Benefits of Microcor in Ambulatory Decompensated Heart Failure
Phase: NA
Conditions: Heart Failure
Sponsor: Zoll Medical Corporation

ZOLL Document Number: 90D0202  
 
 
 
 
      
 
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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
BENEFITS OF MICROCOR (µCORTM) IN 
AMBULATORY DECOMPENSATED HEART 
FAILURE (BMAD TREATMENT) 
 
 
 
 
 
Short Title: 
BMAD Treatment 
ZOLL Study Lead: 
Matt Sundermann, PhD 
121 Gamma Drive, Pittsburgh, PA 15238 
+1-412-968-3333 ext 14413 
Study Device: 
µCor 
Protocol Number: 
90D0202 
IDE Number: 
NA 
    Version Date: 
       
        
Nov 1 2019 
 
 
 
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 
 
 
 
 
 

ZOLL Document Number: 90D0202  
 
 
 
 
      
 
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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 ............................................................................................................................... 3 
2 
STUDY OBJECTIVES ......................................................................................................................... 6 
2.1 
PRIMARY OBJECTIVE(S) .................................................................................................................. 6 
2.2 
SECONDARY OBJECTIVE(S) ............................................................................................................ 6 
2.3 
SAFETY OBJECTIVE(S) ................................................................................................................... 6 
2.4 
ADDITIONAL OBJECTIVE(S) ............................................................................................................. 6 
3 
STUDY DESIGN ................................................................................................................................... 6 
3.1 
GENERAL DESIGN .......................................................................................................................... 6 
3.2 
PRIMARY STUDY ENDPOINTS .......................................................................................................... 8 
3.3 
SECONDARY STUDY ENDPOINTS ..................................................................................................... 9 
3.4 
SAFETY ENDPOINTS ....................................................................................................................... 9 
4 
STUDY SUBJECT ................................................................................................................................ 9 
4.1 
INCLUSION CRITERIA ...................................................................................................................... 9 
4.2 
EXCLUSION CRITERIA ..................................................................................................................... 9 
5 
STUDY ENROLLMENT PLAN .......................................................................................................... 10 
5.1 
ENROLLMENT STRATEGY .............................................................................................................. 10 
5.2 
STUDY SIZE ................................................................................................................................. 10 
5.3 
ENROLLMENT PERIOD .................................................................................................................. 10 
5.4 
EARLY WITHDRAWAL OF SUBJECTS .............................................................................................. 11 
6 
STUDY PROCEDURES ..................................................................................................................... 11 
6.1 
SUBJECT RECRUITMENT, SUBJECT SCREENING, AND DEFINITIONS ................................................. 11 
6.2 
SCHEDULED VISITS AND PHONE CALLS ......................................................................................... 11 
6.3 
UNSCHEDULED VISITS .................................................................................................................. 14 
6.4 
LONG-TERM CLINICAL OUTCOME ASSESSMENT ............................................................................. 15 
6.5 
STUDY PROCEDURES TABLE (FOR ALL SCHEDULED VISITS) ............................................................ 15 
6.6 
WEEKLY PHONE CALLS ................................................................................................................ 15 
6.7 
ECG MONITORING ....................................................................................................................... 15 
7 
STUDY DEVICE MANAGEMENT ...................................................................................................... 16 
7.1 
SUBJECT COMPLIANCE MONITORING ............................................................................................. 16 
7.2 
MANAGING µCOR THERAPY .......................................................................................................... 16 
7.3 
DISPENSING, STORAGE AND RETURN ............................................................................................ 16 
7.4 
DEVICE MALFUNCTION OR DEFECT ............................................................................................... 17 
8 
STATISTICAL PLAN ......................................................................................................................... 17 
8.1 
SAMPLE SIZE ............................................................................................................................... 17 
8.2 
RANDOMIZATION SCHEME ............................................................................................................ 17 
8.3 
ENDPOINT ASSESSMENT .............................................................................................................. 17 
8.4 
STATISTICAL METHODS ................................................................................................................ 18 
8.5 
ADDITIONAL STATISTICAL ANALYSIS .............................................................................................. 19 

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8.6 
HANDLING MISSING DATA ............................................................................................................. 19 
8.7 
FUTILITY ANALYSIS ....................................................................................................................... 19 
9 
HEALTH ECONOMIC EVALUATION ................................................................................................ 19 
10 
SAFETY AND ADVERSE DEVICE EFFECTS .................................................................................. 20 
10.1 
DEFINITIONS ................................................................................................................................ 20 
10.2 
RECORDING AND REPORTING OF ADVERSE DEVICE EFFECTS ......................................................... 20 
10.3 
PROTOCOL DEVIATIONS ............................................................................................................... 20 
11 
ADMINISTRATIVE RESPONSIBILITIES .......................................................................................... 21 
11.1 
SPONSOR .................................................................................................................................... 21 
11.2 
INVESTIGATORS ........................................................................................................................... 21 
11.3 
DATA COORDINATION CENTER (DCC) ........................................................................................... 21 
11.4 
STEERING COMMITTEE ................................................................................................................. 21 
11.5 
DATA SAFETY MONITORING BOARD (DSMB) ................................................................................. 21 
12 
DATA COLLECTION AND MANAGEMENT PLAN .......................................................................... 21 
12.1 
DATA COLLECTION ....................................................................................................................... 21 
12.2 
DATA HANDLING AND RECORD KEEPING ....................................................................................... 22 
12.3 
DATA TRANSMISSION FROM SPONSOR .......................................................................................... 22 
12.4 
STUDY MONITORING PLAN ............................................................................................................ 22 
13 
RISKS AND BENEFITS ..................................................................................................................... 23 
14 
ETHICAL CONSIDERATIONS .......................................................................................................... 23 
14.1 
SUBJECT CONSENT AND CONFIDENTIALITY .................................................................................... 23 
14.2 
SUBJECT FINANCIAL RESPONSIBILITY AND STIPENDS ..................................................................... 23 
15 
PUBLICATION PLAN ........................................................................................................................ 24 
16 
INTELLECTUAL PROPERTY AND PATENTS ................................................................................. 24 
17 
LIST OF ABBREVIATIONS ............................................................................................................... 24 
18 
BIBLIOGRAPHY ................................................................................................................................ 25 
 
 
 

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Study Summary 
 
Title 
BENEFITS 
OF 
MICROCOR 
(µCorTM) 
IN 
AMBULATORY 
DECOMPENSATED HEART FAILURE (BMAD Treatment 
Short Title 
BMAD Treatment 
ZOLL Protocol 
Number 
90D0202 
Study Design 
Prospective non-randomized study  
Study Duration 
The study duration will last an estimated 2.5 years with 2 year estimated 
for enrollment 
Study Center(s) 
Up  to 80 centers (International)  
Primary 
Objective(s) 
To assess investigator engagement of µCor system data in the context 
of heart failure management 
Study Population 
Subjects hospitalized for acute decompensated heart failure and 
enrolled in the study within 10 days post-hospital discharge.  All subjects 
require an additional heart failure event within the previous 180 days. 
Intervention 
Subjects meeting the inclusion/exclusion criteria will wear the µCor for 
up to 90 days. 
During the study, face to face follow up will occur every 30 days. For all 
subjects, each scheduled clinic visit will include assessment of cardiac 
signs, symptoms, and any relevant clinically actionable events.   
The subject will be given a daily diary to track symptoms, hospital visits, 
medication changes, and all other heart failure related clinical events.   
Weekly phone calls to the subject will be given throughout the duration 
of the study to remind the patient to use the subject diary and to collect 
and record heart failure related clinical events.   
The subject’s health care provider team will receive the µCor data 
through reports delivered to the team by an independent clinical review 
team.  The data updates will allow the health care provider team to take 
action when the data indicate worsening heart failure, within the context 
of standard of care medical practice and patient specific parameters.  
Weekly data reports will be delivered to the investigators. 
Subjects will be contacted six months and one year from initial 
enrollment to assess the vital status of the subject, any heart failure 
related clinical events since the end of µCor wear, and any health care 
utilization since the end of µCor wear.  
Study Size 
A total of 300 subjects  
Reference therapy 
NA 

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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), the Code of Federal Regulations Title 21 parts 803 and 812, and other 
applicable government regulations. 
1.1 Background 
Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure (HF) 1. 
Despite improvement in outcomes with medical therapy, readmissions for acute decompensated 
HF are common and place a significant burden on the healthcare system. Therefore, strategies 
for outpatient monitoring and fluid management are needed to reduce HF hospitalizations. 
Rather than low cardiac output, the main reasons for rehospitalization are symptoms associated 
with pulmonary and systemic venous congestion due to elevated ventricular filling (end-diastolic) 
pressures 2. Remote monitoring of these pressure changes in addition to its surrogate measures, 
such as intrathoracic impedance, lung fluid levels, systolic time intervals, or the presence of 
abnormal heart sounds, may help to prevent hospitalization by detecting early evidence of HF 
decompensation 3, 4, 5. In addition, remote monitoring may lead to better access to care and 
coordination of services.   
 
Given the anticipated importance of remote HF monitoring and fluid management, ZOLL has 
developed a novel radiofrequency (RF) based heart failure and arrhythmia management system 
(µCor Heart Failure and Arrhythmia Management System). Using the RF data, µCor provides 
an estimate of the thoracic fluid index (TFI).  To calculate TFI, the thoracic fluid baseline is 
determined, and the normalized value is presented as TFI.  In conjunction with standard clinical 
practice for patients with fluid balance issues, the direction of change of TFI over time may 
provide clinically useful information.  In addition to TFI, the system records the electrocardiogram 
(ECG) through adhesive electrodes and respiration rate, activity, and posture through a tri-axial 
accelerometer. The purpose of this study is to assess investigator engagement of µCor system 
data in the context of heart failure management.   
 
1.2 Preclinical Data  
In animal testing, µCor’s noninvasively determined RF thoracic fluid content was compared with 
invasive thermodilution extravascular lung water measurements (PiCCO - Pulsion Medical 
Systems, Munich, Germany). Pulmonary edema was induced in 15 sheep by intravenous 
volume and pressure overload. µCor was placed on the left lateral torso of the sheep. The 
emitted and reflected RF signals are used by µCor to assess thoracic fluid. These readings were 
compared with the readings from the PiCCO device. Results of the study showed that all 15 
sheep developed increases in left ventricular end diastolic pressure, and the onset of pulmonary 
congestion and edema. A consistent linear correlation (r = 0.97) between measurements of 
invasive lung water fluid and noninvasive thoracic fluid content was observed. µCor RF signals 
were able to detect dynamic accumulation of lung water in the range of 50-60 ml increments. 
The change in lung water needed to produce congestion was between 250-500 ml. The results 
of this study support the use of ZOLL’s external RF sensor for high resolution and precise fluid 
monitoring.       
 
1.3 Clinical Data to Date 
 

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NA 
 
1.4 Study Device  
1.4.1 System Components 
µCor 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, RF readings, heart rate, 
respiration rate, activity, and posture measurements.  Data are automatically transmitted from 
the Sensor to the Data transmission device, and from there to the Server for analysis (see Fig. 
1).  
 
 
 
Figure 1:  Data transmission of µCor 
 
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.  The Patch is a single-use, disposable item.  
 
 
 
 
 
 
 
 
 
 
 
 
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 

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device becomes wearable. The Sensor is not disposable and needs to be returned to ZOLL upon 
the completion of the study. 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3:  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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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. 
 
1.4.7 Device (Sensor +Patch) Placement Location 
The location of the patch is along the left anterior axillary line in line with the nipple. 
 
 
 
 
Figure 6:  Device (Sensor + Patch) placement location.  
 

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2 Study Objectives 
2.1 Primary Objective(s) 
The following primary objectives will be evaluated during BMAD-Treatment: 
2.1.1 To assess investigator engagement of µCor system data in the context of heart failure 
management 
2.2 Secondary Objective(s) 
The specific secondary objectives that will be evaluated during the entire study include: 
2.2.1 To identify correlations between µCor measurements (physiologic variables including 
thoracic impedance, cardiac rhythm, respiration rate) and heart failure related clinical events.  
A heart failure related clinical event is defined in section 6.1.3. 
2.2.2 To identify correlations between µCor measurements (physiologic variables including 
thoracic impedance, cardiac rhythm, respiration rate) and patient reported symptoms. 
2.2.3 To identify the hospital readmission rate, physician visit rate, and outpatient clinic visit rate 
of subjects during the study period. 
2.2.4 To identify the mortality rate, cause of death, quality of life (QoL), and health care utilization 
among patients six months and one year after enrollment into the study. 
 
2.3 Safety Objective(s) 
2.3.1 To document the number and severity of all adverse events that are causally related to the 
µCor system or study specific procedure. 
 
2.4 Additional Objective(s) 
NA 
 
3 Study Design 
3.1 General Design 
3.1.1  Study Description 
 
Subjects meeting the inclusion/exclusion criteria will wear µCor for up to 90 days from the 
day of fitting. 300 total patients will be enrolled.  Subjects will be fitted with µCor during discharge 
of a heart failure related hospitalization or within a clinic visit that has occurred within 10 days of 
a heart failure related hospitalization.  The µCor fitting will mark day 0 of the study.  An LVEF 
measurement will be recorded during enrollment or within 30 days post enrollment if an LVEF 
measurement has not been recorded within 30 days prior to enrollment.  Any LVEF will qualify for 
the study.  An investigator assessment will be performed during all clinic visits.  The assessment 
template is shown in Appendix A.   
 

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Subjects will be given a diary at enrollment that will ask them to rate their degree of specific 
symptoms of heart failure such as shortness of breath and fatigue as well as mark any heart 
failure related clinical events or medication changes that have occurred since the last entry.  The 
subject diary is shown in Appendix A.   
 
Phone calls will be based on weekly data reviews or data updates.  A review of the data 
will be conducted by the site before the weekly phone call and the most recent (Transthoracic 
Fluid Index) TFI will be recorded.  The subject will receive a study based weekly phone call asking 
the subject about any recent heart failure related clinical events or change in heart failure 
symptoms.  The weekly phone calls will continue if the subject has stopped wearing the device.  
During the weekly phone call the subject will be reminded to fill out the daily diary.  No phone calls 
will be given on the week where there is a study follow up visit.   
 
A review of the data will be conducted by the site before the office visit and the most recent 
TFI will be recorded.  Study face to face follow up visits will occur at day 30, day 60, and day 90.  
There will be no follow up visit if the subject has stopped wearing the device.  During follow up 
visits the subjects will be asked about any heart failure related clinical events or change in 
symptoms that have occurred since the last follow up.  
 
Unplanned visits to the physician office or hospital will be captured and defined as visits 
that the subject did not plan beyond 48 hours.  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 48 hours.  In the event the subject has stopped wearing the device completely, 
follow up phone calls will continue to be conducted per protocol in order to capture clinical 
information. 
 
During the Day 90 visit, the subject will be given the option to continue wearing the µCor 
for an additional 90 days. Furthermore, if the subject experienced a heart failure related clinical 
event within the initial 90 days of wear, the subject will be given the option of wearing the µCor 
for 30 days following the heart failure event.  If the subject chooses additional wear time, weekly 
phone calls and monthly visits will be structured identical to that of the main study period.  The 
µCor will be returned at end of use.  
 
Data updates will be delivered to the site when the day averaged TFI exceeds a threshold 
greater than three standard deviations of the baseline TFI level for three consecutive days. Upon 
receiving a device data update, the investigator will receive detailed information into how the 
device measurements have tracked over the days leading up to the notification.  When receiving 
a data update, the site will be required to review the most recent report within 24 hours, and 
explain their reasoning whether they choose to contact the subject or not to contact the subject.  
The data review must occur prior to every scheduled subject contact. 
 
When acting upon the data update, the site may contact the subject to assess the subject’s 
current symptoms and history, and make an informed decision within the context of both device 
measurements and standard medical care as to what actions to take with the subject.  Potential 
actions the site could take will include, a prescription drug change or titration, a request for an 
office visit, a request for hospitalization, and request for lifestyle or diet modifications.  The site 
will document any changes to subject care within the case report forms.  Unscheduled contacts 
that the subject initiates will be recorded as well. 
 

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There will be a follow up at six months and one year post enrollment to document mortality 
data, heart failure related clinical events, and health care utilization data.  A timeline visualization 
of the study procedure is shown in Figure 7. 
 
 
 
 
Figure 7: Procedure Flow of BMAD Treatment Study 
 
3.1.2 Expected Duration of the Study 
The anticipated enrollment period will be 2 years. The total anticipated study period will be 2.5 
years.  
 
 
3.2 Primary Study Endpoints  
The primary endpoint that will be evaluated at the end of the study includes: 
 
3.2.1 Investigator Engagement: Investigator engagement will be assessed at the study site level 
as well as across all study sites.   
 
Investigator engagement will be assessed through the number of data updates delivered by the 
µCor subject management system, the time spent reviewing each data report, the number of 
medication changes based on µCor data, the number of lifestyle modifications that are 
recommended to the subject, the number of medication changes based on symptoms reported 
by subjects or from subject incidental findings, and the number of times high µCor measurements 
are reduced below threshold levels after medication was titrated or lifestyle modifications were 
recommended.  

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3.3 Secondary Study Endpoints 
The various secondary endpoints that will be evaluated during the entire study include: 
 
3.3.1 Correlation between µCor measurements and clinically related heart failure events. 
 
3.3.2 Correlation between µCor measurements and subject reported symptoms. 
 
3.3.3 Hospital readmission rate, physician visit rate, and outpatient clinic visit rate during the study 
period. 
3.3.4 Mortality, heart failure related events, quality of life (QoL), and health care utilization data at 
6 months and one year post enrollment. 
 
 
3.4 Safety Endpoints  
 
3.4.1 The number and severity of all adverse events that are causally related to the µCor system 
or study specific procedure. 
4 Study Subject 
4.1 Inclusion Criteria 
The following criteria will be used to include subjects in the study:  An acute heart failure event 
requiring medical management is defined in section 6.1.3.  The index hospitalization and six 
month prior event must have started two weeks apart from one another. 
4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 
10 days post-hospital discharge.   
4.1.2 Subjects who have had an acute heart failure event requiring medical management in the 
previous 180 days of index hospitalization admission.  This acute heart failure event admission 
must be at least 2 weeks apart from the event admission in 4.1.1  
4.1.3 Subjects 21 years of age or older on the day of screening. 
 
4.2 Exclusion Criteria 
The following criteria will be used to exclude subjects from the study: 
 
4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD) 
 
4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease. 
 
4.2.3 Subjects with skin allergy or sensitivity to medical adhesives. 
 
4.2.4 Subjects anticipated to start dialysis within 90 days. 

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4.2.5 Subjects currently implanted with an S-ICD system. 
 
4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours 
after onset of heart failure related symptoms during index hospitalization. 
 
4.2.7 Subjects who are unable to participate in all follow up visits.  
 
4.2.8 Subjects participating in research other than a non-interventional registry at the time of 
enrollment. 
 
4.2.9 Subjects currently implanted with an LVAD. 
4.2.10  Subjects with self-reported pregnancy. 
4.2.11  Subjects currently being actively managed with any device based remote HF monitoring.  
 
 
5 Study Enrollment Plan 
5.1 Enrollment Strategy  
Patient enrollment strategies may be targeted at both the investigator and the patient as a way to 
engage all interested parties and provide information materials for the study. Strategies may 
include patient and/or investigator focus groups, educational lectures, web sites, flyers, or 
brochures to assist in the recruitment and screening process, if needed.  Any patient facing 
materials will be submitted for approval to the IRB.   
 
5.2 Study Size 
A total of 300 subjects.   
 
5.3 Enrollment Period 
The anticipated total enrollment period for this study is 2 year, with a total anticipated study period 
would be 2.5 years.  
 
5.3.1 Data Usage, Informed Consent and Reflection Period 
All subjects will be informed about the use of their data in the clinical study according to the 
requirements of data privacy regulations, i.e. consent to processing medical data of the 
subject to a central scientific database. Sufficient time will be allowed for data usage 
information to be read and for questions to be asked during the informed consent process. 
The subjects will be informed that withdrawal of their consent in the clinical study is possible 
at any time and that a withdrawal is possible without stating a reason, is conducted without 
prejudice, and does not place the subject at any disadvantage in the study.  The subject will 
receive detailed training on the use of the device by the site researcher.  This will give the 
subject the opportunity to raise further questions about the device and data handling to the 
responsible physician. 

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5.4 Early Withdrawal of Subjects 
5.4.1 When and How to Withdraw Subjects 
All patients enrolled into the study can withdraw at any time regardless of the reason for 
withdrawal.  Patients may withdraw consent for use of data and exit the study at any time 
without prejudice to further treatment. 
 
5.4.2 Data Collection and Follow-up for Withdrawn Subjects 
Reason for subject withdrawal from the study, if known, will be documented and all study 
data will be retained for data analysis.  All possible attempts should be made to obtain follow 
up data at the end of study without contacting the subject.  Only in the case of specific 
withdrawal of consent of use of data will the subject’s data be deleted from the database (if 
possible).  
 
6 Study Procedures 
6.1 Subject Recruitment, Subject Screening, and Definitions 
6.1.1 Subject recruitment 
Subjects will be identified from chart review.  Subjects may be recruited in both inpatient and 
outpatient settings.  The investigator will discuss the details of the clinical study including 
benefits and risks of participating in the study prior to enrollment. 
 
6.1.2 Subject screening 
Subject chart review will take place based on the inclusion/exclusion criteria. 
6.1.3 Definitions 
An acute heart failure event requiring medical management, and a heart failure related clinical 
event, is defined as a hospitalization, emergency room visit, observation unit visit, or 
unplanned clinic visit where medical management or treatment for HF related pulmonary 
congestion is administered.  
 
6.2 Scheduled Visits and Phone Calls 
The scheduled visits are summarized in Table I and include the initial face to face visit along with 
face to face visits at day 30, 60, and 90.  There will also be weekly phone calls to the patient.  No 
monthly visits will occur if the subject has stopped wear.  The phone calls will be conducted within 
no more than 2 days before or after the scheduled date.  The scheduled visits will be conducted 
within no more than 5 days before or after the scheduled date.  During subject wear, phone calls 
will be accompanied by the weekly data review.  The data review will need be completed before 
the phone call.  There will be a weekly report sent to the site. 
 

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During the optional extended 90 day wear period, scheduled clinic visits and weekly phone calls 
will continue to take place following the procedures in Visits 2-4 with the exception of 6.2.4.6 
(asking again for additional wear).  Chart review, study questionnaires, and a follow up phone call 
will take place at 6 months and 1 year post enrollment. 
 
6.2.1 Visit 1: Screening, enrollment and start (To occur during hospital discharge for 
decompensated heart failure or during a clinic visit in an out-patient setting no more than 
10 days post hospital discharge). 
 
6.2.1.1 
Patients meeting the initial Inclusion/Exclusion criteria will be approached for 
consenting. 
 
6.2.1.2 
All subjects will complete the Kansas City HF Questionnaire and study specific 
questionnaire. 
 
6.2.1.3 
A chart review will be used to evaluate patients for enrollment.  A screening log will 
be maintained. 
 
6.2.1.4 
The initial clinical and demographic data will be recorded in every subject. These 
may be done by chart review and will include: 
 
6.2.1.5 
Demographic characteristics, including gender, age, and height will be recorded. 
 
6.2.1.6 
Medical history will be recorded, including comorbidities, heart disease and 
physical disability. 
 
      6.2.1.7 
All medications will be recorded. 
 
6.2.1.8 
LVEF measurement within the past 30 days will be recorded if available.  If a 
previous LVEF is not available, one will be obtained within 30 days of enrollment. 
 
     6.2.1.9 
Subjects will be given a physical assessment. 
 
6.2.1.10 
(US Sites) Device training will be given to the subject. 
 
6.2.1.11 
(European Sites) Subjects will be fitted with µCor at hospital discharge or departure 
from clinic. 
 
     6.2.1.12 
(European Sites) Device fitting will follow current Instructions for Use (IFU)           
 
     6.2.1.13 
(European Sites) The date and time when µCor wear began will be recorded. 
 
6.2.1.14 
A clinic visit appointment will be scheduled to coincide with the end of the first 30 
days of µCor wear. 

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6.2.1.15 
The subject’s weight will be obtained.  
6.2.1.16 
The subject’s previous 90 day hospital admission rate will be determined through 
chart review. 
 
6.2.2 Visit 2: µCor Wear Day 30. 
 
    6.2.2.1 
 All subjects will complete the Kansas City HF and study specific questionnaire. 
 
6.2.2.2 
 An in-center appointment will be scheduled to coincide with the end of 60 days of     
µCor wear. 
 
    6.2.2.3 
All subjects will be asked about the following events since their last visit: 
• 
Any  physician visits, both planned and unplanned 
• 
Any  hospitalization, including heart failure hospitalization 
• 
Any  emergency room visits 
• 
Any  symptoms, including syncope, dyspnea, palpitations and chest pain 
 
    6.2.2.4  
A weight measurement will be obtained. 
 
    6.2.2.5 
Subjects will be given a physical assessment 
 
6.2.2.6 
Daily cardiac medications taken by the subject will be reviewed and compared to 
the last listed cardiac medications documented by the study.  Any new cardiac 
medications or changes in medication will be recorded (i.e. dosage changes or 
new medications administered) 
 
 
6.2.3 Visit 3: µCor Wear Day 60. 
 
    6.2.3.1 
All subjects will complete the Kansas City HF and study specific questionnaire. 
 
 6.2.3.2 
An in-center appointment will be scheduled to coincide with the end of 90 days of 
µCor wear. 
 
    6.2.3.3 
All subjects will be asked about the following events since their last visit: 
• 
Any physician visits, both planned and unplanned 
• 
Any hospitalization, including heart failure hospitalization 
• 
Any emergency room visits 
• 
Any symptoms, including syncope, dyspnea, palpitations and chest pain 
 
    6.2.3.4  
A weight measurement will be obtained. 
 
    6.2.3.5  
Subjects will be given a physical assessment. 
 
6.2.2.6 
Daily cardiac medications taken by the subject will be reviewed and compared to 
the last listed cardiac medications documented by the study.  Any new cardiac 
medications or changes in medication will be recorded (i.e. dosage changes or 
new medications administered) 

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6.2.4 Visit 4: µCor Wear Day 90. 
 
 6.2.4.1 
µCor use will be discontinued unless subject enters optional additional wear  
period. 
 
    6.2.4.2 
All subjects will complete the Kansas City HF and study specific questionnaire. 
 
    6.2.4.3 
All subjects will be asked about the following clinically actionable events: 
• 
Any physician visits, both planned and unplanned 
• 
Any hospitalization, including heart failure hospitalization 
• 
Any emergency room visits 
• 
Any symptoms, including syncope, dyspnea, palpitations and chest pain 
 
    6.2.4.4  
A weight measurement will be obtained. 
 
    6.2.4.5  
Subjects will be given a physical assessment 
 
 6.2.2.6 
Daily cardiac medications taken by the subject will be reviewed and compared to 
the last listed cardiac medications documented by the study.  Any new cardiac 
medications or changes in medication will be recorded (i.e. dosage changes or 
new medications administered) 
 
 6.2.4.7    
Subjects will be asked if they would like to continue wear for an additional 90 days.  
If the subject had experienced a heart failure related clinical event within the 
previous 90 days, the subject will also be given the option to continue wear for 30 
days following the most recent heart failure event.  
 
6.3 Unscheduled Visits  
6.3.1 Clinic visits, ED visits, and hospitalizations that have resulted from a device data update 
will be defined as unscheduled events.  Separately, all heart failure related contact with 
the subject either initiated by the subject or the site will be defined as an unscheduled visit.  
Heart failure contact includes, but is not limited to, contact with the subject concerning 
new or worsening heart failure symptoms such as dyspnea, pedal edema, and shortness 
of breath.  
6.3.2 Upon receiving a data update, which will be initiated when the day averaged TFI 
readings have exceeded for three consecutive days a threshold defined by three standard 
deviations of baseline TFI, the site study team will reach out to the subject within 24 hours.  
The data update will be delivered to the site via either fax, email, or phone call. 
6.3.3 The investigator will make a decision whether to contact the subject or take no further 
action based on the data update, and document the reason.  There will be a structured 
interview between the investigator and subject.  The investigator will have access to a 
report that displays the device data. 
6.3.4 If the subject is called after device data update, the subject’s symptoms and recent 
history will be documented, and a medical decision, within the context of standard of care, 

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will be given to the patient.  The medical decision may include assessment with no action 
required, adjusting or starting new medication, requesting an office visit, requesting and 
ED visit, requesting a lifestyle/diet change, requesting a hospital admission, or no change 
at all.  All decisions will be documented. 
 
6.4 Long-term Clinical Outcome Assessment 
The subject will receive a follow up phone call 6 months (180days) and 1 year (365 days) 
from the enrollment date to assess for mortality status, heart failure related clinical events 
that have occurred since the end of µCor wear, and any health care utilization that has 
occurred since the end of µCor wear.  A chart review will be performed during both of these 
calls as well.  Subjects will answer mailed heart failure questionnaires and mail the 
questionnaires back to the site.  These follow-up calls must occur within +/- 2 weeks of the 
scheduled call. 
 
6.5 Study Procedures Table (For all scheduled visits) 
Summary of the activities and procedures to be followed at each visit is as described below (Table 
1). 
 
 
 
Table 1: Visit Procedure List (*Only for sites outside the US. **All EF measurements will be 
documented if clinically indicated) 
 
6.6 Weekly Phone Calls 
There will be weekly phone calls to the subject to monitor changes in the health status of the 
subject.  These calls will be performed by the site.  The calls will reiterate the importance of 
completing the daily subject diary and document any health care usage by the subject.  The calls 
will also document any heart failure related clinical events reported by the subject.  The calls will 
be accompanied by a weekly data review of the subject’s µCor data that will occur before the 
subject is contacted.  If the study site determines that a change in medical care or lifestyle 
recommendation is warranted based on the data review, the site will document all such changes. 
 
6.7 ECG Monitoring 
ECG will be recorded by the device continuously during the study, but will not be included in any 
real-time reports or update reports to the physician.   
 
Visit 1
Visit 2 
Visit 3
Visit 4
6 Months 1 Year
Eligibility Screening
X
Consent
X
Enrollment
X
Physical Assessment
X
X
X
X
µCor Setup*
X
EF Documentation**
X
HF Event Documentation
X
X
X
X
X
X
Weight Documentation
X
X
X
X
X
X

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7 Study Device Management 
 
Sites Located Within the United States 
The  µCor device management will be managed by the sponsor.   
 
Sites Located Outside the United States 
Sites outside the United States will keep a device log of all available µCor devices and make 
necessary requests to the sponsor when inventory is low.  The study site will collect the device 
when the subject has ended wear. All used and unused devices will be returned to the sponsor 
when the study is completed.   The investigator will be responsible for subject device 
accountability. 
 
7.1 Subject Compliance Monitoring 
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 site, who will then make phone-calls to 
encourage subjects to continue wear the µCor system. In addition, the site, with the support of 
sponsor’s technical support, will try to troubleshoot and alleviate the reasons for subject’s non-
compliance.  
 
7.2 Managing µCor Therapy 
NA. The µCor is a monitoring device 
 
7.3 Dispensing, Storage and Return 
7.3.1 Dispensing of Study Device 
 
Sites Located Within the United States 
The sponsor will be responsible for dispensing the study device.  In order to initiate device 
dispensing in a timely matter, the site will inform the sponsor of subject enrollment on the 
same date as enrollment. 
 
The sponsor will initiate a device shipment directly to the subject via courier within one 
business day of subject enrollment notification.  The site will call the subject daily until receipt 
of the device is confirmed by the subject and instruct the subject to register the device by 
following the set-up instructions in the package and contacting ZOLL technical support for 
final instruction and initiation of the device.  
 
Sites Located Outside the United States 
For sites outside the United States, the investigator will be responsible for dispensing the 
study device and making necessary requests to the sponsor when inventory is low.   
 
7.3.2 Storage 
 

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Sites Located Within the United States 
Sites located in the United States will not store study devices.   
 
Sites Located Outside the United States 
Sites located outside the United States will store devices in an appropriate limited access 
room and storage conditions will adhere to the guidelines outlined in the Clinical Manual.  
 
7.3.3 Return of Study Device 
Return of the device will occur either during the final scheduled visit, or be couriered back to ZOLL 
once the indicated wear time has completed. ZOLL will facilitate return of devices from subjects 
in the US.  
 
7.4 Device Malfunction or Defect 
In case of device malfunction or defect, subjects will call the site for initial troubleshooting.  If the 
site cannot resolve the issue, the sponsor will be contacted for further troubleshooting. In case 
the defect or malfunction cannot be resolved, the sponsor will provide new equipment.  All device 
defects or malfunctions will be reported to the sponsor. In the case of device malfunction or defect 
in the US, subjects will call ZOLL technical support for all trouble shooting and support. 
 
8 Statistical Plan 
8.1 Sample Size  
 
80 sites and 300 subjects will provide a reasonable estimate of site engagement with the device 
data. Three to five subjects per site will provide a reasonable estimate of site engagement per 
subject.  We expect site variability in subject management.  80 study sites will be necessary to 
control for both site and regional differences in subject management.   
 
8.2 Randomization Scheme 
None 
8.3 Endpoint Assessment  
8.3.1 Primary endpoint 
The primary endpoint will be assessed in an observational nature though the frequency and 
characterization of site engagement with uCor data.  The assessment will be made study-wide in 
addition to geographic regions.  Site engagement will be assessed through the following: 

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8.3.1.1 The number of data updates received by the µCor subject management system.  
8.3.1.2 An assessment of the approximate time spent reviewing data reports assessed 
within sites and across sites.  Investigators will be asked, for each report, whether they 
spent 0-5min, 5-10min, or greater than 10 minutes reviewing the data. 
8.3.1.3 The number of medication changes based on µCor data and the number of lifestyle 
modifications were recommended to the subject. 
8.3.1.4 The number of medication changes based on symptoms reported by subjects or 
from subject incidental findings. 
8.3.1.5 The number of times high µCor measurements were reduced below threshold levels 
after medication was titrated or lifestyle modifications were recommended. 
 
8.3.2 Secondary endpoints 
 
8.3.2.1 Strength of association between µCor measurements and clinically related heart 
failure events. 
 
8.3.2.2 Strength of association between µCor measurements and subject reported 
symptoms. 
 
8.3.2.3 Descriptive statistics around hospital readmission rate, physician visit rate, and 
outpatient clinic visit rate during the study period. 
 
8.3.2.4 Descriptive statistics around mortality, heart failure related events, quality of life 
(QoL), and health care utilization data at 6 months and on year post enrollment. 
8.4 Statistical Methods 
 
Concerning the primary endpoint, investigator engagement will be assessed through the number 
of data updates delivered by the µCor subject management system, frequency of medication 
changes based on µCor data, frequency of lifestyle modifications that are recommended to the 
subject, frequency of medication changes based on symptoms reported by subjects or from 
subject incidental findings, and frequency high µCor measurements that are reduced below 
threshold levels after medication was titrated or lifestyle modifications were recommended. 
 
Concerning the secondary endpoints, associations between µCor measurements and clinically 
related heart failure events will be assessed through sensitivity/specificity analyses.  µCor 
measurements at both baseline (first day of fitting) and the time of heart failure admission will be 
compared among subjects with or without heart failure related events using t-tests or other 
appropriate statistical methods.  
 
For primary, secondary, and safety endpoints, descriptive statistics and qualitative analysis will 
be performed as appropriate.  Descriptive statistics will include frequency of data updates 
delivered by the µCor data system, frequency of physician action to µCor data or µCor data 
updates, and physician action events as a percentage of all data updates received.   

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8.5 Additional Statistical Analysis 
NA 
 
8.6 Handling Missing Data 
As with any clinical study, missing data are to be expected during this study.  
 
8.6.1 Sources of Missing Data 
8.6.1.1 
Medical records not available 
 
8.6.1.2 
Subjects who are lost to follow up 
 
8.6.1.3 
Device error 
 
8.6.1.4 
Missed phone calls 
 
8.6.1.5 
Missed visits 
 
8.6.2 Preventing Missing Data 
 
8.6.2.1 
All attempts to maintain contact with the subject should be made by study 
personnel to assure that lost to follow up subjects are kept to a minimum. This may involve 
telephone calls. Multiple phone numbers/contacts for each subjects should be collected. 
Multiple reminders of upcoming visits should be made. 
 
8.6.2.2 
Reasonable windows of time (within 2 days for phone calls and 5 days for clinic 
visits) have been employed. 
 
8.6.2.3 
Routine site monitoring with data verification will occur throughout the study. 
 
8.6.3 Handling missing data 
 
 
8.6.3.1 
Missing data will not be replaced by any algorithm. 
 
8.7 Futility Analysis 
NA 
 
 
9 Health Economic Evaluation 
The Kansas City Heart Failure Questionnaire and study specific questionnaire will be 
administered to subjects during monthly clinic visits.  We will develop a model to examine the 
costs and benefits of using uCor. The model will use health care utilization data from weekly and 
monthly questionnaires, as well as data from recognized sources (e.g. national published data, 
finance department of hospital), and experts’ advice. 
 

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10 Safety and Adverse Device Effects 
10.1 Definitions 
All device related adverse effects will be recorded during the study. All adverse device effects 
(ADEs) will be classified by the investigator as anticipated or unanticipated.  Adverse events will 
also include any adverse events related to medication changes and medical procedures initiated 
by µCor data. 
 
10.1.1 Foreseeable Adverse Device Effects with Study Device 
The most common foreseeable adverse event is skin rash.  This is expected to occur in a small 
minority of patients. 
 
10.1.2 Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect (UADE) is any adverse device effect not identified by 
nature, severity or frequency prior to the investigation. When the frequency of an ADE exceeds 
the previously reported frequency or pre-specified accepted level, and if such ADE is critical in 
evaluating one or more of the study endpoints (such as safety endpoint), then an ADE can 
become an UADE and it must be properly reported and evaluated. 
 
10.2 Recording and Reporting of Adverse Device Effects 
10.2.1 Investigator Recording and Reporting 
The Investigators are responsible for recording and reporting all adverse device effects in the 
pertinent case report form (CRF). Unanticipated adverse device effects that pose a safety risk to 
the patient must be reported to sponsor and reviewing IRBs per local reporting requirements. 
 
The Investigator must next assess the seriousness of the adverse device effect. The Investigator 
should also assess whether the adverse device effect is anticipated or unanticipated.  At each 
contact with the subject, the investigator must collect information on adverse device effects. 
 
All adverse device effects occurring during the study period must be recorded.  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 within 30 days after the study period should be recorded 
and reported promptly.  The report will be sent to the medical monitor. 
 
 
10.3 Protocol Deviations 
Deviations from the protocol must receive both Sponsor and the investigator’s IRB 
approval before they are initiated unless subject safety is at risk. Any protocol deviations initiated 
without Sponsor and the investigator’s IRB 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 

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and to the investigator’s IRB as soon as a possible, but no later than 30 working days (or less if 
specified by the investigator’s IRB). 
 
11 Administrative Responsibilities 
11.1 Sponsor 
ZOLL, the Sponsor, is responsible for study administration 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. 
 
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 subject 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 
significant 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 IRB. 
 
11.3 Data Coordination Center (DCC) 
The Sponsor will act as the Data Coordination Center (DCC) and has responsibility for clinical 
data coordination. The DCC will provide management of data for the overall project. All case 
report forms will be collected directly by the DCC.  
 
11.4 Steering Committee 
There is no steering committee for this study. 
 
11.5 Data Safety Monitoring Board (DSMB) 
The study will be monitored by the Sponsor, who will periodically review all aspects of the trial to 
ensure the safety of the participants. 
 
12 Data Collection and Management Plan  
12.1 Data Collection 
 
Anonymized subject data will be collected from original source documents and transcribed into 
the eCRFs. An electronic data capture (EDC) system with single entry capture will be used. 

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Queries generated manually or by algorithm will be managed within the EDC system. LVN data 
will be anonymized and imported directly into the research database. 
12.2 Data Handling and Record Keeping 
12.2.1 Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities 
and 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. Both ZOLL and Investigators will maintain and retain applicable source data as 
per the regulations 
12.2.2 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.  All data queries, 
whether automatically or manually generated, will be communicated to and cleared by 
investigational site staff via ClindexLIVE.  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 site investigators prior to database lock. 
12.2.3 Electronic Data Capture (EDC) System 
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. 
12.3 Data Transmission from Sponsor 
LVN data will be anonymized and imported directly into the research database. 
 
12.4 Study Monitoring Plan 
Monitoring activities will be conducted according to the Sponsor’s standard operating procedure. 
 

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13 Risks and Benefits 
µCor is a noninvasive medical monitoring device. Common risks associated with devices using 
medical adhesives include but are not limited to discomfort, skin irritation, itching, rash, contact 
dermatitis, or breaching of skin if the patch adhesive is the removed too quickly.   
 
There are risks to medication changes and medical procedures associated with actions taken 
based on µCor data.  These risks include but are not limited to radiation from chest radiography, 
adverse drug effects from medication changes, and adverse drug effects from medication titration. 
 
Subjects in the study may benefit from outcomes associated with early detection of heart failure. 
 
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 local government regulations. 
 
This protocol and any subsequent amendments will be submitted to a properly constituted Ethics 
Committee (EC) or Institutional Review Board (IRB), in agreement with local regulations, 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 will 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 an information and consent form describing this study 
and providing sufficient information for subjects to make an informed decision about their 
participation in this study. See Document 90D0202_ICD for a template of the Subject Informed 
Consent Form.  This informed consent form will be submitted with the protocol for review and 
approval by the IRB for the study. The formal consent of a subject, using the EC/IRB-approved 
informed consent form, must be obtained before that subject undergoes any study specific 
procedure. 
 
Each subject will receive a unique anonymous subject identification number. The subject's name 
and identity will be known to the local principal investigator. The relevant IRB and regulatory 
authorities may have access to original subject records. 
 
At the end of the data collection period, a fully de-identified, Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) compliant dataset will be created using all variables available 
from the Case Report Forms and device data.  This dataset will be used for analysis and 
publication purposes. 
 
14.2 Subject Financial Responsibility and Stipends 
 
14.2.1 Subject Financial Responsibility 
The cost of a subject’s ongoing medical care that is not study specific and would have occurred 
in the absence of the study will remain the responsibility of the subject. Sufficient study devices 

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will be provided to the Investigator at no cost to the subjects. At end of use the subjects will return 
the devices to the Investigator. 
 
14.2.2 Subject Stipend 
Study sites may decide to provide subject stipend for costs related to transportation to study 
procedures. 
 
 
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) Investigator members will be chosen by the sponsor using the following criteria: 
A. Contribution to study design 
B. Contribution to patient enrollment 
C. Willingness to contribute to data analysis 
D. Willingness to contribute to manuscript preparation 
3) The publication committee will then chose authors based on the above criteria 
4) The publication committee will decide on the publication strategy, including all sub studies 
and other presentations. 
5) Physicians on the publication committee can serve as authors 
6) No employees of the sponsor will serve as authors  
7) 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 
 
15.2 Data ownership 
The database(s) resulting from this study are the property of the sponsor. Investigators will 
maintain and retain study records as per the regulations. The sponsor shall have access to all 
such records during this period with adequate prior notice and during normal business hours.  
 
16 Intellectual Property and Patents 
Copyright and patents related to this research is owned by the sponsor. Patents related to this 
research are in place or pending. 
 
17 List of Abbreviations 
ADE – Adverse Device Effect 
CRF – Case Report Form 
CRT – Cardiac Resynchronization Therapy 
DCC – Data Coordination Center 

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DNR – Do Not Resuscitate 
DSMB – Data Safety Monitoring Board 
EC – Ethics Committee 
ECG – Electrocardiogram 
GDMT – Guideline Directed Medical Therapy 
HIPAA – Health Insurance Portability and Accountability Act 
ICD – Implantable Cardioverter Defibrillator 
IRB – Institutional Review Board 
LVEF – Left Ventricle Ejection Fraction 
LVN – LifeVest Network 
NYHA – New York Health Association 
PHI – Protected Health Information 
SCA – Sudden Cardiac Arrest 
SCD – Sudden Cardiac Death 
S-ICD – Subcutaneous Implantable Cardioverter Defibrillator 
TFI – Thoracic Fluid Index 
UADE – Unanticipated Adverse Device Effect 
VF – Ventricular Fibrillation 
VT – Ventricular Tachycardia 
 
18 Bibliography 
1. 
Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart 
failure: Problems and perspectives. J Am Coll Cardiol. 2013;61(4):391-403. 
 
2. 
Zile MR, Bennett TD, St. John Sutton M, et al. Transition from chronic compensated to 
acute d compensated heart failure: Pathophysiological insights obtained from continuous 
monitoring of intracardiac pressures. Circulation. 2008;118(14):1433-1441. 
 
3. 
Bhimaraj A. Remote monitoring of heart failure patients. Methodist Debakey Cardiovasc 
J. 2013;9(1):26-31. 
 
4. 
Abraham WT, Stough WG, Pina IL, et al. Trials of implantable monitoring devices in heart 
failure: which design is optimal? Nat Rev Cardiol. 2014;11(10):576-585.  
 
5. 
Sung S-H, Yu W-C, Cheng H-M, Chang Y-P, Chen C-H. Use of Acoustic Cardiography 
To Guide Outpatient Therapy of Patients With Acute Heart Failure Syndrome. J Am Coll 
Cardiol. 2014;63(12):A541 
 
 
 
 
 
Appendix A 
 

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Signs/symptoms 
0 
1 
2 
3 
Dyspnea 
None 
Seldom 
Frequent 
Continuous 
Orthopnea 
None 
Seldom 
Frequent 
Continuous 
Fatigue 
None 
Seldom 
Frequent 
Continuous 
Jugular Venous 
Distension (cm) 
≤6 
6–9 
10–15 
≥15 
Rales 
None 
At bases 
At bases to 50% way 
up the posterior lung 
field 
At bases to > 50% 
way up the posterior 
lung field 
Pedal edema 
Absent/trace 
Slight 
Moderate 
Marked 
Table 2: Investigator Assessed Congestion Survey 
 
 
 
 
 
 
 

ZOLL Document  
 
 
 
      
 
 
 
 
      Page 27 of 27  
BMAD Treatment 
 
Version: A 
 
PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
 
 
Table 3: Sample month of subject diary for reported symptoms 
Day
Date
Shortness of Breath
Fatigue
Cough
Swelling
Hospitalized?
Medication Change?
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Month 1
Subject Diary
Symptom
Please rate your symptom (0 = Good 10 = Bad)
Event
Yes or No?