AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Phase: NA
Conditions: Typical Atrial Flutter
Sponsor: Acutus Medical

 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 1 of 82 
 
 
AcQBlate Force Sensing Ablation System US IDE for 
Atrial Flutter 
(AcQForce Flutter)  
 
Study CLP-21 
23 September 2021 
Rev 11 
 
 
 
Acutus Medical, Inc 
 
 
 
 
 
 
 
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. 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 2 of 82 
  
 
 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 3 of 82 
 
 
INVESTIGATOR PROTOCOL SIGNATURE PAGE AND AGREEMENT 
CLP-21, Rev 11 
I have read this Clinical Investigational Plan (CIP)/protocol and agree to adhere to all the 
requirements. The signature below constitutes the approval of the AcQForce Flutter 
CIP/protocol and provides assurances that this CIP/protocol will be conducted in 
accordance with all stipulations of the CIP/protocol including all statements regarding 
participant confidentiality. The AcQForce Flutter CIP/protocol will be followed in 
accordance with all national and local legal and regulatory requirements. 
 
 
 
 
 
 
Site Investigator Printed Name 
 
 
 
 
 
Site Investigator Signature 
 
Date 
dd-mmm-yyyy 
 
 
 
 
 
 
 
 
 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 4 of 82 
 
REVISION HISTORY 
 
Revision  Date 
Description of Update 
Reason for Update 
01 
05 May 2020 
Initial release 
N/A 
02 
27 July 2020 
The following protocol edits were made to 
comply with FDA study considerations: 
• Revised pre-procedure TEE requirements 
based on anticoagulation history 
• Revised post-ablation anticoagulation 
requirement to include ≥ 4 weeks  
• Revised parameters/definitions for 
primary endpoint failure (includes catheter 
alternatives) 
• Revised sample size justification and 
calculation 
• Removed historical control as primary 
efficacy endpoint comparator 
• Revised the observational efficacy 
endpoint to be Class I & III AAD use both 
pre-and post-procedure 
• Revised AFL documentation (AFL with 
12-lead ECG) 
• Clarified ablation parameters, and several 
statistical expectations for the study 
• Revised/updated clinical definitions for 
several safety events 
• Clarified anticoagulation 
recommendations (section 7.5.2) 
• Clarified and added language in section 
7.5.3, 7.7.1, and 7.7.2 
FDA 
Recommendation 
03 
25 September 
2020 
Update to section 7.7.1 Entrainment pacing 
Changes to power setting recommendations 
with a limitation of 30 W. 
Internal review 
04 
01 March 
2021 
• Amendments to protocol to include the use 
of RF generator at power settings 31-50 
watts. 
• Adjustments to protocol based on FDA 
feedback and recommendations. 
FDA 
Recommendations 
and increase power 
setting to 50W max 
05 
22 April 2021 
• Changes to power setting recommendations 
with limitation of 30W 
• Adjustments to protocol based on FDA 
feedback and recommendations 
FDA 
Recommendation to 
include AcQMap, 
AcQTag, ATF Cable 

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CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 5 of 82 
• Incorporated language on use of AcQMap, 
AcQTag 
06 
04 May 2021 
• Per FDA request, converted protocol to Rev 
03 with the exception of the language on use 
of AcQMap and AcQTag 
FDA requested 
changes 
07 
17 May 2021 
• Per FDA request, converted protocol to Rev 
03 
• Clarified exclusion criteria #6 and #19, TTE 
and TEE requirements, atrial thrombus 
assessments 
• Adjusted sample size justification based on 
FDA feedback and recommendations 
FDA and study site 
requested 
clarifications 
08 
01 July 2021 
• Incorporated changes implemented in Rev 
06 
• Removed Rev 07 changes not approved by 
FDA 
Combine FDA 
approved changes 
from Rev 06 and 
Rev 07 
09 
05 August 
2021 
• Incorporated use of RF generator at power 
settings 31-40 watts 
• Incorporated clarification on entrainment 
pacing requirements 
• Adjustments to protocol based on FDA 
study design considerations 
Incorporate higher 
power setting, 
feedback from study 
sites and FDA 
recommendations 
10 
19 August 
2021 
• Increased study sites from 16 to 20 
Internal review 
11 
23 September 
2021 
• Replaced 
Intent-to-Treat 
subject 
with 
Intent-to-Treat Failure Subject 
• Revised description of involved procedures 
in section 7.7.1  
FDA Study Design 
Considerations 
 
 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 6 of 82 
SPONSOR INFORMATION 
Acutus Medical, Inc. 
2210 Faraday Ave, Suite 100 
Carlsbad, CA, USA 92008 
 
 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 7 of 82 
1 CLINICAL STUDY SYNOPSIS  
Study Title 
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter 
(AcQForce Flutter) 
Device Name 
The AcQBlate Force Sensing Ablation System (herein known as the 
AcQBlate Force Sensing System) comprises the AcQBlate Force 
Sensing Ablation Catheter (AcQBlate® FORCE), the Qubic Force® 
Sensing Module (Qubic Force), the Qubic Radiofrequency (RF) 
Generator, and the Qiona Irrigation Pump with Tubing Set. The System 
is designed for electrophysiologic (EP) mapping and RF ablation of 
atrial flutter. 
Study Device 
Components 
The AcQBlate Force Sensing System comprises: 
• 
AcQBlate FORCE  
• 
Qubic Force  
• 
Qubic RF Generator 
• 
Qiona Irrigation Pump 
• 
Qiona Irrigation Tubing Set 
• 
Assorted Cables (for EP recording connectivity) 
Indication for 
Use 
(Proposed) 
The AcQBlate® FORCE Sensing Ablation Catheter and related 
accessory devices are indicated for cardiac electrophysiological 
mapping, delivery of diagnostic pacing stimuli, and radiofrequency 
ablation of recurrent and symptomatic atrial flutter (AFL) when used 
with a compatible RF Generator. When used with the Qubic Force® 
module, the AcQBlate® FORCE Sensing Ablation Catheter provides a 
real time measurement of contact force between the catheter tip and the 
heart. 
Sponsor 
Acutus Medical, Inc. 
2210 Faraday Ave, Suite 100 
Carlsbad, CA, USA 92008 
Study 
Objective 
The objective of the clinical study is to demonstrate the AcQBlate Force 
Sensing System is safe and effective when used to ablate the 
cavotricuspid isthmus (CTI) for the treatment of typical atrial flutter 
when compared to a literature-based control.  
Data will be used to support a pre-market approval (PMA) application. 

AcQForce Flutter  
 
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 8 of 82 
Study  
Design 
The Acutus Medical AcQForce Flutter clinical study is a prospective, 
multi-center, non-randomized global study designed to demonstrate the 
safety and effectiveness of the AcQBlate Force Sensing Ablation 
System in the ablation management of symptomatic cavotricuspid 
isthmus dependent atrial flutter. 
All subjects with typical atrial flutter will undergo percutaneous catheter 
ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing 
System with the endpoint of achieving bidirectional block (BDB).  
Post procedural follow-up visits will be completed at pre-discharge, to 
assess device and procedure-related serious adverse events (SAEs), a 7-
day phone call, and a 30-day clinic visit to assure compliance with all 
aspects of the study and report on the observational effectiveness 
endpoint.  
The expected safety and efficacy rates for the primary endpoints were 
derived from a meta-analysis of recently completed IDE trials). Event 
rates were estimated from Summary of Safety and Effectiveness Data 
(SSED) or results disclosed on clinicaltrials.gov and calculated based 
on the occurrence of events that constitute the primary safety and 
efficacy endpoints defined in this protocol. 
Patient 
Population 
Subjects 18 years and older, presenting for a de novo percutaneous 
cardiac ablation of the cavotricuspid isthmus for typical atrial flutter will 
be included in the AcQForce Flutter study.  
Primary 
Safety 
Endpoint 
The Primary Safety Endpoint for the AcQForce Flutter study is a 
comparative analysis of subjects free from a composite list of pre-
specified procedure/device related Serious Adverse Events (SAEs) 
through 7-days post ablation using a literature-based control.  
Serious Adverse Events are pre-defined and include: 
• Death 
• Cardiac tamponade/perforation 
• Myocardial infarction 
• Stroke 
• Systemic embolism 
• Major access site complications 
• Major bleeding requiring transfusion 
• Complete heart block 
• Other SAEs/SADEs adjudicated by an independent 
review as “probably or definitely related” to the 
Investigational device. 

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Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 9 of 82 
Primary 
Effectiveness 
Endpoint 
The Primary Effectiveness Endpoint for the AcQForce Flutter study is 
an analysis of subjects achieving acute procedural success. Acute 
procedural success is defined as the demonstration of bidirectional 
cavotricuspid isthmus block at least 20 minutes following the last 
radiofrequency application at the cavotricuspid isthmus with the 
investigational System. 
Bidirectional block (BDB) confirmation is defined as: 
• Demonstration of bidirectional electrophysiological 
conduction block through the cavotricuspid isthmus (CTI) 
using both coronary sinus ostium (CS) and annular low 
right atrial pacing maneuvers.  
Observational 
Effectiveness 
Endpoint  
Freedom from recurrence of typical CTI dependent atrial flutter OFF 
Class I/III antiarrhythmic drugs (AADs) at 30-days post index 
procedure as measured by a 24-hour continuous electrocardiogram 
(ECG) monitor. 
Study Sample 
Size 
The sample size consists of 110 Modified Intent-to-Treat (mITT) 
subjects, based on using a one-sided α of 0.05, with 90% power. A 
maximum of 120 Modified Intent-to-Treat (mITT) subjects will be 
enrolled. mITT subjects are any enrolled subjects who initiate the 
ablation procedure using the AcQBlate Force Sensing System. 
Study 
Geographies 
The AcQForce Flutter Study will be conducted at up to 20 clinical study 
sites in the USA and Europe.  
Study 
Duration 
The clinical study is anticipated to take approximately 12-months to 
enroll and will include a 30-day follow-up period. Total clinical study 
duration is anticipated to be approximately 12-18 months. The per 
patient clinical study duration is expected to be approximately six (6) 
weeks. 

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Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 10 of 82 
Inclusion 
Criteria 
A potential study subject will meet all the following inclusion criteria: 
1. Subjects are clinically indicated for de novo catheter ablation of 
typical atrial flutter. 
2. At least one (1) documented episode of typical atrial flutter within 
180 days (6 months) prior to enrollment, documented by 12-lead 
ECG. 
3. Age 18 years or older at time of consent.  
4. Subjects are willing and able to provide written informed consent 
to participate in the study and agree to comply with all follow-up 
visits and evaluations. 
Exclusion 
Criteria 
A potential study subject who meets any of the following exclusion 
criteria will be excluded: 
1. In the opinion of the Investigator, any contraindication to the 
planned atrial ablation, including contraindications to 
anticoagulation therapy and any other significant uncontrolled or 
unstable medical condition (e.g. sepsis, acute metabolic illness, 
chronic kidney disease). 
2. Inability to document cavotricuspid isthmus conduction. 
3. Any prior right atrial cavotricuspid isthmus ablation.  
4. Any cardiac ablation for non-atrial flutter arrhythmias within 90 
days prior to enrollment. 
5. Any patient scheduled or anticipating an AF ablation within the 
follow-up period. 
6. Administration of oral amiodarone within 120 days prior to 
procedure excluding a one-time IV/oral administration of ≤ 2000 
mg in a 24-hour period. 
7. Cardiac surgery within 60 days prior to enrollment. 
8. ST-elevation myocardial infarction (STEMI) within 60 days prior 
to enrollment 
9. Current unstable angina. 
10. Documented atrial or ventricular tumors, clots, thrombus, within 
30-days prior to enrollment. 
11. Any history of a known hematologic disorder (bleeding/clotting). 
12. Implantation of permanent leads of an implantable device in or 
through the right atrium within 90-days prior to enrollment. 
13. Subjects with New York Heart Association (NYHA) Class IV 
heart failure within 6-months prior to enrollment.  
14. Subjects with an ejection fraction less than 30% within 90 days of 

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Acutus Medical, Inc.  
 
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CLP-21 Rev 11 23 September 2021 
Page 11 of 82 
enrollment. 
15. Percutaneous Transluminal Coronary Angioplasty (PTCA) within 
30-days of enrollment. 
16. Clinically significant structural heart disease (including moderate 
to severe tricuspid valve regurgitation, tricuspid valve stenosis, or 
tricuspid valve replacement; Ebstein's anomaly, or other 
congenital heart disease) that would preclude catheter introduction 
and placement, as determined by the Investigator. 
17. Any cerebral ischemic/infarct event (excluding transient ischemic 
attacks) within 180 days prior to enrollment. 
18. Body Mass Index (BMI) >42 kg/m2. 
19. International Normalized Ratio (INR) > 3 (required for patients 
taking warfarin). 
20. Severe uncontrolled systemic hypertension (systolic pressure > 
240 mm Hg) within the last 30-days. 
21. Women who are pregnant or plan to become pregnant within the 
course of their participation in the investigation. 
22. Current enrollment in any other study protocol where testing or 
results from the study may interfere with the procedure or outcome 
measurements for this study. 
23. 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). 
Statistical 
Analysis 
A comparative assessment of the safety and effectiveness of the 
AcQBlate Force Sensing System will be made with findings reported in 
the literature for a similar patient population. Sample size calculations 
are based on a literature-based control for the composite SAE and 
efficacy rates for catheter ablation of typical atrial flutter.  
 
 
 

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CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
Page 12 of 82 
Table of Contents 
Sponsor Information .................................................................................................... 6 
1 
Clinical Study Synopsis ........................................................................................ 7 
2 
Abbreviations ...................................................................................................... 17 
3 
Introduction ........................................................................................................ 20 
3.1 
Background .......................................................................................................... 20 
3.2 
Justification for Investigation and Study Design .............................................. 23 
4 
Report of Prior Investigations ........................................................................... 27 
4.1 
Overview ............................................................................................................... 27 
4.2 
AlCath Force Ablation Procedure ...................................................................... 28 
4.3 
Results ................................................................................................................... 28 
4.4 
Conclusions ........................................................................................................... 31 
5 
Study Device Description ................................................................................... 32 
5.1 
Indication for Use (proposed) ............................................................................. 32 
5.2 
AcQBlate® Force Sensing Ablation System ....................................................... 32 
5.3 
AcQBlate Force Sensing Ablation Catheter ...................................................... 32 
5.3.1 
Qubic Force Sensing Module ........................................................................................ 32 
5.4 
Qubic Radiofrequency (RF) Generator ............................................................. 33 
5.5 
Qiona Irrigation Pump and Tubing Set ............................................................. 33 
5.6 
The AcQBlate Force System Operation ............................................................. 33 
5.7 
Investigational Devices ........................................................................................ 35 
6 
Clinical Investigational plan/ Protocol ............................................................. 37 
6.1 
Clinical Study Objective ...................................................................................... 37 
6.2 
Clinical Study Design ........................................................................................... 37 
6.3 
Primary Endpoints ............................................................................................... 37 
6.3.1 
Safety ............................................................................................................................. 37 
6.3.2 
Efficacy .......................................................................................................................... 39 
6.4 
Clinical Study Duration ....................................................................................... 40 
6.4.1 
Clinical Study Sample Size ........................................................................................... 40 
6.4.2 
Clinical Study Site Enrollment ...................................................................................... 40 
6.5 
Clinical Study Sites .............................................................................................. 40 
6.6 
Subject Population ............................................................................................... 40 
6.6.1 
Inclusion Criteria ........................................................................................................... 40 

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CLP-21 Rev 11 23 September 2021 
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6.6.2 
Exclusion Criteria .......................................................................................................... 41 
6.7 
Clinical Study Enrollment Definitions ............................................................... 42 
6.8 
Minimization of Bias ............................................................................................ 44 
6.9 
Subject Withdrawal ............................................................................................. 44 
7 
Clinical Study Treatments and Follow-Up Visits ............................................. 44 
7.1 
General Overview ................................................................................................ 44 
7.2 
Informed Consent ................................................................................................ 45 
7.3 
Subject Screening ................................................................................................. 45 
7.4 
Baseline Evaluation .............................................................................................. 45 
7.5 
Ablation Pre-Procedure Requirements .............................................................. 46 
7.5.1 
Atrial Thrombus ............................................................................................................ 46 
7.5.2 
Anticoagulation and Atrial Thrombus Assessment ....................................................... 46 
7.5.3 
Antiarrhythmic Medications .......................................................................................... 47 
7.5.4 
Subject Preparation ........................................................................................................ 48 
7.5.5 
Anesthesia ...................................................................................................................... 48 
7.5.6 
AcQBlate Force System Set-Up .................................................................................... 48 
7.6 
CTI Ablation Procedure ...................................................................................... 48 
7.6.1 
Confirmation of Conduction through the CTI ............................................................... 48 
7.6.2 
Ablation Considerations ................................................................................................ 49 
7.6.3 
CTI Ablation .................................................................................................................. 51 
7.6.4 
Confirmation of Bidirectional Block ............................................................................. 51 
7.7 
Post Ablation Recovery ....................................................................................... 52 
7.8 
Procedure Data Collection .................................................................................. 52 
7.8.1 
Post Ablation Recovery ................................................................................................. 53 
7.8.2 
Post Ablation Antiarrhythmic Use ................................................................................. 53 
7.8.3 
Post Ablation Anticoagulation Use ................................................................................ 53 
7.8.4 
Hospital Discharge ........................................................................................................ 53 
7.9 
Follow-up Visits .................................................................................................... 54 
7.9.1 
7-Day Follow-up Visit ................................................................................................... 56 
7.9.2 
30-Day Follow-up Visit ................................................................................................. 56 
7.9.3 
Unscheduled Visits ........................................................................................................ 56 
8 
Statistical Methods ............................................................................................. 57 
8.1 
Assumptions for Statistical Analysis .................................................................. 57 
8.2 
Statistical Methods for Safety Evaluation .......................................................... 57 
8.2.1 
Primary Safety Endpoint Hypothesis ............................................................................. 57 
8.2.2 
Other Safety Analyses ................................................................................................... 57 
8.3 
Statistical Methods for Efficacy Evaluation ...................................................... 58 
8.3.1 
Primary Efficacy Endpoint Hypothesis ......................................................................... 58 

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CLP-21 Rev 11 23 September 2021 
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8.4 
Study Success Criteria ......................................................................................... 58 
8.5 
Primary Endpoints Sensitivity Analysis............................................................. 59 
8.6 
Primary Endpoints Subgroup Analysis ............................................................. 59 
8.7 
Secondary Endpoints ........................................................................................... 59 
8.8 
Study Sample Size Rationale ............................................................................... 59 
8.9 
Statistical Methods for Baseline, Screening, Procedural Experience and 
Hospital Discharge Data ................................................................................................... 59 
8.10 
Other Statistical Considerations ......................................................................... 60 
9 
Adverse Events ................................................................................................... 60 
9.1 
Serious Adverse Events/Serious Adverse Device Effect ................................... 60 
9.2 
Adverse Device Effects (ADEs) ........................................................................... 61 
9.3 
Unanticipated Adverse Device Effects (UADEs) ............................................... 61 
9.4 
Adverse Event Reporting .................................................................................... 61 
9.5 
Event Relationship to the Device ........................................................................ 62 
9.6 
Death Notice ......................................................................................................... 62 
9.7 
Device Complaint and Malfunction .................................................................... 63 
9.8 
Adverse Event Analysis ....................................................................................... 63 
9.9 
Clinical Events Adjudication .............................................................................. 63 
10 Risk: Benefit Analysis ........................................................................................ 64 
10.1 
Risks of Clinical Study Procedures .................................................................... 64 
10.2 
Mitigation of Risks ............................................................................................... 65 
11 Data Quality Assurance ..................................................................................... 65 
11.1 
Site Data Management ......................................................................................... 66 
11.2 
Data Management ................................................................................................ 66 
11.3 
Subject Identification ........................................................................................... 66 
11.4 
Screen Failure Subjects ....................................................................................... 66 
11.5 
Subject Study Completion and Withdrawal ...................................................... 66 
11.6 
Subjects Lost-to-Follow-Up ................................................................................. 67 
11.7 
Confidentiality of Data ........................................................................................ 67 
11.8 
Source Documents ................................................................................................ 67 
11.9 
Device Accountability .......................................................................................... 68 

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11.10 Electronic Case Report Forms ............................................................................ 69 
11.11 Records Retention ................................................................................................ 69 
11.12 Clinical Monitor ................................................................................................... 69 
11.13 Clinical Data Monitoring Procedures ................................................................ 69 
11.13.1 
Medical Monitor ....................................................................................................... 70 
11.14 Investigator Responsibilities ............................................................................... 70 
11.15 Deviations from the Clinical Investigational Plan/Protocol ............................. 70 
11.15.1 
Maintaining Records ................................................................................................. 71 
11.15.2 
Submitting Reports ................................................................................................... 72 
11.15.3 
Clinical Study Report and Publication of Data ......................................................... 72 
11.16 Acutus Medical Responsibilities ......................................................................... 72 
11.16.1 
General Duties .......................................................................................................... 72 
11.16.2 
Selection of Investigators .......................................................................................... 72 
11.17 Training ................................................................................................................ 73 
11.17.1 
Role of Representative .............................................................................................. 74 
11.17.2 
Changes in the Clinical Investigational Plan/Protocol .............................................. 74 
11.17.3 
Withdrawal of Regulatory Approval ......................................................................... 75 
12 Financial Obligations ........................................................................................ 75 
13 Ethics and Regulatory Compliance ................................................................... 75 
13.1 
Conduct of the Clinical Study ............................................................................. 75 
13.2 
Institutional Review Board/Ethics Committee Approval ................................. 75 
13.3 
Competent Authority Approval .......................................................................... 75 
13.4 
Clinical Study Informed Consent Approval ...................................................... 76 
13.5 
Identification and Confidentiality ...................................................................... 76 
13.6 
Site Qualification Visits ....................................................................................... 76 
13.7 
Site Initiation Visits .............................................................................................. 76 
13.8 
Insurance .............................................................................................................. 77 
13.9 
Site Audit Plan ...................................................................................................... 77 
13.9.1 
Site Data Audits by Acutus Medical ......................................................................... 77 
13.9.2 
External Audits ......................................................................................................... 77 
13.10 Public Domain Access to the Clinical Study ...................................................... 77 
13.11 Required Reports ................................................................................................. 78 
14 General Considerations ..................................................................................... 78 
14.1 
Discontinuation of the Clinical Study ................................................................. 78 
14.2 
Use of Information and Publications .................................................................. 78 

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15 References .......................................................................................................... 80 
 
 
 
 
 

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2 ABBREVIATIONS  
3D 
Three-Dimensional 
AADs 
Antiarrhythmic Drugs 
ACC 
American College of Cardiology 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
AFL 
Atrial Flutter 
AHA 
American Heart Association 
ARDS 
Acute Respiratory Distress Syndrome 
AT 
Atrial Tachycardia 
Au 
Gold 
AV 
Atrioventricular/Arteriovenous  
BDB 
Bidirectional Block 
BMI 
Body Mass Index 
CA 
Competent Authority 
CF 
Contact Force  
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigational Plan 
CL 
Cycle Length 
CMP 
Clinical Monitoring Plan 
COR 
Classification of Recommendation 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CS 
Coronary Sinus 
CSR 
Clinical Study Report 
CT 
Computed Tomography 
CTI 
Cavotricuspid Isthmus 
DCCV 
Direct Current Cardioversion 
DD 
Device Deficiency 
DMP 
Data Management Plan 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture 
EP 
Electrophysiology/Electrophysiological 
eCRF 
Electronic Case Report Form 
FBG 
Fiber Bragg Grating 
FDA 
Food and Drug Administration 
FTI 
Force Time Integral 

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Page 18 of 82 
G 
Grams 
Gs 
Gram second 
GCP 
Good Clinical Practices 
GDPR 
General Data Protection Regulation 
eGFR 
Estimated Glomerular Filtration Rate 
HCP 
Health Care Professional 
HRS 
Heart Rhythm Society 
IA 
Investigator Agreement 
ICE 
Intracardiac Echocardiogram 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IEGM 
Intracardiac Electrogram 
IFU 
Instructions For Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
ITT 
Intent-to-Treat Failure 
IVC 
Inferior Vena Cava 
LBBB 
Left Bundle Branch Block 
LA 
Left Atrium/Left Atrial 
LFU 
Lost to Follow-up 
LOE 
Level of Evidence 
mITT 
Modified Intent-to-Treat 
mm 
Millimeter 
MRI 
Magnetic Resonance Imaging 
NaCl 
Normal Saline 
NYHA 
New York Heart Association 
OM 
Operator Manual 
PAF 
Paroxysmal Atrial Fibrillation 
PI 
Principal Investigator 
PMA 
Pre-Market Approval 
PPT 
Pre-procedure Testing Failure 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
PtIr 
Platinum Iridium 
PV 
Pulmonary Vein 
PVI 
Pulmonary Vein Isolation 
QAP 
Quality Assurance Procedure 
RA 
Right Atrium/Right Atrial 
RF 
Radiofrequency 

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CLP-21 Rev 11 23 September 2021 
 
Page 19 of 82 
RFA 
Radiofrequency Ablation 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System 
SIV 
Site Initiation Visit 
SOC 
Standard of Care 
SQV 
Site Qualification Visit 
SR 
SSED 
Sinus Rhythm 
Summary of Safety and Effectiveness Data 
SVT 
Supraventricular Tachycardia 
TA 
Tricuspid Annulus 
TEE 
Transesophageal Echocardiogram 
TIA 
Transient Ischemic Attack 
TMF 
Trial Master File 
TTE 
Transthoracic Echocardiogram 
UADE 
Unanticipated Adverse Device Effect 
W 
Watts 
 
 
 

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Page 20 of 82 
3 INTRODUCTION 
3.1 
Background 
Atrial Flutter 
Atrial flutter (AFL) is a macroreentrant atrial arrhythmia typified by regular atrial 
contractions between 250 and 350 beats per minute, a constant P-wave morphology, and a 
2:1 atrial to ventricular conduction.1,2 Atrial flutter, while being a common arrythmia, can 
cause significant symptoms (palpitations, shortness of breath, dizziness or fainting) and 
sequelae. The hemodynamic condition of the patient determines whether immediate 
cardioversion to sinus rhythm (SR) is attempted. Endocardial mapping suggests that typical 
atrial flutter is based on right atrial macro reentry which involves the isthmus between the 
inferior vena cava (IVC) and the tricuspid annulus (TA). An atrial flutter circuit that is 
dependent on conduction through the cavotricuspid isthmus (CTI) is designated CTI-
dependent atrial flutter. A flutter involving a circuit that wraps around the tricuspid valve in 
a counter clockwise fashion is termed “typical” AFL, while a circuit rotates in a clockwise 
fashion is called “clockwise or reverse typical” AFL.1,3 In typical AFL, the flutter waves are 
negative in leads II and III and positive in lead V1.2 
Atrial flutter is a relatively common arrhythmia. The overall incidence of atrial flutter is 
estimated to be 0.088% (or 88 per 100,000 people).4 The incidence is 2.5 times higher in men 
than in women, and increases with age. Over one-half of these patients with atrial flutter also 
have atrial fibrillation (AF). Atrial flutter can be triggered by atrial tachycardia (AT) or atrial 
fibrillation (AF). Atrial flutter alone is seen in 0.037% of the population. The incidence of 
atrial flutter increased markedly with age, from 5 per 100,000 of those older than 50 years of 
age to 587 per 100,000 for those older than 80 years of age. The incidence of atrial flutter 
has been reported to be approximately twice that of paroxysmal supraventricular 
tachycardia.2,5 According to the American Heart Association (AHA) guidelines, the risks of 
thrombo-embolic events due to atrial flutter, including strokes, is the same as that for atrial 
fibrillation, therefore recommendations for anticoagulation therapy should be similar to those 
for subjects with AF.6,7,8 
Current Therapies for Atrial Flutter 
Current treatments offer non-invasive and invasive options which include pharmaceutical 
and ablation catheter-based approaches.7 Since 2003, the FDA has approved premarket 
approval (PMA) applications for ablation catheter systems indicated for the treatment of 
atrial flutter. The American College of Cardiology (ACC) and the American Heart 
Association (AHA Task Force) has applied a Classification of Recommendation (COR) and 
Level of Evidence (LOE) for cavotricuspid isthmus catheter-based ablation for symptomatic 
or drug refractory AFL of COR I and LOE B.7 Catheter ablation of typical AFL has been 
shown to be highly effective with an acute procedural success rate that in some studies may 
be as high as 97%.9 A systematic review and meta-analysis evaluating the safety and efficacy 

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of radiofrequency ablation (RFA) of typical AFL demonstrated a single-procedure acute 
success rate for AFL at 91.7% (95% CI: 88.4%-94.9%). Multiple-procedure success was 
97.0% (95% CI: 94.7%-99.4%). Post-ablation arrhythmia was noted in 13.2% of subjects 
(95% CI: 7.5% -18.9%), while repeat ablation was reported in 8% (95% CI: 4.5%-11.4%). 
Reported all-cause mortality has been relatively low in AFL studies (<1%), while serious 
adverse event rates up to 9% have been reported in clinical studies supporting PMA 
applications. Studies of radiofrequency ablation for the treatment of AFL and 
supraventricular tachycardia (SVT) report high efficacy rates and relatively low rates of 
major complications.9 
Among the various physical principles applied to catheter ablation, the application of RF 
energy is the most widespread technology. Alternative types of ablation energy include cryo-
ablation, laser ablation, and ultrasound ablation. During the process of RF ablation 
electromagnetic energy is transformed into thermal energy, whereby the process of resistive 
heating destroys cardiac tissue, modifying the electrical properties of the tissue, establishing 
electrical isolation of arrhythmic triggers or circuits.10 Currently, RF ablation is considered 
first-line therapy for treatment of AFL. Lesion formation created during RF catheter ablation 
of the CTI depends on multiple factors: power delivery, duration of the energy applied, tissue 
temperature, atrial anatomy, ablation catheter tip size and orientation.11 Success of AFL 
ablation is highly influenced by CTI length and morphology, to perhaps a greater degree than 
choice of catheter tip. Da Costa, et al., evaluated the role of CTI anatomy in the ability to 
achieve acute and chronic procedural success. An 8 millimeter (mm) tip catheter was more 
effective than an irrigated catheter in straight isthmus anatomy, while ablation efficacy was 
increased with an irrigated tip catheter in concave isthmus morphologies.12 The depth of the 
sub-Eustachian pouch has been shown to be the sole factor that influenced RF duration and 
energy during a CTI ablation often necessitating the deflection of the catheter by more than 
90 degrees to ablate within the pouch (knuckle-curve ablation).13 Achieving lesion 
transmurality, i.e., lesions that extend the full thickness along the 1-6 centimeter (cm) of the 
isthmus, is essential for the continuity and durability of catheter ablation success.14 By 
employing catheters which improve the electrode-tissue interface, the transfer of thermal 
energy to the cardiac tissue is enhanced.10  
Contact Force Technology 
Contact force (CF) catheter technology provides real-time sensing of catheter-to-tissue 
pressure enabling the appropriate delivery of RF energy to the endocardial surface. The distal 
tip of a contact force catheter houses a force sensing mechanism, providing real-time 
assessment of catheter-tissue contact.15 With improved electrode-tissue contact the transfer 
of thermal energy to the tissue is maximized. When contact force is increased the proportion 
of the electrode surface in contact with the endocardium is enhanced. Further, by increasing 
catheter-tissue contact, lesion size, volume, and depth are increased.16,17,18 Animal models 
suggest that the optimal contact force required to make transmural lesions is between 10 

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grams (g) and 20 g.19 These findings have been similarly represented with human data.20 The 
benefits of contact force sensing were initially demonstrated by the TOCCATA 
(NCT01223469) study which evaluated the safety and effectiveness of the real-time CF 
sensing using the TactiCath catheter in 77 subjects treated for right sided supraventricular 
tachycardias (SVT) and paroxysmal atrial fibrillation (PAF).21 From this initial study it was 
identified that a mean contact force of > 20 g was associated with an 80% probability of 
being in sinus rhythm 12-months following an index ablation. Results from multiple studies 
have demonstrated that using optimal contact force improves mid to long term AF ablation 
success rates and reduces arrhythmia recurrence rates when CF sensing catheters were 
compared to a non-CF sensing catheters.20,22,23 The TOCCASTAR study established that the 
atrial arrhythmia free rate was significantly higher when a minimum of ≥ 10 g was applied 
to ≥ 90% of the ablation lesions, confirming that optimal contact force is associated with 
improved effectiveness.20  
While the use of contact force is well established for pulmonary vein isolation (PVI), there 
is limited information regarding its utility in CTI ablation. CTI ablation creates unique 
challenges given the anatomy of the CTI is non-uniform, exhibiting decreasing tissue density 
when transitioning from the tricuspid annulus to the vena cava. Additionally, the presence of 
the Eustachian ridge, sub-Eustastian pouches, or pectinate muscle may limit the ability to 
create adequate lesions and may benefit from contact force. While low contact force (< 10 g) 
during PVI has been shown to be a play a critical role in lesion size and has been identified 
as a predictor of acute and chronic PVI reconnection, a similar association was lacking for 
CTI ablation. Kumar et al., examined the effect of varying anatomy on levels of contact force 
achieved during CTI ablation. The CTI was divided into equal length segments; annular, mid, 
and caval. The annular isthmus corresponded to the vestibule leading to the tricuspid valve, 
while the caval segment was closest to the orifice of the inferior vena cava, containing the 
Eustachian ridge. Wide variations in CF were observed within and between CTI regions. The 
highest CF was recorded in the caval region, followed by mid and annular sections. Low 
contact force was correlated with an increase in both the total ablation time to achieve 
bidirectional block and acute reconnection. The majority of reconnections observed during 
the 30 minute post ablation waiting period were in the mid-CTI region (54%).24 Verner et. 
al., found an inverse correlation between RF delivery and the percent of lesions delivered > 
10 g, with total RF time significantly increased with lesions < 10 g.25 Use of a detectible long 
vascular sheath has been suggested to achieve CF catheter stability along the CTI, improve 
maneuverability, thereby enhancing CF.23,24  
When comparing the performance of ablation catheter types, a recent study evaluated the 
acute efficacy of a CF catheter and a non-CF catheter with the endpoint of achieving 
bidirectional block.26 Catheter ablation using a CF catheter achieved acute bidirectional block 
in 100% of patients while only 90% of non-CF catheter ablations met the endpoint of 
bidirectional block. The authors suggest CF parameters may help overcome potential 
anatomical difficulties.26 The recent analysis of the safety and effectiveness of an irrigated, 

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gold tipped contact force catheter (AlCath Force catheter equivalent to AcQBlate FORCE) 
for subjects indicated for CTI and PAF ablation demonstrated acute procedural success 
(bidirectional block) with a mean contact force of 25.6 ± 7.3 g. Detailed results are provided 
in section 4. 
3.2 
Justification for Investigation and Study Design 
Catheter ablation of the cavotricuspid isthmus has been a therapeutic mainstay for the 
treatment of typical atrial flutter for the past decade. The current understanding of the field 
of catheter ablation makes for a mature marketplace of irrigated, non-irrigated, and contact 
force catheters for CTI ablation. The intended use and intended use population of the 
AcQBlate® FORCE is identical to those of current RF ablation catheters from other 
manufacturers approved for the ablation of atrial flutter.  
The expected safety rates for the primary safety and efficacy endpoints were derived from a 
meta-analysis of recently completed IDE trials and publications related to the safety and 
efficacy of typical CTI dependent atrial flutter ablation (see Table 1). Event rates were 
estimated from Summary of Safety and Effectiveness Data (SSED), results disclosed on 
clinicaltrials.gov, peer reviewed publications. and were calculated based on the occurrence 
of events that constitute the primary safety and efficacy endpoints defined in this protocol. 

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Table 1. Meta-Analysis to Determine Sample Size for Efficacy 
Device Trade Name (PMA Number) 
Month/Year 
n 
Efficacy Estimate** 
NaviStar™ DS 8 mm Deflectable Diagnostic Ablation Catheter 
Celsius™ DS 8 mm Deflectable Diagnostic Ablation Catheter 
Stockert 70 RF Generator (model 87001 with software version 001/033) 
Catheter Interface Cables (models D-1195 and D-1170) 
(P010068) 
09/2002 
182 
90.1% 
IBI TherapyTM Dual8 TM Ablation Catheter 
IBI-1500T6 (USA) Cardiac Ablation Generator 
(P040042) 
11/2005 
150 
93.3% 
Therapy Cool Path DuoTM Ablation Catheter 
Safire BLU DuoTM Ablation Catheter 
1500T9-CP Vi.6 Cardiac Ablation Generator 
(P110016) 
01/2012 
188 
96.3% 
Therapy™ Cool Flex™ Ablation Catheter 
(P110016/ S008) 
12/2013 
179 
98.9% 
Blazer® Open-Irrigated Ablation Catheter 
Maestro 4000™ Cardiac Ablation System 
MetriQ™ Irrigation Pump 
MetriQ™ Irrigation Tubing Set 
(P150005) 
02/2016 
109 
87.2% 
Mean 
 
Weighted Mean 
93.2% 
93.7% 
**Bidirectional CTI Block 30-60 minutes following last RF ablation. 

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Of the SSEDs listed in Table 1, none provided a comprehensive, tabular summary of SAEs 
that corresponds with the composite list used for the statistical analysis of the primary 
safety endpoint of the AcQForce Flutter clinical study. The TOCCATTA trial21 was the 
first multicenter, randomized, controlled trial that used direct contact force in human 
subjects. The overall event rate for right sided ablations was 2.3%. A comparison of 
reported events within the SSEDs and the TOCCATTA trial to the pre-defined composite 
safety definitions suggests an approximate SAE mean event rate of 3.0%, and a weighted 
mean of 2.9% (Table 2). Note that rates reported in individual studies varied between 2.1% 
and 5.3%. To account for any differences between the AcQForce Flutter study’s primary 
safety endpoint compared to the previous studies used in the meta-analysis, a derived safety 
event rate of 3% is expected. Based on this, a performance goal is proposed based on an 
expected rate of 98.5% and a 5.5% statistical margin. This will define the safety population 
sample size to support a primary safety endpoint with at least 90% power for the planned 
sample size.  
 
 

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Table 2. Estimated Safety Event Rate Based on Pre-defined Serious Adverse Events 
 
Acutus Pre-defined SAE 
 
Device Trade Name (PMA 
Number) 
N 
Death 
Cardiac 
perforation / 
Pericardial 
Tamponade 
Cerebral 
Infarct or 
Systemic 
Embolism  
Myocardial 
Infarct 
Major 
Access Site 
Complication 
Major 
Bleeding 
requiring 
transfusion 
Complete 
Heart Block 
Other Device 
related SAEs 
/ SADEs 
Estimated 
Safety 
Event Rate 
NaviStar™ DS 8 mm Deflectable 
Diagnostic Ablation Catheter 
Celsius™ DS 8 mm Deflectable 
Diagnostic Ablation Catheter 
Stockert 70 RF Generator (model 
87001 with software version 001/033) 
Catheter Interface Cables (models D-
1195 and D-1170)  (P010068) 
182 
Not 
Specified 
Not Specified 
Not 
Specified 
Not 
Specified 
1 (0.5%) 
Not 
Specified 
1 (0.5%) 
2 (1.1%) 
2.2% 
IBI Therapyr™ Dual 8 ™ Ablation 
Catheter 
IBI-1500T6 (USA) Cardiac Ablation 
Generator  (P040042) 
150 
Not 
Specified 
Not Specified 
Not 
Specified 
1 (0.6%) 
Not Specified 
Not 
Specified 
Not 
Specified 
7 (4.7) 
5.3% 
Therapy Cool Path Duo™ Ablation 
Catheter 
Safire BLU Duo™ Ablation Catheter 
1500T9-CP Vi.6 Cardiac Ablation 
Generator  (P110016) 
188 
1 (0.5%) 
Not Specified 
Not 
Specified 
Not 
Specified 
Not Specified 
Not 
Specified 
Not 
Specified 
3 (1.6%) 
2.1% 
Therapy™ Cool Flex™ Ablation 
Catheter (P110016/ S008) 
179 
1 (0.6%) 
Not Specified 
1 (0.6%) 
Not 
Specified 
Not Specified 
Not 
Specified 
Not 
Specified 
2 (1.1%) 
2.2% 
Blazer® Open-Irrigated Ablation 
Catheter 
Maestro 4000™ Cardiac Ablation 
System 
MetriQ™ Irrigation Pump 
MetriQ™ Irrigation Tubing Set 
(P150005) 
109 
Not 
Specified 
1 (0.9%) 
1 (0.9%) 
Not 
Specified 
1 (0.9%) 
Not 
Specified 
Not 
Specified 
0 (0.0%) 
2.8% 
TOCCATTA20 (NCT01223469) 
152 
Not 
Specified 
2 (1.3%) 
Not 
Specified 
Not 
Specified 
3 (2.0%) 
Not 
Specified 
Not 
Specified 
Not Specified 
3.3% 
Average 
 
Weighted Average 
3.0% 
2.9% 
 

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The overall acute efficacy rate from this meta-analysis is 93.7%. Of the five studies 
evaluated, all studies passed their pre-specified acute efficacy endpoint establishing an 
acceptable procedural efficacy profile for the catheter under evaluation. A performance goal, 
using a weighted mean based on sample size, was derived from the meta-analysis. The 
resultant efficacy performance goal with a 10% statistical margin is 83.7%.  
The Primary Safety endpoint of subjects free from a pre-specified composite list of 
procedure/device related Serious Adverse Events through 7-days post ablation using a 
literature based control comparative analysis will drive the sample size. A maximum of 110 
mITT subjects* will be enrolled based on a one sided α 0.05, 90% power, and a 5.5% 
statistical margin. For the purposes of this study a maximum of 110 patients will be enrolled 
at twenty sites. 
The following assumptions were used in the calculation of sample size: 
 
Endpoint 
Literature 
Based 
Control 
Statistical 
Margin 
Performance 
Goal 
Acutus 
Estimate 
90% Power 
α 0.050 
Primary 
Safety 
97% 
5.5% 
93% 
98.5% 
110* 
Primary 
Efficacy 
93.7% 
10% 
83.7% 
93.7% 
85 
 
Inherent limitations in single arm design will be mitigated by limiting bias and confounders 
in the protocol, including inclusion/exclusion criteria similar to the trials comprising the 
meta-analysis, as well as rigorous patient screening and arrhythmia recurrence monitoring.  
4 REPORT OF PRIOR INVESTIGATIONS 
4.1 
Overview  
In May of 2019, Acutus Medical, via a joint agreement, acquired the Biotronik AlCath Force 
Sensing Catheter and Qubic Force Sensing Module technology. The AlCath Force catheter 
was rebranded as the AcQBlate Force Sensing Ablation Catheter and manufacturing was 
moved to Carlsbad, California. The Qubic Force Sensing Module retained its initial branding.  
Following CE Mark approval, Biotronik conducted the post-market, prospective, 
BIO|CONCEPT AlCath Force study enrolling 30 subjects with PAF and/or typical AFL at 6 
sites in Australia. Ablation procedure included PVI only (n=12), CTI only (n=16), and PVI 
plus CTI (n=2). The study objective was to provide continued clinical evidence supporting 
the safety and efficacy of the devices and identify additional risks associated with use. Safety 
endpoints included the collection of all SAEs and serious adverse device effects (SADEs) 

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through procedure discharge. The efficacy endpoint was the determination of electrical 
isolation defined as PV isolation for the pulmonary vein (PV) ablation and bidirectional block 
for the CTI ablations.  
4.2 
AlCath Force Ablation Procedure 
Electrophysiological examinations during the ablation procedure were performed according 
to clinical study site preference for PVI and CTI ablations. The AlCath Force catheter and 
Qubic Force were operated as labeled. Target values for contact force, contact force ranges, 
and force time integrals (FTI) were at the discretion of the Investigator. The following 
recommendations were adhered to: 
• 
Maximum tip temperature: 42° C (mandatory). 
• 
Energy delivery ≤ FTI of 450 gram seconds (gs) in any catheter position. 
• 
Initial power titration of energy ≤ 25 W. After 15 seconds, the energy could 
be increased until a transmural lesion was achieved.  
• 
When ablating the posterior wall, a reduction in power and FTI was 
recommended. 
• 
Irrigation flow rates during mapping and ablation followed the Instructions 
for Use (IFU). 
4.3 
Results 
Baseline demographics are reported in the Table 3 below: 
Table 3: BIOCONCEPT AlCath Force Baseline Demographics and Co-Morbidities 
Characteristic 
Mean ± SD 
Gender 
Male 23 
Female 7 
Age 
64.7 ± 10.7 
Weight (kg) 
93.7 ± 17 
BMI 
30.3 ± 4.8 
Systolic BP 
142.1 ± 15.9 
Diastolic BP 
76.5 ± 12.9 
Co-Morbidities 
Frequency (%) 
Ischemic heart disease 
5 (16.7) 

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Hypertension 
17 (56.7) 
Asthma or chronic lung disease (except COPD) 
4 (13.3) 
Peripheral vascular disease 
2 (6.7) 
Diabetes Mellitus 
8 (26.7) 
Renal dysfunction/chronic renal disease 
5 (16.7) 
COPD (chronic obstructive pulmonary disease) 
5 (16.7) 
 
Severe Adverse Device Effects (SADE) 
No deaths or SADEs were reported throughout the duration of the clinical study.  
Acute Procedural Success 
Acute procedural success was defined as isolation of all four pulmonary veins with 
demonstrated entrance and exit block in subjects receiving an ablation for AF. Fourteen 
subjects treated for AF demonstrated acute procedural success (14/14, 100%). For subjects 
receiving a CTI ablation, acute procedural success was defined as bidirectional block across 
the cavotricuspid isthmus with conformation via differential pacing. Seventeen subjects 
(17/18 94.4%) achieved the procedure endpoint.  
Device Performance 
A total of 38 catheters were used in the 30 procedures. Six device deficiencies were observed 
(6/38, 15.8%). Three of the device deficiencies required the crossover to another AlCath 
Force catheter. No device deficiencies were noted with the Qubic Force.  
A total of 56 usability parameters were assessed: 27 parameters for the AlCath Force catheter 
and 29 parameters for the Qubic Force. The assessment of usability of the AlCath Force 
catheter and Qubic Force was positive with 99% of usability aspects rated as “adequate”, 
“good”, or “very good”. Approximately 1% of rates were ranked as “poor” or “very poor”. 
Ablation parameters for the PVI and CTI ablations are outlined in the Table 4 below: 
Table 4: BIOCONCEPT AlCath Force Procedure Parameters during RF Ablation 
Variable 
Subgroup 
(n)* 
Data 
Mean ± SD 
(min, max) 
High Rate Irrigation Flow 
Setting (ml) 
CTI Ablation 
(16) 
17.5 ± 3.6 
(12, 30) 
PVI Ablation 
(12) 
19.2 ± 5.1 
(17, 30) 

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Variable 
Subgroup 
(n)* 
Data 
Mean ± SD 
(min, max) 
CTI plus PVI 
(2) 
17.0 ± 0 
(17, 17) 
All 
(30) 
18.1 ± 4.1 
(12, 30) 
Low Rate Irrigation Flow 
Setting (ml) 
CTI Ablation 
2.0 ± 0 
(2, 2) 
PVI Ablation 
2.2 ± 0.6 
(2, 4) 
CTI plus PVI 
2.0 ± 0 
(2, 2) 
All 
2.1 ± 0.4 
(2, 4) 
Cumulative Irrigation 
Volume (ml) 
CTI Ablation 
519 ± 267 
(174, 1100) 
PVI Ablation 
892 ± 441 
(340, 1950) 
CTI plus PVI 
765 ± 101 
(694, 837) 
All 
684 ± 380 
(174, 1950) 
Pre-set RF Power (W) 
CTI Ablation 
30 ± 0 
(30, 30) 
PVI Ablation 
22.9 ± 4.5 
(20, 30) 
CTI plus PVI 
30 ± 0 
(30, 30) 
All 
27.2 ± 4.5 
(20, 30) 
Maximum RF Power (W) 
CTI Ablation 
31.3 ± 3.4 
(30, 40) 
PVI Ablation 
27.5 ± 2.6 
(25, 30) 
CTI plus PVI 
30 ± 0 
(30, 30) 
All 
29.7 ± 3.5 
(25, 40) 

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Variable 
Subgroup 
(n)* 
Data 
Mean ± SD 
(min, max) 
Maximum Tip Temperature 
Reached (C°) 
CTI Ablation 
36.4 ± 3 
(31, 42) 
PVI Ablation 
34.9 ± 2 
(33, 39) 
CTI plus PVI 
38.5 ± 4.9 
(35, 42) 
All 
35.9 ± 2.8 
(31, 42) 
Cumulative Duration of 
Energy Delivery (min) 
CTI Ablation 
22.1 ± 12.5 
(4, 51) 
PVI Ablation 
46.1 ± 21.4 
(19, 97) 
CTI plus PVI 
39.5 ± 4.9 
(36, 43) 
Aimed Contact Force (g) 
CTI Ablation 
25.6 ± 7.3 
(7.3, 20) 
PVI Ablation 
25.0 ± 8.0 
(8.0, 20) 
CTI plus PVI 
30.0 ± 0 
(30, 30) 
All 
25.0 ± 7.3 
(20, 40) 
*N values remain the same for all subgroups 
 
Protocol Deviations 
Protocol related deviations were observed in four subjects, including an application of RF 
power > 40 W (n=2), a minor infraction to the informed consent process, and the enrollment 
of a subject not eligible based on inclusion/exclusion criteria.  
4.4 
Conclusions 
The BIO|CONCEPT AlCath Force post-market clinical study demonstrated the AlCath Force 
Sensing Ablation Catheter and the Qubic Force Sensing Module were safe and effective. 
Although a small sample size was studied, no serious adverse device effects were noted. 
Acute outcomes were 100% and 94.4% for the AF and AFL populations, respectively. The 
clinical study did not evaluate long-term arrhythmia management effectiveness. 

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5 STUDY DEVICE DESCRIPTION 
5.1 
Indication for Use (proposed) 
The AcQBlate® FORCE Sensing Ablation Catheter and related accessory devices are 
indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, 
and radiofrequency ablation of recurrent and symptomatic atrial flutter (AFL) when used 
with a compatible RF Generator. When used with the Qubic Force® module, the AcQBlate® 
FORCE Sensing Ablation Catheter provides a real time measurement of contact force 
between the catheter tip and the heart. 
5.2 
AcQBlate® Force Sensing Ablation System 
The AcQBlate® Force Sensing Ablation System (herein known as AcQBlate Force Sensing 
System) comprises the AcQBlate Force Sensing Ablation Catheter (AcQBlate® FORCE), the 
Qubic Force Sensing Module (Qubic Force), the Qubic RF Generator, and the Qiona 
Irrigation Pump with Tubing Set. The System is designed for EP mapping and RF ablation 
of typical atrial flutter. 
5.3 
AcQBlate Force Sensing Ablation Catheter 
The AcQBlate Force is a unidirectionally deflectable, steerable, quadripolar, irrigated 
ablation catheter with an integrated force sensor for intracardiac application. It is designed 
for EP mapping and RF ablation of cardiac arrhythmias.  
 
 
 
 
 
 
 
5.3.1 
Qubic Force Sensing Module 
The AcQBlate FORCE contact force monitoring capability requires connection with the 
Qubic Force Sensing Module (Qubic Force) by means of an optical cable which is 
permanently attached to the catheter.  
The Qubic Force is a non-sterile, reusable unit that does not contact the patient . It processes 
the contact force signal from the AcQBlate FORCE during an EP procedure irrespective of 
an RF energy application (ablation).  
 

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5.4 
Qubic Radiofrequency (RF) Generator 
The Qubic RF Generator is a modular RF generator that can be used in combination with the 
AcQBlate FORCE for cardiac RF ablation. The values measured during ablation are shown 
on the display and control unit screen. 
 
  
5.5 
Qiona Irrigation Pump and Tubing Set 
The Qiona Ablation Irrigation Pump is used in conjunction with a tubing set to deliver a 
sterile 0.9% sodium chloride solution (normal saline) for the purpose of cooling the AlCath 
Flux catheter tip during ablation procedures.  
 
 
 
 
 
 
5.6 
The AcQBlate Force System Operation 
General 
Equipment used during an EP procedure may include devices for introduction of the catheter 
into the vascular system, catheter visualization, processing the EP signals, and devices 
providing electrical stimulation for diagnostic purposes. In this clinical study, the AcQBlate 
FORCE catheter will be used with the Qubic Force, the Qubic RF Generator and the Qiona 
Ablation Irrigation Pump with Tubing Set . These devices are not FDA approved and 
therefore considered investigational devices.  
In a typical ablation procedure, EP mapping is performed to identify and map the 
arrhythmogenic areas in the heart to be targeted for subsequent ablation. All catheter 
manipulations during mapping and ablation should be performed with a navigational 
guidance (fluoroscopic, intracardiac echo and/or 3D navigation devices). 
Electrophysiologic Mapping 
Prior to the actual ablation, diagnostic EP mapping may be performed with the AcQBlate 
FORCE. During this process, the contact force information provided by the Qubic Force may 
be used to monitor the contact between the catheter tip and the myocardial tissue and may 
assist the operator to obtain stable intracardiac signals of appropriate quality. Moreover, 

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contact force monitoring may reduce the risk of cardiac perforation as a result of excessive 
contact force. During EP mapping the electrodes of the AcQBlate FORCE can be used for 
pacing. Procedures and routines used during the mapping procedure strongly depend on the 
arrhythmia(s) to be treated.  
Advanced Mapping Systems 
The AcQBlate Force System is compatible with the Acutus Medical AcQMap System with 
investigational frame software v3.6.4.XX. Use of the AcQMap System with the 
investigational frame software may be utilized to support display of ablation parameters. The 
ablation specific data includes the below listed parameters: 
• 
Contact force from Qubic Force 
• 
Power from Qubic RF 
• 
AcQTag – used to color and size markers automatically on the 3D anatomy 
model 
• 
Listing of generic auxiliary catheters 
The AcQMap System with the investigational frame software is considered part of the 
investigational device and is an optional accessory to the AcQBlate Force System. Use of 
the AcQMap System with investigational frame software v3.6.4.XX should be at the 
discretion of the Investigator. 
RF Ablation 
Once the targets for ablation have been appropriately identified, ablation is performed using 
the AcQBlate FORCE ablation functionality. The ablation electrode at the tip of the catheter 
is positioned by means of the steering mechanism on the proximal handle and RF current is 
applied by the Qubic RF generator. RF application is a functionality of the Qubic RF 
generator, not directly controlled by the AcQBlate FORCE catheter. Irrigated ablation 
catheters like the AcQBlate FORCE are used in power-controlled mode. In this mode, the 
supply of RF current is regulated and/or discontinued if the power exceeds a user-defined 
threshold. Additionally, a temperature cut-off is set to define a maximum catheter tip 
temperature to stop RF delivery in case of overheat. This may reduce the risk of steam pops 
and cardiac perforation as well as prevent excessive scar formation and thermal coagulation 
of blood at the ablation site.  
The contact force shown by the Qubic Force is an indication of the quality of the contact 
between the ablation electrode and the myocardial tissue. The operator may use the contact 
force information to monitor the tissue-electrode contact and achieve effective lesion creation 
while minimizing the risk of cardiac perforation. The direction of the total contact force 
vector indicated by the Qubic Force may assist the operator to control the orientation of the 
AcQBlate FORCE regarding the tissue. For instance, a perpendicular orientation of the 

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ablation electrode would be indicated by a minimal lateral force component. In addition, the 
FTI parameter informs the operator about the stability of the catheter tip on the tissue, which 
contributes to the effectiveness of lesion creation.  
The tip design of the AcQBlate FORCE allows the application of a heparinized saline flow 
to be dispensed through the irrigation holes of the tip. Irrigated RF ablation is intended to 
allow the application of a relatively high RF power without overheating the tissue surface. 
This may increase the effectiveness of lesion creation.  
As part of the manufacturing process, each AcQBlate FORCE is individually calibrated in 
order to associate the optical signal with the actual contact force. This calibration data and 
additional manufacturing data are stored in an RFID chip integrated in the fiber optics 
connector of the AcQBlate FORCE. Upon connection of the AcQBlate FORCE with the 
Qubic Force, these data are automatically read by the Qubic Force and used to provide 
catheter-specific, calibrated contact force information. As a result, a separate calibration 
procedure before using the catheter is not required, and the contact force reading is accurate 
after zero-setting the contact force while the AcQBlate FORCE is free-floating in the heart 
chamber (i.e., no contact with the cardiac wall). 
 
 
5.7 
Investigational Devices  
Table 5describes the investigation devices and cables that will be used as part of the 
AcQForce Flutter study. 
 
 

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Table 5. Investigational Devices and Cables with Product Numbers 
Product(s) 
Model(s) 
AcQBlate FORCE (Acutus) 
900202, 900203, 900204, 
900205, 900206 
Qubic Force (Acutus) 
900012 
Qiona Irrigation Pump (Biotronik) 
406935 
Qiona Irrigation Tubing Set (Biotronik) 
365775 
Qubic RF Generator (Biotronik) 
396166 
Qubic RF Foot Switch (Biotronik) 
404964 
Power cord US 
NK-11* 
Cable for recording system analog connection (analog signal 
cable that transmits the ECG signals of the ablation catheter 
to the Recording System, where all ECG signals are collected 
and displayed) 
MPK-4-R * 
Neutral electrode/grounding pad 
PK-153*  
Patient cable to connect Qubic Force or Qubic RF to 
AcQBlate FORCE 
PK-147*  
Cable to grounding or neutral electrode (connects the neutral 
electrode, a patch usually on the leg of the patient, with the 
generator to close the current loop between catheter-patient-
generator) 
PK-148* 
Cable to control unit to the Qubic RF unit (ethernet cable to 
connect the RF generator and the remote unit’s digital 
communication) 
VK-118* 
Cable for connecting the Qiona Irrigation pump to the RF unit 
VK-119* 
Cable for connecting the Qubic RF unit to an EP recording 
system digital connection  
VK-120* 
Video Cable for Connecting an External Monitor to Qubic 
Force 
VK-124* 
Adapter Cable for connecting AcQMap to Qubic RF 
800630* 
*Or sponsor specific equivalent 

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6 CLINICAL INVESTIGATIONAL PLAN/ PROTOCOL 
6.1 
Clinical Study Objective 
The objective of the study is to demonstrate the AcQBlate Force Sensing System is safe and 
effective when used to ablate the cavotricuspid isthmus (CTI) for the treatment of typical 
atrial flutter when compared to a literature-based control.  
Data will be used to support a PMA application. 
6.2 
Clinical Study Design 
The AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global 
clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing 
Ablation System in the ablation management of symptomatic cavotricuspid isthmus 
dependent atrial flutter. The subject population will consist of men and women 18 years of 
age or older, presenting for a de novo percutaneous cardiac ablation of symptomatic, typical 
atrial flutter. 
6.3 
Primary Endpoints 
6.3.1 
Safety 
The Primary Safety Endpoint for the AcQForce Flutter study is a comparative analysis of 
subjects who are free from a composite list of pre-specified device/procedure related Serious 
Adverse Events (SAEs) that occur through 7-days post ablation procedure using a literature-
based control.  
Serious adverse events are pre-defined and include: 
• 
Death 
• 
Cardiac tamponade/perforation 
• 
Myocardial infarction 
• 
Stroke 
• 
Systemic embolism 
• 
Major access site complications 
• 
Major bleeding requiring transfusion 
• 
Complete heart block 
• 
Other SAEs/SADEs adjudicated by an independent review as “probably or 
definitely related” to the Investigational device. 

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All adverse clinical events will be collected, coded and reported, for the duration of the study 
according to the definitions of EN ISO 14155. The occurrence rate for all the clinical events 
will be characterized and calculated by independent adjudication. Table 6 outlines SAE 
definitions.  
 
Table 6. Serious Adverse Event Definitions 
SAE 
Study Definition 
Death 
Cessation of life 
Cardiac 
tamponade/perforation 
Development of a significant pericardial effusion during or 
within 30-days of the procedure. A significant pericardial 
effusion is one that results in: 
• hemodynamic compromise; or 
• requires elective or urgent pericardiocentesis; or 
• results in a 1 cm or more pericardial effusion as 
documented by echocardiography.  
Myocardial Infarction 
Presence of any one of the following criteria:  
• detection of ECG changes indicative of new ischemia 
(new ST T wave changes or new left bundle branch 
block (LBBB)) that persist for more than 1 hour;  
• development of new pathological Q waves on an ECG; 
imaging evidence of new loss of viable myocardium or 
new regional wall motion abnormality. 
Stroke 
Rapid onset of a focal or global neurological deficit with at least 
one of the following:  
• change in level of consciousness. 
• hemiplegia, hemiparesis, numbness or sensory loss 
affecting one side of the body; 
• dysphasia or aphasia, hemianopia, amaurosis fugax; 
• other neurological signs or symptoms consistent with 
stroke. 
Duration of a focal or global neurological deficit should be > 24 
hours (less if therapeutic intervention(s) were performed (e.g., 
thrombolytic therapy or intracranial angioplasty)).  
Confirmation of the diagnosis by at least one of the following:  
• neurology or neurosurgical specialist; 
• neuroimaging procedure (Magnetic resonance imaging 
(MRI) or computed tomography (CT) scan or cerebral 
angiography; 
• lumbar puncture (i.e., spinal fluid analysis diagnostic of 
intracranial hemorrhage). 

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Systemic embolism 
Acute vascular insufficiency or occlusion of the extremities or 
any non-CNS organ associated with clinical, imaging, 
surgical/autopsy evidence of arterial occlusion in the absence of 
other likely mechanism (e.g. trauma, atherosclerosis, or 
instrumentation). When there is presence of prior peripheral 
artery disease, angiographic, surgical or autopsy evidence is 
required to show abrupt arterial occlusion. 
Major access site 
complications  
Vascular access complications include development of a 
hematoma, an arteriovenous (AV) fistula, or a pseudoaneurysm. 
A major vascular complication is defined as one that requires 
surgical or pharmacologic intervention. 
Major bleeding 
requiring transfusion  
Significant bleeding that requires and/or is treated with 
transfusion of blood products (≥ 2 units). 
Complete heart block 
Cardiac conduction block of the AV node requiring the 
implantation of a permanent pacemaker. 
Other SAEs/SADEs 
adjudicated by an 
independent review as 
“probably or definitely 
related” to the 
Investigational device. 
A complication that results in permanent injury or death, 
requires intervention for treatment, or prolongs or requires 
hospitalization for more than 48-hours.  
6.3.2 
Efficacy 
The Primary Effectiveness Endpoint for the AcQForce Flutter study is an analysis of subjects 
achieving acute procedural success. Acute procedural success is defined as the demonstration 
of bidirectional cavotricuspid isthmus block at least twenty (20) minutes following the last 
radiofrequency application at the cavotricuspid isthmus with the investigational catheter. 
Bidirectional block (BDB) confirmation is defined as: 
• 
Demonstration of bidirectional electrophysiological conduction block 
through the cavotricuspid isthmus (CTI) using both coronary sinus ostium 
(CS) and annular low right atrial pacing maneuvers.  
6.3.2.1 
Primary Efficacy Endpoint Failure  
A primary efficacy failure will comprise the following: 
• 
The inability to achieve and maintain bidirectional CTI block at least 20 
minutes following the last RF application with the investigation device. A 
second investigative catheter or alternate catheter curve may be used prior to 
designation as failure. Maximum RF time before considering a non-
investigational catheter is at the discretion of the Investigator but shall not 
exceed 60 minutes of RF time. 

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OR 
• 
The use of a commercially available non-investigational catheter for any 
ablation of the CTI. 
NOTE: Use of isoproterenol is at the discretion of the Investigator. 
6.3.2.2 
Observational Effectiveness Endpoint  
The observational effectiveness endpoint is an analysis of the freedom from recurrence of 
typical CTI dependent atrial flutter OFF Class I/III antiarrhythmic drugs (AADs) at 30-days 
post index procedure measured by a 24-hour continuous electrocardiogram (ECG) monitor. 
6.4 
Clinical Study Duration 
The study is anticipated to take approximately 12-months to enroll and will include a 30-day 
follow-up period. Total study duration is anticipated to be 12-18-months. The per patient 
study duration is expected to be approximately 6-weeks. 
6.4.1 
Clinical Study Sample Size  
The sample size consists of 110 mITT subjects, based on using a one-sided α of 0.05 and at 
least 90% power for the comparison of each primary endpoint against the corresponding 
performance goal. A maximum of 120 mITT subjects will be enrolled.  
6.4.2 
Clinical Study Site Enrollment 
Enrollment at any single clinical center will be limited to 20% of the maximum enrollment.  
Clinical centers will be informed in writing by the Sponsor when they have met any of the 
enrollment limits. 
6.5 
Clinical Study Sites 
TBD 
6.6 
Subject Population 
The subject population will consist of men and women 18 years or older, presenting for a de 
novo cavotricuspid ablation for symptomatic typical atrial flutter.  
6.6.1 
Inclusion Criteria 
A potential study subject will meet all of the following inclusion criteria: 
1. Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter. 
2. At least one (1) documented episode of typical flutter within 180-days (6 months) 
prior to enrollment, documented by 12-lead ECG.  
3. Age 18 years or older at time of consent.  

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4. Subjects are willing and able to provide written informed consent to participate in the 
study and agree to comply with all follow-up visits and evaluations. 
6.6.2 
Exclusion Criteria 
A potential study subject who meets any of the following criteria will be excluded from 
participation:  
1. In the opinion of the Investigator, any contraindication to the planned atrial ablation, 
including contraindications to anticoagulation therapy and any other significant 
uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, 
chronic kidney disease). 
2. Inability to document cavotricuspid isthmus conduction. 
3. Any prior right atrial cavotricuspid isthmus ablation.  
4. Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to 
enrollment. 
5. Any patient scheduled or anticipating an AF ablation within the follow-up period. 
6. Administration of oral amiodarone within 120 days prior to procedure excluding a 
one-time IV/oral administration of < 2000 mg in a 24-hour period. 
7. Cardiac surgery within 60 days prior to enrollment. 
8. ST-elevation myocardial infarction (STEMI) within 60-days prior to enrollment. 
9. Current unstable angina. 
10. Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to 
enrollment. 
11. Any history of a known hematologic disorder (bleeding/clotting).  
12. Implantation of permanent leads of an implantable device in or through the right 
atrium within 90-days prior to enrollment. 
13. Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-
months prior to enrollment. 
14. Subjects with an ejection fraction less than 30% within 90-days of enrollment. 
15. Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of 
enrollment. 
16. Clinically significant moderate to severe structural heart disease (including tricuspid 
valve regurgitation, tricuspid valve stenosis, tricuspid valve replacement, Ebstein's 
anomaly, or other congenital heart disease) that would preclude catheter introduction 
and placement, as determined by the Investigator. 
17. Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 
180 days prior to enrollment. 
18. Body Mass Index (BMI) >42 kg/m2. 

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19. International Normalized Ratio (INR) > 3 (required for patients taking warfarin). 
20. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within 
the last 30-days. 
21. Women who are pregnant or plan to become pregnant within the course of their 
participation in the investigation. 
22. Current enrollment in any other study protocol where testing or results from the 
study may interfere with the procedure or outcome measurements for this study. 
23. 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). 
6.7 
Clinical Study Enrollment Definitions 
For the purposes of this clinical study, the following definitions regarding the status of a 
subject will apply: 
Enrolled 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 up to the point of the procedure.  
Pre-procedure Testing Failure (PPT) – An enrolled subject who has presented for 
the procedure in any rhythm other than sinus rhythm or typical atrial flutter and 
has not undergone venous access. These subjects will be treated per the 
recommendations of the study physician and exited from the study. No use of the 
investigational device is allowed. A Study Exit electronic case report form (eCRF) 
will be completed.   
Intent-to-Treat Failure Subject (ITT) – Any enrolled subject who has the venous 
access portion of the ablation procedure initiated and up to the point of completion 
of the right-atrial access but prior to any RF application with the investigational 
device. The ITT population will be followed for safety reasons through the 7-day 
follow-up visit. ITT subjects that the AcQBlate FORCE Catheter has been inserted 
into will be included in the safety data analysis but excluded from the efficacy data 
analysis. All other ITT patients will be excluded from any safety or efficacy data 
analysis. In addition to the Discharge eCRF and the 7-day Follow-up eCRF, a 
Study Exit eCRF will also be completed. The ITT population may include: 
• At the time of the procedure, if the subject does not demonstrate 
conduction through cavotricuspid isthmus, the subject will be exited from 
the study and followed for safety through the 7-day follow-up visit.   

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• At the time of procedure, if atrial fibrillation is initiated during the process 
of inducing typical AFL, a direct current cardioversion (DCCV) may be 
performed to attempt conversion to sinus rhythm so that the CTI 
conduction portion of the study may proceed. If during confirmation of 
CTI conduction, the investigator determines that further ablation beyond 
the CTI is warranted the subject will be exited from the study and followed 
for safety through the 7-day follow-up visit. 
Modified Intent-to-Treat Subject (mITT) – Any enrolled subject who initiates the 
ablation procedure using the AcQBlate Force Sensing System. An initiated 
ablation procedure is defined as a procedure where the AcQBlate Force Sensing 
System is used for the ablation procedure irrespective if a non-investigational 
device was used to complete the ablations. mITT subjects will be followed for all 
study outcome measures for the full duration of the clinical study and will 
comprise the data set for the Primary Safety and Efficacy Endpoints.  
Screened
Screen Failure
Enrolled
Pre Procedure Testing 
(PPT) Failure
Intent-to-Treat (ITT) 
Failure
7-day Follow-up 
eCRF Completed
Modified Intent-to-
Treat (mITT)
7-day Follow-up 
eCRF Completed
30 day Follow-up 
eCRF Completed
Study Completion
ITT Subject Study
Completion
Discharge eCRF 
Completed
Discharge eCRF 
Completed
Study Exit eCRF 
Completed
 
Clinical Study Enrollment Definitions Flow Chart 

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6.8 
Minimization of Bias 
Subject selection, subject treatment, and the evaluation of study data are sources of bias. 
Efforts to minimize potential bias include, but are not limited to: 
• 
Prior to enrollment, rigorous screening will be performed to confirm 
enrollment eligibility with defined inclusion and exclusion criteria. 
• 
Baseline characteristics and medical history will be collected to statistically 
access possible characteristics that may influence study endpoints. 
• 
All clinical study site personnel and sponsor/delegate personnel will be 
thoroughly trained on their respective aspects of the clinical study. 
• 
All Investigators will be trained on and required to follow the Clinical 
Investigational Plan (CIP)/protocol. 
• 
Monitoring visits will be undertaken to verify eCRFs against source data and 
compliance with the CIP/protocol.  
• 
An independent clinical events adjudication reviewer will regularly review 
and adjudicate adverse events and deaths. 
• 
A centralized evaluator will be used to describe atrial arrhythmia data 
received from the continuous ECG monitor. 
6.9 
Subject Withdrawal 
Individual subjects may withdraw their consent to participate in the study at any time. 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. The Investigator or designee will 
attempt to contact a subject at least 3 times prior to designating them as lost to follow-up; 1 
of these 3 attempts should include contacting the subject via certified mail. A Study Exit 
eCRF form will be completed when a subject is lost to follow-up. 
7 CLINICAL STUDY TREATMENTS AND FOLLOW-UP VISITS 
7.1 
General Overview 
The clinical study is a single-arm evaluation of subjects diagnosed with cavotricuspid 
isthmus dependent typical atrial flutter. All subjects will undergo ablation of the 
cavotricuspid isthmus (CTI) for the treatment of typical atrial flutter.  

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7.2 
Informed Consent 
It is the responsibility of the Investigator (or designee) to give each subject full and adequate 
verbal and written information regarding all aspects of the study procedure, device, and 
associated risks. A signed ICF must be obtained from the subject before any study procedures 
not considered standard of care (SOC) for an AFL ablation are undertaken. The informed 
consent form (ICF) must be signed by the subject and witnessed by the Investigator (or 
designee). The original signed ICF 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. 
7.3 
Subject Screening  
The following information should be collected to verify eligibility in the clinical study: 
• 
Review of all inclusion/exclusion criteria to confirm subject eligibility 
• 
Subject demographics 
• 
Medical history review including: 
- Information specific to the exclusion criteria 
- History of atrial fibrillation 
• 
Physical examination (at a minimum Cardiovascular, Respiratory, 
Extremities should be evaluated) 
• 
Vital signs 
• 
12-lead ECG documenting episode of cavotricuspid dependent typical atrial 
flutter within 180 days (6-months) of enrollment 
• 
Subject symptoms  
• 
Current cardiovascular and anticoagulation medications 
7.4 
Baseline Evaluation 
The following information should be collected at baseline and reviewed prior to the ablation 
procedure: 
• 
TTE within 90 days of procedure (if needed) 
• 
12-lead ECG 
• 
Pregnancy test for women of childbearing potential within 7-days prior to the 
study procedure following the institution’s SOC  

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7.5 
Ablation Pre-Procedure Requirements 
7.5.1 
Atrial Thrombus 
No procedure should be completed if there is any evidence of atrial thrombus. The method 
of thrombus assessment should be recorded on the Procedure eCRF.  
7.5.2 
Anticoagulation and Atrial Thrombus Assessment 
Periprocedural anticoagulation and pre-procedure assessment for atrial thrombus should 
follow the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline 
for 
the 
Management 
of 
Patients 
With 
Atrial 
Fibrillation 
and 
the 
2017 
HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical 
ablation of atrial fibrillation  
• 
A transesophageal echocardiogram is required for all subjects with atrial 
flutter for ≥ 48 hours or unknown duration AND the subject has not been 
anticoagulated with a vitamin K antagonist or NOAC for at least 21 days 
before the study procedure. 
- A transesophageal echocardiogram for subjects with atrial flutter 
less than 48 hours duration prior to study procedure may be 
performed at the investigators discretion but is not mandatory. 
• 
Subjects who are required to have a transesophageal echocardiogram, should 
have one performed within 24 hours of the study procedure. 
• 
Any subject who is determined to have cardiac thrombus will not undergo the 
study procedure and will be exited from the study. 
 

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Enrolled & Pre-Procedure Screening
TEE is recommended and may be 
performed at investigators discretion 
but is not mandatory
Episode of AFL for ≥ 48 hours 
or unknown duration?
Anticoagulated with
vitamin K antagonist or NOAC 
for ≥ 21 days before study 
procedure?
No action needed
Yes
Yes
No
TEE is required and should be 
performed within 24 hours of study 
procedure. No procedure should be 
completed if there is any evidence of 
atrial thrombus.
No
 
Transesophageal Echocardiogram Requirement Flow Chart 
 
7.5.3 
Antiarrhythmic Medications 
To minimize the impact of oral antiarrhythmic drugs (AADs), on device effectiveness, Class 
I/III AADs should be discontinued at least 5 half-lives (Table 7) prior to the ablation 
procedure.  
Table 7. Antiarrhythmic Medication 5 half-lives 
Antiarrhythmic Medication  
5 Half-lives 
Class I 
Lidocaine 
7.5-10 hours 
Procainamide 
15-20 hours 
Propafenone 
15 hours- 2 days 
Class III 
Amiodarone* 
120 days 

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Dronedarone 
5 days 
Sotalol 
2-4 days 
Ibutilide 
12 hours-2.5 days 
*Exclusion Criteria #6: Administration of oral amiodarone within 120 days prior to 
procedure excluding a one-time IV/oral administration of ≤ 2000 mg in a 24-hour period. 
 
7.5.4 
Subject Preparation 
Subjects will be prepped and draped for the ablation procedure following standard hospital 
practice. This includes placement of all cables/patches used for ECG monitoring and 
operation of all devices to be used during the procedure. 
7.5.5 
Anesthesia 
Use of conscious sedation or general anesthesia will follow the Investigator preferences as 
directed by the subject’s health status.  
7.5.6 
AcQBlate Force System Set-Up 
The AcQBlate Force System including the AcQBlate FORCE catheter, the Qubic RF 
Generator, the Qiona Irrigation Pump, Tubing Set, and assorted cables should be prepared 
and connected following the IFU and Investigator training. During the procedure, Acutus 
Medical personnel will be available to provide onsite training on any aspects of the AcQBlate 
Force System set-up and operation. 
7.6 
CTI Ablation Procedure 
7.6.1 
Confirmation of Conduction through the CTI 
Entrainment pacing from the cavotricuspid isthmus during atrial flutter will be attempted 
prior to initiating RF ablation to verify that the CTI is part of the arrhythmia circuit. When 
clinically reasonable, the investigator may attempt to induce atrial flutter using pacing 
maneuvers when the subject presents to the lab in sinus rhythm.  
Documentation of concealed entrainment should be printed and recorded on the appropriate 
eCRF. 
If Investigator is unable to induce and entrain CTI dependent AFL, the Investigator may 
choose to confirm and document conduction through the CTI. CTI conduction must be 
confirmed prior to initiating RF ablation. Documentation of inability to induce and/or entrain 
should be printed and recorded on the appropriate eCRF. Confirmation of conduction through 
the CTI should be demonstrated using pacing maneuvers. 

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Documentation of conduction through the CTI should be printed and recorded on appropriate 
CRF. 
If CTI dependent AFL cannot be confirmed or CTI conduction cannot be confirmed, the 
subject will be considered an ITT failure subject and exited from the study at the 7-day 
follow-up visit.  
If during inducement, entrainment, or other pacing maneuvers the subject is paced into AF, 
DCCV may be performed to attempt conversion to sinus rhythm so the CTI conduction 
measurement may proceed. If the investigator determines further ablation beyond the CTI is 
warranted the subject will be exited from the study after being followed for 7-days for safety. 
The AcQBlate FORCE catheter shall not be used to initiate ablation procedure until 
conduction through the CTI is confirmed. 
7.6.2 
Ablation Considerations 
In order to reduce the risk of complications the following measures need to be considered for 
ablation of the atria. Recommended ablation target values are identified in Table 8 below. 
• 
Titrate the energy, starting with an initial power of ≤ 25 W. Do not exceed 30 
W.  
• 
If a transmural lesion is not achieved, defined by 70% - 80% reduction of the 
intracardiac electrogram (IEGM) signal or emergence of double potentials of 
equal and low amplitude, after 20 seconds the energy may be increased but 
not in excess of 40 W. Ablations at 31-40 W should not exceed 15 seconds in 
duration. 
• 
Avoid excessive ablation durations at any focal location. If focal ablations are 
applied, duration of RF power at one location requires careful attention to 
commonly used ablation effectiveness parameters such as electrogram 
amplitude reduction, electrogram morphology change or impedance changes.  
• 
Avoid excessive contact force while using a steerable sheath to guide the 
ablation catheter. 
• 
Optimal contact force is 3-20 g. Do not exceed 40 g for prolonged periods. 
• 
Do not increase power only because no or little temperature increase is 
measured by the AcQBlate FORCE and the Biotronik Qubic RF ablation 
generator. The tip of the AcQBlate FORCE has good cooling properties to 
avoid thrombus formation. The displayed temperature reflects the 
temperature of the irrigated electrode, not of the tissue. 
• 
Irrigation flow rate must follow the IFU. 
• 
Use of half-normal saline is not allowed. 

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Table 8. Recommended Target Values for Ablation 
Parameter 
Value 
Value 
Power Range* 
10 to 30 Watts 
31 to 40 Watts 
Irrigation flow rate during RF application 
8 ml/min 
15 ml/min 
RF Ablation Energy Delivery** 
< 60 seconds 
< 15 seconds 
Temperature monitoring during RF application*** 
40° - 50° C 
Contact Force Range 
3 grams to 20 grams 
*      It is recommended that lower power levels be used and titrated up to 40W when clinically effective 
ablation cannot be achieved at lower energy levels and within the contact force range. Maximum power 
must not exceed 40W. Note that high power levels increase the risk of steam pops, perforation, char, 
coagulum and/or extracardiac damage, especially when applied to the posterior wall. Impedance drops, 
electrogram reduction and/or electrogram morphology change may be used to guide RF termination. 
 
**   Maximum duration of ablation applies to the duration of RF ablation energy delivery at the same 
location.  Duration of ablation as well as the decision to interrupt RF power delivery at any time during RF 
ablation should be guided by the clinical judgement of the investigator and monitoring of commonly used 
ablation effectiveness parameters such as electrogram amplitude reduction, electrogram morphology 
change or impedance changes. 
 
*** The temperature displayed on the RF generator is not representative of the tissue temperature or the 
temperature of the electrode-tissue interface. 
 
Warning: Higher contact forces may not improve the characteristics of lesion formation and may increase 
the risk for perforation during manipulation of the catheter. 
 
7.6.3 
CTI Ablation 
Ablation of the CTI using the investigational device should follow the Investigator’s standard 
of care. Use of a deflectable long vascular sheath to achieve catheter stability is encouraged. 
Pacing from the CS during the ablation is at the discretion of the Investigator. Power and 
irrigation flow setting should follow Table 8. Ablation beyond the CTI is not allowed. No 
left sided ablations are allowed. 
7.6.4 
Confirmation of Bidirectional Block 
Initial bidirectional block (BDB) confirmation should meet the study endpoint definition of:  
• 
Demonstration of bidirectional electrophysiological conduction block 
through the cavotricuspid isthmus (CTI) using both coronary sinus ostium 
(CS) and annular low right atrial pacing maneuvers.  

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This acute endpoint should be re-confirmed at least 20-minutes following the last RF ablation 
with the investigational device. If recovery of isthmus conduction occurs, additional 
ablations 
should 
be 
performed 
at 
the 
site 
of 
the 
reconnection, 
and 
the 
confirmation/reconfirmation steps must be repeated. A reset of the 20-minute wait time for 
reconfirmation is required. A second investigative catheter or alternate catheter curve may 
be used prior to designation as ablation failure. Maximum RF time before considering a non-
investigational catheter is at the discretion of the Investigator but shall not exceed 60 minutes 
of RF time. If the Investigator is unable to achieve bidirectional block with the investigational 
catheter(s), it is recommended, at the Investigator’s discretion, to use a commercially 
available ablation catheter approved for typical atrial flutter to complete the procedure. 
7.7 
Post Ablation Recovery 
At the conclusion of the procedure, the subject should be recovered following the 
Institution’s standard practice. Sheath removal may be completed when acceptable 
hemostasis can be achieved. The use of protamine to reverse anticoagulation is at the 
discretion of the Investigator. Protamine use will be recorded on the Procedure eCRF.  
7.8 
Procedure Data Collection 
Collection of data generated as a result of the procedure should include: 
• 
Print out of 12-lead ECG at procedure start 
• 
Print out of intracardiac AFL  
• 
Print out of entrainment pacing results pre-ablation for the CTI 
• 
Print out of attempts to prove conduction through the CTI 
• 
Print out of 12-lead ECG at end of procedure  
• 
Demonstration of initial BDB  
• 
Demonstration of BDB 20 minutes following initial determination 
• 
Total procedure time (from first venous access to last cardiac catheter 
removed) 
• 
Total ablation time for CTI ablation 
• 
Total fluoroscopy time for the CTI ablation procedure 
• 
Cumulative irrigation volume for CTI ablation 
• 
Pre-set parameters for RF power and temperature 
• 
Maximal parameters for RF power and temperature for CTI ablation 
• 
Number of RF applications for CTI ablation 

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• 
Cross over of any non-investigational catheter (including reason for change 
out) 
• 
Recording of all IV cardiac medications and anticoagulation infused during 
the procedure 
• 
Usability characteristic data will be collected. 
• 
Device identification 
7.8.1 
Post Ablation Recovery 
Post ablation recovery and removal of the introducer sheaths should follow the institution’s 
standard of care. 
7.8.2 
Post Ablation Antiarrhythmic Use 
Following the ablation procedure, Investigators are encouraged to discontinue all Class I/III 
AADs. If continuation of an AAD is clinically indicated, it must be discontinued at least 5 
half-lives (Table 10) prior to the 30-day arrhythmia assessment. Changes in any AAD 
medication will be recorded on the concomitant medication eCRF.  
7.8.3 
Post Ablation Anticoagulation Use 
Due to the potential of atrial stunning following conversion from AFL to SR and to prevent 
the risk of thromboembolic events, it is recommended that therapeutic anticoagulation be 
given for at least four (4) weeks with all subjects that presented with pre-ablation AFL of ≥ 
48-hours. All anticoagulation medications will be recorded on the concomitant medication 
eCRF. 
7.8.4 
Hospital Discharge 
The following evaluations must be completed prior to discharge (see Table 12): 
• 
Arrhythmia History since the procedure 
• 
Physical Exam (at a minimum Cardiovascular, Respiratory, Extremities 
should be evaluated) 
• 
Vital Signs 
• 
Symptoms 
• 
Medications 
• 
Adverse Events  
• 
12-lead 
ECG 
Note: in the event that post-procedure 12-lead ECG documented sinus rhythm 

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AND post-procedure 12-lead ECG was taken ≤ 6 hours from discharge, the 
post-procedure 12-lead ECG may be used to satisfy this requirement. 
Careful attention should be placed in the identification of potential cardiac effusions and 
post-procedure cardiac tamponade. Unexplained reduction in blood pressure, chest pain or 
shortness of breath may require a post-procedure Transthoracic Echo (TTE) and further 
evaluation and management as indicated. 
7.9 
Follow-up Visits 
Screening, procedure, and follow-up visits are outlined in Table 9.  
All treatment subjects will have data collected at screening, procedure, hospital discharge, 7- 
and 30-days post procedure. The table below outlines the procedures and testing performed 
while enrolled in the clinical study. 

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Table 9. Schedule of Events 
Study Activities 
Screening 
& 
Baseline 
Ablation 
Procedure 
Pre-Discharge 
7-Days 
(± 3-days 
Phone call) 
30-Days 
(± 7-days) 
Unscheduled 
Follow-up* 
Informed Consent 
X 
 
 
 
 
 
Medical History & 
Physical Exam 
X 
 
X 
 
X 
X 
Medications 
X 
X 
X 
X 
X 
X 
Transthoracic Echo 
(TTE) 
(if needed) 
X 
Within 90 days of 
index procedure 
 
 
 
 
 
Thrombus Assessment: 
Transesophageal 
Echocardiogram (TEE) 
** 
 
X 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
Symptom History 
X 
 
X 
X 
X 
X 
12-lead ECG 
X 
X 
X 
 
X 
X 
24-hour Holter or 
patch monitor 
 
 
 
 
X 
X 
SOC Pre-procedure 
Labs 
X 
 
 
 
 
 
Pregnancy Test 
(female subjects of 
childbearing age) 
X 
 
 
 
 
 
*Only required if subject reports symptoms associated with cardiac arrhythmia or in the case of a procedure related adverse event 
**A transesophageal echocardiogram is required for all subjects with atrial flutter for ≥ 48 hours or unknown duration AND the subject has not been 
anticoagulated with a vitamin K antagonist or NOAC for at least 21 days before the study procedure. Subjects who are required to have a transesophageal 
echocardiogram, should have one performed within 24 hours of the study procedure (reference section 7.5.2) 

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7.9.1 
7-Day Follow-up Visit 
Subjects will be contacted by phone by the clinical study team at 7-days (7 ± 3-days) following 
their discharge from the hospital. Information regarding their groin access site(s) and sense of 
any irregular heart rate must be obtained. If, during the phone discussion any concerns arise 
that suggest AEs, at the Investigator’s discretion, the subject may be asked to return to clinic 
for a thorough evaluation.   
The following evaluations will be performed during the telephone follow-up visit. Data will 
be recorded on the Follow-Up Visit eCRF. 
• 
Medication history 
• 
Symptoms 
• 
Adverse events assessment  
7.9.2 
30-Day Follow-up Visit 
Subjects will be seen in the study center clinic 30-days (30 ± 7-days) post ablation.  
The following evaluations will be performed during the clinic follow-up visit. Data will be 
recorded on the Follow-Up Visit eCRF. 
• Physical exam (at a minimum Cardiovascular, Respiratory, Extremities should 
be evaluated) 
• Vital signs 
• Medication history 
• Symptoms 
• Adverse events assessment  
• 12-lead ECG 
• 24-hour Holter or patch monitor 
7.9.3 
Unscheduled Visits 
Any visit outside of the scheduled follow-up visit windows will be considered an unscheduled 
visit. All pertinent data will be recorded on the Follow-up Visit eCRF. 
 
 

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8 STATISTICAL METHODS 
8.1 
Assumptions for Statistical Analysis   
The following assumptions were used in the calculation of sample size: 
 
Endpoint 
Literature 
Based 
Control 
Statistical 
Margin 
Performance 
Goal 
Acutus 
Estimate 
(90% Power 
α 0.050) 
Primary 
Safety 
97.0% 
5.5% 
93.0% 
98.5% 
110 
Primary 
Efficacy 
93.7% 
10% 
83.7% 
93.7% 
85 
8.2 
Statistical Methods for Safety Evaluation 
The primary safety endpoint, the proportion of mITT and select ITT subjects who are free 
from device/procedure related SAE that occur through 7-days post ablation procedure, will be 
analyzed using a binomial proportion test. Subjects who do not have evidence of a SAE/SADE 
from the composite list of safety events will be considered a success. 
8.2.1 
Primary Safety Endpoint Hypothesis 
The null and alternate hypotheses for primary safety endpoint are as follows: 
Ho: The proportion subjects in the mITT and select ITT subjects (ρ) who are free from 
device/procedure related SAE through 7-days post ablation procedure is less than or equal to 
93.0%. 
Ho: ρ ≤ 93.0% 
Ha: The proportion subjects in the mITT and select ITT subjects (ρ) who are free from 
device/procedure related SAE through 7-days post ablation procedure is greater than 93.0%. 
Ha: ρ > 93.0% 
The null hypothesis will be rejected if the one-sided 95% Clopper-Pearson Exact lower 
confidence bound is greater than 93.0%. 
8.2.2 
Other Safety Analyses 
Individual procedure-device related SAEs at 7-days will be analyzed by event frequencies and 
proportions of subjects. Total and individual non-serious procedure-device AEs at 30-days 
will also be analyzed by event frequencies and proportion of subjects. Adverse events will be 
analyzed in terms of their severity, action taken, and duration to resolution. 

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Device Deficiency Reports will be analyzed for frequencies of safety events and proportion 
of subjects as part of the safety analyses. 
8.3 
Statistical Methods for Efficacy Evaluation 
The primary efficacy endpoint, the proportion mITT subjects (β) demonstrating bidirectional 
block (BDB) of the CTI confirmed at 20 minutes following the last right atrial radiofrequency 
(RF) application using the investigational catheter, will be analyzed using a binomial 
proportion test. 
8.3.1 
Primary Efficacy Endpoint Hypothesis 
The null and alternate hypotheses for primary efficacy endpoint are as follows: 
Ho: The proportion of mITT subjects (β) demonstrating bidirectional block (BDB) of the CTI 
confirmed at 20 minutes following the last right atrial radiofrequency (RF) application using 
the investigational catheter is less than or equal to 83.7%. 
Ho: β ≤ 83.7% 
Ha: The proportion of mITT subjects (β) demonstrating bidirectional block (BDB) of the CTI 
confirmed at least 20 minutes following the last right atrial radiofrequency (RF) application 
using the investigational catheter is greater than 83.7%. 
Ha: β > 83.7% 
The null hypothesis will be rejected if the one-sided 95% Clopper-Pearson Exact lower 
confidence bound is greater than 83.7%. 
8.4 
Study Success Criteria 
The study success criteria is defined as the rejection of the null (Ho) hypotheses for safety and 
efficacy as defined in sections 8.2.1 and 8.3.1, respectively. 
• 
Safety Ho: The proportion subjects in the mITT and select ITT subjects (ρ) 
who are free from device/procedure related SAE through 7-days post ablation 
procedure is less than or equal to 93.0%. 
Ho: ρ ≤ 93.0% 
• 
Efficacy Ho: The proportion of mITT subjects (β) demonstrating bidirectional 
block (BDB) of the CTI confirmed at 20 minutes following the last right atrial 
radiofrequency (RF) application using the investigational catheter is less than 
or equal to 83.7%. 
Ho: β ≤ 83.7% 

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8.5 
Primary Endpoints Sensitivity Analysis 
Acutus Medical, Inc. and participating investigators will exercise their best efforts to ensure 
subjects are not lost to follow-up and that there is a minimal amount of missing data. However, 
it is recognized that some degree of missing data may exist. To address the potential impact 
of any such missing data, sensitivity analyses of the primary safety and efficacy endpoints 
will be performed using the mITT and select ITT Cohorts.  
8.6 
Primary Endpoints Subgroup Analysis 
Subgroup analyses of the primary safety and efficacy endpoints are exploratory. No labeling 
claims are planned. A Pearson chi-squared test will be performed for any significant 
differences between gender, ethnicity, race and individual co-morbidities and using a logistic 
regression test for age.  
8.7 
Secondary Endpoints 
There are no secondary endpoints established for this study. 
8.8 
Study Sample Size Rationale 
The sample size requirement for this protocol was determined using the Statistical Analysis 
System (SAS) Software (Cary, NC) Proc Power one sample proportion using a normal-
approximate z test, with at least 90% power and a one-sided 5% significance level.  
For the primary safety endpoint, assuming an estimated primary safety rate of 97% and a null 
hypothesis proportion of 93%, a minimum sample size of 110 subjects is required.  
For the primary efficacy endpoint, assuming an estimated primary efficacy rate of 93.7% and 
a null hypothesis proportion of 83.7%, a minimum sample size of 85 subjects is required.  
Therefore, the minimum required sample size for this study will be 110 subjects. A maximum 
of 120 mITT subjects will be enrolled. 
8.9 
Statistical Methods for Baseline, Screening, Procedural Experience and Hospital 
Discharge Data 
Demographics, baseline data, including but not limited to relevant descriptors from the 
medical history, co-morbidities and medications, will be summarized. 
Procedural data collection will also be analyzed and summarized. 
Continuous variables are summarized as means, standard deviations, medians, and ranges.  
Categorical variables are summarized as frequencies and percentages. By-Subject listings of 
baseline and procedural data will be provided.  

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8.10 Other Statistical Considerations 
Confidence intervals and statistical tests are performed at a two-sided 5% significance level 
unless specified otherwise. All p-values are rounded to four decimal places. Analyses of the 
study may be utilized for publication or medical conference presentation purposes if the 
integrity and objectives of the study are not compromised. 
9 ADVERSE EVENTS 
For the purpose of this CIP/protocol, an adverse event is any untoward medical occurrence, 
unintended disease or injury, or any untoward clinical signs in subjects whether or not related 
to the AcQBlate Force Sensing System, and includes events related to the procedures involved 
in the CIP/protocol.  
Any medical conditions, problems, signs, symptoms, or findings that occurs in a subject once 
they are considered a component of the “Intention to Treat” is considered an adverse event 
(AE). Any medical conditions, problems, signs, symptoms, and findings occurring prior to 
enrollment are to be reported as pre-existing conditions on the Medical History eCRF.  
All AEs will be documented with the event term and description, start date, duration, severity, 
seriousness, relatedness to either the device or the procedure, action taken, and outcome, will 
be recorded on the Adverse Event eCRF. The Investigator has the responsibility of classifying 
any event as related to a component of the AcQBlate Force Sensing System, or the ablation 
procedure.   
9.1 
Serious Adverse Events/Serious Adverse Device Effect  
A Serious Adverse Event/ Serious Adverse Device Effect is any event that:1 
• 
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 including 
chronic diseases, 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 fetal distress, fetal death, or a 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 
 
1 EN ISO 14155:2011 section 3.37 

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impairment, until the event has stabilized, and the overall clinical outcome has been 
ascertained. 
A planned, in-patient hospitalization, without a serious deterioration in health, is not 
considered to be an SAE.   
Recurrence of atrial flutter is not considered an adverse event as there is a known recurrence 
rate associated with atrial flutter ablation. Scheduled hospitalizations to treat these 
arrhythmias will not be considered serious in nature. However, if a subject is hospitalized for 
a clinical condition resulting from the arrhythmia, an adverse event should be reported. 
9.2 
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 ADEs is found in the CIP/protocol, IFU, and Operator’s Manual (OM).   
9.3 
Unanticipated Adverse Device Effects (UADEs) 
An Unanticipated Adverse Device Effect is any event that occurs as a result of the device use 
that was not identified as a known or an anticipated risk for the AcQBlate Force Sensing 
System, as found in the CIP/protocol, IFU, and OM for the device.  
When an Investigator suspects an event meets the definition for a UADE, the event term and 
description, start date, duration, severity , seriousness, relatedness to either the device or the 
procedure, action taken, and outcome, will be recorded on the Adverse Event eCRF. 
Additionally, reports must be provided to the reviewing Institutional Review Board/Ethics 
Committee/Competent Authority (IRB/EC/CA) 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 all reviewing IRBs/ECs/CA and participating Investigators within 
five (5) business days after first receiving notice of the effect. 
9.4 
Adverse Event Reporting 
The Investigator is responsible for reporting all procedure and device related AEs that occur 
during the follow-up period. Initial reporting will be with the Adverse Event eCRF; however, 
additional information may be required by the Sponsor or any regulatory authority. The 
Investigator must report any SAEs, SADEs, UADEs, or Device Deficiency (DD) to the 
Sponsor as soon as possible after becoming aware of the event, but no later than ten (10) 
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 

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medical treatment administered. Documentation should include the time of onset, complete 
description of the event, severity, duration, actions taken, and outcome.   
9.5 
Event Relationship to the Device 
The Investigator should provide information regarding the relationship of the event to the 
procedure and/or the AcQBlate Force Sensing System. The device relationships and severity 
definitions are defined in Tables 10 and 11 below: 
Table 10. Adverse Event Relationship Definitions 
Not Related 
The cause of the AE is known and is not related to any aspect of the 
AcQBlate Force System during the ablation procedure. 
Possibly 
Related 
There is a reasonable possibility that the event may be related to 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 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 ablation procedure. A related event 
has a strong temporal relationship and an alternative cause is unlikely. 
 
Table 11. Adverse Event Severity Definitions 
Mild 
Event results in mild or transient discomfort, not requiring intervention 
or treatment; does not limit or interfere with daily activities (e.g., 
insomnia, mild headache). 
Moderate 
Event is sufficiently discomforting so as to limit or interfere with daily 
activities; may require interventional treatment (e.g., fever requiring 
antipyretic medication). 
Severe 
Event results in significant symptoms that prevents normal daily 
activities; may require hospitalization or invasive intervention (e.g., 
anemia resulting in blood transfusion). 
9.6 
Death Notice 
When a site becomes aware of a subject’s death, it will be reported to the Sponsor. Notification 
should be made to the reviewing IRB/EC/CA/local requirements within two (2) days of 
notification. The FDA will be notified within 10 days.   

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The materials to be submitted to the Sponsor for a death include the following:  
• 
Death narrative including a short description by the treating physician of 
record at the time of death regarding the circumstances of death. 
• 
An assessment by the Investigator as to whether the death is related to study 
interventions.  
• 
A copy of the subject’s death certificate if available. 
• 
When applicable, a copy of an autopsy report. 
For reported deaths, the Investigator or designee should supply the Sponsor and the presiding 
IRB/EC/CA with any additional requested information, if available (i.e., hospital records). 
9.7 
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 Quality Assurance Procedures (QAPs) for complaint handling.   
9.8 
Adverse Event Analysis 
All procedure and device related AEs will be independently adjudicated. Analysis of data will 
follow the Safety Management Plan and the Statistical Analysis Plan. Reporting to the 
convening IRB/EC will follow regulatory requirements. 
9.9 
Clinical Events Adjudication 
Acutus Medical, Inc. (or designee) will coordinate meetings with the clinical events 
adjudication reviewer in accordance with Acutus Medical, Inc. QAP and the Safety 
Management Plan for AcQForce Flutter. The selection of a qualified individual will allow 
for the evaluation of individual safety events for adjudication and comment on the overall 
conduct of the clinical trial. The qualified individual will assume the following roles:  
 
• 
To review and independently adjudicate safety data by providing a standard, 
methodical, independent, and unbiased assessment of safety events and 
relationship to the clinical trial. 
• 
To adjudicate individual adverse events within the clinical trial to determine if 
those events are related to the clinical trial or the investigational device. 
• 
To periodically review and evaluate the accumulated safety data to assure the 
safety of subjects is protected while the scientific goals of the clinical trial are 
being met. 

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• 
To monitor safety data trends, reviewing issues critical to the conduct of the 
clinical trial as data is generated. 
10 RISK: BENEFIT ANALYSIS 
10.1 Risks of Clinical Study Procedures 
This clinical study has been designed to involve as little pain, discomfort, fear, and any other 
foreseeable risk as possible for the enrolled subjects. Even when the AcQBlate Force Sensing 
System is used correctly, complications during and after the ablation treatment may occur.  
The following AEs are associated with electrophysiology right atrial ablation procedures: 
• Air embolism 
• Acute Respiratory Distress Syndrome 
(ARDS) 
• Allergic reaction/anaphylaxis 
• Anemia 
• Anesthesia reaction 
• Arrhythmias 
• AV fistula 
• Cardiac tamponade/perforation 
• Cardiac thromboembolism 
• Chest pain/discomfort 
• Complete heart block 
• Congestive heart failure 
• Coronary artery spasm 
• Death 
• Diaphragmatic paralysis 
• Elevated Cardiac Enzymes 
• Endocarditis 
• Esophageal 
abrasion/erosion/perforation 
• Femoral nerve injury 
• Fever 
• Groin hematoma/ecchymosis 
• Hemothorax 
• Hypotension 
• Hypothermia 
• Infections/sepsis 
• Major bleeding requiring surgery or 
transfusion 
• Myocardial infarction 
• Obstruction, perforation or damage to 
the vascular system 
• Oral pharyngeal injury 
• Pericardial effusion 
• Pericarditis 
• Phrenic nerve damage 
• Pleural effusion 
• Pneumonia 
• Pneumothorax 
• Pseudoaneurysm 
• Pulmonary edema 
• Pulmonary embolism 
• Pulmonary hypertension 
• Radiation injury 
• Respiratory depression 
• Retroperitoneal bleeding 
• Skin burns 
• Stroke 
• ST segment elevation 
• Systemic embolism 
• Thromboembolism 
• Tracheal injury 
• Transient ischemic attack 
• Valvular damage/insufficiency 
• Vasovagal reactions 
• Vagal nerve injury /gastroparesis 
 
 

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The following ADEs may be experienced if the IFU is not followed: 
• Injury to user during defibrillation. 
• Excessive force, if applied, may damage the AcQBlate FORCE catheter sensor at 
the distal section.  
• The AcQBlate FORCE may be damaged through introducer sheath if the 
transseptal sheath lumen is less than 8.5F. 
10.2 Mitigation of Risks 
The completed risk analysis (RSK-21) of the AcQBlate Force Sensing System identified all 
known risks to the Investigator and subject. The risks associated with a standard ablation 
procedure are listed in section 10.1. AcQBlate FORCE is similar in design to existing 
commercially available ablation catheters. AcQBlate Force Sensing System does not create 
new safety risks or increase procedural risks beyond those associated with commercially 
available ablation systems. 
Pre-clinical research, and a first-in-man clinical study of the AcQBlate Force Sensing System 
has demonstrated that the system and catheters are safe for human use. All potential risks have 
been evaluated and mitigation strategies have been implemented to reduce potential risks to 
acceptable levels. Any additional information that would alter the risk potential will be 
communicated by the Sponsor.  
Risks associated with participation in this clinical study are minimized through strict 
adherence to the inclusion and exclusion criteria outlined in sections 6.6.1 and 6.6.2, training 
of Investigators and staff, and CIP/protocol compliance. Subjects should be followed as 
described in the CIP/protocol to avoid any potential interaction with concomitant medical 
treatments. Acutus Medical believes that the potential benefits of the AcQBlate Force Sensing 
System outweigh the potential risks in the appropriate patient population and when the 
procedure is completed by an appropriately trained Investigator.   
11 DATA QUALITY ASSURANCE 
Acutus Medical will oversee the data collection for this study in accordance with the Code of 
Federal Regulations (CFR), 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). In the even any discrepancies are identified, they 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.   

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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 IRB/EC/CA, 
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, IRB/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. 
11.2 Data Management 
The following procedures/processes will be defined in the Data Management Plan (DMP):  
• 
procedures used for development, validation and testing of electronic clinical 
data systems, 
• 
procedures used for database access and training,  
• 
procedures used for data review, and issuing and resolving data queries,  
• 
procedures for data lock, transfer and retention. 
11.3 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, and the 
subject is added to the EDC.   
11.4 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 outcome analysis. A Study Exit eCRF will be 
completed. Screening and baseline data will be collected in the EDC and may be used for 
subset data analysis. 
11.5 Subject Study Completion and Withdrawal 
Subject participation will be considered concluded when the 1-month visit is completed, and 
all data collection is complete. Subjects who withdraw for any reason will have all available 
data entered into the EDC. Reasons for withdrawal will be entered on the Study Exit eCRF. 

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11.6 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. See section 6.9 for details. 
11.7 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), and, where applicable, in 
compliance with the General Data Protection Regulation (GDPR). 
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 any core labs), the Investigator, 
clinical site research staff, Clinical Monitors (also known as Clinical Research Associates 
(CRAs)) and authorized Regulatory Authorities. Authorized regulatory personnel have the 
right to inspect and copy all records pertinent to this study. 
11.8 Source Documents 
Source data encompasses all information, original records of clinical findings, observations, 
or other activities, which are required in a clinical study for the reconstruction and evaluation 
of the study. Examples of these original documents, and data records include, but are not 
limited to, hospital records, clinical and office charts, laboratory notes, memoranda, subject 
diaries or evaluation checklists, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate and complete, copies of clinic and 
procedural site coding and billing records, microfiches, photographic negatives, microfilm or 
magnetic media, X-rays, patient files, and records kept at the pharmacy, and at the laboratories 
involved in the clinical study. 
Regulations require that the Investigator maintain information in the patient’s medical records 
that corroborate data collected for the study. 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 CIP/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. 

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- 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 Antiarrhythmic Drugs (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. 
11.9 Device Accountability 
Per EN ISO 14155-2011, the investigational devices/equipment shall be controlled and used 
only in this clinical study and according to this CIP/ protocol. Tracking of subjects and device 
allocations will be performed during the study. The investigational devices, the AcQBlate 
FORCE catheter, the Qubic RF Generator, and the Qiona Irrigation Pump with Tubing Set 
will be labeled “For Investigational Use Only” and must be stored in a locked location and 
away from commercial product.  
The Sponsor keeps records to document the physical location of all investigational devices 
from shipment of investigational devices to the clinical study sites until usage, disposal or 
return. A device accountability log may be used for the documentation of the process. 
Access to investigational devices is controlled and the devices are used in the clinical 
investigation only and according to the CIP/protocol. 
The Investigator or an authorized designee shall keep records documenting the receipt, 
usage, return, and disposal of the investigational devices including the following: 
• 
Date of receipt, 
• 
Identification of each investigational device/piece of equipment (batch number 
or unique code), 
• 
Expiry date, as applicable, 
• 
Date or dates of use, 
• 
Subject identification, 
• 
Date of return of unused, expired, or malfunctioning investigational 
devices/equipment, if applicable. 

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11.10 Electronic Case Report Forms  
This study will use an eCRF as the primary data collection instrument and will record data by 
electronic capture. All data requested on the eCRF should 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 information will be entered on the eCRF. All such changes are 
recorded in audit 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.   
11.11 Records Retention 
The Investigator will retain study essential documents for two (2) years after formal closure 
or discontinuation of the study. 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 study. 
11.12 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 
responsibilities include maintaining regular contact with each clinical study 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. 
11.13 Clinical Data Monitoring Procedures 
Monitoring requirements will be defined in the Clinical Monitoring Plan (CMP).  The Clinical 
Monitors/CRAs (or designees) may conduct site visits at the clinical study sites to monitor the 
clinical study, which will be in compliance with the CIP/protocol, QAPs, and the CMP. When 
a site visit is performed, the clinical study 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 clinical study 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 CIP/protocol 
adherence and source documentation can be verified.   
Monitoring activities may include, but are not limited to:  

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• 
Evaluation of subject screening and selection methods 
• 
Verification of signed ICFs for each subject 
• 
Verification of source documentation against completed eCRFs for each 
subject 
• 
Assurance that required clinical study reports (CSRs), including reports to the 
applicable IRB/EC/CA, 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 CIP/protocol deviations 
• 
Overall clinical study compliance 
• 
Review of the Investigator Site File (ISF) 
11.13.1 Medical Monitor 
The medical Monitor for the clinical study is: 
Jerald L. Cox, PA 
 
Jerry.cox@acutus.com 
Phone: +1 760.529-6310 
11.14 Investigator Responsibilities 
The Investigator is responsible for ensuring that the clinical study is performed in accordance 
with the protocol, 21 CFR, the Declaration of Helsinki, the principles of GCP, International 
Organization for Standardization (ISO) 14155:2011, applicable regulatory requirements, and 
institutional procedures.  
11.15 Deviations from the Clinical Investigational Plan/Protocol 
A CIP/protocol deviation is defined as an event in which the Investigator or site personnel 
deviates from the clinical study protocol or clinical study procedures. It is the Investigator’s 
responsibility to ensure that there are no deviations from the CIP/protocol. Waivers for 
CIP/protocol deviations are prohibited.   
An Investigator may deviate from the CIP/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 IRB/EC/CA/FDA as soon as possible, but no later than five (5) 
business days from the occurrence of the deviation from the CIP/protocol.  

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Except in such an emergency, prior approval by Acutus Medical is required for changes in, or 
deviations from, the CIP/protocol. Additionally, if these changes or deviations affect the 
scientific soundness of the CIP/protocol or the rights, safety, or welfare of human subjects, 
IRB/EC/CA/FDA 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 of all 
CIP/protocol deviations.  
If Acutus Medical becomes aware that an Investigator is not complying with the any part of 
the CIP/protocol, including the signed Investigator Agreement (IA), the CIP/protocol, or any 
conditions of approval imposed by the reviewing IRB/EC/CA, 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 
clinical study at its discretion.  
11.15.1 Maintaining Records 
The Investigator will maintain the following accurate, complete, and current records related 
to the Investigator's participation: 
• Correspondence with another Investigator, an IRB/EC/CA, 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, 
- 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 clinical study, including information 
related to relevant previous medical history and the results of all 
diagnostic tests, 
• Protocol deviations, with documents showing the dates of and reasons for each 
deviation from the CIP/protocol. 

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11.15.2 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 IRBs/ECs/CAs.  
These reports may include: 
• Any UADE occurring during a clinical study.  
• Any deviation from the CIP/protocol made to protect the life or physical well-
being of a subject in an emergency.  
• Any further information requested by an IRB/EC/CA about any aspect of the 
clinical study. 
The Investigator will provide, in writing, any withdrawal of IRB/EC/CA approval of the study 
or an Investigator within five (5) business days of such action.  
11.15.3 Clinical Study Report and Publication of Data 
Within one (1) year of the close of the clinical database a clinical study report (CSR) will be 
provided to the Investigator for input and review. The report will be signed by Acutus Clinical 
Affairs, and all Investigators and a finalized copy will be stored at the clinical study site.  
Acutus Medical is committed to the dissemination of clinical study results. Any publication 
related to the AcQBlate Force clinical study will require the identification of Acutus Medical 
as Sponsor. 
11.16 Acutus Medical Responsibilities 
11.16.1 General Duties 
Acutus Medical has the overall responsibility for the conduct of the clinical study, including 
assurance that the clinical study satisfies the regulatory requirements of the appropriate 
regulatory agencies, ensuring IRB/EC/CA/FDA approvals, selecting Investigators, ensuring 
proper monitoring and that ICF is obtained. Acutus Medical will provide all information 
necessary to conduct the clinical study, including the CIP/protocol and any reports of prior 
investigations, as appropriate. During the conduct of the clinical study, updates regarding 
information that may impact the clinical study will be made available to all appropriate 
national and local regulatory authorities. 
11.16.2 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) (also known as the Investigator). Investigators will be evaluated by Acutus 
Medical based on: 

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• 
Curriculum vitae, or other statement of Investigator’s relevant training and 
experience, including type of experience with the intended procedure and 
clinical study, specifically.  
• 
Education and experience in the ablation management of arrhythmias. 
• 
Whether the Investigator has an adequate patient population to meet 
requirements of the clinical study enrollment. 
• 
Whether the Investigator has adequate time to be personally involved in the 
conduct of the clinical study, and adequate clinical study staff and resources to 
support the clinical study. 
• 
Whether the Investigator’s clinical study center is associated with an IRB/EC 
that satisfies all applicable regulatory requirements. 
• 
Whether an Investigator was involved in an investigation or other clinical 
study that was terminated.  This may require an explanation of the 
circumstances that led to the termination.  
Prior to clinical study initiation, each Investigator must also submit a:  
• 
Certificate of human patient’s protection training (if required by the reviewing 
IRB/EC), 
• 
Signed Investigator’s Agreement, indicating an Investigator’s commitment to: 
- Conduct the clinical study in accordance with the agreement, the 
CIP/protocol, CFRs, GCP, and any conditions of approval imposed by 
the IRB/EC;  
- Supervise all testing of the device involving human subjects;  
- Ensure that the requirements for informed consent are met;  
- Conduct the clinical study according to the CIP/protocol. 
The Sponsor reserves the right to apply additional criteria to site and/or Investigator selection. 
11.17 Training 
Acutus Medical will provide training on the AcQBlate Force Sensing 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 clinical study 
logistics required to complete the clinical study. 
Training of appropriate clinical study staff 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, 

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instructions on data collection, methods for scheduling follow-up visits in the window, etc. 
Detailed feedback regarding completion of the eCRFs, clinical study requirements, and 
protocol compliance will be provided by Acutus Medical, its study monitors, and/or designees 
functioning in a data management capacity. 
11.17.1 Role of Representative 
Acutus Medical may provide technical support to the Investigators and other health care 
personnel (collectively HCP) as needed during the conduct of the clinical study. Support may 
include training, addressing questions, or providing clarifications concerning the operation of 
Acutus Medical products or the procedures and forms related to the CIP/protocol. 
At the request of the Investigator and while under their supervision, Acutus Medical personnel 
may be requested to provide assistance with technical support or other activities during the 
AcQForce procedure. Typical tasks may include: 
• 
Clarifying device behavior, operation or diagnostic output as requested by the 
Investigator or other health care personnel, 
• 
Assisting with the collection of study data from the AcQBlate Force Sensing 
System during the procedure, 
• 
Recording data on study worksheets (as long as the responsible site staff 
verified and signed the completed worksheet). 
Acutus Medical and industry representatives do not practice medicine; provide medical 
diagnosis or treatment to patients; discuss a patient’s condition or treatment with a patient 
without the approval and presence of the site study staff; independently collect critical study 
data (defined as primary or secondary endpoint data), or enter data in electronic data capture 
systems. 
11.17.2 Changes in the Clinical Investigational Plan/Protocol 
Acutus Medical will obtain appropriate regulatory approval for any change to the CIP/protocol 
that may affect the scientific soundness of the clinical study 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 
IRB/EC and CA (if applicable) of the protocol amendment (administrative changes) or 
obtaining IRB/EC/CA approval of the protocol amendment (changes in subject care or safety), 
according to the instructions provided with the protocol amendment. The IRB/EC/CA/FDA 
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). 

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11.17.3 Withdrawal of Regulatory Approval  
Acutus Medical will notify all reviewing IRBs/ECs/CAs and participating Investigators of any 
withdrawal of regulatory approval to conduct the clinical study and shall do so within five (5) 
business days after receipt of notice of the withdrawal of approval. 
12 FINANCIAL OBLIGATIONS 
The AcQForce Flutter clinical study is financed by Acutus Medical, Inc. A financial 
agreement will be established with the clinical study site delineating contracted prices for all 
clinical study services. 
13 ETHICS AND REGULATORY COMPLIANCE 
13.1 Conduct of the Clinical Study 
Conduct of the clinical study will follow QAPs from Acutus Medical, as well as the Code of 
Federal Regulations (CFRs), 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 
clinical study. With the signature, the Investigator agrees to perform all clinical study 
procedures according to the governing local and national regulations and the CIP/protocol. 
13.2 Institutional Review Board/Ethics Committee Approval 
A properly constituted, valid IRB/EC must review and approve the CIP/protocol, ICF, and 
related patient information and recruitment materials prior to initiation of the clinical study. It 
is the responsibility of the Investigator and/or Sponsor to obtain protocol approval from the 
institution’s IRB/EC, and to keep the IRB/EC informed of any SAEs or SADEs and 
amendments to the protocol. Additional requirements imposed by the IRB/EC or other 
regulatory authority shall be followed as appropriate. All correspondence with the IRB/EC 
should be filed by the Investigator and copies sent to Acutus Medical (or designee). 
13.3 Competent Authority Approval 
For European clinical study sites, it is the responsibility of the Sponsor to obtain protocol 
approval from the country’s Competent Authority, and to keep the CA informed of any SAEs 
or SADEs and amendments to the protocol. Additional requirements imposed by the CA or 
other regulatory authority shall be followed as appropriate. All correspondence with the CA 
should be filed in the TMF. 

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13.4 Clinical Study Informed Consent Approval 
In accordance with the principles of Informed Consent, 21 CFR Part 50, 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 
subject (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. 
13.5 Identification and Confidentiality 
Subject identification and confidentiality will be ensured in accordance with all applicable 
regulatory and IRB/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 biostatistician, and, 
if requested, to advisory committees and regulatory authorities (including the 
FDA). 
• 
Data will be stored in accordance with regulations for handling of electronic 
data. 
The site will maintain (anonymous to Acutus Medical) a list identifying all subjects entered 
into the clinical study. The list will be maintained as part of the Investigator Site File (ISF) 
file and monitored for completeness. 
13.6 Site Qualification Visits 
A Site Qualification Visits (SQV) will follow Acutus Medical QAPs.   
13.7 Site Initiation Visits 
All clinical study personnel will be required to participate in a Site Initiation Visit (SIV) that 
follows Acutus Medical’s QAP. Portions of the SIV training may be completed via a web 
access meeting. Components of this initiation visit may include: 
• 
Introduction of the clinical study design including the protocol-specific 
treatment and follow-up phase 
• 
ICF process 

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• 
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 
13.8 Insurance 
Acutus Medical shall maintain insurance coverage for this clinical study. Pertinent 
information regarding the coverage shall be made available to the site upon request. 
13.9 Site Audit Plan 
Participation as an Investigator in this clinical study implies acceptance of potential inspection 
by government regulatory authorities and applicable compliance and quality assurance 
offices. The Investigator and/or designee must be available to respond to reasonable requests 
and queries made by authorized regulatory representatives during the audit process. The 
Investigator must provide Acutus Medical with copies of all correspondence that may affect 
the review of the current clinical study or their qualifications as an Investigator in this and 
future clinical studies conducted by Acutus Medical. 
13.9.1 Site Data Audits by Acutus Medical 
In accordance with local and national regulations and Acutus Medical’s QAPs, an internal 
audit may be requested to access all clinical study records, including source documents, for 
inspection and duplication. The Investigator will ensure the capability for inspections of 
applicable clinical study-related functions. 
A site data quality assurance audit may be conducted during the clinical study.   
13.9.2 External Audits 
Requests by regulatory agencies to inspect the clinical 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. 
13.10 Public Domain Access to the Clinical Study 
A description of this clinical study will be available on http//www.Clinicaltrials.gov.  
Information regarding the public access will be presented in the ICF. 

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13.11 Required Reports 
Acutus Medical will remain in compliance with all required and pre-specified reports during 
the enrollment and follow-up of the clinical study. IRB/EC/CA requirements for reports will 
be provided as requested. 
14 GENERAL CONSIDERATIONS 
14.1 Discontinuation of the Clinical Study 
The Sponsor reserves the right to discontinue the clinical 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 clinical study. 
Acutus Medical, as Sponsor, may terminate Investigator and site participation in the clinical 
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/or IA. 
Notification of suspension or termination will occur no later than five (5) business days after 
Acutus Medical makes the determination. In the event of clinical study suspension or 
termination, Acutus Medical or designee will send a report outlining the circumstances to the 
reviewing IRB/EC/CA, the appropriate regulatory agencies, and to all participating 
Investigators. Any suspension or termination may not be re-initiated without prior approval 
of the IRB/EC/CA and Acutus Medical. 
14.2 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 clinical study materials, worksheets, and eCRFs. 
The information developed in this clinical study may be used by Acutus Medical as support 
for a regulatory filing and in connection with the continued development of the AcQBlate 
Force Sensing System. Any publication or other public presentation of the data resulting from 
this clinical study will require prior review and written approval of Acutus Medical. 
At the conclusion of the clinical study, it is expected that Acutus Medical and the Investigators 
will promptly prepare and submit a manuscript for publication in a reputable scientific journal.  
Further analyses, beyond those presented in the initial publication may be proposed to Acutus 
Medical. For purposes of timely abstract presentation and publication, such secondary 

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publications may be delegated to the appropriate principal authors; however, final analyses 
and manuscript review for data will require the prior written approval of Acutus Medical. 
None of the results, in whole or part, of the clinical study carried out under this CIP/protocol, 
nor any of the information provided by Acutus Medical for the purposes of performing the 
clinical study, will be published or passed on to any third party without the consent of Acutus 
Medical. Any Investigator involved with this clinical study is obligated to provide Acutus 
Medical with complete test results and all data derived from the clinical study. 
 
 

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15 REFERENCES 
1.  
Page RL, Joglar JA, Caldwell MA, et al. 2015 ACC/AHA/HRS Guideline for the 
Management of Adult Patients With Supraventricular Tachycardia: Executive Summary: A 
Report of the American College of Cardiology/American Heart Association Task Force on 
Clinical Practice Guidelines and the Heart Rhythm. J Am Coll Cardiol. 2016;67(13):1575-
1623. doi:10.1016/j.jacc.2015.09.019 
2.  
Wellens HJJ. Contemporary management of atrial flutter. Circulation. 2002;106(6):649-
652. doi:10.1161/01.CIR.0000027683.00417.9A 
3.  
Saoudi N, Cosío F, Waldo A, et al. A classification of atrial flutter and regular atrial 
tachycardia according to electrophysiological mechanisms and anatomical bases: A 
statement from a joint expert group from the working group of arrhythmias of the European 
society 
of 
cardiology 
and 
the 
. 
Eur 
Heart 
J. 
2001;22(14):1162-1182. 
doi:10.1053/euhj.2001.2658 
4.  
Granada J, Uribe W, Chyou PH, et al. Incidence and predictors of atrial flutter in the general 
population. J Am Coll Cardiol. 2000;36(7):2242-2246. doi:10.1016/S0735-1097(00)00982-
7 
5.  
Orejarena LA, Vidaillet H, Destefano F, et al. Paroxysmal supraventricular tachycardia in 
the general population. J Am Coll Cardiol. 1998;31(1):150-157. doi:10.1016/S0735-
1097(97)00422-1 
6.  
Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the 
management of patients with atrial fibrillation (updating the 2006 guideline): A report of 
the american college of cardiology foundation/American heart association task force on 
practice 
guidelines. 
J 
Am 
Coll 
Cardiol. 
2011;57(2):223-242. 
doi:10.1016/j.jacc.2010.10.001 
7.  
Glover BM, Chen J, Hong KL, et al. Catheter ablation for atrial flutter: A survey by the 
European heart rhythm association and canadian heart rhythm society. Europace. 
2016;18(12):1880-1885. doi:10.1093/europace/euw402 
8.  
Bun S, Latcu G, Wedn AM, Hasni K, Saoudi N. Cavotricuspid isthmus-dependent atrial fl 
utter : clinical perspectives. Res Reports Clin Cardiol. 2019;10:7-17. 
9.  
Spector P, Reynolds MR, Calkins H, et al. Meta-Analysis of Ablation of Atrial Flutter and 
Supraventricular 
Tachycardia. 
Am 
J 
Cardiol. 
2009;104(5):671-677. 
doi:10.1016/j.amjcard.2009.04.040 
10.  
Demazumder D, Mirotznik M, Schwartzman D. Biophysics of Radiofrequency Ablation 
using an Irrigated Electrode. J Interv Card Electrophysiol. 2001;5(4):377-389. 
doi:10.1016/j.physbeh.2017.03.040 
11.  
Sacher F, O’Neill MD, Jais P, et al. Prospective randomized comparison of 8-mm gold-tip, 
externally irrigated-tip and 8-mm platinum-iridium tip catheters for cavotricuspid isthmus 
ablation. 
J 
Cardiovasc 
Electrophysiol. 
2007;18(7):709-713. 
doi:10.1111/j.1540-
8167.2007.00861.x 
12.  
Da Costa A, Faure E, Thévenin J, et al. Effect of isthmus anatomy and ablation catheter on 
radiofrequency 
catheter 
ablation 
of 
the 
cavotricuspid 
isthmus. 
Circulation. 

AcQForce Flutter  
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
 
Page 81 of 82 
2004;110(9):1030-1035. doi:10.1161/01.CIR.0000139845.40818.75 
13.  
Shimizu Y, Yoshitani K, Murotani K, et al. The deeper the pouch is, the longer the 
radiofrequency duration and higher the radiofrequency energy needed—Cavotricuspid 
isthmus ablation using intracardiac echocardiography. J Arrhythmia. 2018;34(4):410-417. 
doi:10.1002/joa3.12075 
14.  
Jaïs P, Shah DC, Haïssaguerre M, et al. Prospective randomized comparison of irrigated-tip 
versus conventional- tip catheters for ablation of common flutter. Circulation. 
2000;101(7):772-776. doi:10.1161/01.CIR.101.7.772 
15.  
Zei PC, Hunter TD, Gache LM, O’Riordan G, Baykaner T, Brodt C. Low-fluoroscopy atrial 
fibrillation ablation with contact force and ultrasound technologies: a learning curve. 
Pragmatic Obs Res. 2019;Volume 10:1-7. doi:10.2147/por.s181220 
16.  
Haines DE. Determinants of Lesion Size During Radiofrequency Catheter Ablation: The 
Role of Electrode‐Tissue Contact Pressure and Duration of Energy Delivery. J Cardiovasc 
Electrophysiol. 1991;2(6):509-515. doi:10.1111/j.1540-8167.1991.tb01353.x 
17.  
Yokoyama K, Nakagawa H, Shah DC, et al. Novel contact force sensor incorporated in 
irrigated radiofrequency ablation catheter predicts lesion size and incidence of steam pop 
and 
thrombus. 
Circ 
Arrhythm 
Electrophysiol. 
2008;1(5):354-362. 
doi:10.1161/CIRCEP.108.803650 
18.  
Weiss, Christian, Antz, Matthias, Eick, Olaf, Eshagzaiy, Kablai, Meinertz, Thomas, 
Willems S. Radiofrequency catheter ablation using cooled electrodes: impact of irrigation 
flow rate and catheter contact pressure on lesion dimensions. PACE - Pacing Clin 
Electrophysiol. 2002;25(4):463-469. 
19.  
Okumura Y, Johnson SB, Bunch TJ, Henz BD, O’Brien CJ, Packer DL. A systematical 
analysis of in vivo contact forces on virtual catheter tip/tissue surface contact during cardiac 
mapping 
and 
intervention. 
J 
Cardiovasc 
Electrophysiol. 
2008;19(6):632-640. 
doi:10.1111/j.1540-8167.2008.01135.x 
20.  
Reddy VY, Shah D, Kautzner J, et al. The relationship between contact force and clinical 
outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA 
study. Hear Rhythm. 2012;9(11):1789-1795. doi:10.1016/j.hrthm.2012.07.016 
21.  
Kuck KH, Reddy VY, Schmidt B, et al. A novel radiofrequency ablation catheter using 
contact 
force 
sensing: 
Toccata 
study. 
Hear 
Rhythm. 
2012;9(1):18-23. 
doi:10.1016/j.hrthm.2011.08.021 
22.  
Natale A, Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force 
sensing catheter: Results of the prospective, multicenter SMART-AF trial. J Am Coll 
Cardiol. 2014;64(7):647-656. doi:10.1016/j.jacc.2014.04.072 
23.  
Neuzil P, Reddy VY, Kautzner J, et al. Electrical reconnection after pulmonary vein 
isolation is contingent on contact force during initial treatment: Results from the EFFICAS 
i 
study. 
Circ 
Arrhythmia 
Electrophysiol. 
2013;6(2):327-333. 
doi:10.1161/CIRCEP.113.000374 
24.  
Kumar S, Morton JB, Lee G, Halloran K, Kistler PM, Kalman JM. High incidence of low 
catheter-tissue contact force at the cavotricuspid isthmus during catheter ablation of atrial 

AcQForce Flutter  
Acutus Medical, Inc.  
 
CONFIDENTIAL 
CLP-21 Rev 11 23 September 2021 
 
Page 82 of 82 
flutter: Implications for achieving isthmus block. J Cardiovasc Electrophysiol. 
2015;26(8):826-831. doi:10.1111/jce.12707 
25.  
Venier S, Andrade JG, Khairy P, et al. Contact-force-guided vs. contact-force-blinded 
catheter ablation of typical atrial flutter: A prospective study. Europace. 2017;19(6):1043-
1048. doi:10.1093/europace/euw137 
26.  
Gould PA, Booth C, Dauber K, Ng K, Claughton A, Kaye GC. Characteristics of 
Cavotricuspid Isthmus Ablation for Atrial Flutter Guided by Novel Parameters Using a 
Contact 
Force 
Catheter. 
J 
Cardiovasc 
Electrophysiol. 
2016;27(12):1429-1436. 
doi:10.1111/jce.13087 
27.  
Brugada J, Katritsis DG, Arbelo E, et al. 2019 ESC Guidelines for themanagement of 
patients with supraventricular tachycardia. Eur Heart J. 2020;41(5):655-720. 
doi:10.1093/eurheartj/ehz467 
 

 
 
Statistical Analysis Plan 
Page 1 of 14 
Sponsor 
Study 
Version 
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AcQBlate Force Sensing Ablation System 
US IDE/EU Study for Atrial Flutter 
(AcQForce Flutter & AcQForce Flutter-EU) 
2.0 
 
 
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ACUTUS Medical 
AcQBlate Force Sensing Ablation System US IDE and EU Study for 
Atrial Flutter (AcQForce Flutter & AcQForce Flutter-EU) 
  
Study CLP-21, Rev 12 
Study CLP-21-EU, Rev 03 
 
 
Statistical Analysis Plan 
Version 2.0, 15Mar2022 
 
 
 

 
 
Statistical Analysis Plan 
Page 2 of 14 
Sponsor 
Study 
Version 
ACUTUS 
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US IDE/EU Study for Atrial Flutter 
(AcQForce Flutter & AcQForce Flutter-EU) 
2.0 
 
 
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Version History 
Version 
Version Date 
Author/Title 
Summary of Key Changes 
1.0 
8Feb2022 
Lindsay Lucas/ 
Senior 
Biostatistician 
Initial Release 
2.0 
15Mar2022 
Lindsay Lucas/ 
Senior 
Biostatistician 
Minor change made to Section 6.2.4 per 
FDA recommendation 
 

 
 
Statistical Analysis Plan 
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(AcQForce Flutter & AcQForce Flutter-EU) 
2.0 
 
 
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Table of Contents 
1 
Introduction .................................................................................................................................................. 4 
2 
Abbreviations ................................................................................................................................................ 4 
3 
Clinical Study Objective ................................................................................................................................. 5 
4 
Study Design .................................................................................................................................................. 6 
5 
Sample Size Determination................................................................................. Error! Bookmark not defined. 
5.1 
Assumptions for Statistical Analysis ........................................................... Error! Bookmark not defined. 
5.2 
Study Sample Size Rationale ...................................................................... Error! Bookmark not defined. 
6 
Statistical Analyses ........................................................................................................................................ 6 
6.1 
General Considerations ......................................................................................................................... 6 
6.1.1 
Descriptive Statistics ......................................................................................................................... 6 
6.1.2 
Study Day .......................................................................................................................................... 6 
6.1.3 
Visit Windows ................................................................................................................................... 7 
6.1.4 
Statistical Significance ....................................................................................................................... 7 
6.1.5 
Precision ........................................................................................................................................... 7 
6.2 
Analysis Populations ............................................................................................................................. 7 
6.3 
Handling of Missing Data ...................................................................................................................... 8 
6.4 
Subject Disposition ............................................................................................................................... 8 
6.5 
Demographics and Baseline Characteristics .......................................................................................... 9 
6.6 
Analysis of Study Endpoints .................................................................................................................. 9 
6.6.1 
Primary Safety Endpoint ................................................................................................................... 9 
6.6.2 
Primary Efficacy Endpoint ............................................................................................................... 10 
6.6.3 
Other Safety Analyses ..................................................................................................................... 11 
6.6.4 
Observational Effectiveness Endpoint ............................................................................................. 12 
6.7 
Poolability Analyses ............................................................................................................................ 12 
6.8 
Subgroup Analyses .............................................................................................................................. 13 
6.9 
Interim Analyses ................................................................................................................................. 13 
6.10 
Protocol Deviations ............................................................................................................................. 13 
7 
Changes from Planned Analyses .................................................................................................................. 14 
8 
Subject Listings ............................................................................................................................................ 14 
 

 
 
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1 Introduction 
This statistical analysis plan (SAP) describes the planned statistical methods for the reporting 
and analysis of data collected under the Clinical Investigation Protocol AcQBlate Force Sensing 
Ablation System US IDE for Atrial Flutter (AcQForce Flutter) (CLP-21) and Clinical Investigation 
Protocol AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-
EU) (CLP-21-EU). Data from these studies will be used to support a pre-market approval (PMA) 
application.  
 
This SAP should be read in conjunction with the study clinical investigation plan (CIP) and case 
report forms (CRFs). This version of the SAP has been developed with respect to the Clinical 
Investigation Protocol AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter 
(AcQForce Flutter) Rev 12 19Oct2021 and Clinical Investigation Protocol AcQBlate Force Sensing 
Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU) Rev 02 21May2021. Any 
revisions to the protocols or CRFs that impact the planned analyses may require updates to the 
SAP. 
 
Applicable Documents: 
Document Number, Version 
Document Title 
CLP-21, Rev 12 
Clinical Investigation Plan for AcQBlate Force Sensing Ablation 
System US IDE for Atrial Flutter (AcQForce Flutter) 
CLP-21-EU, Rev 03 
Clinical Investigation Plan for AcQBlate Force Sensing Ablation 
System EU Study for Atrial Flutter (AcQForce Flutter-EU) 
CLP-21-DE Rev 01 
Clinical Investigation Plan for AcQBlate Force Sensing Ablation 
System DE Study for Atrial Flutter (AcQForce Flutter-DE) 
QAP 3.8 
Quality Assurance Procedure for Clinical Studies 
 
2 Abbreviations 
Abbreviation/Term 
Definition 
AAD 
Antiarrhythmic drug 
AE 
Adverse Event 
ASD 
Atrial Septal Defect 

 
 
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BDB 
Bidirectional Block 
CIP 
Clinical Investigational Plan 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
CTI 
Cavotricuspid Isthmus 
DCCV 
Direct Current Cardioversion 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
ICD 
Implantable Cardioverter Defibrillator 
IDE 
Investigational Device Exemption 
ITT 
Intention-to-Treat 
mITT 
Modified Intention-to-Treat 
OUS 
Outside of United States 
PFO 
Patent Foramen Ovale 
PMA 
Premarket Approval 
PPT 
Pre-procedure Testing 
RF 
Radiofrequency 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis System 
SSED 
Safety and Effectiveness Data 
TIA 
Transient Ischemic Attack 
US 
United States 
3 Clinical Study Objective 
The objective is to demonstrate that the AcQBlate Force Sensing System is safe and effective 
when used to ablate the cavotricuspid isthmus (CTI) for the treatment of typical atrial flutter 
when compared to a literature-based control.  
 
Data will be used to support a PMA application. 

 
 
Statistical Analysis Plan 
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4 Study Design 
The AcQForce Flutter and AcQForce Flutter-EU clinical studies are prospective, multi-center, 
non-randomized, global clinical studies designed to confirm the safety and efficacy of the 
AcQBlate Force Sensing System. All subjects with typical atrial flutter will undergo percutaneous 
catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System with 
the endpoint of achieving bidirectional block (BDB). Treated subjects will have data collected at 
screening, procedure, pre-hospital discharge, and 7-and 30-days post procedure. The subject 
population will consist of men and women 18 years of age or older, presenting for a de novo 
percutaneous cardiac ablation of the cavotricuspid isthmus for typical atrial flutter. 
De 
5 Statistical Analyses 
5.1 General Considerations 
Except where otherwise specified, the following general principles apply to the planned 
statistical analyses. All statistical analysis will be conducted using SAS software version 9.3 or 
later or other widely accepted statistical or graphical software as required. 
 
5.1.1 Descriptive Statistics 
Continuous variables will be summarized as means, standard deviations, medians, and ranges. 
Categorical variables will be summarized as frequencies and percentages.  
 
Confidence intervals may be presented, where appropriate, using the t-distribution for 
continuous data and Clopper-Pearson Exact method for categorical variables. 
 
5.1.2 Study Day 
Study day 0 is the date of the index procedure. Day in study will be calculated relative to the 
index procedure as follows: 
Study Day = Assessment Date – Index Procedure Date 
For each subject, duration in study will be based on last study contact date which is the latest 
date of all follow-up visits, assessments, adverse event onset or resolution, and study exit 
including date of death. 

 
 
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Duration variables will be calculated as follows: 
Duration Days = End Date – Start Date 
5.1.3 Visit Windows 
Unless otherwise specified, visit based assessments will be analyzed for each analysis time point 
according to the nominal visit entered in the Case Report Form (CRF) regardless of if it is out of 
window. 
 
5.1.4 Statistical Significance 
Confidence intervals and statistical tests will be performed at a two-sided 5% significance level 
unless specified otherwise. P-values will be rounded to four decimal places. If a p-value is less 
than 0.001 it will be reported as “<0.001”.  
 
5.1.5 Precision 
Unless otherwise specified, the following conventions will apply for data display. In general, 
percentages will be displayed to 1 decimal place. Percentages <0.05% will be reported to 2 
decimal places. 
 
5.2 Analysis Populations 
The following analysis populations are defined for analysis: 
1. The Enrolled Analysis Set will consist of subjects who have signed an informed consent 
form, are deemed study eligible by meeting all of the inclusion and none of the 
exclusion criteria up to the point of the procedure. 
2. The Pre-procedure Testing (PPT) Failure Set will consist of enrolled subjects who have 
presented for the procedure in any rhythm other than sinus rhythm or typical atrial 
flutter and have not undergone venous access. These subjects will be treated per the 
recommendations of the study physician and exited from the study. No use of the 
investigational device is allowed. A Study Exit electronic case report form (eCRF) will be 
completed. 
3. The Intention-to-Treat (ITT) Failure Analysis Set will consist of enrolled subjects who 
have the venous access portion of the ablation procedure initiated, regardless of 
whether the AcQBlate FORCE Catheter has been inserted, and up to the point of 
completion of the right-atrial access but prior to any RF application with the 

 
 
Statistical Analysis Plan 
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investigational device. The ITT Failure subjects will be followed for safety reasons 
through the 7-day follow-up visit. All ITT Failure subjects will be excluded from any 
efficacy data analysis. In addition to the Discharge eCRF and the 7-day Follow-up eCRF, a 
Study Exit eCRF will also be completed. The ITT Failure population may include: 
• At the time of the procedure, if the subject does not demonstrate conduction 
through cavotricuspid isthmus, the subject will be exited from the study and 
followed for safety through the 7-day follow-up visit. 
• At the time of procedure, if atrial fibrillation is initiated during the process of 
inducing typical AFL, a direct current cardioversion (DCCV) may be performed to 
attempt conversion to sinus rhythm so that the CTI conduction portion of the study 
may proceed. If during confirmation of the CTI conduction, the investigator 
determines that further ablation beyond the CTI is warranted the subject will be 
exited from the study and followed for safety through the 7-day follow-up visit. 
4. The Modified Intention-to-Treat (mITT) Analysis Set will consist of enrolled subjects 
who initiates the ablation procedure using the AcQBlate Force Sensing System. An 
initiated ablation procedure is defined as a procedure where the AcQBlate Force Sensing 
System is used for the ablation procedure irrespective if a non-investigational device 
was used to complete the ablations. mITT subjects will be followed for all study 
outcome measures for the full duration of the clinical study and will comprise the data 
set for the Primary Efficacy Endpoints. 
 
5.3 Handling of Missing Data 
All attempts will be made to limit the amount of missing data. Unless otherwise specified, no 
attempt will be made to impute missing data. If a data point is missing, that data point will not 
contribute to that portion of the analysis. The number of evaluable observations will be 
reported in analysis so that extent of missing data can be assessed. Sensitivity analyses will be 
performed for the primary safety and efficacy endpoints as detailed in Section 6.6. 
 
5.4 Subject Disposition 
The number of subjects in each analysis population will be presented along with reason for any 
exclusions. Subject accountability will be summarized by visit. The number of subjects who are 
enrolled, eligible for follow-up, and number completing clinical follow-up will be summarized 
for each protocol-required visit. In addition, the number of subjects who complete the study or 
exit early will be summarized by reason. 

 
 
Statistical Analysis Plan 
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2.0 
 
 
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5.5 Demographics and Baseline Characteristics 
Demographics, baseline data, including but not limited to relevant descriptors from the medical 
history, co-morbidities, and medications, will be summarized. 
 
Procedural data collection will also be analyzed and summarized. 
 
5.6 Analysis of Study Endpoints 
5.6.1 Primary Safety Endpoint 
The primary safety endpoint is defined as the proportion of mITT and select ITT Failure subjects 
(i.e., subjects who had the AcQBlate FORCE Catheter inserted) who are free from a composite 
list of pre-specified device/procedure related SAEs that occur through 7-days post ablation 
procedure. Subjects who do not have evidence of a SAE/SADE from the composite list of safety 
events will be considered a success.   
 
Serious adverse events that meet the definition for Primary Safety Endpoint are pre-defined 
and include: 
• Death 
• Cardiac tamponade/perforation 
• Myocardial infarction 
• Stroke 
• Systemic embolism 
• Major access site complications 
• Major bleeding requiring transfusion 
• Complete heart block 
• Other SAEs/SADEs adjudicated by an independent review as “probably or definitely 
related” to the Investigational device. 
 
 
 Primary Safety Endpoint Analysis 
The null and alternate hypotheses for primary safety endpoint are as follows: 
 

 
 
Statistical Analysis Plan 
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Ho: The proportion of mITT subjects and select ITT Failure subjects (ρ) who are free from 
device/procedure related SAE through 7-days post ablation procedure is less than or equal to 
93.0%. 
 
Ho: ρ ≤ 93.0% 
 
Ha: The proportion of mITT and select ITT Failure subjects (ρ)who are free from 
device/procedure related SAE through 7-days post ablation procedure is greater than 93.0%. 
 
Ha: ρ > 93.0% 
 
The null hypothesis will be rejected if the one-sided 95% Clopper-Pearson Exact lower 
confidence bound is greater than 93.0%. 
 
 Sensitivity Analysis 
Sensitivity analyses to assess the effect of missing data on the primary safety endpoint will be 
performed including: 
 
• A tipping point analysis in which missing data are varied from worst case to best case to 
evaluate mITT and ITT Failure subjects with missing primary safety data. 
 
5.6.2 Primary Efficacy Endpoint 
The primary efficacy endpoint is defined as the proportion of mITT subjects (β) achieving acute 
procedural success. Acute procedural success is defined as the demonstration of bidirectional 
cavotricuspid isthmus block confirmed at least 20 minutes following the last radiofrequency 
(RF) application at the cavotricuspid isthmus with the investigational catheter.  
 
 Primary Efficacy Endpoint Analysis 
The null and alternate hypotheses for primary efficacy endpoint are as follows: 
 
Ho: The proportion of mITT subjects (β) demonstrating bidirectional cavotricuspid isthmus 
block confirmed at 20 minutes following the last right atrial radiofrequency (RF) application at 
the cavotricuspid isthmus with the investigational catheter is less than or equal to 83.7%. 

 
 
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Ho: β ≤ 83.7% 
 
Ha: The proportion of mITT subjects (β) demonstrating bidirectional cavotricuspid isthmus block 
confirmed at 20 minutes following the last right atrial radiofrequency (RF) application at the 
cavotricuspid isthmus with the investigational catheter is greater than 83.7%. 
 
Ha: β > 83.7% 
 
The null hypothesis will be rejected if the one-sided 95% Clopper-Pearson Exact lower 
confidence bound is greater than 83.7%. 
 
A primary efficacy failure will comprise the following: 
• The inability to achieve and maintain bidirectional CTI block at least 20 minutes 
following the last RF application with the investigation device. A second investigative 
catheter or alternate AcQBlate FORCE catheter curve may be used prior to designation 
as failure. Maximum RF time before considering a non-investigational catheter is at the 
discretion of the Investigator but shall not exceed 60 minutes of RF time. 
OR 
• The use of a commercially available non-investigational catheter for any ablation of the 
CTI. 
 
NOTE: Use of isoproterenol is at the discretion of the Investigator. 
 
 Sensitivity Analysis 
Sensitivity analyses to assess the effect of missing data on the primary efficacy endpoint will be 
performed including: 
 
• A tipping point analysis in which missing data are varied from worst case to best case to 
evaluate subjects with missing primary efficacy data in the mITT analysis set. 
 
5.6.3 Other Safety Analyses 
Adverse events (AE) will be reported for all mITT and ITT Failure subjects.  
 

 
 
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Individual device/procedure related SAEs at 7-days will be analyzed by event frequencies and 
proportions of subjects. Total and individual non-serious, device/procedure related AEs at 30-
days will also be analyzed by event frequencies and proportion of subjects. Adverse events will 
be analyzed in terms of their severity, action taken, and duration to resolution. 
 
Device Deficiency Reports will be analyzed for frequencies of safety events and proportion of 
subjects as part of the safety analyses. 
 
All AEs and SAEs will be tabulated with the number of events and subjects with event for each 
event type and overall. The rate of all AEs and SAEs reported in the study will be reported as 
well as the rates at 7 and 30 days. AEs and SAEs will also be summarized by relatedness and 
severity. Adverse events leading to death or study discontinuation will be provided in listing 
format. Rates will be reported as the number of subjects who experience at least one event 
during the analysis interval out of the total number of subjects with follow-up to the beginning 
of the analysis interval.  
 
5.6.4 Observational Effectiveness Endpoint 
The observational effectiveness endpoint, defined as the proportion of mITT subjects free from 
recurrence of typical CTI dependent atrial flutter OFF Class I/III antiarrhythmic drugs (AADs) at 
30-days post index procedure measured by a 24-hour continuous electrocardiogram (ECG) 
monitor, will be reported with 95% Clopper-Pearson Exact confidence intervals. 
 
5.7 Poolability Analyses 
All investigational sites will follow the requirements of a common protocol and standardized 
data collection procedures and forms. The primary endpoints will be presented separately for 
each site using descriptive statistics. Poolability of the primary endpoints across investigational 
sites will be evaluated using a logistic regression model with fixed effect for site.  If the p-value 
for the site effect is below 0.15, additional exploratory analyses will be performed to 
understand any variations in outcomes by site. Assessment of poolability by geography (US vs. 
OUS) will also be performed as described for site. 
 

 
 
Statistical Analysis Plan 
Page 13 of 14 
Sponsor 
Study 
Version 
ACUTUS 
Medical 
AcQBlate Force Sensing Ablation System 
US IDE/EU Study for Atrial Flutter 
(AcQForce Flutter & AcQForce Flutter-EU) 
2.0 
 
 
 Acutus Medical Confidential 
 
5.8 Subgroup Analyses 
Subgroup analyses of the primary safety and efficacy endpoints are exploratory. No labeling 
claims are planned. Analyses will include mITT and ITT Failure subjects for the primary safety 
endpoint and mITT subjects for the primary efficacy endpoints. 
 
A Pearson chi-squared test or Fisher’s exact test will be performed for any significant 
differences between gender, ethnicity, race and individual co-morbidities and logistic 
regression will be performed for age.  The following comorbidities will be included: 
• Diabetes Mellitus 
• Coronary Artery Disease 
• Hypertension 
• Cardiomyopathy (ischemic, non-ischemic)  
• Valvular Disease (moderate or severe)  
• Congenital Heart Disease  
• Patent Foramen Ovale (PFO) or Atrial Septal Defect (ASD)  
• Pacemaker or Implantable Cardioverter Defibrillator (ICD)  
• Peripheral Vascular Disease  
• Stroke, TIA, Systemic Embolic Event  
• Coagulopathies (Bleeding Disorders) 
• Asthma or other chronic lung disease (except COPD)  
• Chronic Obstructive Pulmonary Disease (COPD) 
• Renal Dysfunction/Chronic Renal Disease  
• Obstructive Sleep Apnea  
• Anemia 
5.9 Interim Analyses 
No interim analyses are planned. 
 
5.10 Protocol Deviations 
Deviations from the procedures outlined in the CIP will be reported by investigational sites on 
the CRF.  Protocol deviations will be summarized for all deviations with event counts and 
number of subjects with at least one deviation. 

 
 
Statistical Analysis Plan 
Page 14 of 14 
Sponsor 
Study 
Version 
ACUTUS 
Medical 
AcQBlate Force Sensing Ablation System 
US IDE/EU Study for Atrial Flutter 
(AcQForce Flutter & AcQForce Flutter-EU) 
2.0 
 
 
 Acutus Medical Confidential 
 
6 Changes from Planned Analyses 
Any changes to planned statistical analyses determined necessary prior to performing the 
analyses will be documented in an amended Statistical Analysis Plan and approved prior to the 
analysis when possible. Any other deviations or changes from the planned analyses deemed 
necessary due to violation of critical underlying statistical assumptions, data characteristics, or 
missing data will be clearly described in the clinical study report with justification and rationale. 
7 Subject Listings 
Subject listings will be provided for the primary endpoints, observational effectiveness 
endpoint, and baseline and procedural data.