Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
Conditions: Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
Sponsor: HelpWear Inc.

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 1 of 35 
 
 
 
 
 
 
 
 
 
Preliminary Research Evaluation for Ambulatory Leadless 
Electrocardiogram Recorder Trial (PRE-ALERT)  
 
 
 
 
 
 
Contact: 
Derek Exner, MD, MPH 
Chief Medical Officer, HelpWear Inc. 
Li Ka Shing Knowledge Institute – St. Michael’s Hospital 
Room 774 
209 Victoria Street 
Toronto, ON 
Canada 
M5B 1T8 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 2 of 35 
1.0 
Approvals 
 
Name 
Title 
Signature 
Date  
(dd-mmm-yyyy) 
Andre Bertram 
Chief Executive Officer 
 
 
Frank Nguyen 
Chief Technology Officer 
 
 
Derek Exner 
Chief Medical Officer 
 
 
 
 
2.0 
Document Revision History 
 
Revision 
Date 
By 
Comments 
1 
22/OCT/2020 
Chief Medical Officer 
Revised CIP Release 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 3 of 35 
 
3.0 
Table of Contents 
 
1.0 
Approvals ..................................................................................................................... 2 
2.0 
Document Revision History ........................................................................................... 2 
3.0 
Table of Contents .......................................................................................................... 3 
4.0 
Signatures .................................................................................................................... 6 
5.0 
Study Synopsis .............................................................................................................. 7 
 
Background .................................................................................................................... 10 
6.1 
Atrial Fibrillation (AF) ......................................................................................................... 10 
6.2 
Supra-Ventricular Tachycardia (SVT) ................................................................................... 10 
6.3 
Bradyarrhythmias and Pauses ............................................................................................. 10 
6.4 
Ventricular Arrhythmias ..................................................................................................... 11 
6.5 
Monitoring Technologies .................................................................................................... 11 
7.0 
Investigational Device................................................................................................. 11 
7.1 
Device Description ............................................................................................................. 11 
7.2 
Indication for Use ............................................................................................................... 12 
7.3 
Prior Investigations ............................................................................................................ 12 
7.4 
Manufacturing Information ................................................................................................ 12 
7.5 
Release and Distribution for Study ...................................................................................... 12 
7.6 
Storage Requirements ........................................................................................................ 13 
7.7 
Labeling ............................................................................................................................. 13 
7.8 
Modification of Investigational Product for Study ............................................................... 13 
7.9 
Accountability Procedures .................................................................................................. 13 
8.0 
Study Overview .......................................................................................................... 13 
8.1 
Primary purposes ............................................................................................................... 14 
8.2 
Primary Research Questions ............................................................................................... 14 
8.3 
Secondary Research Questions ........................................................................................... 14 
8.4 
Ancillary Research Questions .............................................................................................. 14 
8.5 
Hypothesis .................................................................................................................. 14 
8.6 
Objectives .......................................................................................................................... 15 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 4 of 35 
8.7 
Endpoints ........................................................................................................................... 15 
8.8 
Study Duration ................................................................................................................... 15 
8.9 
Subjects ............................................................................................................................. 15 
8.9.1 Study Population ........................................................................................................................................ 15 
8.9.2 Inclusion Criteria ......................................................................................................................................... 15 
8.9.3 Exclusion Criteria ........................................................................................................................................ 15 
8.9.4 Recruitment ................................................................................................................................................ 16 
8.9.5 Screening Procedures ................................................................................................................................. 17 
8.9.6 Enrollment................................................................................................................................................... 17 
8.10 
Study Schedule of Assessments .......................................................................................... 17 
8.11 
Clinical Benefits/Risks ........................................................................................................ 18 
8.11.1    HeartWatch Usage Benefit .................................................................................................................... 18 
8.11.2    HeartWatch Usage Risks ........................................................................................................................ 18 
8.11.3    Ambulatory ECG Recording Risks .......................................................................................................... 18 
8.12 
Discontinuation of Study .................................................................................................... 18 
9.0 
ECG Data Collection and Transfer ................................................................................ 19 
9.1 
Event Recorder ................................................................................................................... 19 
9.2 
Event Recorder Event Adjudication ..................................................................................... 20 
9.3 
Holter Monitor ................................................................................................................... 20 
9.4 
Holter Data Evaluation ....................................................................................................... 21 
9.5  
HeartWatch ....................................................................................................................... 21 
9.6 
HeartWatch Data Adjudication ........................................................................................... 21 
10.0 
Methods ..................................................................................................................... 22 
10.1 
Baseline Visit ...................................................................................................................... 22 
10.2 
Study Visits ........................................................................................................................ 22 
10.3 
Follow Up........................................................................................................................... 22 
10.4 
Unscheduled Visits ............................................................................................................. 22 
10. 5 
Site Selection, Participation, and Management ................................................................... 22 
10.5.1 Clinical Monitoring Procedures ................................................................................................................ 23 
10.5.2 Site Monitoring Procedures ...................................................................................................................... 23 
10.5.4 Training ..................................................................................................................................................... 24 
10.6 
Data Collection ................................................................................................................... 24 
10.6.1 Event Recorder and Holter Data............................................................................................................... 24 
10.6.2 Clinical Data .............................................................................................................................................. 24 
11.0 
Statistical Analysis Plan .............................................................................................. 24 
11.1 Statistical Considerations ........................................................................................................ 24 
11.2 Primary Measure of Study Success .......................................................................................... 25 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 5 of 35 
11.3 Sample Size ............................................................................................................................ 25 
11.4 Statistical Analysis .................................................................................................................. 25 
11.5 Safety Evaluation .................................................................................................................... 25 
11.6 Usability Endpoint Analyses .................................................................................................... 26 
12.0 
Risk Management ....................................................................................................... 26 
12.1 Adverse Events ....................................................................................................................... 26 
12.2 Recording Adverse Events, Device Deficiencies and Protocol Deviations ................................... 26 
12.3 Reporting Requirements ......................................................................................................... 26 
13.0 
Clinical Site and Informed Consent .............................................................................. 27 
13.1 Participating Sites ................................................................................................................... 27 
13.2 Institutional Review Boards .................................................................................................... 27 
13.3 Informed Consent Process ....................................................................................................... 27 
13.4 Informed Consent for Minors .................................................................................................. 28 
13.5 Special Populations ................................................................................................................. 28 
13.6 Confidentiality ........................................................................................................................ 28 
14.0 
Data Management ..................................................................................................... 28 
14.1 Electronic Case Report Forms .................................................................................................. 28 
14.2 Source Documents .................................................................................................................. 28 
14.3 Investigator Records ............................................................................................................... 29 
14.4 Investigator Reports................................................................................................................ 29 
15.0 
Literature Cited ........................................................................................................... 30 
16.0 
Instructions for Use and Labelling ............................................................................... 30 
 
 
 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 6 of 35 
4.0 
Signatures 
 
Sponsor Signatures 
 
 
____________________________________ __________________________________ 
CEO, HelpWear Inc. Signature  
 
 Date (dd/mmm/yyyy) 
 
 
____________________________________ __________________________________ 
CTO, HelpWear Inc. Signature  
 
 Date (dd/mmm/yyyy) 
 
 
____________________________________ __________________________________ 
CMO, HelpWear Inc. Signature 
 
 Date (dd/mmm/yyyy) 
 
 
 
 
Site Principal Investigator Signature 
 
  
____________________________________ _________________________________ 
PI Signature 
  
 
 
 
 
 Date (dd/mmm/yyyy) 
 
Address: 
 
____________________________________  
____________________________________ 
____________________________________ 
 
Phone:  ______________________________ 
 
Email:  ______________________________ 
 
 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 7 of 35 
5.0 
Study Synopsis 
Sponsor 
HelpWear Inc. 
Product name 
HeartWatch 
Product 
Description 
The HeartWatch arm band provides continuous, high-quality single lead 
electrocardiograph (ECG) data in a variety of environments. The ECG data is 
transmitted via Bluetooth and stored on the user’s smartphone. It is then uploaded to 
the cloud for subsequent analysis using either a commercial ECG software package 
or a customized software package from HelpWear. 
Intended 
Purpose of 
Investigational 
Device 
The HeartWatch is indicated for extended diagnostic evaluation of patients with 
transient symptoms of possible cardiac origin such as syncope and palpitations, as 
well as patients at risk for arrhythmias, but without significant symptoms. While the 
use of the device itself can be managed by both healthcare professionals and 
patients, interpretation of the collected data for diagnosis is restricted to healthcare 
professionals, as the data must be loaded and analyzed separately after recording. 
Study 
Objectives 
Collect and pair user-triggered ECG data from the HeartWatch and Event Recorder. 
Collect and pair auto-triggered ECG data from the HeartWatch and Event Recorder. 
Collect and pair continuous ECG data from the HeartWatch and Holter. 
Implement the HelpWear customized ECG software analysis system to import and 
analyze paired HeartWatch and comparator device ECG data. 
Primary 
Purpose 
To implement and test the collection and analysis of paired ECG data from the 
HeartWatch and two comparator devices, an Event Recorder and Holter. 
Primary 
Question 
Can HeartWatch and comparator device ECG data be collected, paired, and 
analyzed? 
Sites 
One site in Canada, Toronto Heart Centre, Toronto 
Subjects 
Consecutive patients referred for extended ambulatory ECG monitoring will be 
approached for participation. Up to 50 subjects will be enrolled (Figure 1). 
Study design 
Concurrent, prospective, paired and real-world observational study (Figure 1). 
Based on the duration of monitoring requested by the referring physician, subjects 
will undergo simultaneous comparison of the HeartWatch to an Event Recorder (Arm 
A) or simultaneous comparison of the HeartWatch to a Holter monitor (Arm B). 
Study duration 
Up to 6 months, with 3 months of analysis time (9 months total) 
Inclusion 
Criteria (all 
• 
At least 22 years of age at time of consent 
• 
Clinically-indicated for an ambulatory Event Recorder or Holter monitor  

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 8 of 35 
must be 
present) 
• 
Able to follow the protocol 
• 
Provision of written-informed consent 
Exclusion 
Criteria (none 
may be present) 
 
• 
Known allergy to any component of the Event Recorder 
• 
Known allergy to any component of the Holter monitor 
• 
Known allergy to any component of the HeartWatch 
• 
Dextrocardia 
Study 
Intervention 
Collect and pair user-triggered and auto-triggered ECG data from the HeartWatch 
and Event Recorder. 
Collect and pair continuous ECG data from the HeartWatch and Holter monitor. 
Analyze ECG data from the HeartWatch, Event Recorder, and Holter using the 
customized ECG software system. 
Description of 
Procedure / 
Methods 
Patients indicated for extended ambulatory ECG testing will be approached for 
participation. Subject flow is shown in Figure 1. Subjects will wear the HeartWatch 
and an Event Recorder for up to 72 hours (Figure 1, left) or the HeartWatch and 
Holter monitor for up to 48 hours (Figure 1, right). Subjects will be asked to 
document their activities (standing, sitting, walking, exercise, or laying down). Event 
recorder subjects (Arm A) will collect user-triggered and auto-triggered data, while 
Holter subjects (Arm B) will record diary information on their activities and any 
relevant symptoms. Adverse events and user preference for one device versus the 
other being used in that arm will also be collected from all subjects. 
 
Figure 1. Overview of the PRE-ALERT study (see descriptions above). 
Types of data 
collected during 
the study 
• 
Demographics (age, gender, race) 
• 
Indication for extended ambulatory ECG monitoring 
• 
Limited medical history 
Consecutive patients referred for extended ambulatory ECG testing
Event Recorder – Arm A
Holter monitor – Arm B
Subjects simultaneously wear a HeartWatch 
and Event Recorder x 72 hours
Subjects simultaneously wear a HeartWatch 
and Holter monitor x 48 hours
Symptomatic arrhythmias (Triggered events)
Auto-detected arrhythmias
User Preference
Adverse events
Interpretable ECG data
Patient Diary
User Preference
Adverse events
Comparison
Study Details
Outcomes

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 9 of 35 
• 
Symptoms during the extended ambulatory ECG monitoring assessment 
• 
ECG data during the extended ambulatory ECG monitoring assessment 
• 
Usability of the extended ambulatory ECG monitoring assessment devices 
• 
Adverse events related to the extended ambulatory ECG monitoring devices 
• 
User preference of the ambulatory ECG monitoring devices being assessed 
Criteria for 
Evaluation: 
1. Ability to collect, pair, and analyze at least 20 user-triggered HeartWatch and 
Event Recorder ECGs. 
2. Ability to collect, pair, and analyze at least 20 auto-detected HeartWatch and 
Event Recorder ECGs. 
3. Ability to collect, pair, and analyze at least 200 hours of HeartWatch and 
Holter data. 
4. Assess adverse events with the HeartWatch, Event Recorder, and Holter 
5. Assess user preference for the HeartWatch, Event Recorder, and Holter.  
 
 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 10 of 35 
 Background  
Heart rhythm disorders are common and significantly impact the lives of those affected and 
their families. The four main problems are: a) atrial fibrillation or AF, b) supra-ventricular 
tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) 
ventricular arrhythmias.  
6.1 
Atrial Fibrillation (AF) 
AF is the most common heart rhythm disorder. In this condition the upper heart chambers 
beat rapidly and erratically. This results in the sensation of an abnormally fast heartbeat 
(i.e., palpitations) and can lead to other serious health problems including stroke, weakened 
heart muscle (i.e., cardiomyopathy) or death. Nearly 1% of Canadians, 350,000 persons, 
are affected with AF. Further, the number of persons with AF is growing. It is one of seven 
causes of death that are increasing worldwide. Deaths from AF relate primarily to much 
higher risk of stroke (six-fold) and heart failure (four-fold).  
The problem with AF determination is two-fold. First, many patients with AF do not know 
they have this arrhythmia, so treatments are either delayed or not provided. Although there 
are many proven therapies that both control AF and reduce the risk of stroke, they require 
that the AF first be diagnosed. Second, among those with AF and symptoms, reduced 
exercise capacity, anxiety, depression and a loss of control are common complaints. 
Methods to identify the frequency and severity of AF will allow for improved management.  
Continuous ECG monitoring allows doctors to detect and to better treat patients with AF and 
provides patients with control over the management of their disease. Both result in better 
health outcomes.  
6.2 
Supra-Ventricular Tachycardia (SVT) 
SVT are another common group of disorders. In these conditions the upper and lower heart 
chambers beat rapidly, resulting in palpitations and a feeling of dread. If this condition is not 
treated quickly, chest pain, a heart attack, fainting or another serious problem can result.  
SVT episodes often come and go, making a diagnosis difficult, since an ECG during the 
SVT episode is necessary to confirm the diagnosis and determine the best therapy. 
Moreover, having ECG data just prior (onset of SVT) and at the end of the episode (offset of 
the SVT) is vital in determining what the most likely electrical mechanism(s) of the SVT are, 
as this helps to guide the best treatment. This is extremely important information in deciding 
upon the person’s suitability for and guiding delivery of, a curative procedure called a 
cardiac ablation. 
6.3 
Bradyarrhythmias and Pauses 
Bradyarrhythmias can present as slow or missed heart beats are relatively common and 
typically treated with a permanent pacemaker, but other therapeutic options may be 
preferable in some patients. Symptoms that herald significant bradycardia or pauses include 
tiredness, fatigue, near-fainting and fainting.  
Identifying persons who do and those who do not, need a pacemaker can be difficult as 
these slow heart rhythm problems, as well as the patients’ symptoms, frequently come and 
go. This delays diagnosis, treatment and puts the patient at risk of serious problems. As 
with SVT, an ECG is necessary to confirm the diagnosis. Like SVT, having ECG data just 
prior (onset) and immediately after an episode (offset) is key to determining what the most 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 11 of 35 
likely electrical mechanism(s) of the bradyarrhythmia or pause are very important, as this 
information in extremely useful deciding whether a permanent pacemaker is necessary or if 
other treatments are required. 
6.4 
Ventricular Arrhythmias 
Ventricular arrhythmias occur when the bottom heart chambers beat in a dangerous, 
irregular manner. This can lead to cardiac arrest, where the heart is not pumping sufficiently 
to allow for blood flow to the brain, vital organs and death. It is estimated by the Heart and 
Stroke Foundation that 40,000 Canadians will die prematurely this year from cardiac arrest, 
a persistent, dangerous and irregular beating of the lower heart chambers. These events 
occur over a vast array of ages, across genders and are difficult to reliably predict. 
However, certain groups are known to have a higher risk of cardiac arrest, including 
patients with diabetes, heart failure, a family history of certain inherited conditions, or those 
who have had a prior heart attack.  
6.5 
Monitoring Technologies 
Two general types of consumer products are used to monitor patients with or at risk of heart 
rhythm disorders. Most estimate heart rhythm using blood flow (photoplethysmography) 
alone or in combination with activity sensors (accelerometer). Other methods record an 
ECG when the patient has symptoms. These devices are useful, but require the wearer to 
recognize their symptoms, attach the device and rest quietly in order to obtain an ECG 
recording of reasonable quality. The user then needs to send that information to a 
healthcare provider in order for verification. Hence, existing technologies are far from ideal.  
7.0 
Investigational Device 
7.1 
Device Description 
The HeartWatch is a low cost, continuous, and non-invasive ECG monitor worn on a 
patient's bicep. The device leverages 4 novel dry sensors to extract the voltage difference in 
the subject’s heart to determine lead 1 ECG. Collected ECG data is sent via Bluetooth 
wireless transmission to the patient’s smartphone. The HeartWatch allows the user to note 
(tag) any symptoms they experience (e.g., palpitations, light-headedness, fainting, etc.) 
using the device itself or the paired smartphone to allow for symptom-rhythm correlation 
and subsequent review by a physician. The HeartWatch displays all the elements of an 
ECG signal (i.e., PQRST) to facilitate diagnoses by physicians. The form factor of the 
device is comprised of medical grade plastics (e.g. Makrolon 2858, 2859), metal electrodes, 
and elastane fabric.  
For this study, participants will be provided a smartphone with the HeartWatch which they 
will return upon completing their monitoring session. Additionally, the HeartWatch system 
itself will only record patient’s ECG data categorized using the research patient ID from the 
study’s master linking log.  
For the study the data will be collected using the HelpWear app and stored on the phone. 
The app does not require any identifying information to be entered. As such, only de-
identified ECG, user symptom, and user activity data is collected and stored. 
 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
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7.2 
Indication for Use 
The HeartWatch device is indicated for extended diagnostic evaluation of patients with 
symptomatic and transient symptoms such as light-headedness, syncope and palpitations, 
as well as patients at risk for arrhythmias, but without significant symptoms. While the use 
of the device itself can be managed by both healthcare professionals and patients, 
interpretation of the collected data for diagnosis is restricted to healthcare professionals, as 
the data must be downloaded and analyzed separately using dedicated software analysis 
systems. 
7.3 
Prior Investigations 
HelpWear conducted an exploratory study of the HeartWatch to determine whether the 
device was capable of collecting a continuous single lead ECG. Other biometrics (e.g. 
temperature, pulse oximetry) were collected to obtain data on their relationship to the ECG 
data and to temporally synchronize the ECG data. The main purpose of the feasibility study 
was to demonstrate the ability to collect continuous ECG from the bicep. 
7.4 
Manufacturing Information 
The design and manufacture of the HeartWatch device is managed by HelpWear Inc. at the 
following location: 209 Victoria Street, Room 774, Toronto, Ontario M5B1T8. 
Individual components are purchased by HelpWear. Manufacturing is done at No.3 Zhen An 
Middle Road, Wu Sha Community, Changan Town, Dongguan City, Guangdong, China 
523857. Devices are tested at HelpWear’s office (previously listed address). 
The design and developing activities are outlined in the project design history file managed by 
HelpWear Inc. The HeartWatch is manufactured in a clean and controlled environment 
according to approved manufacturing specifications. Manufacturing records are created and 
maintained for each lot of HeartWatch devices providing traceability to raw materials and 
components. Each device is carefully inspected and must meet all quality control acceptance 
criteria prior to release. The safety of the device was designed to meet following standards:  
• 
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic 
safety and essential performance; 
• 
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic 
safety and essential performance - Collateral Standard: Electromagnetic disturbances 
- Requirements and tests; 
• 
IEC 60601-2-47 Particular requirements for the basic safety and essential performance 
of ambulatory electrocardiographic systems; 
• 
ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing 
within a risk management process; 
While formal audit for these compliances is pending, HelpWear will attain an Investigation 
Testing Authorization (ITA) to use the device for the PRE-ALERT study. Any additional 
requirements imposed by the EC or regulatory authority shall be followed, if appropriate. 
7.5 
Release and Distribution for Study 
Product is released and distributed to clinical sites by HelpWear Inc. only following and 
executed investigator agreement. 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
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PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
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7.6 
Storage Requirements  
The HeartWatch device and any associated components are shipped to the clinical site by 
HelpWear Inc. The device has no special storage or handling requirements. Product can be 
stored at ambient room conditions.  
7.7 
Labeling 
The HeartWatch device has labels for identification and to communicate essential 
information related to the product. See attached label and Instructions for Use in Section 16.  
7.8 
Modification of Investigational Product for Study 
All investigational products will be stored and used in accordance with the protocol. No 
modifications to the study product will be permitted. If a device malfunctions or produces an 
unexpected result, as deemed by the technician, physician, participant, etc., the site 
coordinator will notify the sponsor immediately to troubleshoot the device and, if need be, 
replace the malfunctioning device.  
7.9 
Accountability Procedures 
HelpWear Inc. will ship the investigational device only to qualified sites.  
The Principal Investigator at each site is responsible for proper storage of received devices 
and for maintaining a current Clinical Inventory Form for the duration of the study. The study 
monitor will review device storage conditions and the completion of the site’s Clinical 
Inventory. Reconciliation of device disposition will be documented. The names of all 
persons who received and/or used the device at the site will be recorded. At the end of the 
study, all investigational products remaining at the sites will be returned to the Sponsor.  
8.0 
Study Overview  
This proof of concept study will enroll consecutive patients referred for extended ambulatory 
ECG testing. All clinical decisions will be based on data from the clinical comparator devices 
(i.e., Event Recorder or Holter) and the approved software analysis systems for those 
devices. Neither the HeartWatch data nor the paired ECG signal analyses will be used for 
clinical decision-making.  
Subject flow is shown in Figure 1. Subjects will wear the HeartWatch and an Event 
Recorder for up to 72 hours (Figure 1, arm A) or the HeartWatch and Holter monitor for up 
to 48 hours (Figure 1, arm B). Subjects will be asked to document their activities (standing, 
sitting, walking, exercise, or laying down). Event Recorder subjects (arm A) will collect user-
triggered and auto-triggered data, while Holter subjects (arm B) will record diary information 
on their activities and any relevant symptoms. Adverse events and user preference for one 
device versus the other being used in that arm will also be collected from all subjects. 
In Arm A, the HeartWatch triggered and auto-detected data will be compared to single or 
two-lead triggered and auto-detected data Event Recorder data. Subjects will be required to 
wear both the HeartWatch and ambulatory Event Recorder for a 72-hour period. In Arm B 
the HeartWatch continuous ECG data compared to continuous ECG Holter data. Subjects 
will be required to wear both the HeartWatch and Holter for a 48-hour period.  
All participants will be required to provide written, informed consent. 

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
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Figure 1. Study overview 
 
8.1 
Primary purposes 
A. To demonstrate the capacity to collect and pair user-triggered (tagged) and auto-
triggered ECG data from the HeartWatch and Event Recorder in preparation for a 
larger, multi-centre study. 
B. To demonstrate the capacity to collect and pair continuous ECG data from the 
HeartWatch and Holter monitor in preparation for a larger, multi-centre study. 
8.2 
Primary Research Questions 
A. Can paired user-triggered (tagged) and auto-triggered ECG data from the 
HeartWatch and Event Recorder be successfully collected? 
B. Can paired continuous ECG data from the HeartWatch and Holter monitor be 
successfully collected? 
8.3 
Secondary Research Questions 
Does body position and activity affect the quality of the HeartWatch, Event 
Recorder, and Holter data? 
8.4 
Ancillary Research Questions 
Collect initial data to estimate the following: 
a) Incidence of adverse events among the HeartWatch and comparator devices, 
b) The types of adverse events that may occur, and 
c) User preferences of subjects with the HeartWatch versus the comparator devices. 
8.5 Hypothesis 
Paired ECG data from the HeartWatch and comparator devices will be similar in terms 
of the events documented and the proportion of data that is clinically interpretable. 
Consecutive patients referred for extended ambulatory ECG testing
Event Recorder – Arm A
Holter monitor – Arm B
Subjects simultaneously wear a HeartWatch 
and Event Recorder x 72 hours
Subjects simultaneously wear a HeartWatch 
and Holter monitor x 48 hours
Symptomatic arrhythmias (Triggered events)
Auto-detected arrhythmias
User Preference
Adverse events
Interpretable ECG data
Patient Diary
User Preference
Adverse events
Comparison
Study Details
Outcomes

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)  
HelpWear Inc. (CONFIDENTIAL) 
PRE-ALERT Clinical Investigation Protocol (CIP) v 1.0 
22/ October/ 2020 
 
Page 15 of 35 
8.6 
Objectives 
1. To demonstrate the capacity to collect and pair user-triggered (tagged) and auto-
triggered, clinically interpretable ECG data from the HeartWatch and Event 
Recorder in preparation for a larger, multi-centre study. 
2. To demonstrate the capacity to collect and pair clinically interpretable, continuous 
ECG data from the HeartWatch and Holter monitor in preparation for a larger, 
multi-centre study. 
8.7 
Endpoints 
A. Primary endpoints:  
1. User-triggered (tagged) and auto-triggered ECG data from the HeartWatch and 
Event Recorder. 
2. Continuous ECG data from the HeartWatch and Holter monitor. 
B. Secondary endpoints 
1. 
Incidence of adverse events.  
The HeartWatch is anticipated to have a similar rate of adverse events as 
compared to the Event Recorder and Holter monitor. 
2. 
User preference for the extended ECG monitoring test.  
The HeartWatch is anticipated to be similarly preferred to the Event Recorder and 
Holter monitor. 
8.8 
Study Duration 
It is anticipated that the enrolment period will last up to 6 months, with a total study duration 
of 9 months total. 
8.9 
Subjects 
8.9.1 Study Population 
Consecutive patients referred to participating clinics for extended ambulatory ECG testing.  
8.9.2 Inclusion Criteria 
• 
At least 22 years of age at time of consent 
• 
Clinically-indicated for an ambulatory Event Recorder or Holter monitor test 
• 
Able to follow the protocol  
• 
Provision of written-informed consent 
8.9.3 Exclusion Criteria 
• 
Known allergy to any component of the Event Recorder 
• 
Known allergy to any component of the Holter monitor 
• 
Known allergy to any component of the HeartWatch 
• 
Dextrocardia 

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8.9.4 Recruitment 
Subjects referred for extended ambulatory ECG testing will be recruited from the Toronto 
Heart Centre.  
Referring physicians will be asked to indicate if longer-term (i.e., Event Recorder) or 
shorter-term monitoring (i.e., Holter monitor) is desired for a given patient. If no preference 
is provided by the referring physician, the Heart Rhythm Society guidance documenta will be 
used to select the appropriate extended ECG monitoring tool, as outlined in Table 1. 
 
Table 1. Summary of Guidance from the 2017 ISHNE-HRS expert consensus 
statement on ambulatory ECG and external cardiac monitoring / telemetry.a 
Medical history and indication(s) for 
extended ECG testing 
Shorter-term, 
(Holter) 
Longer-term, 
(Event Recorder) 
Symptomatic event frequency 
Frequent, daily 
Less than daily or 
uncertain 
Correlation of symptoms and underling 
rhythm 
+ 
+ 
Qualitative analysis of QRS morphology 
+ 
- 
Quantification and trending of arrhythmia 
burden / pattern 
+ 
- 
Detection of asymptomatic arrhythmias 
(e.g., atrial fibrillation among patients with 
a cryptogenic stroke) 
- 
+ 
Assessment of the efficacy of arrhythmia 
suppression 
+ 
- 
Detection of non-sustained arrhythmias 
+ 
+ 
Assessment of heart rate dynamics 
+ 
- 
Detection of pro-arrhythmic adverse drug 
responses 
+ 
- 
Detection of pacemaker / defibrillator 
device malfunction 
+ 
- 
Legend: ‘+’ preferred / acceptable, ‘-‘ not preferred / not acceptable 
Patients referred for a clinically-indicated ambulatory ECG testing will be provided with 
information about the two studies and a screening appointment will be scheduled.  
Potential subjects will be evaluated by a study coordinator against the inclusion and 
exclusion criteria prior to enrollment.  

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8.9.5 Screening Procedures 
All subjects screened for participation in this study will be documented using the study 
screening log. A screening log will be used to provide insight into the reasons for study 
exclusion. No information will be recorded in that log apart from the number of potential 
subjects exclude and the reason(s) for refusal. Consent will not be obtained for patients that 
are screened, but not enrolled since no identifying or personal data will be collected. 
Patients meeting the study criteria will be asked to participate in this study and sign 
informed consent.  
Patients who are screened but not eligible to participate or who are eligible but do not want 
to participate in this study, with reason, will be documented on the screening log.  
Patients who fulfill eligibility criteria will be asked to sign the study-specific informed 
consent.  
8.9.6 Enrollment 
A subject is considered enrolled when they meet all eligibility criteria, including having 
signed the study-specific informed consent. All study-specific procedures will be collected 
after subjects provide written informed consent.  
Upon signing the consent form, the following procedures will be completed to ensure 
eligibility: 
• 
Information received from the referring physician 
• 
History obtained from the patient 
• 
Review of medical records 
Both male and female subjects will be uniquely and consecutively enrolled.  
8.10 
Study Schedule of Assessments  
The study’s schedule of events is shown in Table 2. Details of assessments are provided. 
Information captured in assessments will be documented in study- case report forms. 
Table 2. Schedule of Assessments 
Study Requirement 
Screening 
Study 
Adverse 
events 
Informed consent 
X 
 
 
Medical history and medications 
X 
 
 
Eligibility criteria assessment 
X 
 
 
Reason(s) for extended ECG testing 
X 
 
 
Symptoms during extended ECG testing 
 
X 
 
Activities during extended ECG testing 
 
X 
 

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Adverse events related to ECG testing 
 
 
X 
Usability of ECG monitoring tests 
 
X 
 
User preference of ECG monitoring tests 
 
X 
 
8.11 
Clinical Benefits/Risks 
The HeartWatch is a non-invasive, accurate solution to ambulatory ECG monitoring. 
8.11.1    HeartWatch Usage Benefit 
The HeartWatch is painless and non-invasive. It is a small, light-weight, self-contained arm 
band that continuously records the electrical activity of the heart. It does not require 
electrodes (skin patches) or other bulky equipment and can be worn discreetly under 
everyday clothing.  
The HeartWatch automatically detects and records abnormal heart rhythms and allows 
users to indicate when they are having symptoms, so that their physician can determine 
whether these symptoms are related to changes in the user’s heart rhythm. 
8.11.2    HeartWatch Usage Risks 
While the HeartWatch is painless and non-invasive, participants may experience minor skin 
irritation from where it is in contact with their skin. 
8.11.3    Ambulatory ECG Recording Risks 
Ambulatory ECGs, Holter and Event Recorder devices are painless and non-invasive. They 
require the user to keep a log of activities and symptoms, remove and replace skin patches 
when they are worn for extended periods and carry a monitor (receiver) on their belt or 
other clothing. Users may experience skin irritation and discomfort from the gel patches 
(adhesive electrodes) on their skin are required to record the electrical activity of the heart.  
8.12 
Discontinuation of Study 
During study conduct, if the Sponsor or site Principal Investigator discover a condition that 
indicates that the study should be discontinued, this action will be taken. If the study is 
terminated, the investigator will inform the ethics board or Institutional Review Board (IRB) 
of the study termination and the reason(s) for its’ termination. If a terminated study is 
planned to be resumed, the Sponsor may not re-engage without first obtaining ethics 
approval.  
If the study was terminated related to an unanticipated adverse device effect (UADE) the 
study may not be resumed without IRB and Food and Drug Administration (FDA) approval. 
If the study was terminated related to withdrawal of IRB approval, the Sponsor shall notify 
the FDA. The investigator(s) will return all study materials, documentation, and Case Report 
Forms to the Sponsor. The IRB will be informed of study termination and the reason(s) for 
the termination by the Sponsor or investigator, as specified by the applicable regulatory 
requirements.  
Conditions that may warrant termination of the study include, but are not limited to, the 
following: 
• 
Discovery of an unexpected, serious, or unacceptable risk to subjects. 

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• 
Recommendation by an Institutional Review Board or Regulatory authority 
• 
The Sponsor decides to discontinue testing of the study device. 
Conditions that may warrant study termination at site include, but are not limited to: 
• 
Failure to comply with pertinent regulations and ethical guidelines 
• 
Deliberate submission of false information 
• 
Inadequate adherence to protocol requirements 
• 
Inadequate enrollment 
All subjects have the right to withdraw at any point during the study without prejudice. A 
subject may be withdrawn from study at any time for any of the following reasons: 
• 
Voluntary withdrawal of consent 
• 
Termination of the study by the Sponsor 
The withdrawal of the subject is documented with the case report forms for this study. If a 
subject withdraws prematurely from the study all documentation must be completed as best 
as possible up until the withdrawal, such as documenting the patient as "lost". The patient 
also retains the right to request that any and all data collected up to the point of withdrawal 
be omitted from the final analysis. 
All study-related documents will be stored for 25 years as required for all regulated studies. 
A privacy breech is considered unlikely due to the fact that only de-identified data are being 
collected and provided to the Sponsor. Nonetheless, the Research Ethics Board and the 
Privacy Office will be notified in the event of a privacy breach. 
9.0 
ECG Data Collection and Transfer 
9.1 
Event Recorder 
For participants in Arm A, the Event Recorder and HeartWatch will be worn for a period of 
72 consecutive hours. The comparator Event Recorder for arm A is the Sirona Event / 
Holter Recorder (Intricon Datrix Corporation, FDA 510(k) number K112601). Like the 
HeartWatch, the Sirona records ECG data on demand when the patient has symptoms 
(manual activation) and has automatic arrhythmia detection for bradycardia, tachycardia, 
AF, and pauses. It can store up to 2,000 events. Electrodes are placed on the chest and 
connected, via leads, to the recorder. The Sirona Event Recorder has an input impedance 
of 5 MΩ, a bandwidth: 0.05 Hz to 40 Hz, samples at 256 samples per second, and has a 
resolution of 10 bits.  
Sirona data will be downloaded for analysis with Global ECG Management System (GEMS, 
CardioComm Inc.) software after the 72 hours, as per usual clinical practice at the 
participating sites. The GEMS data is stored on the clinic network. As per the usual clinical 
care pathway, ECG technicians will analyze the Sirona data and the results will be over-
read by a cardiologist.  
Only the data collected using the Sirona recorders and interpreted using the GEMS 
software will be used for clinical decision making. 

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9.2 
Event Recorder Event Adjudication 
For the purposes of this study in Arm A, at least two cardiac electrophysiologists will 
adjudicate all clinical events (subject activated episodes, as well as auto-detected abnormal 
rhythms). Additionally, they will classify these as clinically-interpretable (i.e., adequate 
quality ECG to make a clinical arrhythmia diagnosis; such as tachycardia, bradycardia, AF 
event or to exclude a clinical arrhythmia diagnosis). In cases of disagreement between the 
categorization of initial two cardiac electrophysiologists a third cardiac electrophysiologist 
will evaluate the data. The final categorization will be based on majority consensus. The 
categorization of events by the cardiac electrophysiologists will be used as the gold 
standard by which the HeartWatch is compared. 
Event categorizations will be done through a customized research software interface 
(Figure 2). The interface allowing the HeartWatch and Event Recorder data to be masked 
(i.e., the data form the devices will appear similar), as will the interpretation of the other 
cardiac electrophysiologist. 
 
9.3 
Holter Monitor 
For participants in Arm B, the Holter and HeartWatch will be worn for a period of 48 
consecutive hours. The comparator in Arm B is the SEER Holter recorder (GE Medical 
Systems Information Technologies, Inc., FDA 510(k) number K130626). The Holter monitor 
is considered the gold standard for ambulatory ECG recordings. Electrodes are placed on 
the chest and connected, via leads, to the recorder. Unlike an Event Recorder, the Holter 
continuously records ECG data. Patients are provided with a diary to record their symptoms 
and activities. All ECG data, including arrhythmia events, are recorded. The SEER Holter 
has an input impedance of 10 MΩ, a bandwidth: 0.05 Hz to 40 Hz, samples at 125 samples 
per second, with a resolution of 10 bits.  
 
T – Manual Trigger 
Figure 2. Customized research software interface. 

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SEER data will be downloaded for analysis with MARS software for analysis after the 48 
hours, as per usual clinical practice at the participating sites. The MARS Database is stored 
on the local clinic network. As per the usual clinical care pathway, ECG technicians will 
analyze the SEER data and the results will be over-read by a cardiologist. 
Only the data collected using the SEER recorders and interpreted using the MARS software 
will be used for clinical decision making. 
9.4 
Holter Data Evaluation 
For the purposes of this study in Arm AB, the percent of data that is interpretable will be 
based on hour-by-hour analysis by experienced Holter technicians and confirmed by at 
least two cardiac electrophysiologists. The over-read adjudications by the cardiac 
electrophysiologists will be used as the gold standard by which the HeartWatch is 
compared. Data will be segmented into blocks of one hour. The percentage of data will be 
calculated as the number of blocks where the overall ECG data is clinically-interpretable 
(the heart rate is measurable, all bradyarrhythmias and tachyarrhythmias are identified, and 
abnormal beats are identified) over the total number of blocks recorded (e.g., data 
interpretable in 17 of 21 blocks = 81%). 
9.5  
HeartWatch 
For participants completing either study, the HeartWatch will be worn for the same length of 
time as the comparator device. The HeartWatch arm band is designed to provide non-
invasive, continuous ECG data. It continuously records ECG data for subsequent, offline 
analysis using a custom-designed research software product (Figure 2). The HeartWatch 
allows the user to note (flag) symptoms they experience (e.g., palpitations, chest pain, 
fainting, etc.) to allow for symptom-rhythm correlation and subsequent review by a 
physician. The HeartWatch displays the elements of an ECG signal to facilitate diagnoses 
by the physician. 
When secured to the left upper arm, the device collects continuous ECG signals from four 
(4) built-in electrodes and transmits the data to the user’s personal communication device 
(e.g., smartphone) and the cloud using the Android Operating System (OS) and Bluetooth. 
The HeartWatch is powered by a rechargeable lithium ion battery. The HeartWatch collects 
a single channel ECG, has bandwidth from 0.67 Hz to 45 Hz (and impedance 10 MΩ), 
sampling rate of 300 samples per second, and 12-bit resolution. 
The data obtained using he HeartWatch and any data analyzed using the customized 
research software interface will be not used for clinical decision making. 
9.6 
HeartWatch Data Adjudication 
For the purposes of this study in Arm A, at least two cardiac electrophysiologists will 
adjudicate all clinical events (subject activated episodes, as well as auto-detected abnormal 
rhythms). Additionally, they will classify these as clinically-interpretable (i.e., adequate 
quality ECG to make a clinical arrhythmia diagnosis [e.g., tachycardia, bradycardia, or AF 
event or to exclude a clinical arrhythmia diagnosis]). In cases of disagreement between the 
categorization of initial two cardiac electrophysiologists a third cardiac electrophysiologist 
will evaluate the data. The final categorization will be based on majority consensus. The 
categorization of events by the cardiac electrophysiologists will be used as the gold 
standard by which the HeartWatch is compared. 

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Event categorizations will be done through a customized software interface (Figure 2). The 
interface allowing the HeartWatch and Event Recorder data to be masked (i.e., the data 
form the devices will appear similar), as will the interpretation of the other cardiac 
electrophysiologist.  
For Arm B, the over-read adjudications of the cardiac electrophysiologists will be used as 
the gold standard by which the HeartWatch is compared. 
10.0 Methods 
10.1 
Baseline Visit 
Unless otherwise specified, the study coordinators will conduct the following study activities. 
Prior to collecting ECG data, an assessment of the participant will be conducted to confirm 
eligibility. Subjects will be provided with the HeartWatch and instructed on proper 
placement, use, and troubleshooting at the same clinical appointment in which they receive 
the comparator device. The recorders will be placed and turned on within the same time 
frame (within 2 hours).  
The baseline visit will also include a collection of relevant medical data, including: age, 
gender, height, weight, blood pressure, medications used, medical history, the indication for 
the extended ECG test and relevant symptoms. 
10.2 
Study Visits 
Participants will be seen at a baseline visit when they will receive the devices and a 
subsequent visit where the Event Recorder or Holter monitor data are downloaded and 
assessment of adverse events conducted. Both of these visits follow the usual clinical work 
flow and procedures for extended ambulatory ECG testing. Hence, no additional in person 
study visits, outside of these usual visits will be required. A phone follow-up 1 to 3 days after 
the ECG monitoring devices are returned will be performed to assess for any adverse 
events that were not apparent at the time the devices were returned. 
10.3 
Follow Up 
None beyond the stated study periods (72 hours for Arm A and 48 hours for Arm B). 
10.4 
Unscheduled Visits 
There is potential for unscheduled clinic visit occurring in the event of a clinical or study 
device malfunction, inadequate recording from either device, or the development of an 
adverse event.  
Should clinical or study device malfunction or inadequate recording from either device occur 
the subject will be offered the opportunity to repeat the recordings. If they chose not to 
repeat the testing their data will be considered incomplete or they will be excluded from the 
analyses (see Section 10.2). The details surrounding subject data that is excluded from the 
analyses (i.e., frequency, device type, device and subject reason(s), and relevant 
demographic features) will be tabulated and reported. 
10. 5 Site Selection, Participation, and Management 
This study will be undertaken at one site, with enrollment of up to 50 subjects. The Sponsor 
has determined that the Principal Investigator and their staff have the facilities and expertise 
required. The selected site has a sufficient volume of patients who meet the inclusion and 

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no exclusion criteria, is able and willing to follow this clinical study protocol (including the 
collection of data, and has a staff member who can serve as a research coordinator). 
10.5.1 Clinical Monitoring Procedures 
Site Monitors may be used and will be managed by the Sponsor. They will have relevant 
experience in clinical trials involving cardiac conditions. Monitors will be chosen, based on 
monitoring experience in medical devices, preferably with IDE/ITA trial experience. These 
individuals have experience in GCP/ICH guidelines for conducting clinical studies. At a 
minimum, these individuals hold the credentials equivalent to that of a Clinical Research 
Associate (CRA). 
10.5.2 Site Monitoring Procedures 
Prior to study initiation, the Sponsor will develop a site monitoring plan. Monitoring the study 
will consist primarily of site qualification and initiation, remote monitoring of the case report 
forms (CRFs) and ongoing on-site monitoring and source verification. 
 
10.5.3 On-site Monitoring 
A representative of the Sponsor will visit the Investigator periodically for the purpose of 
monitoring the progress of this study and data collection within the chosen electronic data 
capture (EDC) system, in accordance with current Good Clinical Practice regulations. These 
include but are not limited to assuring subjects are protected, study data integrity, and 
compliance with applicable regulations. Any additional requirement imposed by the monitor 
or other regulatory authorities shall also be followed. 
It is the responsibility of the Investigator to be present or available for consultation during 
such scheduled monitoring visits. During these routine visits, all medical source data 
pertaining to a patient's participation in this clinical investigation must be made available to 
the monitor. Medical source data are any medical records associated with the subject’s 
health prior to study initiation and change in health during the study period. 
On-site review of eCRFs focuses primarily on source verification, a comparison of data 
entered into the eCRF vs. source records. eCRF data points will undergo source verification 
using a risk-based approach that will be outlined a study-specific clinical monitoring plan. 
The Sponsor, or Sponsor’s authorized representatives, will also review study files, including 
the administrative and regulatory files, subject binders and all source documentation for 
review in order to verify the accuracy and completeness of the records, as well as 
appropriate subject consent procedures. 
The Investigator and appropriate personnel may be invited to attend meetings/workshops 
organized by the Sponsor to assure acceptable protocol execution. The study may be 
subject to audit by the Sponsor, Sponsor’s representatives, or by regulatory authorities. If 
such an audit is announced or occurs, the Investigator must agree to allow access to 
required patient records. By signing this protocol, the Investigator grants permission to 
qualified personnel from the Sponsor, its authorized representatives, and appropriate 
regulatory authorities for on-site monitoring of all appropriate study documentation, as well 
as on-site review of the procedures employed in CRF generation, where clinically 
appropriate. 

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At study termination, a monitor will conduct an on-site study closeout visit, the purpose of 
which is to review all study documents and CRFs and prepare this information for proper 
storage. 
Monitoring visits will occur as appropriate and commiserate with subject enrollment. The 
frequency of monitoring visits will be determined by ongoing evaluation of site performance 
and level of enrollment. 
10.5.4 Training 
All physicians and support staff who will participate in this study will undergo orientation by 
the Sponsor prior to study initiation at the site. Training consists of: 
• Review of the study protocol 
• Review of the HeartWatch device Instructions for Use 
• Product Training log for study staff 
10.6 
Data Collection  
10.6.1 Event Recorder and Holter Data 
A standard 1 or 2-lead Sirona Event Recorder will be used to collect high-resolution data. 
Subjects will be asked to wear the clinical monitor for at least 48 hours and no longer than 
84 hours. ECG signals will be continuously collected as long as the skin patches are 
attached to the skin and the recorder is properly connected to the wires. 
A standard 5-lead SEER Holter will be used to collect 3-channels of high-resolution data. 
Subjects will be asked to wear the clinical, conventional monitor for at least 36 hours and 
no longer than 60 hours. During this time ECG signals will be continuously collected. 
Specific variables of interest within both ambulatory recordings are: 
• 
Symptoms during the extended ambulatory ECG monitoring assessment 
• 
ECG data during the extended ambulatory ECG monitoring assessment 
• 
Usability of the extended ambulatory ECG monitoring assessment tests 
• 
Adverse events related to the extended ambulatory ECG monitoring tests 
• 
User preference of the ambulatory ECG monitoring tests assessed 
10.6.2 Clinical Data 
Basic data related to each subject’s medical history and their medications will be 
collected:  
• 
Demographic (age, sex, race) 
• 
Indication for extended ambulatory ECG testing 
• 
Medical history 
All data will be managed as per the outlined procedures in Section 8, Data Management.  
11.0 Statistical Analysis Plan  
11.1 Statistical Considerations 
This is a preliminary study to assess the feasibility of conducting a larger multi-centre study. 
The objectives of this study are largely logistical (see 8.6, demonstrate the capacity to collect 
and pair user-triggered and auto-triggered ECG data from the HeartWatch and Event 

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Recorder and the capacity to collect and pair continuous ECG data from the HeartWatch and 
Holter monitor). As such, only a limited number of subjects need to be enrolled. The sample 
size and statistical plan are based on the comparison of the paired data. 
11.2 Primary Measure of Study Success 
The capacity to collect clinically-interpretable paired data. The criteria for evaluation include: 
1. Ability to collect, pair, and analyze at least 20 user-triggered HeartWatch and Event 
Recorder ECGs. 
2. Ability to collect, pair, and analyze at least 20 auto-detected HeartWatch and Event 
Recorder ECGs. 
3. Ability to collect, pair, and analyze at least 200 hours of HeartWatch and Holter data. 
4. Assess adverse events with the HeartWatch, Event Recorder, and Holter 
5. Assess user preference for the HeartWatch, Event Recorder, and Holter. 
 
11.3 Sample Size  
A total of 50 patients will be enrolled to collect the required number of events in Arm A (20 
triggered and 20 auto-detected) and 200 hours of continuous ECG data. This sample size 
takes into account that up to 20% of the data may be uninterpretable. Although we expect 
that less than 10% of the data will be missing or uninterpretable, a more conservative 
estimate is being used given the uncertainties involved in this preliminary study.  
Up to 40 patients will be enrolled in Arm A, providing a sufficient number of triggered and 
auto-triggered events. While patients undergoing extended ECG monitoring have an 
unpredictable number of events, clinical observations indicate that ~25% of patients will 
have events, with an average of 3 triggered and 3 auto-detected events per recording. 
Thus, the 40 patients will provide up to 30 triggered and up to 30 auto-detected events. 
Assuming 20% of the data may be missing or uninterpretable, ~24 triggered and ~24 auto-
detected events will be available for analysis. 
Up to 10 patients will be enrolled in Arm B, providing over 250 hours of continuous ECG 
data. This will provide over 200 hours of usable data, assuming 20% of the data may be 
missing or uninterpretable. 
11.4 Statistical Analysis 
The purpose of this study is to collect data to allow for paired data evaluation. As such, 
descriptive statistics will be employed. Standard statistical methods will be used. It is 
anticipated that the following techniques may be used: descriptive summary statistics, 
Student’s t-test, Chi-square, Fisher’s exact test, analysis of variance, analysis of 
covariance, and graphical displays. 
11.5 Safety Evaluation 
All adverse events reported in the study will be tabulated for all subjects enrolled. Events 
will be tabulated by severity and relationship. Latent events will be tabulated separately. 
Adverse events will be evaluated and described as outlined in Section 13. 

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11.6 Usability Endpoint Analyses 
Behavioral qualitative data from the product usability testing sessions will be assessed 
separately. In addition, all subjects participating in Study A and Study B will be asked to 
complete a brief questionnaire on device preference (Figure 3). 
 
 
 
Please check off the box above the statement that best described your experience? 
ࠫ 
ࠫ 
ࠫ 
ࠫ 
ࠫ 
Strongly prefer 
chest monitor 
Slightly prefer 
chest monitor 
No preference 
of monitor 
Slightly prefer 
arm monitor 
Strongly prefer 
arm monitor 
Numeric values assigned to the subjects’ response. 
-2 
-1 
0 
1 
2 
 
Figure 3: Extended ECG Monitoring Test Preference. 
User preference will be summarized and values ranging from -2 to +2 (Figure 3, lower 
panel) assigned to the subject’s selection.  
12.0 Risk Management 
12.1 Adverse Events 
Information on all adverse events (non-serious, serious and unanticipated events, device 
deficiencies) will be collected for the entire duration of the Study 
12.2 Recording Adverse Events, Device Deficiencies and Protocol Deviations  
All adverse and serious adverse events will be recorded on the adverse event case report 
form. Information to be collected and recorded will include event description, onset and 
resolution dates, severity, interventions performed (including the administration of 
pharmaceuticals) and the Investigator’s assessment of relatedness to the investigational 
procedure and treatment. 
The Sponsor or Sponsor’s designee may also identify reportable events during audits or 
monitoring visits. Each event will be followed until resolved or stabilized at a level 
acceptable to the Investigator and the Sponsor’s medical monitor, if utilized. 
All deficiencies, anticipated or not, will be recorded on the device deficiency event case 
report form. Information to be collected and recorded will include the date of device 
deficiency, a detailed description of the deficiency and actions taken due to deficiency, 
model and serial number. 
12.3 Reporting Requirements  
Any serious adverse events (SAEs) or UADEs that may occur must be reported by the 
Principal Investigator to their Institutional Review Boards, and per 21 CFR 812.150(b)(1). 
The Investigator will obtain, in writing, the requirements for reporting such events and file 
requisite documentation along with the Study documents. Serious Adverse Events should 
be reported to the local Institutional Review Board (IRB) per local policy. In addition, all 

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SAEs and UADEs must be reported to the Sponsor within 24 hours of the Investigator’s (or 
other Study staff) knowledge of the event. The reporting individual shall telephone the 
Sponsor to report all known details at that time; if no live telephone conversation is possible, 
the reporting individual shall leave a telephone message followed by an electronic mail 
(email) transmission of all known details to the Sponsor.  
Within three (3) days of the Investigator’s knowledge of the SAE or adverse device effect, 
the appropriate adverse event case report form should be entered in the EDC system and 
accompanying source documentation shall be sent to the Sponsor (or the authorized 
representative). The Sponsor will be responsible for reporting as applicable per the statutory 
reporting requirements. 
13.0  Clinical Site and Informed Consent 
13.1 Participating Sites 
One Canadian site will participate in this preliminary study. 
13.2 Institutional Review Boards 
This protocol and related documents will be approved by local or regional IRBs as per local 
policies before the study is initiated at the site. A copy of the study-specific IRB approval 
letter and the IRB-approved Informed Consent Form must be sent to the Sponsor prior to 
initiating the study at the site. Subsequently, the Investigator is responsible for keeping the 
IRB advised of the progress of the study as deemed appropriate but, in any case, at least 
once a year during the course of the study. Also, the Investigator must keep the IRB and 
Sponsor informed of any significant adverse events. After the completion or termination of 
the study, the Investigator will submit a report of its experience in the study to the IRB and 
to the Sponsor. 
13.3 Informed Consent Process 
Informed consent is required of all subjects participating in this study. An informed consent 
form should be signed before performing any test or intervention that goes beyond standard 
medical care. The consenting process must be compliant with the U.S. Code of Federal 
Regulations 21 CFR 50, 21 CFR 812 and all other applicable national, local and institutional 
requirements.  
The consenting process, oral and written, must take place in the patient’s native language. 
Patients must be informed of their right to withdraw from the study at any time, and for any 
reason, without sanction, penalty or loss of benefits to which the subject is otherwise 
entitled, and that withdrawal does not jeopardize their future medical care. The patient will 
then be given sufficient opportunity to discuss the study with family members, to carefully 
read the written consent form, and have any questions answered. To participate, the patient 
must sign and date the written consent form. The investigator and/or designee must also 
sign and date the form. A copy should be provided to the patient and the original should be 
placed in the patient’s study binder.  
In the event of a consent form or consent process revision, subjects who were already 
enrolled at the time of the revision may be required to re-consent, as determined by the 
IRB. New subjects entering the study after a consent revision should be consented with the 
currently in-force consent form and consenting process.  

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13.4 Informed Consent for Minors 
This study excludes subjects who are below the age of minority, therefore there is no 
consent process for minors.  
13.5 Special Populations 
The study will not focus on any particular subset of patients based on ethnicity or race. 
Further, no subject will be excluded from the study on the basis of racial or ethnic origin. 
The racial and ethnic composition of the study is expected represent the demographics of 
the typical population seeking evaluation of symptoms related to cardiac disease.  
In situations where informed consent cannot be provided to the coordinator (perceived lack 
of understanding of the consent form or protocol, language barrier, emergency 
circumstances or otherwise), the subject will not be enrolled.  
13.6 Confidentiality 
The clinical investigation shall be conducted in accordance with the ethical principles that 
have their origin in the Declaration of Helsinki. All documents in the study files must identify 
the subject by subject ID number and initials only. All subject information will be handled in 
strict compliance with the professional standards of confidentiality, institutional and national 
requirements. Compliance with the guidelines of ICH E6 regarding subject confidentiality 
are also recommended. All subject study records and files must be kept in a secure location 
with limited access. Access will be granted only to those individuals who are recorded as 
authorized study staff members, the Sponsor and their authorized representatives, 
regulatory agencies and when required by law.  
Data collected during the clinical trial will be stored within a password-protected electronic 
database, which is managed by the Clinical Research Unit at the University of Calgary and 
protected behind institutional firewalls. Master study files and any paper-based source 
documents with identifying information (i.e. consent forms) will be stored securely within the 
locked and secure Clinical Research Unit laboratory. All staff in contact with data must 
complete standardized ethics training, and privacy and security training at their respective 
institutions. Paper-based data and all study files will be stored confidentially and securely in 
Iron Mountain once the study is complete.  
14.0  Data Management  
14.1 Electronic Case Report Forms 
Data will be entered on study-specific electronic CRFs as part of a 21 CFR 11 compliant 
EDC system hosted and managed by the Clinical Research Unit, who follows protocol 
regarding weekly data back-ups, validation and security provisions. Therefore, any and all 
data collected in this study and entered into the EDC is protected by those same protocols. 
CRF data will be entered only by qualified site personnel. At the sponsor’s discretion, when 
a study record is complete (has undergone both monitoring and source verification), the 
record may be locked to prevent further modifications. In general, the study coordinator 
oversees the process of data entry and cleaning. The site Principal Investigator will log on 
to the EDC system periodically to verify that each subject’s EDC-recorded data is accurate.  
14.2 Source Documents 
Data entered into electronic CRFs will be compared with available source documents by the 
clinical monitor to ensure high data quality. Source documents include the reports of 

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tests/procedures, lab results, history and physical reports, progress notes and any other 
original medical document(s).  
14.3 Investigator Records 
21 CFR 812 (IDE regulations) require that the site Principal Investigator maintains accurate 
and complete records related to his/her participation in the study, including: 
• 
All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, 
including required reports 
• 
Records of receipt, use or disposition of an investigational device 
• 
Records of each subject's case history and exposure to the device 
• 
Signed and dated consent forms 
• 
Relevant medical records and progress notes 
• 
Records describing adverse device effects 
• 
The protocol itself 
• 
Any other records required by FDA or the local IRB or hospital/clinic 
All records will be retained by the Investigator for a minimum period of two (2) years after 
the study is completed (21 CFR 812.140(d)). To avoid any possible errors, the Investigator 
must contact the Sponsor prior to the destruction of any study records. The Investigator will 
also notify the Sponsor in the event of unintended loss or destruction of any study records.  
14.4 Investigator Reports  
The reporting requirements and the timeframes for such reports are provided in Table 4. 
 
Table 4. Reporting and Submission Timelines for Study Form/Report 
Event 
Report to 
Timing 
Unanticipated adverse device 
effects 
IRB & Sponsor 
As soon as possible, but no 
later than 10 working days 
after the investigator first 
learns of the effect 
Withdrawal of IRB approval 
Sponsor 
Within 5 working days of 
withdrawal 
Study progress reports 
IRB & Sponsor 
At least yearly 
Deviations from investigational plan 
IRB & Sponsor 
If done to protect subject 
safety, within 5 working days 
after the emergency 
occurred 
Use of device without informed 
IRB & Sponsor 
Within 5 working days 

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consent 
Final report 
IRB & Sponsor 
Within 3 months after 
termination or completion of 
study 
 
15.0 Literature Cited 
a. Steinberg Varma, N, Cygankiewicz I, et al. 2017 ISHNE-HRS expert consensus statement 
on ambulatory ECG and external cardiac monitoring / telemetry. Heart Rhythm 
2017;14:e55–e96. 
b. Davis BR, Friedman LM, Lichstein E. The prognostic value of the duration of the 
ambulatory electrocardiogram after myocardial infarction. Med Decis Making 1988;8:9–18.  
16.0 Instructions for Use and Labelling 
See the following section (pages 31 to 35). 
 
 
 
 
 

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HeartWatch 10 
Information of 
Use Manual 
 
Investigational Device/Instrument de 
recherche; To Be Used by Qualified 
Investigators Only/Réservé uniquement à 
l’usage de chercheurs compétents 
 
DESCRIPTION 
 
The HeartWatch 10 is a non-invasive ECG 
monitor that is worn on a patient’s left 
bicep to extract electrocardiogram data. 
The device uses dry sensors to collect this 
information and relay it to a smart device 
via Bluetooth.  
 
___________________________ 
HelpWear, HeartWatch and the HelpWear 
logo are trademarks of HelpWear Inc. All 
other trademarks are the property of their 
respective owners. 
 
INDICATIONS 
 
HeartWatch is indicated for extended 
diagnostic evaluation of patients with 
symptomatic and transient symptoms such 
as chest pain, syncope, and palpitations, 
as well as patients at risk for arrhythmias, 
but without significant symptoms. 
 
While the use of the device itself can be 
managed by both healthcare 
professionals and patients, interpretation of 
the collected data for diagnosis is 
restricted to healthcare professionals, as 
the data must be loaded and analyzed 
separately. 
 
SETTING UP THE HEARTWATCH 
 
1) Unpack the HeartWatch and ensure 
that the following 3 components (see 
Figure 1) are available: a) Main Enclosure, 
b) Sensor Strap and c) Disposable Strap. 
 
 
 
Figure 1: HeartWatch Components  
 
2) Charge the device using a micro USB 
cable (see Figure 2). 
 
Note: The phone application indicates 
when the device is charging with a 
lightning bolt in the battery symbol once 
this is done, the device is effectively turned 
on until the battery runs out (indicated on 
the HelpWear App). 
 
 
 
Figure 2: HeartWatch (bottom view). 
 
3) The Sensor Strap (see Figure 1) comes in 
multiple sizes. Select a Sensor Strap based 

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on the circumference of the subject’s 
upper left arm. 
 
4) Connect the Sensor Strap to the left side 
of the Main Enclosure using the connector 
on the Strap Mate (see Figure 3). 
 
 
 
Figure 3: Connecting the Sensor Strap to 
the Main Enclosure 
 
5) Attach the Disposable Strap to the Strap 
Connector Ring (see Figure 3) by inserting 
the Disposable Strap into the gap of the 
connector ring.  
 
6) Put the remaining side of the Disposable 
Strap through the Length Adjuster Lock 
(see Figure 3).  
 
7) Place the device on the subject’s left 
bicep. Tighten the disposable strap and 
close the Forward Hinge (see figure _).  
 
 
Figure 4: Securing Disposable Strap onto 
Length Adjustment Lock.  
 
8) Check for signs of loss in circulation in 
the subject’s left arm. If loss in circulation is 
detected, repeat step 7. If the issue 
persists, consider starting again from step 3 
with a larger strap size. 
 
Note: Loss in circulation can present 
through the subject feeling numbness, 
tingling, cold hands, change in skin color, 
pain, fatigue, or swelling. 
 
9) Push down the Back Hinge (see Figure 4) 
of the Length Adjuster Lock. This secures 
the strap in place.  
 
10) Pull the Finger Loop (see Figure 5) to 
open the Quick Release in the Sensor Strap 
and loosen the strap. This allows for the 
sensors under the Main Enclosure to be 
shifted into position. The Main Enclosure 
sensors typically go on the anterior region 
of the bicep.  
 
 
 
Figure 5: Sensor Strap with Quick Release 
open 
 
11) Close the Quick Release by connecting 
the Magnet Pocket (see Figure 5) to the 
corresponding magnet on top of the Strap 
Mate.  
 

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12) Pull the Finger Loop to open the Quick 
Release (without loosening the Sensor 
Strap). 
 
 
 
Figure 6: HeartWatch (top view) 
 
13) Use one hand to secure the strap in 
place and another to move the Adjustable 
Sensor along the strap. The Adjustable 
Sensor typically goes along the Axillary 
Vein (between the inner bicep and tricep). 
 
14) Once setup has been completed, take 
the scissor provided and cut the excess 
fabric on the Disposable Strap with about 
0.5 – 1 inch of slack.  
 
COLLECTING DATA 
 
15) Open the HelpWear App and select 
which HeartWatch unit to pair the smart 
device to.  
 
 
 
Figure 7: App Screen for Connecting to 
HeartWatch Devices 
 
Note: Smart Devices with the HelpWear 
App Installed (and that already paired to 
the HeartWatch 10) are provided to users 
for HeartWatch 10. 
 
Note: To connect the HeartWatch 10 to 
other smart devices, enable the Bluetooth 
settings of the device and select the 
HeartWatch 10 to establish the Bluetooth 
connections. Specific instructions on how 
to enable Bluetooth settings can be found 
in the instruction manual of the designated 
smart device. 
 
16) HeartWatch 10 will assess the 
placement of the device on the subject. If 
placement is not correct, the app will 
guide provide direction on moving the 
device either left or right or up or down. 
Once successful, press ‘start monitoring’ to 
go into patient mode.  
 
 
 

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Figure 8: App Calibration Screen for 
assessing signal quality. 
 
17) Going into patient mode, subjects can 
press the tag button on the HeartWatch 10 
to report an event when experience 
symptoms or irregular activity. 
 
 
 
Figure 9: Reporting Screen for Patients to 
report symptoms after pressing the Tag 
Button  
 
18) After monitoring is complete, users can 
extract data from the paired smart device 
via its document file manager.  
 
REMOVING THE DEVICE 
 
19) Press down on the Forward Hinge of the 
Length Adjuster Lock and then lift the Back 
Hinge.  
 
20) Open the Forward Hinge and pull the 
Disposable Strap out of the Strap Mate. 
 
21) Do the reverse of Step 5 to detach the 
Disposable Strap.  
 
22) Remove Sensor Strap from its Strap 
Mate. 
 
DATA QUALITY CHECK 
 
If the data quality presented on the 
HelpWear app does not meet the 
requirements of either a member of the 
designated healthcare professional, 
repeat steps 3-11.  
 
The ideal signal should show a strong T 
wave. Most of the time P wave and the 
QRS should be quite large inflict and not a 
large deflection.  
 
In some cases, depending on the patient’s 
arm size and shape, adjusting the positions 
of the Adjustable Sensor in either direction 
along the strap can help better data 
quality.  
 
RECOMMENDATIONS 
 
The HeartWatch works non-invasively via 
the patient's bicep and may require 
tightening. After wearing the HeartWatch, 
patients may notice some imprints on their 
skin from the sensors of the device. If the 
patient(s) feels any irritation or dryness, it’s 
recommended that they apply a 
moisturizing lotion to the affected area.  
 
TECHNICAL ASSISTANCE 
 
For technical assistance, please contact 
HelpWear Inc. Support at the following 
numbers: 
 
During the hours of 9:00 AM - 5:00 PM EST 
647.884.3298 
 
24 Hours - 647.863.2420 
 
WARNINGS/CAUTIONS 

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WARNING - improper placement or 
alignment of the HeartWatch 10 can lead 
to inaccurate monitoring 
 
WARNING - do not place HeartWatch 10 
on injured skin as this may cause further 
discomfort. 
 
WARNING - do not use HeartWatch 10 on 
the right bicep. 
 
WARNING - do not use more than one unit 
of HeartWatch 10 on the left arm. 
 
WARNING - do not use a damaged 
HeartWatch 10. This may result 
in inaccurate measurements or may 
damage the HeartWatch 10 further.