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

 
 
 
 
 
 
 
 
 
Document Type: Protocol 
Document Date: RevD, May 15th, 2018 
Protocol Title: Beneﬁts of Microcor (µCor) in Ambulatory Decompensated Heart Failure 
Short Title: BMAD HF 
ClinicalTrials.gov IdenƟﬁer: NCT03476187 

ZOLL Document Number: 90D0182 
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[BMAD HF] 
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PROPRIETARY AND CONFIDENTIAL 
ZOLL MEDICAL CORPORATION 
BENEFITS OF MICROCOR (CORTM) IN 
AMBULATORY DECOMPENSATED HEART 
FAILURE 
Short Title: 
BMAD HF 
ZOLL Study Lead: 
Matt Sundermann, PhD 
121 Gamma Drive, Pittsburgh, PA 15238 
+1-412-968-3333 ext 14413
Study Device: 
µCor 
Protocol Number: 
90D0182 
IDE Number: 
NA 
  Version Date: 
May 15, 2018 
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 

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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) ................................................................................................................... 7 
2.4 
ADDITIONAL OBJECTIVE(S) ............................................................................................................. 7 
3 
STUDY DESIGN ................................................................................................................................... 7 
3.1 
GENERAL DESIGN .......................................................................................................................... 7 
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 .............................................................................................. 10 
6 
STUDY PROCEDURES ..................................................................................................................... 11 
6.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 11 
6.2 
SCHEDULED VISITS AND PHONE CALLS ......................................................................................... 11 
6.3 
UNSCHEDULED VISITS .................................................................................................................. 13 
6.4 
LONG-TERM CLINICAL OUTCOME ASSESSMENT ............................................................................. 14 
6.5 
STUDY PROCEDURES FLOWCHART (OR TABLE) ............................................................................. 14 
6.6 
WEEKLY PHONE CALLS ................................................................................................................ 14 
6.7 
BLINDING AND UNBLINDING OF STUDY ........................................................................................... 14 
7 
STUDY DEVICE MANAGEMENT ...................................................................................................... 14 
7.1 
SUBJECT COMPLIANCE MONITORING ............................................................................................. 15 
7.2 
MANAGING COR THERAPY .......................................................................................................... 15 
7.3 
DISPENSING, STORAGE AND RETURN ............................................................................................ 15 
7.4 
DEVICE MALFUNCTION OR DEFECT ............................................................................................... 15 
8 
STATISTICAL PLAN ......................................................................................................................... 15 
8.1 
SAMPLE SIZE AND POWER CALCULATION ...................................................................................... 15 
8.2 
RANDOMIZATION SCHEME ............................................................................................................ 16 
8.3 
ENDPOINT ASSESSMENT .............................................................................................................. 16 
8.4 
STATISTICAL METHODS ................................................................................................................ 16 
8.5 
ADDITIONAL STATISTICAL ANALYSIS .............................................................................................. 16 

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8.6 
HANDLING MISSING DATA ............................................................................................................. 16 
8.7 
FUTILITY ANALYSIS ....................................................................................................................... 17 
9 
HEALTH ECONOMIC EVALUATION ................................................................................................ 17 
10 
SAFETY AND ADVERSE DEVICE EFFECTS .................................................................................. 17 
10.1 
DEFINITIONS ................................................................................................................................ 17 
10.2 
RECORDING AND REPORTING OF ADVERSE DEVICE EFFECTS ......................................................... 18 
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 HANDLING AND RECORD KEEPING ....................................................................................... 19 
12.3 
DATA TRANSMISSION FROM SPONSOR .......................................................................................... 20 
12.4 
STUDY MONITORING PLAN ............................................................................................................ 20 
13 
RISKS AND BENEFITS ..................................................................................................................... 20 
14 
ETHICAL CONSIDERATIONS .......................................................................................................... 21 
14.1 
SUBJECT CONSENT AND CONFIDENTIALITY .................................................................................... 21 
14.2 
SUBJECT FINANCIAL RESPONSIBILITY AND STIPENDS ..................................................................... 21 
15 
PUBLICATION PLAN ........................................................................................................................ 21 
16 
INTELLECTUAL PROPERTY AND PATENTS ................................................................................. 22 
17 
LIST OF ABBREVIATIONS ............................................................................................................... 22 
18 
BIBLIOGRAPHY ................................................................................................................................ 23 
 
 
 

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Study Summary 
 
Title 
BENEFITS 
OF 
MICROCOR 
(CorTM) 
IN 
AMBULATORY 
DECOMPENSATED HEART FAILURE 
Short Title 
BMAD HF 
ZOLL Protocol 
Number 
90D0182 
Study Design 
Prospective and Observational Study  
Study Duration 
The study duration will last an estimated 2.5 years with 1 year estimated 
for enrollment 
Study Center(s) 
30 to 50 centers (Multinational)  
Primary 
Objective(s) 
To identify correlations between Cor measurements (thoracic fluid 
index, respiration rate, cardiac rhythm, physical activity, and posture) 
with occurrences of heart failure related clinical events within 90 days 
of hospital discharge for acute decompensated heart failure.   
Study Population 
Subjects hospitalized for acute decompensated heart failure or subjects 
presenting to an outpatient clinic within 10 days post-hospital discharge 
for heart failure.  All subjects require an additional heart failure event 
within the previous 6 months. 
Intervention 
Subjects meeting the inclusion/exclusion criteria will wear the Cor for 
up to 90 days. 
During the study, clinic follow up will occur every 30 days. For all 
subjects, each scheduled clinic visit will include assessment of cardiac 
symptoms and any relevant clinically actionable events.   
The subject will be given a daily diary to track symptoms, unplanned 
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.   
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 500 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 impedance. In addition, 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 
correlate Cor readings with clinically actionable heart failure events during the ninety days 
after hospital discharge.  In addition, the rate of occurrence of VT/VF episodes and 
arrhythmic death in patients with an LVEF greater than 35% will be observed. 
 
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 
A validation study was conducted in human subjects to compare µCor noninvasively-
determined RF thoracic fluid content with invasive thermodilution extravascular lung water 

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measurements (PiCCO - Pulsion Medical Systems, Munich, Germany). 36 patients in 
critical care unit with a clinical indication for thermodilution based extravascular lung water 
monitoring were studied. uCor was placed on the patients left chest. Noninvasive thoracic 
fluid assessment was compared to the invasive extravascular lung water measurement 
every 30 minutes. Cardiac output, systolic and diastolic blood pressure, and heart rate were 
also measured. Results showed that the pooled correlation between measurements of 
invasive lung water fluid and noninvasive thoracic fluid content was excellent (r = 0.86). 
Also, increases in lung water of 90 ml could be detected by the RF signal. Furthermore, 
lung water change did not correlate to systolic blood pressure, diastolic blood pressure, 
cardiac output, and cardiac index (correlation range, r = 0.12-0.54). This study 
demonstrated accuracy and usability of this RF technology to support its use for high 
resolution fluid monitoring in patients.    
 
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.  

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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 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.  
 
 

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 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.  
 
 
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 
There are two locations for device (Sensor + Patch) placement:  (1) along the left anterior 
axillary line in line with the nipple (side location) and (2) along the left mid-clavicular line, 
above the nipple and below clavicle.   
 

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Figure 6:  Device (Sensor + Patch) placement location. Side location is the left anterior axillary 
position. Front location is the left mid-clavicular position. 
 
2 Study Objectives 
2.1 Primary Objective(s) 
The following primary objectives will be evaluated during the wear period of the µCor device: 
2.1.1 To identify correlations between Cor measurements (thoracic fluid index, cardiac rhythm, 
respiration rate, physical activity, and posture) with occurrences of heart failure related 
clinical events occurring within 90 days of hospital discharge for acute decompensated 
heart failure. 
 
2.2 Secondary Objective(s) 
The specific secondary objectives that will be evaluated during the entire study include: 
 
2.2.1 To identify the rate of occurrence of VT/VF and arrhythmic death in heart failure patients 
based on left ventricular ejection fractions (LVEF). 
 
 
2.2.2 To identify correlations between Cor measurements (physiologic variables including 
thoracic impedance, cardiac rhythm, respiration rate,) and patient reported symptoms. 
 
 
2.2.3 To identify the hospital admission rate of patients during the study period. 
 
 
2.2.4 To identify the hospital admission rate of patients in the previous 90 days before 
enrollment into the study. 
 

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2.2.5 To define the mortality rate, cause of death, and health care utilization among patients six 
months and one year after enrollment into the study. 
 
 
2.3 Safety Objective(s) 
To document the number and severity of all adverse events that are causally related to the 
µCor system.  
 
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 Cor for up to 90 days from the 
day of fitting. 500 total patients will be enrolled.  There will be an interim analysis when the 200th 
subject has finished the study to assess for distribution of patients with reduced and preserved 
LVEF.  The first 200 subjects enrolled in the US will exclusively wear the device in the side 
position.  The subsequent subjects in the US will follow an alternating pattern of front position and 
side position placement. 
 
Subjects will be fitted with µCor during discharge of a heart failure related hospitlatization 
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.  An investigator assessment will be performed during all clinic 
visits.  The assessment template is shown in Appendix A.   
 
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.   
 
Study 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.  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.  
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.  There will be no follow up visit if 
the subject has stopped wearing the device.  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 

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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.  
 
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 Study 
 
3.1.2 Expected Duration of the Study 
The anticipated enrollment period will be 1 year. The total anticipated study period will be 2.5 
years.  
 
 
 
3.2 Primary Study Endpoints 
The primary endpoints that will be evaluated at the end of the study include: 
 
3.2.1 Correlation of µCor readings (thoracic fluid index, cardiac rhythm, respiration rate, posture, 
and physical activity) to clinical events 
 

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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 Establishment of rate of occurrence of VT/VF episodes and arrhythmic death in patients. 
 
3.3.2 Correlation between µCor measurements and patient reported symptoms 
3.3.3 Frequency, timing, and severity of patient reported symptoms 
 
3.3.4  Hospital readmission rate during the study period 
3.3.5 Hospital readmission rate during previous 90 days prior to enrollment in study. 
3.3.6 Cost-effectiveness data that supports a benefit in quality adjusted life years (QALY) 
3.3.7 Mortality, heart failure related events, and health care utilization data at six months and 
one year post enrollment 
 
 
3.4 Safety Endpoints  
All adverse events related to the use of the µCor will be used to assess safety during the 
study.  
 
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. 
4.1.1 Subjects being discharged from the hospital for acute decompensated heart failure either 
HFrEF (systolic) or HFpEF (diastolic) OR subjects who have been discharged from the 
hospital with either HFrEF (systolic) or HFpEF (diastolic) within the previous 10 days. 
 
4.1.2 Subjects who have had an acute heart failure event requiring medical management in the 
previous 6 months. 
 
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) 
 

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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. 
 
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 any other research at time of enrollment. 
 
4.2.9 Subjects currently implanted with an LVAD. 
4.2.10 Subjects with self-reported pregnancy. 
 
 
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 500 subjects.   
 
5.3 Enrollment Period 
The anticipated total enrollment period for this study is 1 year, with a total anticipated study period 
would be 2.5 years.  
 
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. 
 

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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 and Screening 
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 Screening definitions 
An acute heart failure event requiring medical management 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 visit along with visits at day 
30, 60, and 90.  There will also be weekly phone calls to the patient.  No monthly visits or weekly 
phone calls 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 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 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 
All subjects will complete the Kansas City HF and study specific questionnaire. 
 
6.2.1.2 
A chart review will be used to evaluate patients for enrollment. A screening log will 
be maintained. 
 

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6.2.1.3 
Patients meeting the initial Inclusion/Exclusion criteria will be approached for 
consenting. 
 
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, height and weight will be 
recorded. 
 
6.2.1.6 
Medical history will be recorded, including comorbidities, heart disease and 
physical disability. 
 
      6.2.1.7 
Medical therapy for heart failure will be recorded for all subjects. 
 
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 
Subjects will be assigned to wear the patch at either the front or side location 
(alternating 1:1) 
 
6.2.1.11 
Subjects will be fitted with Cor at hospital discharge or departure from clinic. 
 
     6.2.1.12 
Device fitting will follow current Instructions for Use (IFU) procedures. 
 
     6.2.1.13 
The date and time when Cor 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 Cor wear. 
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: Cor 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     
Cor wear. 
 
    6.2.2.3 
All subjects will be asked about the following events since their last visit: 
 
Any medication changes 
 
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 

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    6.2.2.4  
A weight measurement will be obtained. 
 
    6.2.2.5 
Subjects will be given a physical assessment 
 
 
6.2.3 Visit 3: Cor 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 
Cor wear. 
 
   6.2.3.3 
All subjects will be asked about the following events since their last visit: 
 
Any medication changes 
 
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. 
 
6.2.4 Visit 4: Cor Wear Day 90. 
 
   6.2.4.1 
Cor use will be discontinued unless patient 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 medication changes 
 
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 
 
6.2.4.6    
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  
NA 

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6.4 Long-term Clinical Outcome Assessment 
The subject will receive a follow up phone call 6 months and 1 year 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. 
 
6.5 Study Procedures Flowchart (or Table) 
Summary of the activities and procedures to be followed at each visit is as described below (Table 
1). 
 
 
 
Table 1: Visit Procedure List (*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.  No phone 
calls will occur if the subject has s topped wear. 
 
6.7 Blinding and Unblinding of Study 
During the study, physicians and subjects will be blinded to all µCor data.  If the sponsor observes 
a potentially life threatening arrhythmia, the site will be notified. 
 
7 Study Device Management 
TheCor device log will be managed by the sponsor.  The sites will keep a device log of all 
available Cor devices and make necessary requests to the sponsor when inventory is low.  The 
study site will collect the device when the patient 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. 
 
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
HF Questionnaires
X
X
X
X
X
X

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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, site with the support of 
sponsor’s technical support will try to trouble shoot and alleviate the reasons for subject’s non-
compliance.  
 
7.2 Managing Cor Therapy 
NA 
 
7.3 Dispensing, Storage and Return 
7.3.1 Dispensing of Study Device 
The investigator will be responsible for dispensing the study device.   
 
7.3.2 Storage 
Devices will be stored in an appropriate limited access room.  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 during the final scheduled visit.  
 
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 of malfunctions related to device defect or malfunction will be reported to the sponsor on 
the appropriate CRF.   
 
8 Statistical Plan 
8.1 Sample Size and Power Calculation 
The sample size was chosen to answer the primary and secondary objectives.  We expect a 50/50 
distribution between patients enrolled with an LVEF less than 35% and an LVEF greater than 
35%.  After the 200th patient is enrolled, we will conduct an interim analysis to confirm the LVEF 
distribution.   
 
The first 200 patients will generate a convenience sample of heart failure related clinical events   
Assuming a 20% event rate within the first 30 days in patients with reduced LVEF, we estimate 
that we will observe at least 25-30 heart failure related events among patients with reduced EF 
through the length of the 90 day study period (accounting for not all patients reaching completion).  

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We believe that 25-30 heart failure related events will be enough events to draw meaningful 
correlations among Cor device measurements and heart failure related episodes.  
 
Following the interim analysis, the additional 300 subjects will further generate heart failure related 
clinical events to answer the primary objective and be monitored for VT/VF arrhythmic events to 
answer the secondary objectives. 
8.2 Randomization Scheme 
The first 200 subjects in the US will exclusively wear the patch in the side position.  In the following 
300 subjects, the position of the patch location will be alternated by subject to either front or side 
location in a 1:1 scheme, stratified by site.  Outside the US, all subjects will follow an alternating 
pattern of patch location wear. 
 
8.3 Endpoint Assessment 
8.3.1 Primary endpoint 
The first primary endpoint will be assessed by the strength of the correlation between Cor device 
readings and heart failure related clinical events.   
 
8.3.2 Secondary endpoints 
The secondary endpoints will also be assessed on their strength of correlation as well as the 
magnitude of rate of occurrence of VF/VT and arrhythmic death in the subjects with an LVEF 
greater than 35%.    
 
8.4 Statistical Methods 
For primary, secondary, and safety endpoints, descriptive statistics and qualitative analysis will 
be performed as appropriate. 
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 
 

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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. 
 
8.6.3.2 
If a subject is missing more than 50% of data, the subject’s data will not be included 
in the analysis. 
 
8.7 Futility Analysis 
The study will be considered ineffective if the interim analysis determine the study will be 
unsuccessful enrolling the required number of subjects (≥1 subject per center-month), or if 
occurrence of the primary endpoint is deemed insufficient to successfully complete the study with 
the planned number of subjects. 
 
Both an interim and futility analysis will be performed once the 200th subject has completed wear 
time.  Primary and secondary endpoints will be assessed.  With 200 patients completing wear 
time, it is expected that there would be about 25 -30 heart failure related clinical events.  If during 
the interim and futility assessments, there are less than 5 heart failure events, a protocol change 
will be considered. 
 
 
9 Health Economic Evaluation 
The Kansas City Heart Failure Questionnaire will be given to the subjects at all monthly clinic 
visits.  We will develop a model to examine the costs and benefits of using uCor. The model will 
use data from our review of monthly collected questionnaire, heart failure event,  as well as data 
from recognized sources (e.g. national published data, finance department of hospital), and 
experts’ advice 
 
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. 
 

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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 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. 

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ZOLL MEDICAL CORPORATION 
 
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. 
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, 

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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 
NA 
 
12.4 Study Monitoring Plan 
Monitoring activities will be conducted according to the Sponsor’s standard operating procedure. 
 
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.  
 
No study specific benefits to participation are anticipated. 
 

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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 90D0182_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 
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. 
 
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 

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ZOLL MEDICAL CORPORATION 
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 
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 
UADE – Unanticipated Adverse Device Effect 
VF – Ventricular Fibrillation 
VT – Ventricular Tachycardia 
 

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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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix A 
 
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 
 
 
 
 
 
 
 

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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?