Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study
Conditions: Heart Arrhythmia
Sponsor: Zoll Medical Corporation

 
  
DOCUMENT APPROVAL PAGE 
 Document Number:  
Rev:  
Page: 
90D0167 
C 
1 of 32 
Title: Ambulatory Remote Patient Monitoring using the µCor Heart Failure and 
Arrhythmia Management System (PATCH) Feasibility Study: Protocol 
NCT04512703 
Author: 
Ramu Perumal, PhD 
Date:   9-February-2018 
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ZOLL Services Form Number:  90A0001-A01 
Form REV Level:  A 

 
  
DOCUMENT REVISION HISTORY PAGE 
 Document Number:  
Rev:  
Page: 
90D0167 
C 
2 of 32 
Title: Ambulatory Remote Patient Monitoring using the µCor Heart Failure and 
Arrhythmia Management  System (PATCH)Feasibility Study: Protocol 
Revision History Of Document 
 
 
Rev 
 
CO 
Number 
 
 
Description of Change 
 
 
Author  
 
 
Effective Date 
FI 
NA 
First version 
Changed the device name from Continuous Mobile Cardiac 
Telemetry System to uCor Heart Failure and Arrhythmia 
Management System. 
The following changes were made: 
1. Removed CE-mark reference for the device 
2. Subjects no longer have to send photographs of the skin and 
device placement. Instead, they will note their skin condition 
and device location on the subject diary 
3. Study coordinators will collect subject diaries once a week 
4.  Removed the requirement that phase II of the study can start 
only after completion of phase I 
5. Updated the adverse event section per MEDDEV guidelines 
6. Edits to improve the study implementation   
RP 
7/17/17 
 
 
 
 
A 
NA 
RP 
8/22/17 
 
 
 
 
 
 
 
 
 
 
 
 
B 
NA 
RP 
10/16/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C 
NA 
The following changes were made: 
1. First monitoring report to be sent within 24 hours rather than 
2 hours. 
2. Devices that are worn for only the first 7 days will now be 
sent to the sponsor 
3. End of use study visit will occur at 90 days or when subject 
decides to end the study.  
4. In the Subject Diary, replaced AM/PM with the 24-hour clock
numbers  
5. In the Subject Diary, subjects now will record when they 
replace  the patch 
RP 
2/19/18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ZOLL Services Form Number:  90A0001-A03 
Form REV Level:  FI

ZOLL Document Number: 90D0167  
 
 
 
 
      
 
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PATCH Feasibility Study 
 
Version: C 
 
PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
REMOTE PATIENT MONITORING USING THE 
µCOR HEART FAILURE AND ARRHYTHMIA 
MANAGEMENT SYSTEM (PATCH) FEASIBILITY 
STUDY 
 
 
 
 
Short Title: 
PATCH  Feasibility Study 
Principal Investigator(s): 
 
ZOLL Study Lead: 
Ramu Perumal, PhD 
121 Gamma Drive, Pittsburgh, PA 15238 
+1-412-968-3333 ext. 14416 
Study Device: 
ZOLL µCor Heart Failure and Arrhythmia Management 
System (µCor System)  
Protocol Number: 
90D0167  
 
 
  Version: 
       
                     C 
 
 
 
 
 
I have read and understand the information in the protocol and I understand my 
requirements for executing the protocol based on sound knowledge of GCP and ICH 
Guideline for Good Clinical Practice (E6). 
 
 
 
 
PRINTED NAME OF INVESTIGATOR 
 
SITE NUMBER 
 
 
 
INVESTIGATOR SIGNATURE 
 
DATE 
 
 
 
 
 
 
SPONSOR  
 
DATE 
 
 

ZOLL Document Number: 90D0167  
 
 
 
 
      
 
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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
 
Table of Contents 
 
Study Summary ........................................................................................................................................... 1 
1 
Introduction ......................................................................................................................................... 2 
1.1 
BACKGROUND ................................................................................................................................ 2 
1.2 
PRECLINICAL DATA ........................................................................................................................ 2 
1.3 
CLINICAL DATA TO DATE................................................................................................................. 2 
1.4 
STUDY DEVICE ............................................................................................................................... 2 
2 
Study Objectives ................................................................................................................................ 6 
2.1 
PRIMARY OBJECTIVE(S) .................................................................................................................. 6 
2.2 
SECONDARY OBJECTIVE(S) ............................................................................................................ 6 
2.3 
SAFETY OBJECTIVE(S) ................................................................................................................... 7 
2.4 
ADDITIONAL OBJECTIVE(S) ............................................................................................................. 7 
3 
Study Design ....................................................................................................................................... 7 
3.1 
GENERAL DESIGN .......................................................................................................................... 7 
3.2 
PRIMARY STUDY ENDPOINTS .......................................................................................................... 9 
3.3 
SECONDARY STUDY ENDPOINTS ..................................................................................................... 9 
3.4 
SAFETY ENDPOINTS ....................................................................................................................... 9 
4 
Study Subject .................................................................................................................................... 10 
4.1 
INCLUSION CRITERIA .................................................................................................................... 10 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 10 
5 
Study Enrollment Plan ..................................................................................................................... 11 
5.1 
ENROLLMENT STRATEGY .............................................................................................................. 11 
5.2 
STUDY SIZE ................................................................................................................................. 11 
5.3 
ENROLLMENT PERIOD .................................................................................................................. 11 
5.4 
EARLY WITHDRAWAL OF SUBJECTS .............................................................................................. 11 
6 
Study Procedures ............................................................................................................................. 12 
6.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 12 
6.2 
SCHEDULED VISITS ...................................................................................................................... 12 
6.3 
UNSCHEDULED VISITS .................................................................................................................. 14 
6.4 
LONG-TERM CLINICAL OUTCOME ASSESSMENT ............................................................................. 14 
6.5 
STUDY PROCEDURES FLOWCHART (OR TABLE) ............................................................................. 14 
6.6 
BLINDING AND UNBLINDING OF STUDY ........................................................................................... 15 
7 
Study Device Management .............................................................................................................. 15 
7.1 
SUBJECT COMPLIANCE MONITORING ............................................................................................. 15 
7.2 
DISPENSING, STORAGE AND RETURN ............................................................................................ 15 
7.3 
DEVICE MALFUNCTION OR DEFECT ............................................................................................... 15 
8 
Statistical Plan .................................................................................................................................. 16 
8.1 
SAMPLE SIZE AND POWER CALCULATION ...................................................................................... 16 
8.2 
RANDOMIZATION SCHEME ............................................................................................................ 16 
8.3 
ENDPOINT ASSESSMENT .............................................................................................................. 16 
8.4 
STATISTICAL METHODS ................................................................................................................ 16 
8.5 
ADDITIONAL STATISTICAL ANALYSIS .............................................................................................. 16 
8.6 
HANDLING MISSING DATA ............................................................................................................. 16 
8.7 
FUTILITY ANALYSIS ....................................................................................................................... 16 

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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
9 
Health Economic Evaluation ........................................................................................................... 16 
10 
Safety and Adverse Events ............................................................................................................. 16 
10.1 
DEFINITIONS ................................................................................................................................ 16 
10.2 
RECORDING AND REPORTING OF ADVERSE EVENTS ...................................................................... 17 
10.3 
PROTOCOL DEVIATIONS ............................................................................................................... 18 
11 
Administrative Responsibilities ...................................................................................................... 18 
11.1 
SPONSOR .................................................................................................................................... 18 
11.2 
INVESTIGATORS ........................................................................................................................... 19 
11.3 
DATA COORDINATION CENTER (DCC) ........................................................................................... 19 
11.4 
STEERING COMMITTEE ................................................................................................................. 19 
11.5 
DATA SAFETY MONITORING BOARD (DSMB) ................................................................................. 19 
12 
Data Collection and Management Plan .......................................................................................... 19 
12.1 
DATA COLLECTION ....................................................................................................................... 19 
12.2 
DATA COORDINATING CENTER (DCC) ........................................................................................... 20 
12.3 
DATA HANDLING AND RECORD KEEPING ....................................................................................... 20 
12.4 
DATA TRANSMISSION FROM SPONSOR .......................................................................................... 21 
12.5 
STUDY MONITORING PLAN ............................................................................................................ 21 
13 
Risks and Benefits ........................................................................................................................... 21 
14 
Ethical Considerations .................................................................................................................... 21 
14.1 
SUBJECT CONSENT AND CONFIDENTIALITY .................................................................................... 22 
14.2 
SUBJECT FINANCIAL RESPONSIBILITY AND STIPENDS ..................................................................... 22 
15 
Publication Plan ................................................................................................................................ 22 
15.1 
AUTHORSHIP ................................................................................................................................ 22 
15.2 
DATA OWNERSHIP ........................................................................................................................ 23 
16 
List of Abbreviations ........................................................................................................................ 23 
17 
Bibliography ...................................................................................................................................... 23 
18 
Appendix A ........................................................................................................................................ 24 
 
 
 

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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
Study Summary 
 
Title 
Ambulatory remote patient monitoring with the µCor Heart Failure and 
Arrhythmia Management System (PATCH) feasibility study. 
Short Title 
PATCH Feasibility Study  
ZOLL Protocol 
Number 
90D0167  
Study Design 
Prospective, non-interventional, feasibility study.  
Study Duration 
8 months, from start of screening to finishing the study. 
Study Center(s) 
Multi-center study, with a maximum of 8 centers in Europe.   
Primary 
Objective(s) 
To observe the feasibility of remotely monitoring patients with the novel 
µCor Heart Failure and Arrhythmia Management System (µCor system ) 
that non-invasively captures thoracic fluid content, electrocardiogram, 
heart rate, respiratory rate, activity, and body posture.    
Study Population 
Health adult volunteers (21 years or older) and adult patients with a 
clinical indication for ambulatory outpatient cardiac monitoring.   
Intervention 
The study will consist of two phases. 
Phase I of the study will enroll 6 healthy volunteers, who have no 
indication for remote cardiac monitoring. Subjects are required to 
participate in the study for 30 days.  
 Phase II of the study will enroll up to 44 patients indicated for outpatient 
cardiac monitoring and will participate in the study for up to 90 days. 
 All subjects will wear the device in two locations, one along the left 
midaxillary line and the other along the left midclavicular line for the first 
seven days.  
Thereafter, for the remainder of the study, half the enrolled subjects will 
only wear the device in the left midclavicular position and the other half 
will wear the device in the left midaxillary position. Subjects will use a diary 
to keep a daily log their activities of daily living (phase I) or a log of any 
symptoms related to heart rhythm abnormalities and heart failure (phase 
II).  
Data will be acquired with the µCor system and wirelessly transmitted 
daily to a remote server for processing, generating thoracic fluid content, 
ECG, heart rate, respiration rate, activity, and posture measurements. 
Investigators will have access only to ECG data.  
Study staff will make weekly phone calls to subjects and record any new 
clinically actionable events. Patients will have monthly office visits. At the 
end of 30 days (phase I) or 90 days (phase II), patients will end wear and 
will complete the study follow-up questionnaire. 
Study Size 
The study will enroll a maximum of 50 subjects. Six healthy volunteers will 
be enrolled for phase I of the study.  Remaining 44 subjects will be 
enrolled for phase II and will have an indication of outpatient cardiac 
monitoring. 

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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
1 Introduction 
 
This document is a protocol for a human research study. This study is to be conducted according 
to US and international standards of Good Clinical Practice (International Conference on 
Harmonization ICHE6).  
1.1 Background 
Mobile cardiac telemetry (MCT) allows for ambulatory monitoring of electrocardiograph 
(ECG) signal continuously.1 When a cardiac event occurs, the MCT system instantaneously 
transmits the data to a monitoring center, where the data is analyzed live and a report is 
sent to the patient’s physician for diagnosis and therapy management.1,2  Previous studies 
have shown that use of MCT, instead of a Holter or event monitor, leads to better outcomes 
with regard to diagnostic yield, management of arrhythmias through the use antiarrhythmic 
drugs, and cost savings in the hospital for cardiac procedures.2–4 
 
Given the patient management capabilities of the MCT system, ZOLL has developed a 
novel radiofrequency (RF) based µCor Heart Failure and Arrhythmia Management System 
(µCor system). The system records ECG and heart rate through 2 electrodes and 
respiration rate, activity, and posture through a tri-axial accelerometer. Thoracic impedance, 
a measure of lung fluid, is estimated using low-power electromagnetic pulses at radio 
frequencies of 0.5-2.5GHz. The µCor system continuously records and transmits ECG and 
accelerometer data to the monitoring center. RF data are recorded periodically according 
to a predefined schedule. Physiological parameters such as thoracic impedance, heart rate, 
respiration rate, activity, and posture are extracted from the recorded data by dedicated 
software at the monitoring center. Certified technicians at the monitoring center review 
received data and prepare clinical reports to the prescribing physician. Because the µCor 
system has not yet been tested in a real-world setting, the purpose of this study is to observe 
the feasibility of the novel µCor system to remotely monitor patients in a real-world, 
ambulatory setting. 
1.2 Preclinical Data  
NA 
1.3 Clinical Data to Date 
NA 
1.4 Study Device  
1.4.1 System Components 
The µCor System consists of the following components: 
A) Patch 
B) Sensor  
C) Charger  
D) Data transmission device (Gateway) 
E) Server 
 
Once activated, the wearable Sensor automatically acquires ECG, thoracic impedance, 
Heart Rate, Respiration Rate, Activity, and Posture measurements.  Patients can also 
activate a patient trigger when they experience symptoms such as palpitations, shortness 

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ZOLL MEDICAL CORPORATION 
of breath, or lightheadedness  by double tapping the Sensor when it is on the body. Data 
are automatically transmitted from the Sensor to the Data transmission device, and from 
there to the Server for analysis (see Fig. 1).  Certified technicians at the Monitoring Center 
review the data generated by the Server and prepare reports according to the pre-defined 
criteria as requested by the prescribing physician.  Data provided in the report will aid the 
prescribing physicians in the diagnosis and identification of various clinical conditions, 
events and/or trends.  The µCor System is designed for use in outpatient clinic and home 
settings.  
 
 
Figure 1:  Data transmission of the µCor System 
 
1.4.2 Patch 
The Patch (Fig. 2) consists of a plastic frame intended for housing the Sensor, and two ECG 
electrodes on each side of the frame.  It is applied to your body. 
The Patch is a single-use, disposable item. At the end of 5 days, it should be replaced with a 
new Patch.  
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2: Patch  
1.4.3 Sensor 
The Sensor (Fig. 3) is a battery powered unit that acquires data.  The Sensor connects to the 
Patch via the snap-in clip and positioning tabs.  Through the adhesive backing on the Patch, 
the device becomes wearable. The Sensor is not disposable and needs to be returned to 
ZOLL upon the completion of the prescription. A light indicator is located close to the center 
and serves to communicate the Sensor’s status at different points of use.  Note that the light 
indicator is visible only when lit. 

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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2:  Sensor's front view 
1.4.4 Charger 
A dedicated Charger (Fig 4) is supplied with the µCor System for recharging the Sensor and 
the Data Transmission Device.  A blue light appears when the Charger is connected to an 
AC outlet.  
 
 
 
 
 Figure 4:  Charger 
1.4.5 Data transmission device (Gateway) 
A Data Transmission Device or Gateway is responsible for sending data from the Sensor to 
the Server for data analysis. When the screen display is on, the gateway battery status is 
visible on the screen. Once the battery status is under a certain level, a short beeping sound 
will be made every few minutes until the battery is depleted or the Gateway is placed in the 
Charger.  

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ZOLL MEDICAL CORPORATION 
 
Figure 5: Gateway 
1.4.6 Server 
The Server refers to the hardware and the processing software and resides in a remote 
cyber-secure location.  The software analyzes the data received from the Sensor via the 
Gateway and processes the data into clinical values for presentation to your healthcare 
provider after review by certified technicians at the Monitoring Center. 
 
1.4.7 Device (Sensor +Patch) Placement Location 
There are two locations for device (Sensor + Patch) placement:  (1) along the left midaxillary 
line in line with the nipple (side location) and (2) along the left midclavicular line, above the 
nipple and below clavicle.   
 
 
 
Figure 6:  Device (Sensor + Patch) placement location 

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ZOLL MEDICAL CORPORATION 
2 Study Objectives 
2.1 Primary Objective(s) 
The primary objective of this study is to observe the feasibility of the novel µCor system to 
remotely monitor patients. Feasibility will be assessed in terms of: 
2.1.1 Logistics of equipping patients with the µCor system in the physician’s office. This 
will include verifying that the system is able to transmit data to a remote server and 
that a monitoring report is received by the physician’s office. 
2.1.2 Subject’s ability to wear the device for the specified time period of up to 90 days. 
2.1.3 Subject’s ability to place the device in the correct anatomical position during every 
reapplication, as described in the patient instructions for use. Device placement case 
report forms and daily device data signal quality will be used to track the accuracy 
of device placement and repeatability.  
2.1.4 Ability of the system to transmit data daily to the remote servers for processing.   
2.1.5 Ability to provide a timely arrhythmia monitoring (daily, episodic, and end of 
monitoring) reports to physicians.    
2.1.6 Documenting the following clinically actionable events in an outpatient setting via 
weekly phone calls to the subject: 
2.1.6.1 Emergency room visits  
2.1.6.2 Unplanned physician visits 
2.1.6.3 New arrhythmia and heart failure (HF) symptoms  
2.1.6.4 All-cause and HF hospitalizations 
2.1.6.5 Alterations and additions in HF and cardiac medications  
2.1.6.6 All-cause and cardiovascular mortality at 90 days 
2.2 Secondary Objective(s) 
A number of secondary objectives will be evaluated and these will include: 
2.2.1 Equivalency of data recorded by the device placed along the left midaxillary line 
versus the data recoded by the device placed along the left midclavicular line.   
2.2.2 Correlation between detected heart rhythm abnormalities and any clinically 
actionable events.  
2.2.3 Correlation between detected thoracic fluid content changes and any clinically 
actionable events.  
 

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ZOLL MEDICAL CORPORATION 
2.2.4 Correlation between changes in thoracic fluid content and/or detected heart rhythm 
abnormalities with all-cause and cardiovascular mortality. 
2.2.5 Short term (days), mid-term (weeks), and long-term (months) stability of the device 
recorded data in the same patient. 
2.2.6 Stability of the device recorded data with multiple reapplications of the µCor system. 
2.3 Safety Objective(s) 
To document the number and severity of serious adverse events and adverse events 
related to use of the µCor system.    
2.4 Additional Objective(s) 
NA 
 
3 Study Design 
3.1 General Design 
A) Phase I 
 
 
 
 
 
 
 
 
 
 

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Figure 2: Schematic of trial design with various phases of the study.  
 
This is a multicenter, prospective, non-interventional, feasibility study. A maximum of 8 
centers in Europe will participate in the study. Phase I of the study will enroll 6 healthy 
volunteers, who have no indication for remote monitoring. Subjects are required to 
participate in the study for 30 days. For the first seven days, all subjects will wear the µCor 
system in two locations, one along the left midaxillary line and the other along the left 
midclavicular line. Thereafter, for the remainder of the study period (23 days), 3 subjects 
will wear the device in the midclavicular position and the remaining 3 subjects will wear the 
device in the midaxillary position. Data will be acquired with the µCor system and wirelessly 
transmitted daily to a remote server for processing. Subjects will keep a diary to record their 
daily activities of living, their skin condition due to use of the µCor device/s, and placement 
location of the device/s. (Appendix A). In addition, the subjects will receive weekly phone 
calls to ensure that the device is performing as intended. Furthermore, the study staff will 
ask the subject send their diaries after each week of wear to the study coordinator. At the 
end of 30 days, these subjects will end wear and will complete study follow-up 
questionnaire.     
 
For phase II of the study, up to 44 patients eligible for remote monitoring will receive a µCor 
system after they are enrolled in the study. Subjects must be willing to wear the µCor system 
continuously for 90 days. In case of adverse skin reaction to the µCor adhesive and/or 
electrodes, on the discretion of physician, subjects may discontinue wearing the device for 
up to 72 hours.  All subjects will wear the device in two locations, one along the left 
midaxillary line and the other along the left midclavicular line for the first seven days. 
Thereafter, for the remainder of the study, half the enrolled subjects will only wear the device 
in the left midclavicular position and the other half will wear the device in the left midaxillary 
B) Phase II 
 

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ZOLL MEDICAL CORPORATION 
position. Subjects will use a diary to keep a daily log of their daily activities of living, any 
symptoms related to heart rhythm abnormalities and heart failure, their skin condition due 
to use of the µCor device/s, and the placement location of the device/s  (Appendix A). Data 
will be acquired with the µCor system and wirelessly transmitted daily to a remote server 
for processing, generating thoracic fluid content, ECG, heart rate, respiration rate, activity, 
and posture measurements. Investigators will have access only to ECG data. Study staff 
will make weekly phone calls to subjects and record any new clinical actionable events. 
Furthermore, the study staff will ask the subject send their diaries after each week of wear 
to the study coordinator. Patients will have monthly office visits. At the end of the 
participation period (anticipated 90 days), patients will end wear and will complete the study 
follow-up questionnaire. 
3.2 Primary Study Endpoints 
Only observational data will be collected to assess the feasibility of implementing the µCor 
system to monitor patients in an outpatient setting. There are no target objectives 
associated with these data; however, these endpoints will be assessed: 
3.2.1 
Logistics that captures device placement, subject training, device data transmission, 
and monitoring report receipt during the initial device fitting at the physician’s office. 
3.2.2 
Total number of days the device is worn and wear time per day.  
3.2.3 
Accuracy and repeatability of device placement during the anticipated 90 day wear 
period. 
3.2.4 
Number of data transmissions from the device to the remote severs during the study 
period.  
3.2.5 
Timing of the monitoring reports to physicians. 
3.2.6 
Weekly documentation of skin condition.  
3.2.7 
Timely documentation of clinically actionable events.  
3.3 Secondary Study Endpoints 
Various secondary endpoints that will be evaluated for the study are detailed in Section 2.2.   
3.4 Safety Endpoints  
Adverse events related to the use of the µCor system and all serious adverse events will 
be used to assess safety during the study.  
 
 
 
 
 
 

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4 Study Subject  
4.1 Inclusion Criteria 
The following criteria will be used to include subjects in phase I portion of the study: 
4.1.1 
Healthy male and female volunteers.  
4.1.2 
Subjects older than 21 years of age. 
4.1.3 
Subjects willing to wear the µCor device for up to 30 days. 
4.1.4 
Subjects willing to answer weekly phone calls from the study staff.  
 
The following criteria will be used to include subjects in phase II portion of the study: 
4.1.5 
Patients with a clinical indication for outpatient cardiac monitoring.  
4.1.6 
Patients older than 21 years of age. 
4.1.7 
Patients willing to wear the µCor device for up to 90 days. 
4.1.8 
Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study 
period. 
4.1.9 
Patients willing to answer weekly phone calls regarding their health status.  
4.2 Exclusion Criteria 
The following criteria will be used to exclude subjects from phases I and II portions of the 
study: 
4.2.1 
Subjects reporting or planning to be pregnant.  
4.2.2 
Subjects with any cardiac implantable electronic devices, including loop recorders. 
4.2.3 
Subjects with a wearable cardioverter defibrillator. 
4.2.4 
Subjects with Holter monitors, wearable event recorders, and other mobile cardiac 
telemetry devices. 
4.2.5 
Subjects with any skin condition that would prevent them from wearing the µCor 
system. 
4.2.6 
Subjects who are non-ambulatory. 
4.2.7 
Subjects without adequate cellular transmission access that would prevent data 
download from the µCor device. 
4.2.8 
Subjects participating in another clinical study. 
 
 

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4.2.9 
Subjects unable to give informed consent. 
4.2.10 Employees of ZOLL or their family members. 
4.2.11 Subjects traveling during the study participation period that prevents planned office 
visits and weekly phone calls from the study coordinator.   
4.2.12 Subjects expected to undergo a planned MRI exam during the participation period. 
 
5 Study Enrollment Plan 
5.1 Enrollment Strategy  
Physicians with clinical research capabilities and willing to use the µCor system will be 
identified as potential investigators for the study. Study related educational training may be 
provided to study coordinators and clinicians to increase awareness about the trial. In 
addition, study brochure describing the potential benefits and risks of the study may be 
provided to likely candidates for the study.     
5.2 Study Size 
The study will enroll a maximum of 50 subjects. Six healthy volunteers will be enrolled for 
phase I of the study.  Remaining 44 subjects will be enrolled for phase II and will have an 
indication of outpatient monitoring. Subjects will be enrolled from a maximum of 8 sites. All 
sites will be located in Europe. 
5.3 Enrollment Period 
The anticipated total enrollment period will be 5 months. All subjects are anticipated to 
complete the µCor wear period at 8 months from start of the study.  
5.4 Early Withdrawal of Subjects 
5.4.1 When and How to Withdraw Subjects 
Subjects may voluntarily withdraw participation at point during the study period. In 
addition, subjects will be withdrawn from the study prior to study completion under 
following scenarios: 
5.4.1.1 
 Skin irritation and/or rash due to use of the µCor device that prevents subjects 
from wearing the device for longer than 72 hours. 
5.4.1.2 
Any life-threatening condition that prevents subjects from participating in the 
study for longer than 7 days. 
5.4.1.3 
Subjects no longer meeting the inclusion/exclusion criteria. 
5.4.2 Data Collection and Follow-up for Withdrawn Subjects 
 
All data from withdrawn subjects will be retained. Reasonable attempts should be made 
to obtain the end of study follow-up data. At minimum, the end of study follow-up data 
should include survival data. 

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6 Study Procedures 
6.1 Subject Recruitment and Screening 
6.1.1 Subject recruitment 
Subjects will be identified from investigator sites. The investigator or the designated study 
coordinator will approach potential subjects to discuss the details of the clinical study, 
including benefits and risks of participating in the study. 
6.1.2 Subject screening 
Screening of subjects will be take place based on the inclusion/exclusion criteria. For 
phase I of the study, healthy volunteers will be screened. For phase II, only subjects with 
a documented clinical indication for outpatient cardiac monitoring will be screened for the 
study.  
6.2 Scheduled Visits 
6.2.1 Visit 1: Screening and fitting of the µCor system 
6.2.1.1 
For phase I of the study, healthy volunteers will be screened. For phase II, a 
chart review of patients will be used to evaluate patients for enrollment. A 
screening log will be maintained. 
6.2.1.2 
Informed consent will be obtained on eligible patients who wish to participate 
in the study.   
6.2.1.3 
The initial clinical and demographic data will be recorded. This may be done 
by chart review.  
6.2.1.4 
Subjects will be trained on care and use of the µCor system per the Instructions 
for Use manual.  
6.2.1.5 
Each site will sequentially assign a number to each subject as they are 
enrolled, starting at 001.  
6.2.1.6 
Subjects will be then fitted, per the Instructions for Use manual, with two µCor 
systems, one along the left midaxillary line and the other along the left 
midclavicular line. Subjects will wear the two devices for first seven days. After 
that, subjects with an odd number will be assigned to wear the device only   

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along the midaxillary line and those with an even number will wear the device 
only along midclavicular line.    
6.2.1.7 
A confirmation e-mail will be sent to the designated study staff within 1 hour of 
fitting and activating the devices that the µCor system is able to transmit data 
to a remote server. 
6.2.1.8 
First monitoring report will be sent the physician-investigator or designated 
study staff within 24 hours of fitting and activating the devices.   
6.2.2 Visit 2: Wear period from 0 to 7 days 
Subjects will wear two µCor devices for the first 7 days. All subjects will keep a diary to 
record their daily activities of living, their skin condition due to use of the µCor device/s, 
and the placement location of the device (Appendix A). For subjects participating in phase 
II of the study they will keep a dairy to record any symptoms related to heart rhythm 
abnormalities and heart failure (Appendix A). Symptoms associated with transient 
arrhythmias include syncope, near syncope, dizziness, palpitation, shortness of breath, 
chest discomfort, weakness, and diaphoresis. Symptoms of heart failure include: dyspnea, 
fatigue and weakness, edema, persistent coughing or wheezing, lack of appetite and 
nausea, confusion and impaired thinking, and increased heart rate. Arrhythmia monitoring 
reports will be provided to the physician when an actionable arrhythmia is detected per 
the notification specified by the physician-investigator.  On day 7, the study coordinator 
will call the subjects to record any clinical actionable events and check on status of the 
device. During the call, subjects will be requested to send to send their dairy every week 
to the study coordinator.  In addition, the study coordinator will remind the subjects to 
remove one of the devices, midaxillary or midclavicular, depending on whether the 
subjects are assigned an odd or even number. Subjects will also be instructed on how to 
send one of the study devices back to the sponsor.     
6.2.3 Visit 3: Wear period from 8 to 30 days 
Study coordinators will make weekly phone calls to record any clinical actionable events 
and ask subjects to send their weekly diaries. During this phone call, study coordinators 
will answer any device related questions, and if possible help with troubleshooting per the 
µCor Instruction for Use manual. All subjects will continue recording the requested 
information in their diary (Appendix A) and send their diaries to the study coordinator once 
a week. Arrhythmia monitoring reports will be provided to the physician when an 
actionable arrhythmia is detected per the notification specified by the physician-
investigator. At day 30, all subjects will perform an office visit. During this visit, the study 
coordinator will collect subject diaries, answer questions related to the study and the 
device. In addition, subjects participating in phase I of the study will return all their study 
devices and study related material.   
6.2.4 Visit 4 and 5: Wear period from 31 to 90 days 
Only subjects participating in phase II of the study will wear the device up to 90 days. All 
subjects will continue recording the requested information in their diary (Appendix A) and 
send their diaries to the study coordinator once a week. Study coordinators will make 
weekly phone calls to record any clinical actionable events. During this phone call, study 
coordinators will ask the subjects to send their diary, answer any device related questions, 
and if possible help with troubleshooting per the µCor Instruction for Use manual. 
Arrhythmia monitoring reports will be provided to the physician when an actionable 

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arrhythmia is detected per the notification specified by the physician-investigator. At day 
60 and 90, subjects will perform an office visit. During this visit, study coordinator will 
collect the subject diaries, and answer questions related to study and the device.   
6.2.5 Visit 5: End of study follow-up 
End of study follow-up will take place at the 90 day office visit or when the subject decides 
to end the study. Study coordinators will be responsible for collecting the subject diaries, 
any adverse events, and the study device. 
 
6.3 Unscheduled Visits  
Based on the physician-investigator discretion, subjects can be seen at any time during the 
study period.  
6.4 Long-term Clinical Outcome Assessment 
NA 
6.5 Study Procedures Flowchart (or Table) 
Summary of the activities and procedures to be followed at each visit is as detailed below 
(Table I) 
 
Table I 
Visit 1 
(Day 0) 
Visit 2  
(Day 7) 
Visit 3 
(Day 30) 
Visit 4  
(Day 60) 
Visit 5  
(Day 90 / End 
of Study) 
Eligibility 
X 
 
 
 
 
Consent 
X 
 
 
 
 
Subject number 
assignment 
X 
 
 
 
 
Clinical and 
demographic data 
X 
 
 
 
 
Device training 
X 
 
 
 
 
Device fitting 
X 
 
 
 
 
Data transmission 
confirmation 
X 
 
 
 
 
Monitoring report 
X 
 
 
 
 
Collection of subject 
diary 
 
X 
X 
X 
X 
Weekly phone calls  
 
X 
X 
X 
X 
Subject diaries 
 
X 
X 
X 
X 
Office visit 
 
 
X 
X 
X 
Filling of case report 
forms 
X 
X 
X 
X 
X 
Return of device 1 
 
X 
 
 
 
Return of device 2 
 
 
X (for phase I subjects) 
 
X 
Survival information 
 
X 
X 
X 
X 
 

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6.6 Blinding and Unblinding of Study 
Investigator-physicians and study staff will not be blinded to the ECG data.  They will be 
blinded to the thoracic impedance, respiration rate, activity, and posture data. Furthermore, 
all patients will be blinded to all device data. 
 
 
 
 
7 Study Device Management 
 
7.1 Subject Compliance Monitoring 
7.1.1 
µCor wear time 
µCor wear time will assessed throughout the study period. Wear time will be monitored by 
the sponsor based on the daily data transmissions from the µCor device.  It is anticipated 
that the wear time with µCor system will be over 70% through the study period. For subjects 
who show early signs of non-compliance, the sponsor will inform the study coordinators, 
who will then make phone-calls to encourage subjects to continue wear the µCor system. 
In addition, the study coordinators with the support of sponsor’s technical support will try to 
trouble shoot and alleviate the reasons for subject’s non-compliance.  
  
7.2 Dispensing, Storage and Return 
7.2.1 Dispensing of Study Device 
The sponsor will ship sufficient µCor devices and other study-related supplies to each site. 
The site will be responsible for safe storage of the devices. The Investigator will be 
responsible for recording the receipt of the µCor system in an appropriate device log. 
Similarly, devices fitted on subjects will also be logged in an appropriate device log.   
7.2.2 Return of Study Device 
The Investigator will be responsible for ensuring all study devices are returned back to the 
site by the subjects in a timely manner. During the study, the study coordinator must ship 
these returned devices to the sponsor within 10 working days. In addition, at the end of 
the study all unused devices must be returned to the sponsor.    
7.3 Device Malfunction or Defect 
In case of device malfunction or defect, subjects will call the study coordinator to help debug 
the issue with the help of sponsor. In case the defect or malfunction cannot be resolved, 
new equipment will be provided to the subject. 
 
 
 

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8 Statistical Plan 
8.1 Sample Size and Power Calculation 
No sample size estimates or power calculations were performed for this feasibility study. 
The number of subjects for this study was determined by convenience sampling, where a 
maximum of 50 subjects are anticipated to participate in the study.    
 
8.2 Randomization Scheme 
NA 
 
 
8.3 Endpoint Assessment 
Study endpoints will be assessed in this feasibility study without predefined acceptance 
criteria. 
8.4 Statistical Methods 
Data from all subjects in the study will be analyzed. Descriptive statistics and qualitative 
analysis will be used to analyze the primary, secondary, and safety endpoints.  
 
8.5 Additional Statistical Analysis 
NA 
 
8.6 Handling Missing Data 
NA 
8.7 Futility Analysis 
NA  
 
9 Health Economic Evaluation 
NA 
 
10 Safety and Adverse Events 
10.1 Definitions 
 
Adverse event are any untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs in subjects, users, or other persons whether or not related to the 
study device. Serious adverse events (SAEs) are adverse events that: 
• 
led to a death, injury or permanent impairment to a body structure or a body function 
• 
led to a serious deterioration in health of the subject, that either resulted in a life-
threatening illness or injury, a permanent impairment of a body structure or a body 

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function,  in-patient hospitalization or prolongation of existing hospitalization, or in 
medical or surgical intervention to prevent life threatening illness 
• 
led to fetal distress, fetal death or a congenital abnormality or birth defect.  
 
Adverse device effects (ADEs) are events related to of study device. An unanticipated ADE 
is any adverse effect not identified by nature, severity, or frequency prior to the study. 
Serious device effect are adverse device effect that has resulted in any of the consequence 
characteristics of a serious adverse event. Unanticipated serious adverse device effects are 
serious ADEs that by its nature, incidence, severity or outcome has not been identified prior 
to the study.  
10.1.1 Common Anticipated Device Effects with µCor Study Device 
Anticipated events include, but are not limited to: 
10.1.1.1 Discomfort from wearing the device. 
10.1.1.2 Skin irritation, redness, itching, or rash. 
10.1.1.3 Tearing of the skin if the adhesive patch is not removed carefully. 
10.1.1.4 Allergic reaction to the hydrogel and/or Patch adhesive 
 
10.2 Recording and Reporting of Adverse Events 
10.2.1 Investigator Recording 
Investigators must assess the seriousness of all adverse events. All serious adverse events must 
be recorded in the pertinent case report form (CRF). The investigator must also record if the 
serious adverse event is related to the study device and assess whether it is anticipated. For non-
serious adverse events, the Investigators are responsible for only recording the adverse device 
effects and whether the ADE is anticipated or unanticipated in the pertinent case report form 
(CRF).    
The clinical course of each event should be followed until resolution, stabilization, or until it has 
been determined that the study treatment or participation is not the cause.  Serious adverse 
device effects that are still ongoing at the end of the study period must be followed up to determine 
the final outcome.  Any serious adverse device effects that occur after the study period should be 
recorded.  
 
The minimum initial information to be captured in the subject’s source document concerning the 
adverse device effect includes:  
• 
Study identifier 
• 
Study Center 
• 
Subject number 
• 
Device model and serial 
number 
• 
A description of the event 
• 
Date of onset 
• 
Investigator assessment of the association 
between the event and study treatment 
• 
Current status 
• 
Whether study treatment was discontinued 
• 
Whether the event is serious and reason for 
classification as serious 
 

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10.2.2 Reporting of Adverse Events 
The following events are considered as reportable events per MEDDEV 2.7/3 revision 3 
guidelines: 
• 
any serious adverse event, 
• 
any device deficiency that might have led to a serious adverse event if: 
1. suitable action had not been taken or 
2. intervention had not been made or 
3. if circumstances had been less fortunate 
• 
new findings/updates in relation to already reported events 
 
Investigators are to report all reportable events to the sponsor immediately, but no later than 3 
calendar days after the investigational site study personnel’s awareness of the event. 
Reportable event are to be reported by the sponsor of the clinical investigation to all the National 
Competent Authorities (NCAs) where the clinical investigation has commenced. The sponsor 
must report to the NCAs: 
• 
immediately, but no later than 2 calendar days of becoming aware of all reportable events 
that indicate an imminent risk of death, serious injury, or serious illness and that requires 
prompt remedial action for subjects 
• 
immediately, but no later than 7 calendar days of becoming aware of other reportable 
events or new findings or updates to it. 
 
 
10.3 Protocol Deviations 
 
Deviations from the protocol must receive both Sponsor and the investigator’s Ethics Committee 
approval before they are initiated. Any protocol deviations initiated without Sponsor and the 
investigator’s Ethics Committee  approval that may affect the scientific soundness of the study, 
or affect the rights, safety, or welfare of study subjects, must be reported to the Sponsor and to 
the investigator’s Ethics Committee  as soon as a possible. 
 
 
11 Administrative Responsibilities 
11.1 Sponsor 
ZOLL Services LLC, the Sponsor, is responsible for study administration as well as providing 
devices and related materials for the study. The Sponsor will select appropriate investigators, 
assure collection of investigator agreements, assure IRB approval of the protocol, and monitor 
informed consent records.  

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The Sponsor will designate appropriately trained and qualified individuals to monitor the 
investigation.  These individuals will verify the adherence to procedures specified in the protocol, 
and verify maintenance of required subject and data records.   
 
11.2 Investigators 
The Investigators are responsible for obtaining and maintaining ethics approval of the study 
protocol.  The Investigators are responsible for obtaining patient consent, and maintaining 
Informed Consent Forms and Case Report Forms for each subject.  All forms must be signed by 
the Investigator or by the Investigator’s designee. If the Investigators designate an individual to 
sign these forms, written notification must be provided to the Sponsor. The Investigators are 
responsible for maintaining records of study protocol deviations and amendments and all 
correspondence relating to the study.  The Sponsor will provide an Investigator Notebook to serve 
as a study reference and regulatory binder.  At the conclusion of the study, the Investigators will 
provide a summary report to the Sponsor and the reviewing Ethics Committee.  
 
11.3 Data Coordination Center (DCC) 
ZOLL Services LLC, the Sponsor, will be the acting DCC. The DCC has the responsibility 
for clinical data coordination. 
 
11.4 Steering Committee 
There is no steering committee for this study. 
11.5 Data Safety Monitoring Board (DSMB) 
The study will not be monitored by an independent Data Safety Monitoring Board (DSMB).  
ZOLL Services LLC, the Sponsor, will be the acting DSMB. They will periodically review all 
aspects of the trial, including all adverse events, to ensure the safety of the participants. 
12 Data Collection and Management Plan  
12.1 Data Collection 
The following data points will be collected during the study: 
 
• 
Patient demographics 
• 
Clinical history, including comorbidities 
• 
Medication and dosage 
• 
Device placement, subject training, device data transmission, and monitoring 
report receipt during the initial device fitting at the physician’s office 
• 
Wear time data 
• 
Accuracy and repeatability of device placement 
• 
Skin condition 
• 
Number of data transmissions from device to remote servers 
• 
Timing of monitoring reports to physicians 
• 
Emergency room visits 
• 
Physician visits 
• 
New arrhythmia and HF symptoms 
• 
All-cause and HF hospitalizations 

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• 
Survival information 
 
12.2 Data Coordinating Center (DCC) 
NA 
12.3 Data Handling and Record Keeping 
12.3.1 Case Report Forms (CRFs) 
Data will be collected at the investigational sites using the electronic data capture (EDC) 
system ClindexLIVE (Fortress Medical Systems, LLC, Hopkins, MN).  Electronic Case 
Report Forms (eCRFs) will be implemented within ClindexLIVE by ZOLL’s Clinical Data 
Manager.  Data will be entered at the investigational sites by trained staff.  Entered data 
will be reviewed by the site investigator, who will affirm its accuracy and completeness by 
electronic sign-off.  The capability of the ClindexLIVE system to implement edit checks 
during the data entry process (front end edit checks) will be utilized to generate queries 
automatically at the time of data entry when malformed, out-of-bounds or missing required 
data are detected.    All data queries, whether automatically or manually generated, will 
be communicated to and cleared by investigational site staff via ClindexLIVE, which 
provides a full featured query handling capability.  Center staff will either correct or affirm 
all data that generates queries, which keeps all data processing in the hands of the 
investigational sites, not ZOLL.  ZOLL’s Clinical Data Manager and Clinical Scientist will 
review all cleared queries for appropriateness.  A final comprehensive review of all of the 
data will occur at the conclusion of the trial.  All queries will be resolved and all eCRFs will 
be electronically signed by appropriate center investigators prior to database lock. 
 
Paper CRFs will be available for recording patient data in the event that the data entry 
system becomes unavailable because of a technical failure.  All paper CRFs will be 
completed by the same trained personnel who would otherwise use the EDC system.  
Appropriately completed and signed paper CRFs may become the source data, and will 
be retained by the individual centers.  Once the EDC system again becomes available, 
the patient data will be transcribed from the paper form into the EDC system by the same 
person who completed the paper form.   
 
The paper CRFs for this study are documented under 90D0167_CRF.  
  
12.3.2 Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Source data are contained in source documents.  Examples of these original documents, 
and data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after 
verification as being accurate and complete, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at 
the laboratories, and at medico-technical departments involved in the clinical trial. 
 

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12.3.3 Electronic Data Capture (EDC) System 
The ClindexLIVE software system was selected for use for this clinical trial because of its 
full-featured capability, security features, and wide acceptance within the clinical trial 
industry.  ZOLL’s Clinical Data Manager, in consultation with ZOLL’s Clinical Scientist, will 
implement the set of eCRFs in Clindex LIVE, and develop a set of test data.  User 
acceptance testing at ZOLL will demonstrate accurate and complete functioning of all data 
and edit check elements prior to rollout of the EDC system to the investigational sites.  The 
clinical database will be hosted at Fortress Medical Systems, LLC, using redundant on- and 
off-site resources, throughout the data collection process.  Data access (both entry and 
review) will be controlled by user ID and password restricted user authentication.  Only 
users who have been appropriately trained will be permitted to perform data entry.  Once 
entered by site personnel, data will be reviewed by the site investigator who will have eCRF 
signature authority.  The ClindexLIVE system features a fully documented audit trail on all 
CRF data modified after first pass entry and automatic audit trail on all data changes.  
Individual report level security allows for a customized report environment for individual 
users and sites, so that users and sites may access only the data which they have entered 
into the system.  The ClindexLIVE system has been independently certified to be 21 CFR 
Part 11 compliant. 
12.4 Data Transmission from Sponsor 
NA 
12.5 Study Monitoring Plan 
Monitoring activities will be conducted according to ZOLL's Monitoring of Clinical Studies 
Standard Operating Procedure (ZOLL 90D0013) and will be documented. 
  
13 Risks and Benefits 
The µCor system is a non-significant risk, noninvasive medical monitoring device. The potential 
risks from wearing the device may include discomfort, skin irritation, itching, rash, contact 
dermatitis, or breaching of skin if the patch adhesive is the removed too quickly. The µCor system 
has not been tested for compatibility with magnetic resonance imaging machines and external 
defibrillators.   
 
No benefits to participation in this study are anticipated for subjects participating in phase I portion 
of the study. For subjects participating in phase II portion of the study, the µCor system may help 
to detect abnormal heart rhythms in a timely manner and thus prompting a suitable treatment.  
 
 
 
 
14 Ethical Considerations 
 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 

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This protocol and any amendments will be submitted to a properly constituted independent Ethics 
Committee (EC) or Institutional Review Board (IRB), in agreement with local legal prescriptions, 
for formal approval of the study conduct.  The decision of the EC/IRB concerning the conduct of 
the study will be made in writing to the investigator and a copy of this decision will be provided to 
the sponsor before commencement of this study.  The investigator should provide a list of EC/IRB 
members and their affiliate to the sponsor. 
 
14.1 Subject Consent and Confidentiality 
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study.  See Documents 90D0167_ICD for a copy of the Subject Informed Consent Form.  This 
consent form will be submitted with the protocol for review and approval by the EC/IRB for the 
study.  The formal consent of a subject, using the EC/IRB-approved consent form, must be 
obtained before that subject undergoes any study procedure.  The consent form must be signed 
by the subject or legally acceptable surrogate, and the investigator-designated research 
professional obtaining the consent.  
 
Each subject will receive a unique subject identification number.  The subject's name and identity 
will be known to the local principal investigator and the Sponsor, as necessary for device use and 
study conduct, but will be kept confidential.  Authorized personnel from the IRB and regulatory 
authorities may have access to original subject records. 
 
At the end of the data collection period, a fully de-identified, HIPAA-compliant dataset will be 
created using all variables available from the Case Report Forms and device data contained 
within LifeVest network. This dataset will be used for analysis and publication purposes. 
 
In the event that a subject revokes authorization to collect or use Protected Health Information 
(PHI), the investigator, by regulation, retains the ability to use all information collected prior to the 
revocation of subject authorization.  For subjects that have revoked authorization to collect or use 
PHI, attempts should be made to obtain permission to collect at least vital status (i.e. that the 
subject is alive) at the end of their scheduled study period. 
 
14.2 Subject Financial Responsibility and Stipends 
 
There is no cost to the patient to participate in this research study. The sponsor will cover the cost 
of the device. The cost of a subject’s ongoing medical care will remain the responsibility of his/her 
insurance. 
15 Publication Plan 
15.1 Authorship 
 
The publication committee will consist of the following members: 
1. The sponsor’s Vice President of Medical and Clinical Affairs and/ or their representatives, 
up to three individuals in total. 
2. A minimum of 3 physician investigators will be chosen by the sponsor using the following 
criteria: 

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A. Contribution to study design 
B. Contribution to patient enrollment 
C. Contribution to data analysis 
D. Contribution to manuscript preparation 
 
The publication committee will then chose authors based on the above criteria. The publication 
committee will decide on the publication strategy, including all sub-studies and other 
presentations. Physicians on the publication committee can serve as authors. No employees 
of the sponsor will serve as authors. The authors agree that any proposed publication relating 
to the research conducted under this protocol will be submitted to the sponsor for review at 
least forty five (45) days prior to submission for publication. Upon notice by the sponsor during 
this period that any of sponsor’s confidential information is contained in the publication(s) and/or 
intellectual property considerations apply, the publication may be delayed for an additional 
period of up to ninety (90) days (for intellectual property considerations) or until all confidential 
information has been eliminated from the publication(s) and sponsor has approved the 
publication. It may be determined by the sponsor that no data from this study will be published. 
 
15.2 Data ownership 
Data resulting from this study are the property of the sponsor, with each site having co-
ownership with sponsor of the data generated within their site. The sponsor may make copies 
of all documents and reports related to the study at sponsor’s expense, and all sites will 
maintain and retain study records for a period of ten (10) years following the termination of 
the study. The sponsor shall have access to all such records during this period with adequate 
prior notice and during normal business hours.  
16 List of Abbreviations 
 
ECG – Electrocardiograph  
HF – Heart Failure 
MCT – Mobile Cardiac Telemetry 
RF – Radio Frequency 
17 Bibliography 
1.  
Joshi AK, Kowey PR, Prystowsky EN, et al. Telemetry ( MCOT ) System for the Diagnosis 
and Management of Cardiac Arrhythmia. 2005;95:878-881.  
 
2.  
Rothman SA, Laughlin JC, Seltzer J, et al. The diagnosis of cardiac arrhythmias: a 
prospective multi-center randomized study comparing mobile cardiac outpatient telemetry 
versus standard loop event monitoring. J Cardiovasc Electrophysiol. 2007;18(3):241-247.  
 
3.  
Tsang J-P, Mohan S. Benefits of monitoring patients with mobile cardiac telemetry (MCT) 
compared with the Event or Holter monitors. Med Devices Evid Res. 2014;7:1-5. 
 
4.  
Zimetbaum P, Goldman A. Ambulatory Arrhythmia Monitoring Choosing the Right Device. 
2010:1629-1636.  
 
 
 
 

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18 Appendix A 
 
 
 
Subject Diary 
 
 

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DATE_______________________________  Sun  Mon  Tue  Wed  Thu  Fri  Sat 
 
Daily activities 
Please circle the level of activity for each time slot. If applicable, you should add 
additional detail. For example: “I watched television from 10:30 am - 11:30 am” or “I 
walked around the mall from 01:45 pm - 02:30 pm” 
 
morning 
Circle your activity level. 
 
evening 
Circle your activity level. 
 
00:00 – 02:00  
Active              Sitting             Sleeping         
 
Details: 
 
12:00 – 14:00 
Active              Sitting             Sleeping    
 
Details: 
02:00 – 04:00 
Active              Sitting             Sleeping         
 
Details: 
 
14:00 – 16:00 
Active              Sitting             Sleeping    
 
Details: 
04:00 – 06:00 
Active              Sitting             Sleeping         
 
Details: 
 
16:00 – 18:00 
Active              Sitting             Sleeping    
 
Details: 
06:00 – 08:00 
Active              Sitting             Sleeping         
 
Details: 
 
18:00 – 20:00 
Active              Sitting             Sleeping    
 
Details: 
08:00 –10:00 
Active              Sitting             Sleeping         
 
Details: 
 
20:00 – 22:00  
Active              Sitting             Sleeping    
 
Details: 
10:00 –12:00 
Active              Sitting             Sleeping         
 
Details: 
 
22:00 – 24:00 
Active              Sitting             Sleeping    
 
Details: 
 
Symptoms 
Please circle any of the following symptoms that you are experiencing. If possible, 
note the time when the symptoms started and duration.  
 
Racing heartbeat               Slow heartbeat            Flutter in your chest             Chest pain 
 
Shortness of breath            Lightheadedness or dizziness              Sweating            Near fainting 
 
Fatigue              Swelling of feet, ankles, legs, or abdomen         Other:___________________ 
 
Time:_________________ 
 
Duration:_______________ 
Racing heartbeat               Slow heartbeat            Flutter in your chest             Chest pain 
 
Shortness of breath            Lightheadedness or dizziness              Sweating            Near fainting 
 
Fatigue              Swelling of feet, ankles, legs, or abdomen         Other:___________________ 
 
Time:_________________ 
 
Duration:_______________ 
Racing heartbeat               Slow heartbeat            Flutter in your chest             Chest pain 
 
Shortness of breath            Lightheadedness or dizziness              Sweating            Near fainting 
 
Fatigue              Swelling of feet, ankles, legs, or abdomen         Other:___________________ 
 
Time:_________________ 
 
Duration:_______________ 
 
 
 

ZOLL Document Number: 90D0167  
 
 
 
 
     
Page 26 of 27  
PATCH Feasibility Study 
 
Version: C 
 
PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
DATE_______________________________  Sun  Mon  Tue  Wed  Thu  Fri  Sat 
 
Skin Condition 
Please rate the skin condition under the µCor patch adhesive. Do this before 
reapplying the new patch. Provide the skin condition rating for each device (front and 
side location) that you are wearing.  
 
 
Front Location 
 
Date and Time of patch replacement:  _______________________________________ 
Please rate the skin condition in the following manner: 
1. Grade 0 (None): No redness, rash, irritation, or itchiness   
 
                   
2. Grade 1 (Mild): Redness   
 
 
 
 
 
 
        
   Rash  
 
 
 
 
 
 
 
        
   Irritation   
 
 
 
 
 
 
        
   Itchiness  
 
 
         
 
 
        
3. Grade 2 (Moderate): Rash that breaks skin, hard or soft pimples or light 
peeling/scaling 
 
 
 
 
 
 
 
 
        
4. 
Grade 3 (Severe): Blistering, open ulcers, wet peeling, serious rash over a large 
area  
 
 
 
 
 
 
 
 
 
        
 
 
 
 
 
Date and Time of patch replacement: ________________________________________  
Please rate the skin condition in the following manner: 
1. Grade 0 (None): No redness, rash, irritation, or itchiness   
 
                   
5. Grade 1 (Mild): Redness   
 
 
 
 
 
 
        
   Rash  
 
 
 
 
 
 
 
        
   Irritation   
 
 
 
 
 
 
        
   Itchiness  
 
 
         
 
 
        
2. Grade 2 (Moderate): Rash that breaks skin, hard or soft pimples or light 
peeling/scaling 
 
 
 
 
 
 
 
 
        
3. 
Grade 3 (Severe): Blistering, open ulcers, wet peeling, serious rash over a large 
area  
 
 
 
 
 
 
 
 
 
        
 
 
 
Side Location 

ZOLL Document Number: 90D0167  
 
 
 
 
     
Page 27 of 27  
PATCH Feasibility Study 
 
Version: C 
 
PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
Patch Location 
Please outline the µCor patch location for each device that you are wearing.  
 
Front Location 
 
Outline the approximate location of the patch.   
Mark location of the arrow in the clock diagram 
 
 
 
 
 
Outline the approximate location of the patch.  
 
 
 
Mark location of the arrow in the clock diagram 
 
Side Location 
Right 
Left