities to Objectively 
Visualize the Etiology of Recurrent Atrial Fibrillation 
Following a Failed AF Ablation  
(RECOVER AF) 
 
Protocol: CLP-AF-004, Revision 02 
07 June 2018 
 
Sponsor: 
Acutus Medical, Inc. 
2210 Faraday Ave, Suite 100 
Carlsbad, CA  92008 
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. 
 
 

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF 
Ablation (RECOVER AF) 
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PROTOCOL SIGNATURE PAGE 
CLP-AF-004 Rev 02 
 
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 
 
 
 
 
 
 
 
 
 

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF 
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Revision History 
Revision # 
Date 
Description 
01 
30 October 2017 
Initial release 
02 
07 June 2018 
Changed inclusion criteria, modified Schedule of Events to include 
retreatment procedure and the application of an additional continuous ECG 
monitor, changed contact information, and added Medical Monitor.  
 
 
 

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF 
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1 CLINICAL STUDY SYNOPSIS 
 
 
STUDY TITLE 
Utilizing Novel Dipole Density Capabilities to Objectively Visualize 
the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation 
(RECOVER 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 to be used in 
the right and/or left atria to visualize the selected chamber and display 
atrial electrical impulses. 
SPONSOR 
Acutus Medical®, Inc. 
2210 Faraday Ave., Suite 100 
Carlsbad, CA  92008 
STUDY 
OBJECTIVES 
To evaluate the performance and efficiency of the AcQMap Imaging 
and Mapping System in an ablation retreatment procedure for recurrent 
atrial fibrillation following a failed AF ablation 
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 High Resolution Imaging and Mapping 
System during an atrial fibrillation retreatment ablation procedure.  The 
patient population includes men and women, eighteen (18) years of age 
or older, who in the past twenty-four (24) months have had no more than 
two (2) previous left-atrial ablations for AF treatment.  The treatment 
plan must include evaluation and ablation (as indicated) of pulmonary 
vein reconnections plus AcQMap guided non-PV substrate ablation. 
Subject assessments will occur at screening, procedure, hospital 
discharge, 3-, 6-, and 12-months. 
SAMPLE SIZE 
Enrollment of up to one hundred (100) subjects that complete the 
ablation procedure using the AcQMap System 
CLINICAL SITES 
Up to fifteen (15) Clinical Sites 
DURATION 
Enrollment is anticipated to take approximately twelve (12) months.  
Post-procedure assessments will occur at 3-, 6-, and 12-months.  The 

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total study duration is anticipated to be approximately twenty-four (24) 
months.     
OUTCOME 
MEASURES 
The measurable objectives are a descriptive analysis of the following: 
• 
At the procedure conclusion, confirmation of electrical 
isolation of all pulmonary veins and elimination/modification 
of all non-PV targets as identified by the AcQMap System 
• 
Recording of all subjects who are atrial fibrillation free from 
events lasting > 30 seconds at 6-, and 12-months as measured 
by a 48-hour continuous ECG 
o A subset analysis of AAD use 
o A subset analysis of subjects with freedom from 
AF/AT/AFL events lasting > 30 seconds as measured 
by a 48-hour continuous ECG  
• 
Documentation of procedure data including total time, 
fluoroscopy time, ablation times for PVI, and ablation times 
for non-PV targets 
• 
Safety – Recording of all device and procedure related safety 
events through 24 hours post-ablation 
INCLUSION 
CRITERIA  
The patient population will consist of men and women eighteen (18) 
years of age or older, scheduled for a repeat endocardial ablation of AF 
following a failed ablation for atrial fibrillation. 
A potential subject will be eligible for study enrollment only if all the 
following inclusion and none of the exclusion criteria apply: 
IC 1 
Male or female eighteen (18) years of age or older 
IC 2 
Currently scheduled for a repeat endocardial ablation of AF  
IC 3 
Willingness, ability, and commitment to participate in baseline 
and follow-up evaluations for the full length of the study  
IC 4 
Willingness and ability to give informed consent 
EXCLUSION 
CRITERIA 
EC 1 
In the opinion of the Investigator, any known contraindication to a 
left-atrial ablation or concerns for left-atrial thrombus 
EC 2 
No more than two (2) previous left-atrial ablations   
EC 3 
Atrial arrhythmias secondary to electrolyte imbalance, thyroid 
disease, or any other reversible or non-cardiac cause 
EC 4 
Structural heart disease or implanted devices as described below: 
a. An implanted pacemaker or ICD 
b. Previous cardiac surgery, ventriculotomy, or atriotomy 
(excluding atriotomy for CABG)  
c. Previous cardiac valvular surgical or percutaneous 
procedure, or prosthetic valve 
d. Interatrial baffle, closure device, patch, or PFO occluder 
e. Presence of a left atrial appendage occlusion device 
f. Unstable angina or ongoing myocardial ischemia 

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EC 5 
History of blood clotting or bleeding disease 
EC 6 
Pregnant or lactating (current or anticipated during study follow 
up) 
EC 7 
Current enrollment in any study protocol sponsored by Acutus 
Medical or any other study that may impact the results of 
RECOVER AF 
EC 8 
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, extensive travel away 
from the research center, etc.) 
DATA 
COLLECTION 
• 
Screening data to include demographics, arrhythmia history, 
current AAD use, and previous AF ablation history (3D 
system use, ablation targets including PV and non-PV 
locations, etc.). 
• 
Procedure data to include procedure time, fluoroscopy time, 
maps of ablation targets, pre-and post-procedure rhythm, 
DCCV for conversion, and a post-ablation AcQMap in the 
procedure ending rhythm.  All alterations to ablation due to 
esophageal proximity will be noted. 
• 
Follow-up data to include safety events reported through 
discharge, continuous ECG monitor (≥ 48-hr), and AAD 
medications at 3-, 6- and 12-months post-procedure. 
STATISTICAL 
METHODS AND 
ANALYSIS 
SUMMARY 
Descriptive statistical analysis of all data recorded 
FOLLOW-UP 
EVALUATIONS 
See Table Below 
 
 
 

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF 
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Table 1:  Schedule of Events 
 
Screening 
& 
Baseline 
Procedure 
Discharge 
3-month 
(± 14 days) 
6-month 
(± 30 days) 
12-Month 
(± 30 days) 
Retreatment 
Visit (if 
medically 
necessary) 
CIP Informed 
Consent 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Arrhythmia 
Management 
Assessment 
 
 
 
X 
X 
X 
X 
Cardiovascular 
Exam 
X 
 
X 
 
 
 
X 
AAD Medications 
X 
X 
X 
X 
X 
X 
X 
Procedure Data 
 
X 
 
 
 
 
X 
Adverse Events 
 
X 
X 
 
 
 
X 
12-lead ECG 
 
X 
X 
X 
X 
X 
X 
Continuous 48-hr 
ECG monitor 
 
 
 
X 
X 
X 
X (prior to 
retreatment) 
 
 
 

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2 TABLE OF CONTENTS 
1 
Clinical Study Synopsis .......................................................................................4 
2 
Table of Contents .................................................................................................8 
3 
Contact Information ...........................................................................................11 
3.1 
Name and Address of Sponsor .......................................................................... 11 
4 
Abbreviations .....................................................................................................12 
5 
Introduction to the Clinical Investigational Plan/Protocol.................................14 
5.1 
Background ....................................................................................................... 14 
5.2 
Clinical Study Design Justification ................................................................... 17 
5.3 
Indication for Use Statement ............................................................................ 17 
5.4 
Device Description............................................................................................ 17 
5.4.1 
General System Description ....................................................................... 17 
5.4.2 
The AcQMap 3D Imaging and Mapping Catheter ..................................... 18 
5.4.3 
AcQGuide Steerable Sheath ....................................................................... 18 
6 
Clinical Study.....................................................................................................18 
6.1 
Clinical Study Objective ................................................................................... 18 
6.2 
Clinical Study Design ....................................................................................... 18 
6.2.1 
Measurable Objective ................................................................................. 18 
6.3 
Clinical Study Duration .................................................................................... 19 
6.4 
Clinical Study Sample Size and Clinical Sites ................................................. 19 
6.5 
Clinical Study Enrollment Definitions.............................................................. 19 
6.6 
Clinical Study Population ................................................................................. 20 
6.6.1 
Inclusion Criteria ........................................................................................ 20 
6.6.2 
Exclusion Criteria ....................................................................................... 20 
6.7 
Subject Withdrawal ........................................................................................... 21 
7 
Clinical Study Treatments and Follow-up Visits ...............................................21 
7.1 
Informed Consent.............................................................................................. 21 
7.2 
Subject Screening and Baseline ........................................................................ 21 
7.2.1 
Mapping and Ablation ................................................................................ 22 

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7.2.2 
Procedure Data Collection .......................................................................... 22 
7.3 
Follow-Up Procedures ...................................................................................... 22 
7.3.1 
Hospital Discharge ...................................................................................... 22 
7.3.2 
Visits at Three, Six and Twelve Months ..................................................... 23 
7.4 
Recurrence of Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia ................. 23 
8 
Statistical Methods .............................................................................................25 
9 
Adverse Events ..................................................................................................25 
9.1 
Adverse Event Reporting .................................................................................. 26 
9.2 
Event Relationship to the Device ...................................................................... 27 
9.3 
Death Notice ..................................................................................................... 27 
9.4 
Device Complaint and Malfunction .................................................................. 27 
9.5 
Adverse Event Analysis .................................................................................... 28 
10 
Risk: Benefit Analysis .......................................................................................28 
10.1 
Risks .................................................................................................................. 28 
10.2 
Mitigation of Risks ........................................................................................... 29 
11 
Data Quality Assurance .....................................................................................29 
11.1 
Site Data Management ...................................................................................... 29 
11.2 
Subject Identification ........................................................................................ 30 
11.3 
Screen Failure Subjects ..................................................................................... 30 
11.4 
Subject Study Completion and Withdrawal ...................................................... 30 
11.5 
Subjects Lost-to-Follow-Up.............................................................................. 30 
11.6 
Confidentiality of Data ..................................................................................... 30 
11.7 
Source Documents ............................................................................................ 30 
11.8 
Electronic Case Report Forms .......................................................................... 31 
11.9 
Records Retention ............................................................................................. 32 
11.10 Clinical Monitor ................................................................................................ 32 
11.11 Clinical Data Monitoring Procedures ............................................................... 32 
11.11.1 Medical Monitor ......................................................................................... 33 
11.12 Investigator Responsibilities ............................................................................. 33 

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11.13 Deviations from the Clinical Investigational Plan ............................................ 33 
11.13.1 Maintaining Records ................................................................................... 34 
11.13.2 Submitting Reports ..................................................................................... 35 
11.14 Acutus Medical Responsibilities....................................................................... 35 
11.14.1 General Duties ............................................................................................ 35 
11.14.2 Selection of Investigators ............................................................................ 36 
11.15 Training ............................................................................................................. 37 
11.15.1 Changes in the Clinical Investigational Plan .............................................. 37 
11.15.2 Withdrawal of Regulatory Approval .......................................................... 37 
12 
Ethics and Regulatory Compliance ....................................................................38 
12.1 
Conduct of the Clinical Study ........................................................................... 38 
12.2 
Ethics Committee Approval .............................................................................. 38 
12.3 
Clinical Study Informed Consent Approval ..................................................... 38 
12.4 
Identification and Confidentiality ..................................................................... 38 
12.5 
Site Qualification Visits .................................................................................... 39 
12.6 
Site Initiation Visits .......................................................................................... 39 
12.7 
Insurance ........................................................................................................... 39 
12.8 
Site Audit Plan .................................................................................................. 39 
12.8.1 Site Data Audits by Acutus Medical ........................................................... 40 
12.8.2 External Audits ........................................................................................... 40 
12.9 
Public Domain Access to the Clinical Study .................................................... 40 
12.10 Required Reports .............................................................................................. 40 
13 
General Considerations ......................................................................................40 
13.1 
Discontinuation of the Clinical Study ............................................................... 40 
13.2 
Use of Information and Publications ................................................................ 41 
14 
Appendix ............................................................................................................42 
14.1 
Bibliography ..................................................................................................... 42 
 

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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 
AFL 
Atrial Flutter 
AIU/PIU 
Ablation Interface Unit/Patient Interface Unit 
AT 
Atrial Tachycardia 
ATP 
Adenosine 
CABG 
Coronary Artery Bypass Grafting 
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 
CTI 
Cavo-tricuspid Isthmus 
DCCV 
Direct Current Cardioversion 
DMP 
Data Management Plan 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EGM 
Electrogram 
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 
ISF 
Investigator Site Files 
ISO 
International Organization for Standardization 
IV 
Intravenous 
LA 
Left Atrium 
LFU 
Lost to Follow-Up 
OM 
Operator’s Manual 

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PAF 
Paroxysmal Atrial Fibrillation 
PFO 
Patent Foramen Ovale 
PI 
Principal Investigator 
PV 
Pulmonary Vein 
PVI 
Pulmonary Vein Isolation 
QAP 
Quality Assurance Procedure 
RF 
Radio Frequency 
RMV 
Routine Monitoring Visit 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SIV 
Site Initiation Visit 
SOC 
Standard of Care 
SOP 
Standard Operating Procedure 
SVT 
Supraventricular Tachycardia 
SQV 
Site Qualification Visit 
TIA 
Transient Ischemic Attack 
TMF 
Trial Master File 
TS 
Transseptal Puncture 
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/PROTOCOL 
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 AF that terminates spontaneously 
or with intervention within seven days of 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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• Persistent AF is defined as continuous AF that is sustained beyond 
seven days.  It is further sub-stratified into early persistent AF 
(continuous AF > 7-days but ≤ 3 months). 
• Long-standing persistent AF is defined as continuous AF of greater 
than 12 months 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.4 
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.5,6,7,8,9  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.10,11  This landmark observation caused the 
electrophysiology (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. 
 
4 Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS?APHRS/SOLAECE Expert Consensus 
Statement on Catheter and Surgical Ablation of Atrial Fibrillation.  Epub Heart Rhythm, May 12, 2017. 
5 Jalife J, Berenfeld O, Mansour M. Mother rotors and fibrillatory conduction: a mechanism of atrial 
fibrillation. Cardiovasc Res. May 2002;54(2):204–216. 
6 Nattel S. New ideas about atrial fibrillation 50 years on. Nature. Jan 10 2002; 415(6868):219–226. 
7 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. 
8 Schotten U, Verheule S, Kirchhof P, Goette A. Pathophysiological mechanisms of atrial fibrillation: a 
translational appraisal. Physiol Rev. Jan 2011;91(1):265–325. 
9 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 
10 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. 
11 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. 

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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.12  AF can also be the result of 
preexisting atrial disease. Although much has been learned about the mechanisms of 
AF, they are not 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 non-contact 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.13  Additionally, 
electromagnetic navigation systems have been shown to substantially reduce the 
fluoroscopy time required for AF ablation.14,15,16 
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 AF, which can be targeted for ablation. 
 
12 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 
13 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.  
14 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.  
15 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.  
16 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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5.2 
Clinical Study Design Justification 
Previous clinical studies utilizing the AcQMap System in an ablation procedure for 
supraventricular tachycardias (SVTs) have initially demonstrated an acceptable safety 
profile when mapping and imaging cardiac chambers.  The RECOVER AF 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 High 
Resolution Imaging and Mapping System during an atrial fibrillation retreatment 
ablation procedure.  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, AcQGuide Steerable Sheath, and the AcQMap 
System.   
Since it is hypothesized the technology advances of dipole density mapping may better 
identify and more precisely direct lesion locations during atrial arrhythmia ablations, 
the study is additionally designed to record longer term (6- and 12-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 arrhythmias 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.   
Automatic, instantaneous, and simultaneous 3D display of the LA surface with 
associated charge densities may potentially shorten atrial arrhythmia ablation 
procedure time and provide an intuitive tool to rapidly identify and guide effective 
treatment.   
5.3 
Indication for Use Statement 
The AcQMap Imaging and Mapping System is intended to be used in the right and/or 
left atria to visualize the selected chamber and display atrial electrical impulses. 
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.   
 
 

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AcQMap System Hardware 
The AcQMap System hardware consists of the AcQMap Console, AcQMap 
Workstation and the AcQMap Ablation Interface Unit/Patient Interface Unit 
(AIU/PIU).  The AcQMap Console contains all electronics for interfacing with patient-
contacting devices such as the AcQMap Catheter and the Patient Electrode Kit.   
 
5.4.2 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.   
5.4.3 
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. 
6 CLINICAL STUDY  
6.1 
Clinical Study Objective 
The objective of the clinical study is to evaluate the performance and efficiency of the 
AcQMap Imaging and Mapping System in an ablation retreatment procedure for 
recurrent atrial fibrillation following a failed AF ablation.  
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 High Resolution Imaging and Mapping System during an AF retreatment 
ablation procedure.  The patient population includes men and women, eighteen (18) 
years of age or older, who in the past twenty-four (24) months have had no more than 
two (2) previous LA ablations for AF treatment.  Subject assessments will occur at 
screening, procedure, hospital discharge, 3-, 6-, and 12-months. 
6.2.1 
Measurable Objective 
The measurable objectives are a descriptive analysis of the following: 
• At the procedure conclusion, confirmation of electrical isolation of all 
pulmonary veins and elimination/modification of all non-PV targets as 
identified by the AcQMap System 

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• Recording of all subjects who are atrial fibrillation free from events lasting > 
30 seconds at 6- and 12-months as measured by a 48-hour continuous ECG 
o A subset analysis of AAD use 
o A subset analysis of subjects with freedom from AF/AT/AFL events 
lasting > 30 seconds as measured by a 48-hour continuous ECG  
• Documentation of procedure data including total time, fluoroscopy time, 
ablation times for PVI, and ablation times for non-PV targets 
• Safety - Recording of all device and procedure related safety events 
through twenty-four (24) hours post-ablation 
6.3 
Clinical Study Duration 
Enrollment is anticipated to take approximately twelve (12) months.  Post-procedure 
assessments will occur at 3-, 6-, and 12-months.  The total study duration is anticipated 
to be approximately twenty-four (24) months.     
6.4 
Clinical Study Sample Size and Clinical Sites 
Up to one hundred (100) patients will be treated at up to fifteen (15) clinical sites in 
Europe. The sample size will include only those that complete an ablation procedure 
using the AcQMap technology (Treatment Subjects). 
6.5 
Clinical Study Enrollment Definitions 
For the purposes of this clinical study, the following definitions regarding the status 
of a subject will apply: 
Pre-Treatment Subject – Any subject who has signed an informed consent form, is 
deemed study eligible by meeting all of the inclusion and none of the exclusion criteria, 
and who has the venous access portion of the ablation procedure initiated.  Pre-
Treatment subjects 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 
using the AcQMap System. A completed ablation procedure is defined as a procedure 
where the PVI was evaluated and additional non-PV targets were mapped and ablated 
using the AcQMap System.  Treatment subjects should be followed for all study 
outcome measures for the full duration of the clinical study.   

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6.6 
Clinical Study Population 
The patient population will consist of men and women eighteen (18) years of age or 
older, scheduled for a repeat endocardial ablation of AF following a failed ablation for 
atrial fibrillation. 
A potential study subject will be eligible for study enrollment only if all the following 
inclusion and none of the exclusion criteria apply: 
6.6.1 
Inclusion Criteria 
IC 1 
Male or female eighteen (18) years of age or older 
IC 2 
Currently scheduled for a repeat endocardial ablation of AF  
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 
a left-atrial ablation or concerns for left-atrial thrombus 
EC 2 
No more than two previous left-atrial ablations  
EC 3 
Atrial fibrillation secondary to electrolyte imbalance, thyroid 
disease, or any other reversible or non-cardiac cause 
EC 4 
Structural heart disease or implanted devices as described below: 
a. An implanted pacemaker or ICD 
b. Previous cardiac surgery, ventriculotomy, or atriotomy 
(excluding atriotomy for CABG)  
c. Previous cardiac valvular surgical or percutaneous 
procedure, or prosthetic valve 
d. Interatrial baffle, closure device, patch, or PFO occluder 
e. Presence of a left atrial appendage occlusion device 
f. Unstable angina or ongoing myocardial ischemia 
EC 5 
History of blood clotting or bleeding disease 
EC 6 
Pregnant or lactating (current or anticipated during study follow 
up) 
EC 7 
Current enrollment in any study protocol sponsored by Acutus 
Medical or any other study that may impact the results of 
RECOVER AF 
EC 8 
Any other condition that, in the judgment of the investigator, 
makes the patient a poor candidate for this procedure, the study, 

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or compliance with the protocol (includes vulnerable patient 
population, mental illness, addictive disease, terminal illness 
with a life expectancy of less than two years, extensive travel 
away from the research center, etc.) 
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 subject.   
Subjects missing follow-up visits will not be considered lost to follow-up (LFU) until 
adequate attempts to contact the subject have been made. 
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 form (ICF) must be obtained from the 
subject before any study procedures not considered standard of care (SOC) 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 subject’s study records with one copy placed in the subject’s medical notes and 
one copy provided to the subject. 
7.2 
Subject Screening and Baseline  
The following information should be acquired to verify eligibility in the clinical study: 
• Subject demographics  
• Medical history review including: 
- 
Procedural data of the previous AF ablation(s) including 
date(s), ablation strategy (PVI, PVI plus, etc.) and 
advanced mapping systems used, if any 
- 
Current AADs  
- 
Date of most recent direct current cardioversion (DCCV) 
with duration of sinus rhythm following the cardioversion 
• Review of all inclusion/exclusion criteria to confirm subject eligibility 
• Cardiovascular Exam 

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7.2.1 
Mapping and Ablation 
The objective of this clinical study is to evaluate the performance and efficiency of the 
AcQMap System when mapping and imaging the left and right atria during retreatment 
procedures for recurrent atrial fibrillation.  Therefore, the utilization of devices for 3D 
anatomic reconstruction, navigation, and electrical mapping will be limited to the 
AcQMap System.  Ablation energies for PVI may include RF, cryo, or laser. Ablation 
strategies to create pulmonary vein isolation is at the discretion of the investigator and 
may include antral ablations, wide area circumferential ablation (WACA), or “single 
shot” therapy.  Radio frequency (RF) ablation catheters utilized during the procedure 
must be limited to those compatible with the AcQMap System.  All PVI ablation 
strategies and catheter types shall be recorded on the procedure eCRF. 
Refer to the Instructions for Use and Training Materials for a thorough description of 
the AcQMap preparation and delivery into the left atrium. 
7.2.2 
Procedure Data Collection 
Collection of data generated during the procedure should include: 
• Recording of 12-lead ECG at procedure start 
• Recording of 12-lead ECG for predominant atrial arrhythmia(s) 
• Recording of 12-lead ECG at procedure completion  
• Total procedure time (from first venous access to last cardiac catheter 
removed) 
• Total ablation time for PVI and non-PVI ablations 
• Total fluoroscopy time for the ablation procedure 
• Recording of all DCCV used during the procedure 
• Recording of all IV cardiac medications infused during the procedure 
• All alterations to ablation strategies due to esophageal proximity 
7.3 
Follow-Up Procedures 
Screening, procedure, and follow-up visits are outlined in Table 2. 
7.3.1 
Hospital Discharge 
Subjects should be monitored with telemetry prior to hospital discharge for the 
documentation of recurrence of any atrial arrhythmias.  A recurrence prior to discharge 
should not be considered an adverse event unless it delays the discharge. 
The following evaluations should be completed prior to discharge: 

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• Evaluation of femoral access sites 
• AADs at discharge 
• Evaluation and recording of adverse events 
• 12-lead electrocardiogram 
7.3.2 
Visits at 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. 
• Arrhythmia recurrence/treatment since last visit 
• AAD use and changes since last visit 
• DCCV history since last visit 
• 12-lead electrocardiogram 
• 48-hour continuous monitor (may include Holter recording, BardyDx 
CAM or equivalent) 
7.4 
Recurrence of Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia  
Occurrences of symptomatic AF or other tachyarrhythmias during the first 90 days 
post-ablation (blanking period) may be transient in nature and not associated with the 
long-term effectiveness of the ablation treatment.  However, prolonged AF should be 
treated as soon as possible to maintain SR during the remodeling period.  Treatment 
should follow the Investigator’s SOC for arrhythmia recurrence, which may include a 
DCCV and/or AAD administration.  If the Investigator elects to repeat an ablation, a 
48-hour continuous ECG monitor will be worn within two weeks and no later than 3 
days prior to the procedure to document the presenting rhythm. The AcQMap System 
will be used during the procedure. Procedure and discharge data will be collected as 
part of RECOVER AF.  There will be no adjustments to the scheduled follow-up 
periods and the study will be completed at 12-months post RECOVER AF index 
procedure. 
 
 
 

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Table 2:  Schedule of Events 
 
 
Screening 
& 
Baseline 
Procedure 
Discharge 
3-month 
(± 14 days) 
6-month 
(± 30 days) 
12-Month 
(± 30 days) 
Retreatment 
Visit (if 
medically 
necessary) 
CIP Informed 
Consent 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Arrhythmia 
Management 
Assessment 
 
 
 
X 
X 
X 
X 
Cardiovascular 
Exam 
X 
 
X 
 
 
 
X 
AAD Medications 
X 
X 
X 
X 
X 
X 
X 
Procedure Data 
 
X 
 
 
 
 
X 
Adverse Events 
 
X 
X 
 
 
 
X 
12-lead ECG 
 
X 
X 
X 
X 
X 
X 
Continuous 48-hr 
ECG monitor 
 
 
 
X 
X 
X 
X (prior to 
retreatment) 
 
 

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8 STATISTICAL METHODS  
Analysis of all data generated by the clinical study will be reported with descriptive 
statistics. There are no hypotheses established for the study therefore, the study sample 
size has not been established for power.  
9 ADVERSE EVENTS 
The safety outcome measure for this post-market study is a recording of all device and 
procedure related safety events through twenty-four (24)-hours post-ablation.  Any 
event that occurs through twenty-four (24)-hours post-ablation is considered an AE 
and will be recorded on an Adverse Event eCRF.  Any medical conditions, problems, 
signs, symptoms, or findings occurring prior to the AcQMap ablation procedure are to 
be considered as pre-existing conditions. The investigator has the responsibility of 
classifying any event as related to a component of the AcQMap System or the ablation 
procedure.   
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 
• led to congenital anomaly or birth defect 
Reports relating to the subject’s subsequent medical course following an SAE must be 
submitted to the Sponsor until the event has subsided or, in the event of permanent 
impairment, until the event has stabilized, and the overall clinical outcome has been 
ascertained. 
 
17  EN ISO 14155:2011 section 3.37 

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Adverse Device Effects (ADEs) 
Adverse Device Effects (ADEs) are a subset of AEs. The ADEs are only those AEs 
caused by, or related to the device, including any AE 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 AEs for the AcQMap System is found in the CIP/protocol, 
Instructions for Use (IFU) and OM.   
Unanticipated Adverse Device Effects (UADEs) 
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 no 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 Ethics Committee (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 procedure and device related AEs that 
occur within the first twenty-four (24) hours of the ablation procedure.  Initial 
reporting will be with the Adverse Event eCRF; however, additional information may 
be required by the Sponsor or any regulatory authority.  The Investigator should report 
any SAEs, SADEs, or UADEs to the Sponsor as soon as possible after becoming aware 
of the event, but no 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.   

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9.2 
Event Relationship to the Device 
The Investigator should provide information regarding the relationship of the event to 
the procedure and/or the AcQMap System or any of the components (AcQMap 
Catheter, AcQGuide Sheath, or Patient Electrode Kit). The device relationships are 
defined in the table below: 
 
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 ablation procedure. 
Possibly 
Related 
There is a reasonable possibility that the event may be related to 
the mapping and imaging portion of the 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 is related to the mapping and 
imaging portion of the 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 is definitely related to the mapping and imaging 
portion of the 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.   
9.4 
Device Complaint and Malfunction 
Each clinical procedure will be attended by Acutus Medical personnel responsible for 
the proper use of the technology.  If a malfunction occurs, the Sponsor representative 
will report the findings to the Clinical and Product Complaints departments.  
Evaluations of all complaints will follow Acutus Medical QAPs for complaint 
handling.   

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9.5 
Adverse Event Analysis 
All procedure and device related adverse events will be evaluated by a clinical 
representative for Acutus Medical. Reporting to convening ECs will follow local 
regulatory requirements. 
10 RISK: BENEFIT ANALYSIS 
10.1 Risks 
The following adverse events are associated with electrophysiology mapping and 
ablation procedures: 
• Adult Respiratory Distress Syndrome 
• Local hematomas/ecchymosis 
• Air embolism 
• Major bleeding, requiring surgery 
or transfusion 
• Anemia 
• Myocardial infarction 
• Anesthesia reaction 
• Obstruction, perforation or damage 
to the vascular system 
• Aorto-right atrial fistula 
• Pericardial effusion 
• Arrhythmias 
• Pericarditis 
• Arteriovenous (AV) fistula 
• Phrenic nerve damage 
• AV or SA node damage 
• Pleural effusion 
• Atrial esophageal fistula 
• Pneumonia 
• Cardiac perforation/tamponade 
• Pneumothorax 
• Cardiac thromboembolism 
• Pseudoaneurysm 
• Cerebral infarct (hemorrhagic or 
thromboembolic) 
• Pulmonary edema 
• Chest pain/discomfort 
• Pulmonary embolism 
• Complete heart block (transient or 
permanent 
• Pulmonary hypertension 
• Congestive heart failure 
• Pulmonary vein dissection 
• COPD exacerbation 
• Pulmonary vein stenosis 
• Coronary artery spasm/dissection 
• Pulmonary vein thrombosis 
• Coronary artery thrombosis/occlusion • Radiation injury 
• Death 
• Respiratory depression 
• Diaphragmatic paralysis 
• Seizure 
• Dislodgement of ICD/pacemaker 
leads 
• Skin burns 
• Elevated cardiac enzymes 
• ST segment elevation 
• Endocarditis 
• Temporary complete heart block 

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• Fever 
• Thromboembolism 
• Fluid overload 
• Transient ischemic attack (TIA) 
• Heart failure/pump failure 
• Valvular damage/insufficiency 
• Hemothorax 
• Vasovagal reaction 
• Infection/sepsis 
 
 
10.2 Mitigation of Risks 
Pre-clinical research and ongoing 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 the data collection for this study in accordance with Good 
Clinical Practices (GCP), regulatory requirements, the Data Management Plan (DMP), 
and corporate QAPs.  Data will be collected and stored in an Electronic Data Capture 
(EDC) system.  Data will be reviewed for accuracy and completeness by Acutus 
Medical (or designees).  Any discrepancies will be resolved with the Investigator or 
designees, as appropriate.  In order to preserve data integrity and security of the data, 
access to the study in the EDC will be controlled by Acutus Medical and shall be 
limited to appropriately trained personnel with assigned log-on credentials.   
11.1 
Site Data Management 
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 ICFs, correspondence with the 
reviewing EC, correspondence with Acutus Medical (or designees) and study 
monitors, AE 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 ICF process, permission for authorized Sponsor employees, study monitors 
or regulatory authorities to review, in confidence, any records that identify subjects in 
this study. 

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11.2 Subject Identification 
Subjects will be identified on all eCRFs and source documents by a unique, 
anonymized identification reference number, which will be issued once the ICF has 
been signed.  An identification reference number 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.  
11.4 Subject Study Completion and Withdrawal 
A subject will be considered completed when the 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 Exit eCRF. 
11.5 Subjects Lost-to-Follow-Up 
A subject will be considered LFU 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.   
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 Clinical Research Organizations (CROs). 
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 

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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 ICF 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. 
• AEs 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 AADs 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  
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 within two (2) weeks of the data being generated/collected.  
All missing data must be explained.  If a data entry error has been made, the corrected 

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information will be entered on the eCRF.  All such changes are recorded in the audit 
and queries reports.   
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 on 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. 
11.10 Clinical Monitor 
A CRO may be designated as the clinical monitor for this study.  Their personnel will 
be qualified by training and experience to oversee the conduct of the study.  The 
Clinical Monitors (also known as Clinical Research Associates (CRAs)) 
responsibilities include maintaining regular contact with each investigational site 
through telephone contact or email to ensure that: 1) the CIP/protocol is followed; 2) 
complete, timely, and accurate data are submitted; 3) problems with inconsistent and 
incomplete data are addressed; 4) complications and UADEs are reported to the 
Sponsor; and 5) the site facilities continue to be adequate. 
11.11 Clinical Data Monitoring Procedures 
Monitoring requirements will be defined in the Clinical Monitoring Plan (CMP).   The 
Clinical Monitors (or designees) may conduct site visits at the study facilities to 
monitor the study, which will be in compliance with the CIP/protocol, QAPs, and the 
CMP.  When a site visit is performed, the Investigational site agrees to allow the 
monitors and other authorized Acutus Medical personnel access to information.  The 
monitors may 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 activities may include, but are not limited to:  
• Evaluation of subject screening and selection methods 

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• 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 protocol deviations 
• Overall study compliance 
• Review of the Investigator Site File (ISF) 
11.11.1 Medical Monitor 
The medical Monitor for the clinical study is: 
Andrew Grace, MD 
Consultant, Papworth Hospital 
Cambridge CB38RE 
United Kingdom 
Phone: +44 1223 333 631 
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 GCP, 
International Organization for Standardization (ISO) 14155:2011, applicable 
regulatory requirements, and institutional procedures.  
11.13 Deviations from the Clinical Investigational Plan 
A CIP/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.   

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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 no later than 
five (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 Investigator’s 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 CIP, including the signed Investigator Agreement (IA), 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: 
• 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 ICF 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 ICF, 

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- 
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 UADE occurring during an investigation.  
• Any deviation from the CIP/protocol 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. 
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 ICF is obtained.  Acutus Medical will provide all information 
necessary to conduct the study, including the CIP/protocol and any reports of prior 
investigations, as appropriate.  During the conduct of the clinical study, updates 

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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 (PI).  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), 
• Signed Investigator’s Agreement, indicating an Investigator’s 
commitment to: 
- 
Conduct the investigation in accordance with the 
agreement, the CIP/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 CIP/protocol. 

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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.  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 (or designee).  To ensure uniform data collection and protocol compliance, 
training will include a review the CIP/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 
CIP/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 
EC approval of the protocol amendment (changes in subject care or 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. 

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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, GCPs, EN ISO 14155:2011, and other regional and local laws.  
Each Investigator must sign and date the IA 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 CIP/protocol. 
12.2 
Ethics Committee Approval 
A properly constituted, valid EC must review and approve the CIP/protocol, ICF, 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 SAEs or SADEs 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 designee). 
12.3 
Clinical Study Informed Consent Approval 
In accordance with the principles of Informed Consent, the Declaration of Helsinki, 
GCP, and EN ISO 14155:2011, ICF 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 ICF 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 the conduct of 
the clinical study that may impact the patient ICF may require revisions to the ICF.  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 
Subject identification and confidentiality will be ensured in accordance with all 
applicable regulatory and EC governance.  This includes, but is not limited to, the 
following: 
• Subjects will be identified on all eCRFs and source documents by a 
unique anonymized identification reference number. 
• eCRFs are confidential documents and will only be made available to 
Acutus Medical (and appropriate designees), the Investigator, the 

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biostatistician, and, if requested, to advisory committees and 
regulatory authorities (including United States Food and Drug 
Administration (USFDA)). 
• Data will be stored in accordance with regulations for handling of 
electronic data. 
Each study site will maintain (anonymous to Acutus Medical) a list identifying all 
subjects entered into the trial.  The list will be maintained as part of the investigation 
file and monitored for completeness. 
12.5 Site Qualification Visits 
Site Qualification Visits (SQV) will follow Acutus Medical QAPs.   
12.6 Site Initiation Visits 
All study personnel will be required to participate in a Site Initiation Visit (SIV) that 
follows Acutus Medical’s QAP.  When possible, the SIV training will be completed 
via a web access meeting. Components of this initiation visit may include: 
• Introduction of the study design including the protocol-specific 
treatment and follow-up phase 
• ICF process 
• Product training to all end-users  
• eCRF completion training 
• 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 

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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 
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 ICF. 
12.10 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 
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.  
Similarly, Investigators may withdraw from the study, subject to providing written 
notification to the Sponsor within thirty (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. 

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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 
CIP/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. 
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. 

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14 APPENDIX 
14.1 Bibliography 
A bibliography of pertinent publications identified or supportive of the clinical study 
will be maintained by Acutus Medical and is available upon request.