Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Phase: NA
Conditions: Supraventricular Tachycardia
Sponsor: Acutus Medical

Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy in Complex Supraventricular Tachycardia (DDRAMATIC-SVT) 
 
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Dipole Density Right (and left) Atrial Mapping and Assessment of 
Therapy In Complex Supraventricular Tachycardia 
(DDRAMATIC-SVT) 
 
 
Protocol: CL-SVT-005, Revision 05 
Date: 10 March 2016 
 
 
 
 
 
 
 
 
Sponsor: 
Acutus Medical, Inc. 
2210 Faraday Avenue, Suite 100 
Carlsbad, CA  92008 
 
 
 
 
 
 
 
 
 
 
 
Investigational device - exclusively for use in a clinical investigation. 
  
 
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: CL-SVT-005 
 
 
 
 
 
I have read this protocol and agree to conduct the study as outlined herein. 
 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to 
me who assist in the conduct of this study.  I will discuss this material with them to ensure they 
are fully informed regarding the device and the conduct of the study. 
 
 
 
 
 
______________________________________________________________________ 
Principal Investigator’s Signature 
 
 
 
 
Date 
 
 
 
______________________________________________________________________ 
Name of Principal Investigator (Typed or Printed) 
 
 
 
 

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TABLE OF CONTENTS 
 
 
1.0 REVISION HISTORY ..................................................................................................... 4 
2.0 SYNOPSIS ......................................................................................................................... 4 
3.0 INTRODUCTION............................................................................................................. 6 
4.0 STUDY OVERVIEW ..................................................................................................... 10 
4.1 
Study Design ........................................................................................................ 10 
4.2 
Study Objectives.................................................................................................. 10 
4.2.1 Primary Endpoints.............................................................................................. 10 
5.0 STUDY POPULATION ................................................................................................. 10 
5.1 
General Considerations .......................................................................................10 
5.2 
Inclusion Criteria .................................................................................................11 
5.3 
Exclusion Criteria ................................................................................................11 
6.0 DEVICE DESCRIPTION .............................................................................................. 12 
6.1 
General Description .............................................................................................12 
6.2 
Intended Use .........................................................................................................12 
6.3 
The AcQMap 3D Imaging and Mapping Catheter and AcQGuide Steerable 
Sheath Description ...........................................................................................................12 
6.4 
Hardware Description .........................................................................................13 
6.5 
Clinical Procedure .............................................................................................. 13 
7.0 STUDY EVALUATIONS ............................................................................................... 14 
7.1 
Overview .............................................................................................................. 14 
7.2 
Screening .............................................................................................................. 15 
7.3 
Procedure ............................................................................................................. 15 
7.4 
Follow-up Visit for Non-AF Patients (7 Days, +3/-0) ....................................... 15 
7.5 
Follow-up Visit for AF Patients (7 Days, +3/-0 and 3, 6&12 months +1/-0 
months)............................................................................................................................. 15 
7.6 
Patient Care Following the Investigation ......................................................... 15 
8.0 STATISTICAL METHODS .......................................................................................... 16 
8.1 
Sample Size Determination ................................................................................ 16 
8.2 
Data Analyses ...................................................................................................... 16 
9.0 RISK ANALYSIS............................................................................................................ 17 
9.1 
Summary of Expected Benefits .......................................................................... 17 
9.2 
Summary of Potential Risks ............................................................................... 17 
9.3 
Justification of Clinical Trial Design ................................................................ 17 
10.0 ADVERSE EVENTS ...................................................................................................... 18 
10.1 
Definitions ............................................................................................................ 18 
10.2 
Categories ............................................................................................................ 19 
10.3 
Reporting Timeline ............................................................................................. 19 
11.0 ETHICS ........................................................................................................................... 19 
12.0 MONITORING RESPONSIBILITIES & PLAN ........................................................ 20 
13.0 DATA MANAGEMENT ................................................................................................ 21 
15.0 REFERENCES ................................................................................................................ 22 
 
 

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1.0 
REVISION HISTORY 
Revision # Date 
Description 
01 
06-Feb-2014 
Initial release 
02 
28-May-2014 
Limited use of the system to offline analysis 
03 
17-Apr-2015 
Add additional patients and update the AcQMap System schematic 
diagram. Add the OTW AcQMap Catheter and AcQGuide Steerable 
Sheath. Also update previous clinical experience. 
04 
21-Apr-2015 
Removed limitation to guide therapy, updated enrollment duration 
and formatting/grammatical errors. 
05 
10-Mar-2016 
Increased sample size, clarified portions of the left atrial procedure, 
and revised reason for early termination of the study. 
 
 
2.0 
SYNOPSIS 
 
Study Objective 
To demonstrate safety and performance of the AcQMap™ High Resolution 
Imaging and Mapping System (AcQMap System) in gathering data to create 
right and/or left atrial dipole density activation maps in subjects with 
supraventricular tachycardias (SVTs). 
Study Device 
The AcQMap System consists of a diagnostic recording catheter with 
intracardiac ultrasound and electrical mapping components advanced through a 
steerable sheath and accessories that are connected to a computerized medical 
instrument. 
Study Design 
A prospective, non-randomized, open-label study. 
Sample Size 
A total of 50 subjects will be enrolled  
Study Duration 
Enrollment is anticipated to take approximately 3-6 months.  Follow-up is 7-10 
days for non-AF patients and 1 year for AF patients following the procedure for 
each patient. 
Primary 
Endpoints  
• 
The primary effectiveness endpoint of the study is the construction of pre- 
and post-treatment activation maps with the AcQMap System. 
• 
The primary safety endpoint is the incidence of device-and procedure-
related adverse events through 7 days post-procedure. 
Inclusion Criteria 
Subjects must: 
 
1. Be aged 18 to 75 years 
2. Be scheduled for ablation of a supraventricular tachycardia due to the 
arrhythmia being recurrent, poorly tolerated and/or unable to be controlled 
with antiarrhythmic drug therapy 
3. Be able and willing to give informed consent 

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Exclusion Criteria 
Subjects must not: 
 
1. 
Have any of the following: 
a. 
Patients with implanted prosthetic, artificial, or repaired cardiac 
valves in the chamber being mapped. 
b. 
Patients with permanent pacemaker or ICD leads in the chamber 
being mapped. 
c. 
Patients with hypercoagulopathy or an inability to tolerate 
anticoagulation therapy during an electrophysiology procedure. 
2. 
Have had a myocardial infarction within the prior two months  
3. 
Have had cardiac surgery within the prior three months  
4. 
Have an intracardiac thrombus 
5. 
Have clinically significant tricuspid and/or mitral valve regurgitation or 
stenosis  
6. 
Have had any cerebral ischemic event (including transient ischemic 
attacks) in the prior six months  
7. 
Be pregnant or nursing 
8. 
Be currently enrolled in any other clinical investigation 
Data Collection 
Screening 
a. Demographics (e.g., age, sex, race) 
b. Documentation of disease-related characteristics  
c. Presence/History of arrhythmia 
d. Previous and current treatments for arrhythmias  
e. Review of all inclusion/exclusion criteria to confirm subject eligibility 
f. 
Adverse events 
g. Transesophageal Echocardiography (TEE) or similar scan to rule out 
thrombus. 
 
Procedure 
a. Map of the heart chamber anatomy using standard tools and  the AcQMap 
System  
b. Confirmation of arrhythmia with 
c. Recording of the following (if present or performed) with the AcQMap 
System: 
• 
Pre-ablation: sinus rhythm, arrhythmia induction pacing, any induced or 
spontaneously occurring arrhythmia, and any pacing maneuvers, 
including entrainment pacing. 
• 
Post-ablation: sinus rhythm, arrhythmia induction pacing, any induced 
or spontaneously occurring arrhythmia, and any pacing maneuvers, 
including entrainment pacing and therapy assessment. 
d. Delivery of therapy using standard techniques. 
e. Confirmation of therapy treatment (post-ablation)  
f. Device- and procedure-related safety events 
Follow-up visit(s) 
a. Device- and procedure-related safety events 
b. Recurrence monitoring for AF patients 
 
 
 
 

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3.0 
INTRODUCTION 
3.1 
Background 
A supraventricular tachycardia (SVT) is an abnormally fast rhythm, greater than 100 
beats per minute that originates superior to the ventricles. SVT refers to a range of 
conditions in which atrial tissue or the atrioventricular node is essential for sustaining an 
arrhythmia.21  
The incidence of SVT is about 35 cases per 100 000 population per year, with a 
prevalence of 2.25 cases per 1000 population. SVT usually manifests as recurrent 
paroxysms of tachycardia. It is generally well tolerated but can produce uncomfortable 
symptoms that lead to acute presentation.21 
Some of the most common forms of SVTs are: atrial flutter, atrial fibrillation, AV nodal 
reentrant tachycardia (AVNRT), and atrial tachycardia.  
Atrial Flutter 
Atrial Flutter (AFL) is the second most common supraventricular tachyarrhythmia, 
following atrial fibrillation (AF).  It can result in significant patient symptoms and 
hospital visits.  AFL has an overall incidence rate of 88/100,000 person-years.  Incidence 
rates increase with age, and range from 5/100,000 in patients less than 50 years of age to 
587/100,000 in patients over 80 years old.  The incidence of atrial flutter for men is twice 
that of women.  The incidence of atrial flutter in the United States is estimated at 200,000 
new cases per year.1 
The most common atrial flutter is typical cavotricuspid isthmus (CTI)-dependent flutter.  
Non-typical atrial flutters (NTAFLs) are less common and vary in mechanistic cause.  
However, their symptoms are similar to typical atrial flutter most commonly presenting 
with an atrial rate of about 300 beats per minute (bpm) and 2:1 conduction to the 
ventricle resulting in a ventricular rate of about 150 bpm.  NTAFLs can be present in the 
right or left atrium. Non-typical atrial flutter may cause significant symptoms including 
palpitations, shortness of breath, chest-pain, lightheadedness, fatigue, and low blood 
pressure.2 Patients are also often anticoagulated to reduce thromboembolic risk. 
Atrial Fibrillation 
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 
mortality7. 
 
Symptoms arise from the rapid, irregular rhythm as well as the loss of cardiac pump 
function related to uncoordinated atrial contractions.  These uncoordinated contractions 

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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.8,9 
 
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.9 
 
AF can be characterized into 4 classifications23. 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. A 
third category of AF is “longstanding persistent AF” that is defined as continuous AF of 
greater than one year’s duration. The term 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.9 
 
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.10-14 
 
Significant progress has been made in defining the mechanisms of initiation and 
perpetuation of AF.14-17 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.17, 18 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.7 
 
Sustained high rates in the atrium and/or the presence of heart disease are associated with 
structural remodeling of the atria and can alter the substrate even further and help to 
perpetuate AF.19 AF can also be the result of preexisting atrial disease. Although much 
has been learned about the mechanisms of AF, they remain incompletely understood. 
Because of this, it is not yet possible to precisely tailor an ablation strategy to a particular 
AF mechanism in the great majority of AF patients.7 

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3D Mapping 
Three-dimensional (3D) electroanatomical contact and noncontact mapping systems have 
been reported to facilitate ablation of SVTs by identifying anatomical structures and 
highlighting the precise location of ablated sites.  This can guide the initial ablation and 
help identify existing gaps in an incomplete lesion set.10, 11 Additionally, electromagnetic 
navigation systems have been shown to substantially reduce the fluoroscopy time 
required for SVT.12-15 
Electrogram reconstruction using noncontact mapping for SVT has been validated in the 
right atrium.16 Noncontact mapping has also been shown to be useful in identifying the 
tachycardia mechanism of different forms of SVT.17 
The AcQMap™ High Resolution Imaging and Mapping 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 System 
will be used to collect data from the AcQMap 3D Imaging and Mapping Catheter 
(AcQMap Catheter or AcQMap OTW Catheter) and create Dipole Density maps.  The 
evaluation of these maps will include assessing anatomical data, the source and 
progression of cardiac electrical activation, and evaluation of therapy. 
This study will evaluate the safety and potential effectiveness of the AcQMap System in 
supraventricular tachycardia’s (SVTs).  Previous studies evaluated the System in typical 
atrial flutter, which is a better-understood arrhythmia. 
The System also includes the AcQMap Workstation with a software interface for online 
control of recording waveforms that are acquired from the AcQMap Catheter.  The 
interface also enables graphical display of acquired AcQMap Catheter signals for the 
purpose of assessing signal quality before storing them on the workstation hard drive. 
 
3.2 
Alternative Treatments and Methods 
 
Acute treatments that can be used to convert or control SVTs include electrical 
cardioversion, pharmacologic therapy with rate-lowering or antiarrhythmic drugs, and 
rapid atrial pacing to interrupt the arrhythmia. Curative therapy involves catheter ablation 
where catheters are typically advanced from the femoral vein into the right or left atrium.  
After electrogram-guided verification of the focal source or reentrant circuit, the ablation 
catheter is used to deliver radiofrequency energy to generate electrically unexcitable 
tissue (or scar) at a localized area and/or to block activation through tissue critical to a 
circuit.  Procedural success is most commonly assessed by a return to sinus rhythm and 
the inability to re-induce the arrhythmia with aggressive pacing maneuvers.3-6 
 

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Additionally, three non-fluoroscopic advanced mapping systems are currently in use for 
SVTs, one of which may be used during the procedure as is standard of care: 
  
3.2.1 The CARTO mapping System (manufactured by Biosense Webster, CA) 
incorporates the use of low energy magnetic fields and a specific 
mapping/ablation catheter with a magnetic sensor to locate the catheter in space 
and reconstruct a 3D geometry of the heart.  Color-coded electrical activation or 
voltage maps are obtained on a point-by-point basis and superimposed on the 
geometry for analysis and to guide ablation.  
 
3.2.2 The EnSite System (manufactured by St. Jude, MN) can also be used to similarly 
create 3D geometry with corresponding activation and voltage maps.  It also 
utilizes contact mapping (NavX mode) using an ablation catheter and three low 
energy currents through orthogonally-located skin patches allowing localization 
of any intra-cardiac catheter.  The EnSite System is also capable of noncontact 
mapping (EnSite Array mode) via the EnSite Array, which is a basket mesh 
catheter with 64 electrodes capable of measuring electrical activity within a 
chamber without contacting the heart wall.  In this mode, single-beat mapping of 
an arrhythmia is possible.  
 
3.2.3 The Polar Constellation Advanced Mapping Catheter System (manufactured by 
Boston Scientific, MA) is a multielectrode basket catheter with 64 electrodes on 8 
splines.  Once deployed, each electrode is automatically traced.  The information 
enables a 3D model of the basket catheter to be computed. Color-coded activation 
maps are reconstructed online and displayed on a monitor.  By using this catheter, 
a precise electrical map of the atrium can be obtained in several heartbeats. 
 
3.3 
Rationale for the AcQMap System 
 
SVTs may cause significant symptoms, including palpitations, shortness of breath, chest 
pain, lightheadedness, fatigue, and low blood pressure. Some patients with may be at risk 
of stroke if certain other risk factors are present.  Some patients may exhibit no symptoms 
at all.  The potentially curative solution for SVT is catheter ablation.22 
 
The AcQMap System is designed to provide automatic and instantaneous 3D displays of 
the chamber surface, so placement of the AcQMap Catheter is similar to other noncontact 
catheter-based navigation systems.  In this study, the AcQMap Catheter will be placed in 
the right or left atrium.  Online display of AcQMap Catheter signals may be performed 
during the procedure. 
 
3.4 
Previous Clinical Experience 
 
The AcQMap System has been the subject of two previous similar clinical trials resulting 
in the System being used in 15 total patients; twelve (12) patients with typical atrial 
flutter, and three (3) with atrial fibrillation.  Additional details regarding this experience 
can be found in the Investigator Brochure.   

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4.0 
STUDY OVERVIEW 
4.1 
Study Design 
The study is a prospective, non-randomized, open-label study conducted at Na Homolce 
Hospital, Prague, Czech Republic. Up to fifty (50) subjects will be enrolled to create high 
quality activation maps.  Enrollment is anticipated to take approximately 3-6 months with 
follow-up expected to take 7-10 days following the procedure for non-AF patients and 1 
year for AF patients.  Each patient’s participation in the study will be approximately 10-
20 days for non-AF patients and approximately 1 year and 1 week for AF patients.  It is 
anticipated that 1-2 AcQMap Catheters may be used per patient.  A single Console with a 
corresponding Workstation is anticipated to be used at the site. 
 
4.2 
Study Objectives 
The primary objective of the study is to demonstrate safety of the AcQMap System 
during data collection in subjects with SVT.  
 
4.2.1 Primary Endpoints 
The primary effectiveness endpoint is the collection of data adequate to construct 
pre- and post-treatment activation maps.  The purpose of this endpoint is to 
determine if the System is capable of obtaining data sufficient enough to produce 
the electrophysiology maps it is designed to generate. 
 
The primary safety endpoint is the incidence of device- and procedure-related 
adverse events through 7 days post-procedure.  This endpoint was chosen to 
determine if there are any device- or procedure-specific complications that can be 
identified in the short-term following the procedure.  It may be more difficult to 
determine the cause of longer-term complications relative to the investigational 
device compared to the ablation procedure itself. 
 
5.0 
STUDY POPULATION 
5.1 
General Considerations 
Subjects will undergo baseline evaluation to determine eligibility for the study.  Subjects 
who do not meet the entry criteria are considered screen failures.  Case report forms do 
not need to be completed for screen failures. 
 
The investigator and/or designated study personnel are responsible for screening all 
potential candidates and selecting those who are appropriate study candidates as defined 
by the study inclusion and exclusion criteria.   
 
Signed informed consent will be obtained from the patient before any specific study 
procedures are undertaken.  The patient will be provided with a copy of the signed 
consent form.  The study requirements should be discussed with the patient with ample 
time provided for the consent review.  All required parties should sign and date on the 
same consent as the patient.  Patients will be considered enrolled once the AcQMap 
Catheter is introduced into the patient.  In the event that the patient is not able to give 
consent, the patient will not be enrolled in the trial.  Vulnerable patient populations are 
not included in this trial. 

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Acutus Medical 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 trial. 
 
If a safety concern arises that would affect the rights, safety, or welfare of a patient, the 
study shall be immediately halted until that safety concern can be adequately addressed.  
If the safety concern cannot be adequately addressed, then the study will be terminated. 
 
Enrollment at the site may be halted or terminated due to non-compliance issues as 
determined by the Sponsor.  In this case, enrollment at the site would not continue until 
the compliance issue(s) has been fully addressed and documented. 
 
In any case of halting or terminating a study, any outstanding patient follow-up will be 
completed unless doing so would contribute to or exacerbate the reason for halting or 
terminating the study or would affect the patient’s rights, safety, or welfare.  In such a 
case, the patient would return to the care of their primary physician and the patient would 
be considered withdrawn from the study.  In all other cases, all required patient follow-up 
will be completed through the enrolling site. 
   
Individual patients may withdraw their consent to participate in the trial at any time.  
Also, an Investigator may discontinue a patient’s participation in the trial at any time to 
protect the safety, rights, or welfare of the patient.  Attempts to contact patients will 
consist of telephone, e-mail, and mailed letter before a patient is considered lost to 
follow-up.  
 
5.2 
Inclusion Criteria 
Subjects must: 
1. Be aged 18 to 75 years 
2. Be scheduled for ablation of a supraventricular tachycardia due to the arrhythmia 
being symptomatic, recurrent, poorly tolerated and/or unable to be controlled 
with antiarrhythmic drug therapy: 
3. Be able and willing to give informed consent 
 
5.3 
Exclusion Criteria 
Potential subjects must not: 
1. Have any of the following: 
a. Patients with implanted prosthetic, artificial, or repaired cardiac valves in the 
chamber being mapped. 
b. Patients with permanent pacemaker or ICD leads in the chamber being 
mapped. 

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c. Patients with hypercoagulopathy or an inability to tolerate anticoagulation 
therapy during an electrophysiology procedure. 
2. Have had a myocardial infarction within the prior two months  
3. Have had cardiac surgery within the prior three months  
4. Have an intracardiac thrombus (by transesophageal echocardiography) 
5. Have clinically significant tricuspid and/or mitral valve regurgitation or stenosis  
6. Have had any cerebral ischemic event (including transient ischemic attacks) in the 
prior six months  
7. Be pregnant or nursing 
8. Be currently enrolled in any other clinical investigation 
 
6.0 
DEVICE DESCRIPTION  
 
6.1 
General Description 
 
The AcQMap System consists of a diagnostic recording catheter (non-OTW or OTW) 
with ultrasound and electrical mapping components (which is advanced through a 
steerable sheath) and accessories that are connected to a computerized medical 
instrument.  The System is designed to create a 3D image of a chamber’s endocardial 
surface as well as a chamber-wide electrical activation map for percutaneous procedures.  
The AcQMap System should only be used by physicians thoroughly trained in 
electrophysiology procedures and trained on the use of the System in the DDRAMATIC-
SVT protocol. 
 
6.2 
Intended Use 
The AcQMap System is intended to be used to record and map right and left atrial 
electrical impulses.  During the DDRAMATIC-SVT trial, this will be performed during 
the course of procedures in which patients will be treated for supraventricular tachycardia 
(SVT). 
 
6.3 
The AcQMap 3D Imaging and Mapping Catheter and AcQGuide Steerable 
Sheath Description  
 
The AcQMap 3D Imaging and Mapping Catheter (AcQMap Catheter) has deployable 
splines formed in the shape of a spheroid at the distal end where an array of 48 electrodes 
and 48 ultrasound transducers are spatially distributed.  A catheter sheath is placed within 
the desired chamber and the array of the AcQMap Catheter is introduced.  There is no 
requirement for the array electrodes or transducers to be in contact with the heart wall.  
The AcQMap Catheter is capable of endovascular delivery and contains a flexible distal 
segment that allows it to be directed via a compatible catheter sheath to various locations 
of interest within the heart.  
 
 
 

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6.4 
Hardware Description 
The Acutus Medical hardware consists of a Console and a Workstation.  The Console 
contains all electronics for interfacing with patient-contacting devices such as the 
Catheter, localization surface patches and ECG surface electrodes.  The Console also 
provides patient isolation, signal filtering, signal digitization, transmission of ultrasound 
and localization signals, and processors for algorithm execution.  The Workstation is the 
primary user interface and in this study, will consist of a computer running Windows 7 or 
later software.  The Workstation will also be running custom software developed by 
Acutus Medical. 
 
6.5 
Clinical Procedure 
 
Preparation and Access 
The following supplies are not provided with the devices and need to be available and 
prepped per laboratory standard operating procedures prior to use of the AcQMap 
Catheter:  
• Introducers 
• Guiding sheath for lab supplied diagnostic catheter(s) and/or transeptal needle 
• Angiographic imaging supplies (i.e. radiopaque contrast, manifold, tubing, etc.) 
• Heparinized normal saline 
• Guidewire for sheath insertion 
• Other supplies as needed to complete the established laboratory protocol 
 
Perform the procedure using general anesthesia or conscious sedation with Propofol, or 
combination of Benzodiazepines and Opioids as previously reported.18 Insert three (3) 7-
8F sheaths into the left or right groin (the lab staff will decide which will be in the left 
femoral vein and which will be in the right femoral vein) to allow placement of: a 
positional reference catheter (6-7F), an electrical reference catheter used for the AcQMap 
System unipolar reference and analog ground (7-8F), and positioning of the irrigated 
mapping/ablation catheter (8F).  Insert one 16-18F introducer into the left or right 
femoral vein to accommodate a compatible sheath through which the AcQMap Catheter 
is inserted.  Irrigate the compatible sheath with heparinized saline through its use.  
Administer a single bolus of heparin after sheath placement. 
 
Right Atrial Access 
In accordance with the AcQMap Catheters Instructions for Use: 
1. Advance a guidewire into the superior vena cava (SVC) approximately 5 cm past the 
right atrium. 
2. Over the guidewire, advance a compatible sheath to the SVC-right atrial junction per 
manufacturer’s instructions 
 
Left Atrial Access 
1. Using standard practice, obtain left atrial access via transseptal puncture. 
2. Advance a compatible sheath into the left atrium per manufacturer’s instructions. 
 
NOTE: Monitor the saline drip to ensure a constant flow throughout the procedure 

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Introduce AcQMap Catheter 
1. Connect the sheath to a pressurized drip of heparinized saline to ensure a constant 
flow through the sheath. 
2. Remove any guidewire used in sheath placement  
3. Insert the distal end of the Catheter into the sheath with the introducer device 
covering the distal array. 
4. While holding on to the proximal portion of the introducer device, advance the 
Catheter into the sheath. 
5. Retract the introducer device from the sheath to the proximal section of the catheter. 
6. Advance the distal array of the Catheter through the distal sheath. 
7. Under fluoroscopic guidance, simultaneously advance the Catheter and retract the 
sheath to allow the Catheter splines to deploy within the approximate center of the 
atrium. 
 
7.0 
STUDY EVALUATIONS 
 
7.1 
Overview 
The visit schedule and procedures required by this protocol are summarized below: 
Table 1: Patient Visit Schedule (non-AF) 
Event 
Screening 
 Visit 1 
Visit 2 
Visit 3 
Timing 
≤ 30 Days Pre-Procedure 
Day 0 
Day 7  
(+3/-0 days) 
Medical History Review 
X 
 
 
 
Sign Informed Consent 
 
X 
 
 
Physical Exam 
 
X 
 
X 
Mapping – AcQMap System 
 
 
X 
 
Confirmation of SVT 
 
 
X 
 
Confirmation of therapy 
 
 
X 
 
Device- & procedure-related safety data 
 
X 
X 
X 
 
Table 2: Patient Visit Schedule (AF) 
Event 
Screening 
 Visit 1 
Visit 2 
Visit 3 
Visit 4,5,6 
Timing 
≤ 30 Days Pre-Procedure 
Day 0 
Day 7  
(+3/-0 days) 
3,6,12 Month 
(+1/-0 months) 
Medical History Review 
X 
 
 
 
 
Sign Informed Consent 
 
X 
 
 
 
Physical Exam 
 
X 
 
X 
X 
Mapping – AcQMap System 
 
 
X 
 
 
Confirmation of AF 
 
 
X 
 
 
Confirmation of therapy 
 
 
X 
 
 
Device- & procedure-related 
safety data 
 
X 
X 
X 
X 

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7.2 
Screening 
The following tests and activities must be performed to verify eligibility and/or document 
baseline status: 
a. Documentation of demographic information (e.g., age, sex, race); 
b. Documentation of disease-related characteristics 
c. Medical history review; 
d. Previous treatments for arrhythmias; 
e. Current treatments for arrhythmias; 
f. Review of all inclusion/exclusion criteria to confirm subject eligibility. 
g. Adverse events 
h. Transesophageal Echocardiography (TEE) or similar scan to rule out thrombus. 
 
7.3 
Procedure 
a. Map of the heart chamber anatomy using standard tools and the AcQMap System 
b. Confirmation of arrhythmia 
c. Recording of the following (if applicable) with the AcQMap System: 
• Pre-ablation: sinus rhythm, arrhythmia induction pacing, any induced or 
spontaneously occurring arrhythmia, and any pacing maneuvers, including 
entrainment pacing. 
• Post-ablation: sinus rhythm, arrhythmia induction pacing, any induced or 
spontaneously occurring arrhythmia, and any pacing maneuvers, including 
entrainment pacing and therapy assessment. 
d. Delivery of therapy using standard techniques. 
e. Confirmation of therapy treatment (post-ablation) 
f. Device- and procedure-related safety events 
7.4 
Follow-up Visit for Non-AF Patients (7 Days, +3/-0) 
a. Adverse events, including device- and procedure-related safety data 
b. No patients will be replaced if they are lost to follow-up 
7.5 
Follow-up Visit for AF Patients (7 Days, +3/-0 and 3, 6&12 months +1/-0 
months) 
c. Adverse events, including device- and procedure-related safety data 
d. No patients will be replaced if they are lost to follow-up 
7.6 
Patient Care Following the Investigation 
Following the patient’s involvement in the clinical investigation, there will be no special 
care provided.  Patient care following the investigation will be exactly the same as it 
would be following a non-investigational procedure for the ablation of their arrhythmia.  
For patients with non-AF SVT, there will be no further patient follow-up or care unless 
the patient experiences symptoms or complications or a recurrence in which case the 
patient will need to see their primary physician and/or return to the hospital for care.  For 
patients with atrial fibrillation, the institutional standard practice of monitoring the 
patient’s need for anticoagulation therapy and/or recurrence of the arrhythmia will be 
followed. 
 
 
 

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8.0 
STATISTICAL METHODS 
 
8.1 
Sample Size Determination 
Because this is an early-stage use of the AcQMap System in humans, the sample size has 
been established as up to 50 subjects for an initial assessment of the System’s ability to 
create high quality anatomies and procedural activation maps in this patient population. 
No statistical determination of sample size is required as this study is simply to determine 
the feasibility of the System to generate and collect data in a limited sample. 
 
8.2 
Data Analyses 
8.2.1 Statistical Methods 
Tabulation of summary statistics, graphical presentations, and analyses will be 
performed.  No formal hypotheses will be used in this study. 
 
8.2.2 Demographic and Baseline Characteristics 
Demographic characteristics, patient history, and baseline patient data will be 
tabulated.  
 
8.2.3 Safety Analysis 
The safety population is comprised of all subjects enrolled in the study.  The 
number of subjects with at least one adverse event will be tabulated.  The number 
of subjects and the number of adverse events will be tabulated by severity and 
causality. 
 
8.2.4 Effectiveness Analysis 
The primary measure for effectiveness of this clinical study is the creation of pre- 
and post-ablation activation maps of the atrium.  The percentage of patients in 
which this is accomplished will be calculated. 
 
8.2.5 Claims and Intended Performance Verification 
The intended performance of the AcQMap System is that it is capable of 
generating three-dimensional images and corresponding electrophysiology maps 
of the right and left atrium.  The only claim to be made from the DDRAMATIC-
SVT trial is that the System can obtain the data for creating these maps safely. 
 
8.2.6 Number of Devices 
It is anticipated that one Console and one Workstation will be used at the site.  A 
backup will be available in case of a malfunction.  It is also anticipated that one 
AcQMap Catheter will be used for each patient enrolled.  A backup Catheter will 
be available for each procedure in case of a malfunction. 
 
 
 
 
 
 

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9.0 RISK ANALYSIS 
 
9.1 
Summary of Expected Benefits 
The potential benefit of the AcQMap System is providing automatic and instantaneous 
3D displays of the chamber surface. This has the potential to improve ablation efficiency 
and potentially shorten procedure time.  This may also prove to be more effective at 
verifying an appropriate endpoint to the ablation.  This could provide the investigator 
with an intuitive tool to rapidly identify and guide treatment of clinically-relevant sites 
within the chamber wall.  There is, however, no guarantee that this will happen.  Through 
the subject’s participation in this study the information gathered will add to the 
understanding of the Dipole Density Mapping.  This knowledge may advance medical 
science and may benefit future patients as well as society at large. 
 
9.2 
Summary of Potential Risks 
The following adverse events are associated with catheterization and/or cardiac ablation: 
 
• Adult Respiratory Distress 
Syndrome 
• Heart Failure  
• Pulmonary edema 
• Air embolism 
• Hemothorax 
• Pulmonary embolism 
• Anemia 
• Increased phosphokinase level 
• Radiation injury 
• Anesthesia reaction 
• Infections 
• Respiratory Depression 
• Arrhythmias 
• Laceration 
• Seizure 
• AV fistula  
• Leakage of air or blood into 
the lungs or other organs due 
to perforation 
• Skin burns 
• Cardiac perforation/tamponade 
• Local hematomas/ecchymosis 
• Temporary complete heart 
block 
• Cardiac thromboembolism 
• Myocardial infarction 
• Thrombi 
• Cerebrovascular accident 
• Obstruction or perforation or 
damage to vascular system 
• Thromboembolism 
• Chest pain/discomfort 
• Pericardial effusion 
• Transient ischemic attack 
• Complete heart block  
• Pericarditis 
• Unintended (in)complete AV, 
sinus node block or other 
heart block or damage 
• Congestive heart failure 
• Phrenic nerve damage 
• Valvular 
damage/insufficiency 
• Coronary artery spasm 
• Pleural effusion 
• Vascular bleeding 
• Death 
• Pneumonia 
• Vasovagal reactions 
• Endocarditis 
• Pneumothorax 
• Ventricular tachycardia 
• Expressive aphasia  
• Pseudoaneurysm 
• Worsening chronic 
obstructive  pulmonary 
disease 
 
The use of the AcQMap System is not expected to incrementally or significantly impact 
the severity or occurrence of any of these risks. 
 
9.3 
Justification of Clinical Trial Design 
Because this is an early-stage use of the AcQMap System, limited clinical data on fifteen 
(15) patients are available on the use of the System as mentioned above.  Therefore, care 
has been taken to ensure the safety of the System prior to clinical use.  The System is 

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similar in concept to other 3D mapping systems that have been safely and effectively 
used for many years.4-11,18.19.  These mapping systems have become the gold standard of 
electrophysiology procedures with superior clinical results and a significant reduction in 
the amount of fluoroscopy used during procedures. 
 
In addition, several separate animal studies have been conducted to test the safety of the 
AcQMap Catheters and AcQGuide Sheath and applicable bench and biological testing 
has been performed to test the basic function, construction, and biocompatibility of the 
Catheter and Sheath. The Investigator Brochure provides additional details on this 
testing.  The results of this testing demonstrates that the System is safe to be used for 
initial clinical evaluation.  The DDRAMATIC-SVT trial has been designed to perform 
this evaluation in a manner that exposes the fewest possible number of patients to the 
new device while still generating sufficient data to provide an adequate assessment of the 
initial safety and technical feasibility of the System.  The data from this trial will be used 
to support additional, larger trials in the future that will focus on the effectiveness of the 
System in treating more complex arrhythmias. 
 
10.0 ADVERSE EVENTS 
It is not anticipated that the use of the AcQMap System will result in an incremental risk above 
those normally encountered during a SVT ablation procedure.  Therefore, the endpoint of this 
study is the incidence of device- and procedure-related adverse events through 7 days post-
procedure to track any complications that are related to the use of the new System or the 
procedure. 
 
10.1 
Definitions 
Adverse Event: Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in patients, users or 
other persons, whether or not related to the investigational device. 
 
Adverse Device Effect: An adverse event related to the use of the investigational device 
 
Serious Adverse Event: An adverse event that:  
• Led to death 
• Led to serious deterioration in the health of the patient that resulted in: 
o A life-threatening illness or injury 
o A permanent impairment of a body function 
o In-patient or prolonged hospitalization 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function 
• Led to fetal distress, fetal death, or congenital abnormality or birth defect 
 
Serious Adverse Device Effect: An adverse device effect resulting in any of the 
consequences characteristic of a serious adverse event. 
 

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Unanticipated Serious Adverse Device Effect:  A serious adverse device effect which by 
its nature, incidence, severity or outcome has not been identified in the current version of 
the risk analysis report. 
 
10.2 
Categories 
The following categories of adverse device events severity are to be used: 
Mild 
Easily tolerated by the patient, caused minimal discomfort, and did not 
interfere with everyday activities; 
Moderate 
Sufficiently discomforting to interfere with everyday activities; 
Severe  
Prevents everyday activities. 
 
The following categories of adverse device events causality are to be used:  definitely 
related, possibly related, probably unrelated, or unrelated to device. 
 
10.3 
Reporting Timeline 
Adverse events are to be reported on case report forms, typically within two weeks of the 
event.  Serious adverse events must be reported immediately to the Sponsor Vigilance 
Responsible Person.  Serious adverse events must also be reported to the Ethics 
Committee according to the Ethics Committee guidelines.  In addition serious adverse 
events must be reported by both the Sponsor and the Investigator to competent authorities 
according to their guidelines.  In Germany this must be performed according to § 3 (5) 
and § 5 of the Ordinance on Medical Devices Vigilance (MPSV) using the appropriate 
report form. 
 
 
11.0 ETHICS 
 
11.1 
Sponsor Statement of Compliance 
The Sponsor will conduct the clinical study in accordance with the clinical investigational 
plan, the ethical practices with their origin in Declaration of Helsinki, the principles of 
ISO 14155 - Good Clinical Practices (GCP), and applicable regulatory requirements.  
This trial will not commence until a favorable opinion has been obtained by an 
appropriate ethics committee, including any conditions imposed by the committee.  
Insurance will be provided by the Sponsor as required by applicable laws in the countries 
in which the study is being conducted.  
 
11.2 
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 Clinical 
Practice (GCP), applicable regulatory requirements, and institutional procedures.  
 
 
 
 

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11.3 
Ethics Committee (EC) 
The investigator will undertake the study after full approval of the protocol and 
adjunctive materials (e.g., informed consent form) has been obtained from a local EC and 
a copy of this approval has been received by the Sponsor.   
 
During the conduct of the study, investigators must submit progress reports to the EC as 
required and request re-review and approval of the study at least once a year.  After the 
study is concluded, the investigator should notify the EC of this status and prepare a final 
report for EC review. 
 
12.0 
MONITORING RESPONSIBILITIES & PLAN 
 
Acutus Medical (ACM) will serve as the Sponsor of this clinical investigation.  It is the 
responsibility of ACM as the Sponsor of the study to ensure proper monitoring of the 
investigation and to see that all the clinical requirements are met. 
 
All information and data sent to ACM concerning subjects and their participation in this 
investigation will be considered confidential.  Only authorized ACM personnel, ACM 
representatives, and regulatory agencies will have access to these confidential files.  All data 
used in the analyses and reporting of this investigation will be coded without identifiable 
reference to the subject.  Any data obtained by ACM that is not de-identified will either be 
destroyed or de-identified upon receipt. 
 
12.1 
Source Documentation 
Source documents are original records, or certified copies of original records, that contain 
clinical findings, observations or other activities in a clinical trial (e.g., hospital records, 
clinical and office charts, laboratory notes, subject diaries, or evaluation checklists) 
necessary for the documentation and evaluation of the clinical trial.   
 
Source document worksheets may be used to supplement other medical records, but 
should not be reviewed as the only source.  Worksheets must be treated as medical 
records, that is, signed and dated by the person performing the evaluation. 
 
Photocopies of source documents are acceptable for review only if the original document 
can be provided upon request. 
 
The monitor will check the case report form (CRF) data points against the source 
document data points during a monitoring visit. 
 
12.2 
Monitors 
Field and monitoring personnel contact information is as follows: 
Acutus Medical, Inc. 
2210 Faraday Avenue, Suite 100 
Carlsbad, CA  92008 
 
 

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12.3 
Monitoring Visits 
Prior to beginning the study, ACM personnel will contact each investigator to discuss the 
investigational plan and to review the data requirements in detail.  The monitor will visit 
the investigator periodically during the study to monitor progress, verify that all study 
requirements are completed and answer any questions that may arise.  During these visits, 
the monitor may review the subject records to verify that all records and files are current 
and to assure compliance with all requirements of this investigational plan. 
 
The monitoring plan will consist of a study initiation visit to train the site on the CIP and 
case report forms.  After the index procedure, a monitoring visit will take place to review 
the pre-procedure and index procedure forms.  A final monitoring visit will take place to 
review any outstanding items from the previous visit and any follow-up visit forms.  This 
last monitoring visit may or may not be combined with a study close-out visit. 
 
12.4 
Publication Policy 
The right of individual Investigators to publish trial results with regard to educational and 
scientific purposes shall not be infringed.  Investigators will submit drafts of all 
manuscripts to the Sponsor prior to submission to ensure accuracy of technical details 
regarding the AcQMap System.  Publication of individual results will await the 
publication of the multicenter study results, however, if the multicenter results are not 
published within 1 year, individual site data may be published. 
 
13.0 
DATA MANAGEMENT 
 
Data will be collected using an electronic data capture database (eClinical OS) that allows direct 
data entry by the clinical site.  This database will undergo both system and database-specific 
validation prior to the entry of clinical data.  Data will be entered and monitored from any 
computer directly into the online database.  Embedded edit checks will aid data entry by 
reducing the number of entry errors due to missing data, incorrect data format, and/or improper 
data type.  In addition, some limited logistical data checks will also be employed to verify certain 
data fields.  Once the data points are entered, further edit checks will generate queries that will 
be forwarded to the site for clarification and/or correction.  All data entry and/or edits will be 
tracked by user in the database to ensure data integrity.  Once all queries are answered and all 
data is entered, the online database will be closed. 
 
13.1 
Data Retention 
Once the online database is closed, data will be exported from the online database into 
offline files for data analysis.  This original export will be maintained according to 
applicable regulatory requirements.  In Germany, record retention is required for 10 years 
after completion or termination of the trial. 
 
14.0 CLINICAL INVESTIGATIONAL PLAN (CIP) 
 
14.1 
Deviations 
Deviations from the CIP, GCP, applicable regulatory requirements, or institutional 
procedures should be documented.   In general deviations are not allowed except to 

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protect the rights, safety or well-being of a patient.  Deviations to maintain the scientific 
integrity of the trial are also allowed with prior approval from the Sponsor.  In all cases, 
the deviations will be reported to the Sponsor as soon as possible if not reported prior to 
the deviation taking place but no later than 10 days after the deviation has taken place.   
 
Subject non-compliance, which is not within the control of the Investigator and is a 
subject’s right, does not need to be reported unless it impacts study data.  Non-
compliance issues include, but are not limited to, informed consent not obtained, 
inclusion or exclusion criteria not met, missed visits due to site oversight, protocol visits 
conducted outside the defined time period, required testing not completed. 
 
Under emergency circumstances, deviations from the CIP to protect the rights, safety and 
well-being of patients are allowed without prior approval of the Sponsor but shall be 
documented and reported to the Sponsor and the Ethics Committee as soon as possible 
but no later than 5 days after the deviation has taken place and/or according to Ethics 
Committee policy.  All deviations will be recorded by the Sponsor and reported to ethics 
committees according to their reporting requirements. 
 
14.2 
Modifications 
Due to the small nature of this trial, modification of the CIP and related documents is not 
anticipated but in the event it is necessary, the Sponsor will consult with the Investigators 
to revise the plan or related documents.  A record of the revision will be maintained 
within the plan or other document that will include the revision letter, the date of the 
revision and a summary of the revision(s).  All modifications will be reported to ethics 
committees and competent authorities as required. 
 
14.3 
Final Report 
At the conclusion of the trial, or in the event of premature trial termination, a final report 
of the study results will be generated by the Sponsor.  This report will be submitted to all 
participating sites and competent authorities within the timeline required by applicable 
regulations. 
 
 
15.0 
REFERENCES 
 
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