A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication
Phase: NA
Conditions: Telemetry, Patient Monitoring
Sponsor: Medtronic - MITG

Clinical Investigation Plan
Study Title 
A Prospective Evaluation of Surveillance Monitoring as an 
Alternative to Telemetry in Patients Scheduled for Telemetry 
without AHA Indication
Document Revision
E
Document date
09Aug2017 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title 
A Prospective Evaluation of Surveillance Monitoring as 
an Alternative to Telemetry in Patients Scheduled for 
Telemetry without AHA Indication 
Clinical Investigation Plan Identifier 
COVMOPO0561 
Study Product Name 
Vital Sync™ Informatics Manager & Virtual Patient 
Monitoring Platform  
BioModule™ BH3-M2 sensor 
Sponsor/Local Sponsor 
Medtronic  
MITG, Patient Monitoring & Recovery 
Health Informatics & Monitoring 
6135 Gunbarrel Ave  
Boulder, CO, 80301 USA 
Document Revision 
Revision E 
Principal Investigator 
Stacey L. House, MD, PhD 
Director of Research in Emergency Medicine  
Washington University School of Medicine Office 
660 S. Euclid Ave., Campus 8072 
St. Louis, MO 63110 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any 
distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may 
not be further disclosed by them. 

 
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1. 
Revision History 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

 
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2. 
Investigator Statement 
Study Product Name 
Vital Sync™ Informatics Manager & Virtual Patient 
Monitoring Platform 
BioModule™ BH3-M2 sensor  
Sponsor 
Medtronic  
MITG, Patient Monitoring & Recovery 
Health Informatics & Monitoring 
Clinical Investigation Plan Identifier 
COVMOPO0561 
Revision/Date  
Revision E / 09AUG2017 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for me 
and my staff to conduct this study as described. I will conduct this study as outlined herein and will make 
a reasonable effort to complete the study within the time designated. 
I agree that this clinical study will be conducted in compliance with 21 CFR 803, laws and regulations of 
the countries in which the clinical study is conducted, including data protection laws, the Clinical 
Investigation Agreement, and the Clinical Investigation Plan. I agree to ensure that the confidential 
information contained in this document will not be used for any purpose other than the evaluation and 
conduct of the clinical investigation without the prior written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date: 
 
 

 
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Table of Contents  
 
1. 
Revision History .......................................................................................................... 2 
2. 
Investigator Statement................................................................................................. 4 
Table of Contents ................................................................................................................. 5 
3. 
Glossary ....................................................................................................................... 8 
4. 
Synopsis .................................................................................................................... 12 
5. 
Introduction .............................................................................................................. 14 
5.1. 
Background ................................................................................................................. 14 
5.2. 
Purpose ........................................................................................................................ 15 
6. 
Objectives and Endpoints ......................................................................................... 16 
6.1. 
Objectives ................................................................................................................... 16 
6.1.1. 
Primary Objective ................................................................................................................ 16 
6.1.2. 
Secondary Healthcare Economic and Resource Utilization Objectives ....................... 16 
6.1.3. 
Secondary Clinical and Qualitative Objectives ................................................................ 16 
6.2. 
Endpoints .................................................................................................................... 17 
6.2.1. 
Definition of Primary Endpoint .......................................................................................... 17 
6.2.2. 
Definition of Secondary Healthcare Economic and Resource Utilization Endpoints .. 17 
6.2.3. 
Definition of Clinical and Qualitative Endpoints .............................................................. 18 
7. 
Study Design ............................................................................................................. 19 
7.1. 
Duration ....................................................................................................................... 19 
7.2. 
Rationale ..................................................................................................................... 19 
8. 
Product Description .................................................................................................. 19 
8.1. 
Surveillance Monitoring System............................................................................. 19 
8.1.1. 
Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) ............ 19 
8.1.2. 
Wearable Physiological Monitor ........................................................................................ 20 
8.2. 
Packaging .................................................................................................................... 21 
8.3. 
Intended Population ................................................................................................. 21 
8.4. 
Product Use ................................................................................................................. 21 
8.5. 
Product Training Requirements ............................................................................. 22 
8.6. 
Product Receipt and Tracking ................................................................................. 22 
8.7. 
Product Return ........................................................................................................... 22 
8.8. 
Product Storage and Accountability ...................................................................... 22 
8.9. 
Recalls .......................................................................................................................... 22 
9. 
Selection of Subjects .................................................................................................. 23 
9.1. 
Study Population ....................................................................................................... 23 
9.2. 
Subject Enrollment .................................................................................................... 23 

 
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9.3. 
Inclusion Criteria ....................................................................................................... 23 
9.4. 
Exclusion Criteria ....................................................................................................... 23 
9.5. 
Childbearing Potential and Pregnancy Testing ................................................... 24 
10. 
Study Procedures ....................................................................................................... 24 
10.1. 
Monitoring Group Assignment ................................................................................ 24 
10.2. 
Data Collection and Schedule of Events ............................................................... 27 
10.2.1. 
Screening/Enrollment Visit ............................................................................................. 29 
10.2.2. 
Inpatient Data Collection................................................................................................ 29 
10.2.3. 
End of Study Visit ............................................................................................................ 30 
10.2.4. 
Clinician Focused Qualitative Assessments ................................................................. 30 
10.3. 
Subject Screening...................................................................................................... 31 
10.4. 
Subject Consent ......................................................................................................... 32 
10.5. 
Blinding ........................................................................................................................ 32 
10.6. 
Randomization ........................................................................................................... 32 
10.7. 
Assessment of Safety................................................................................................ 32 
10.8. 
Recording Data .......................................................................................................... 32 
10.9. 
Deviation Handling .................................................................................................... 33 
10.10. 
Subject Withdrawal or Discontinuation ............................................................ 34 
10.11. 
Role of Sponsors Representatives ...................................................................... 34 
11. 
Risks and Benefits ..................................................................................................... 34 
11.1. 
Potential Risks ........................................................................................................... 34 
11.2. 
Potential Benefits ...................................................................................................... 36 
11.3. 
Risk-Benefit Rationale.............................................................................................. 36 
12. 
Adverse Event Assessments....................................................................................... 36 
12.1. 
Anticipated Adverse Events ..................................................................................... 37 
12.2. 
Definitions/Classifications ...................................................................................... 37 
12.3. 
Recording and Reporting Adverse Events and Device Deficiencies ............... 38 
12.3.1. 
Product Complaint Reporting ......................................................................................... 38 
12.3.2. 
Emergency Contact Information in case of SAE/SADE .............................................. 39 
13. 
Statistical Design and Methods ................................................................................. 39 
13.1. 
Sample Size Justification ......................................................................................... 39 
13.2. 
Hypotheses and Endpoints ...................................................................................... 39 
13.3. 
Statistical Analysis .................................................................................................... 40 
14. 
Ethics ........................................................................................................................ 41 
14.1. 
Statements of Compliance ...................................................................................... 41 
14.2. 
Subject Compensation ............................................................................................. 41 
15. 
Study Administration ................................................................................................. 41 
15.1. 
Monitoring ................................................................................................................... 41 
15.2. 
Data Management ..................................................................................................... 42 
15.3. 
Accessibility of Investigation Site Staff and Study Materials .......................... 43 
15.4. 
Audits and Investigation Site Inspections ........................................................... 43 
15.5. 
Confidentiality ............................................................................................................ 43 
15.6. 
IRB Approval .............................................................................................................. 43 

 
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15.7. 
CIP Amendments ....................................................................................................... 44 
15.8. 
Reporting Requirements and Record Retention ................................................. 44 
15.9. 
Publication and Use of Information ...................................................................... 47 
15.10. 
Suspension or Early Termination ........................................................................ 47 
16. 
Advisory Committees ................................................................................................ 47 
16.1. 
Data Monitoring Committee .................................................................................... 47 
17. 
References ................................................................................................................. 48 
 

 
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3. 
Glossary 
Term 
Abbreviation 
Definition 
Adverse Event  
AE 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not 
related to the medical device. 
NOTE 1:  This definition includes events related to the medical 
device or the comparator. 
NOTE 2:  This definition includes events related to the 
procedures involved. 
NOTE 3:  For users or other persons, this definition is restricted 
to events related to the medical devices. 
American Heart 
Association 
AHA 
A non-profit organization in the United States that fosters 
appropriate cardiac care in an effort to reduce disability and 
deaths caused by cardiovascular disease and stroke. 
The AHA published guidelines in 2003 for telemetry monitoring 
that are still applicable and being used currently.  
Adverse Device Effect 
ADE 
Adverse event related to the use of a medical device. 
Clinical Investigation 
Plan 
CIP 
The present document describing the study protocol. 
CIP Deviation 
CIP Deviation 
An event when the investigator or site personnel did not 
conduct the study according to the CIP or the clinical trial 
agreement. Medtronic’s term for protocol deviation.  
Case Report Forms / 
Electronic CRF 
CRF/eCRF 
Forms where the clinical data are collected. eCRF is the 
electronic version of the CRF. 
Device Deficiency 
DD 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
NOTE 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of 
the medical device. 
NOTE 2: This definition includes any event resulting from use 
error or from intentional misuse of the medical device 
Electrocardiogram 
ECG 
A clinical technique measuring transthoracic electrical activity of 

 
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Term 
Abbreviation 
Definition 
the heart over time. 
Electronic Data 
Capture 
EDC 
Electronic system where the data are collected through the 
eCRF (Oracle Clinical). May also be referred to as RDC (Remote 
Data Capture). 
Emergency 
Department 
ED 
Medical treatment facility specializing in emergency medicine, 
the acute care of patients who present without prior 
appointment; either by their own means or by that of an 
ambulance. 
Electronic Medical 
Record 
eMR 
Digital version of a patient’s medical record within a single 
facility.  
Food and Drug 
Administration 
FDA 
Federal agency of the United States Department of Health and 
Human Services; regulates medical devices. 
Heart Rate 
HR 
A unit of measure that indicates speed of heartbeat in beats 
per minute.  
Intensive Care Unit 
ICU 
A hospital unit with concentrated special equipment and 
specially trained personnel for the care of seriously ill patients 
requiring immediate and continuous attention 
Informatics Manager 
IM 
A type of software that is intended to route and store medical 
device data and device diagnostic information from supported 
devices to the VPMP, 3rd Party Annunciation Systems, 
Electronic Medical Record (eMR) and Clinical Information 
System (CIS). 
Institutional Review 
Board 
IRB 
An independent body in US, consisting of healthcare 
professionals and non-medical members, whose responsibility is 
to protect rights, safety and well-being of human subjects 
involved in a clinical trial and to provide public assurance of 
that protection, by, among other things, expressing an opinion 
on the clinical trial protocol, the suitability of the investigators 
involved in the trial and the adequacy of facilities, and on the 
methods and documents to be used to inform trial subjects and 
obtain their informed consent. 
Investigator Site File 
ISF 
Regulatory binder supplied by the sponsor. 
Length of stay 
LOS 
The overall hospital length of stay, time of admission to 
discharge. 
Post-anesthesia care 
unit 
PACU 
Hospital until typically attached to an operating suite that 
provide care to patients recovering from anesthesia 
Product Accountability 
Log 
PAL 
A log maintained by investigative site personnel to document 
that the study product (s) have been used according to the 
protocol, and to document the final accounting of study 
product(s) received at the site, dispensed to subjects, returned 
by the subjects, and returned to the sponsor. 

 
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Term 
Abbreviation 
Definition 
Patient-controlled 
analgesia 
PCA 
A drug-delivery system that dispenses a preset intravascular 
dose of a narcotic analgesic when the patient pushes a switch 
on an electric cord. 
Rapid Response Team 
RRT 
A team of health care providers that responds to hospitalized 
patients with early signs of clinical deterioration on non-
intensive care units to prevent respiratory or cardiac arrest. 
Respiration Rate 
RR 
A unit of measure that indicates rate of breathing in breaths 
per minute. 
Serious Adverse Event  
SAE 
Adverse event that  
1. led to death,  
2. led to serious deterioration in the health of the subject, 
that either resulted in  
a. a life-threatening illness or injury, or  
b. a permanent impairment of a body structure or a body 
function, or  
c. in-patient or prolonged hospitalization, or  
d. medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to a 
body structure or a body function,  
3. led to fetal distress, fetal death or a congenital 
abnormality or birth defect  
 
Note: Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Serious Adverse 
Device Effect 
SADE 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Surveillance Monitoring 
SM 
The SM group will serve as the group who will be monitored by 
the study device for the duration of study enrollment on a 
medical-surgical unit(s).   
Standard Operating 
Procedures 
SOP 
Medtronic Quality Standard Operating Procedures 
Telemetry Monitoring 
TM 
The TM group will serve as the control group in this study and 
will be monitored via the site’s standard of care telemetry 
practice/protocol. 
Vital Sync™ 
Informatics Manager & 
Virtual Patient 
Monitoring Platform  
Vital Sync™ 
IM & VPMP 
A software only device that provides mobile and centralized 
remote monitoring.  
Virtual Patient 
Monitoring Platform 
VPMP 
A display system that provides visual and audible renderings of 
physiologic data, waveforms, alarms and alerts routed through 
the Vital Sync™ IM from supported devices. The Vital Sync™ 

 
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Term 
Abbreviation 
Definition 
VPMP displays information received from the IM on any web-
enabled device. 

 
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4. 
Synopsis 
Title 
A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry 
in Patients Scheduled for Telemetry without AHA Indication 
Clinical Study Type 
Post-market 
Product Name 
Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (Vital 
Sync™ IM & VPMP)  
BioModule™ BH3-M2 sensor  
Sponsor  
Medtronic  
Investigation 
Purpose 
The purpose of the study is to evaluate the impact of surveillance monitoring 
versus telemetry monitoring on clinical, healthcare economics, resource 
utilization, and qualitative outcomes.  
Product Status 
Vital Sync™ IM & VPMP 
 and the BioModule™ BH3-M2 sensor are Class II 
devices and 510(k) cleared by the FDA.  
Primary Objective 
The primary objective of this study is to compare hospital length of stay (LOS) 
between the surveillance monitoring (SM) and telemetry monitoring (TM) period 
on patients without AHA telemetry indication. 
Secondary 
Objectives  
Healthcare Economic and Resource Utilization Objectives 
1. Compare telemetry bed, emergency department (ED) bed, and intensive 
care unit (ICU) bed availability between monitoring periods 
2. Compare associated health care costs between monitoring periods 
3. Compare the number of ICU, ED, post-anesthesia care unit (PACU), and 
telemetry delays in transfer between monitoring periods  
4. Compare the number of hospital unit transfers between monitoring groups 
5. Compare the number of unplanned ICU transfers between monitoring 
groups 
6. Compare ICU LOS for subjects having unplanned transfers to the ICU 
between monitoring groups 
7. Compare the number of unnecessary diagnostic tests and therapeutic 
procedures generated by artifacts and/or misdiagnosis between monitoring 
groups 
Clinical and Qualitative Objectives 
1. Compare the number of Rapid Response Team (RRT) interventions between 
monitoring groups 
2. Compare survival rates post RRT interventions between monitoring groups 

 
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3. Compare code blue rates between monitoring groups 
4. Compare unplanned intubations between monitoring groups 
5. Compare time of RRT activation to time of threshold notifications from SM 
system following clinical deterioration events 
6. Assess clinical team satisfaction with surveillance monitoring and study 
product 
7. Assess patient satisfaction with surveillance monitoring and study product 
8. Assess perceptions of clinicians who prescribe telemetry to patients without 
AHA indication 
9. Assess clinicians’ perceptions on telemetry utilization and impact on hospital 
resource utilization and patient flow 
Study Design 
This will be single-center, prospective, pilot, pre/post implementation study to 
collect post-market data on hospitalized subjects monitored via telemetry 
monitoring and surveillance monitoring.   
The planned duration of the study is greater than or equal to six months. The TM 
(control) group will complete enrollment first over an estimated three month 
period, followed by an estimated three month enrollment period for the SM 
group. 
Subject participation will last less than or equal to the duration of the hospital 
stay.  Each subject will be followed in the hospital for a maximum period of 30 
days (± 2 days) from the start of enrollment. No follow-up will occur after 
subjects are discharged from the hospital. 
Sample Size 
The subject population will include up to a total of 440 subjects with up to 220 
subjects in each monitoring group.  
Inclusion/Exclusion 
Criteria 
Inclusion Criteria: 
Each subject must meet the following criteria to be enrolled in the study: 
1. Signed and dated informed consent by subject  
2. Male or female 18 years of age or older  
3. Expected hospitalized admission on the general care floor or medical 
surgical unit for at least one overnight stay and/or >12 hours 
4. Scheduled for telemetry monitoring  
5. Diagnosis indicates AHA telemetry Class III or none and therefore not 
indicated for telemetry monitoring  
6. For SM group subjects, treating provider who scheduled subject for 
telemetry agrees to alternative monitoring plan of surveillance monitoring 
7. Willingness to have study devices attached and hair shaved at sensor 
location as needed during study participation 
8. Willingness to participate in all aspects of the study 
 
Exclusion Criteria: 
Subjects who meet any of the following criteria will be excluded from the study: 
1. Implanted pacemaker or automatic defibrillator  
2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads 
3. Current AHA Class I or II indication/prescription for telemetry monitoring 
4. Prescription for other continuous condition monitoring such as capnography 
or pulse oximetry 

 
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5. Ongoing opioid therapy by PCA, by epidural or intrathecal infusions or by 
intravenous analgesia, per Investigator discretion  
6. Ventilated or intubated patients at the time of enrollment 
7. Female subject is pregnant, lactating, trying to get pregnant, or has a 
positive pregnancy test for women with childbearing potential  
8. Condition that, in the opinion of the investigator, may prevent completion of 
the study or protocol requirements 
9. Subject is considered as being morbidly obese (defined as BMI >50.0) 
Study Procedures 
and Assessments 
Subjects who meet all of the inclusion criteria and none of the exclusion criteria 
will be assigned to either one of the monitoring groups and then followed for the 
duration of their hospital stay.  
The monitoring groups will be enrolled in two prospective phases: telemetry 
monitoring (TM) OR surveillance monitoring. Enrollment of the TM group will 
occur first. After TM enrollment is complete, the enrollment phase of SM will 
initiate. 
The TM group will serve as the control group and will be monitored via the site’s 
standard of care telemetry practice/protocol. Subjects will continue to be enrolled 
in the study if subjects are transferred to medical-surgical unit after initial period 
of TM. No additional monitoring will be used for duration of study enrollment. 
The SM group will undergo placement of the study device following study 
enrollment and hospital staff will implement the SM strategy for the duration of 
study enrollment. A dedicated medical-surgical unit(s) will be utilized for the SM 
phase.  
Study procedures during the hospital stay will involve assessing eligibility, 
collecting baseline information, documenting clinical data from the eMR, unit 
transfers, discharges, and evaluating changes in health status.  
All study related subject data will be documented and entered into the subjects’ 
eCRF. All treatment will be standard of care per institutional practice. 
Safety Assessments 
Subjects will be monitored for Serious Adverse Events and Device-Related 
Adverse Events as noted in Section 12. 
 Statistics 
Baseline and study outcomes will be summarized using descriptive statistics. One-
way analysis of variance will be used to compare continuous variables (e.g., age, 
length of study) and Chi-square or Fisher’s exact test will be used for categorical 
variables. Multivariate regression will be used to assess impacts of potential 
confounders. A P-value <0.05 is considered statistically significant unless 
otherwise specified. 
5. 
Introduction  
5.1. 
Background  
Continuous ECG monitoring (telemetry) is indicated and highly valuable for monitoring patients at risk for 
cardiac events. The use of telemetry has gradually expanded to lower-risk patients for whom such 
monitoring may not provide substantial clinical benefit. Moreover, clinicians often use telemetry with the 
intent to provide enhanced vigilance over patients’ clinical status, even when that patient does not have a 

 
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significant underlying cardiac risk (1,2). The American Heart Association (AHA) has published a guideline 
indicating that low-risk patients do not require telemetry, as outcomes of these patients are not affected 
by telemetry monitoring (3,4). Despite these recommendations and evidence, one study reported that 
three of the top diagnoses of patients admitted to telemetry units are not clinically indicated, per AHA 
guidelines (4) and other studies report non-indicated monitoring may account for ~35% of patient 
telemetry days (5,6). 
 
Telemetry in non-indicated patients has been shown to have limited clinical benefit. In lower-risk 
patients, clinically significant telemetry-monitored events are rare. The use of telemetry in these patients 
does not often change clinical management. In a retrospective analysis of 501 patients on telemetry, 
Benjamin and colleagues reported the incidence of arrhythmias on non-indicated days to be low (3.1 per 
100 non-indicated days) as compared to indicated days (20.7 per 100 indicated days) (5). Dressler et al 
redesigned their cardiac telemetry sets and reduced telemetry use by 70% with no change in code blue, 
mortality, or rapid response team activation rates (7).  
 
Overuse of telemetry in lower-risk patients can overburden the hospital system and was highlighted by 
the Choosing Wisely campaign as one of five “opportunities for improved healthcare value (8).” As such, 
the authors stated that telemetry overuse “can be linked to increased length of stay, boarding in the 
emergency department, reduced hospital throughput, increased ambulance diversion, increased operation 
costs,” and “lead to a false sense of security and alarm fatigue (8).” In addition to the direct costs of 
telemetry, there are indirect costs related to Emergency Department (ED) backlog and hospital 
overcrowding. One study estimated that a delay in the ED of more than three hours before admission to 
a telemetry bed results in an opportunity cost in lost revenue of about $204 per patient (9). Other studies 
estimate savings ranging from $250,000 – $4.8 million annually through adherence to the AHA 
recommendations for telemetry use (5,7). 
 
Overall, available data indicate that reducing the incidence of unnecessary telemetry could increase bed 
availability, shorten length of stay, and decrease the cost of care with relatively low clinical risk. Recent 
advances in monitoring technology may allow for cost-effective monitoring alternatives of key vital signs, 
provide for the early detection of patients who warrant increased attention, aid in ED triage, and improve 
overall caregiver workflow. These newer technologies have the ability to monitor multiple variables at 
once, including single-lead ECG and respiratory rate, and thus allow for the pre-programming of ‘smart-
alerts’ better designed to detect clinically significant changes in patient condition. In these patients where 
physiologic monitoring is desired yet clinical diagnoses do not meet the AHA criteria for cardiac telemetry, 
such alternative surveillance monitoring strategies may provide acceptable clinical benefit while reducing 
hospital burden. This may be enabled through the provision of monitoring and enhanced vigilance within 
the general medical/surgical floor without requiring patient transfer to a dedicated telemetry bed. 
 
While these newer monitoring technologies are novel, prospective evidence to support surveillance 
monitoring is limited. This study is designed to address the gap in evidence to compare surveillance 
monitoring to telemetry monitoring. 
5.2. 
Purpose 
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring 
on clinical, healthcare economics, resource utilization, and qualitative outcomes.  

 
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6. 
Objectives and Endpoints 
6.1. 
Objectives 
6.1.1. 
Primary Objective 
The primary objective of this study is to compare hospital length of stay (LOS) between the surveillance 
monitoring and telemetry monitoring period on patients without AHA telemetry indication. 
6.1.2. 
Secondary Healthcare Economic and Resource Utilization Objectives 
1. Compare telemetry bed, emergency department (ED) bed, and intensive care unit (ICU) bed 
availability between monitoring periods 
2. Compare associated health care costs between monitoring periods 
3. Compare the number of ICU, ED, PACU, and telemetry delays in transfer between monitoring 
periods 
4. Compare the number of hospital unit transfers between monitoring groups 
5. Compare the number of unplanned ICU transfers between monitoring groups 
6. Compare ICU LOS  for subjects having unplanned transfers to the ICU between monitoring 
groups 
7. Compare the number of unnecessary diagnostic tests and therapeutic procedures generated by 
artifacts and/or misdiagnosis between monitoring groups 
6.1.3. 
Secondary Clinical and Qualitative Objectives  
1. Compare the number of Rapid Response Team (RRT) interventions between monitoring groups 
2. Compare survival rates post RRT interventions between monitoring groups 
3. Compare code blue rates between monitoring groups 
4. Compare unplanned intubations between monitoring groups 
5. Compare time of RRT activation to time of threshold notifications from SM system following 
clinical deterioration events  
6. Assess clinical team satisfaction with surveillance monitoring and study product 
7. Assess patient satisfaction with surveillance monitoring and study product 
8. Assess perceptions of clinicians who prescribe telemetry to patients without AHA indication 
9. Assess clinicians’ perceptions on telemetry utilization and impact on hospital resource utilization 
and patient flow 

 
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6.2. 
Endpoints 
6.2.1. 
Definition of Primary Endpoint  
1. Length of stay 
 
Definition: The overall hospital LOS; time(in minutes) of admission to discharge during 
indexed hospitalization. 
6.2.2. 
Definition of Secondary Healthcare Economic and Resource Utilization 
Endpoints 
1. Telemetry bed, ED, and ICU bed availability  
 
Definition: Daily available number of beds available in both telemetry ED, and the ICU 
measured daily in hours from 12:00 AM to 11:59 PM. 
 
2. Associated health care costs 
Definition: Costs attributable to the primary and secondary clinical and resource utilization 
endpoints. 
 
3. ICU, ED, PACU, and telemetry delays in transfer  
Definition: Number of patients delayed admission to the ICU, ED, PACU, and to a telemetry 
bed. 
 
4. Hospital unit transfers 
Definition: Number of inpatient transfers from one unit to another unit during course of 
hospital stay. 
 
5. Unplanned ICU transfers  
Definition: Direct transfers from either study monitoring group to the ICU where the 
transfer was not planned during the hospital stay. For example, a transfer may be planned in 
advance of certain procedures for high risk patient as a preventative measure. The study 
team will determine if transfer were considered planned versus unplanned by review of the 
medical record.  
6. LOS for ICU transfers  
Definition: The LOS (time in minutes) in the ICU for subjects who have an unplanned 
transfer to the ICU.  
 
7. Diagnostic tests and therapeutic procedures generated by artifacts and/or misdiagnosis  
Definition: Any diagnostic test or therapeutic procedure that was performed because of an 
ECG artifact or misdiagnosis made by clinician using monitoring technology 

 
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6.2.3. 
Definition of Clinical and Qualitative Endpoints 
1. RRT interventions  
Definition: RRT’s that are activated due to clinical deterioration as reported by the hospital 
or subject’s medical record. 
 
2. Survival rates post RRT interventions  
Definition: Survival at discharge or study completion following RRT activation.  
 
3. Code blue rates  
Definition: Code blue teams that are initiated due to cardiopulmonary arrest as reported by 
the hospital or subject’s medical record.  
 
4. Unplanned intubations  
Definition: An intubation and mechanical ventilation that was not planned during the course 
of the hospital stay. 
 
5. Time of RRT activation to time of a threshold notification(s) from the SM system following clinical 
deterioration events  
Definition: Time of RRT activation is the time that a clinician called or initiated the RRT 
team.  Time of a threshold notification(s) is the time when the SM system alerts or alarms 
when a hospital protocol-defined threshold is exceeded.  
 
6. Clinical team satisfaction with surveillance monitoring and study product 
Definition: Clinical team (nurse or physician) who treated at least one study subject will be 
asked to take a qualitative survey on satisfaction and confidence.  
 
7. Patient satisfaction with surveillance monitoring and study product 
Definition: Each subject will be asked to take a qualitative survey on satisfaction and 
comfort and the end of enrollment. 
 
8. Perceptions of clinicians who prescribe telemetry to patients without AHA indication 
Definition: Each eligible clinician will be asked to take a qualitative survey focused on the 
AHA guidelines and the monitoring modalities of the study. 
 
9. Clinicians’ perceptions on telemetry utilization and impact on hospital resource utilization and 
patient flow 

 
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Definition: Each eligible clinician will be asked to take a qualitative survey focused on 
telemetry utilization and the monitoring modalities of the study. 
7. 
Study Design  
This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data 
on hospitalized subjects monitored via telemetry and surveillance monitoring.   
Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be assigned to either 
one of the monitoring groups and then followed for the duration of their hospital stay. 
The subject population will include up to a total of 440 subjects with up to 220 subjects in each 
monitoring group.  
7.1. 
Duration 
The planned duration of the study is greater than or equal to six months. The control (TM) group will 
complete enrollment first over an estimated three month period, followed by an estimated three month 
enrollment period for the SM group. 
Subject participation will last less than or equal to the duration of the hospital stay.  Each subject will be 
followed in the hospital for a maximum period of 30 days (± 2 days) from the start of enrollment. 
No follow-up will occur after subjects are discharged from the hospital. 
7.2. 
Rationale  
The rationale for the study is fueled by: 1) reported widespread overuse of telemetry in US hospitals; 2) 
recommendations from the Choose Wisely campaign to reduce overutilization of resources; 3) recent 
advances in monitoring technology alternatives; 4) lack of prospective clinical evidence to support 
surveillance monitoring as an alternative to telemetry. 
8. 
Product Description 
8.1. 
Surveillance Monitoring System 
8.1.1. Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring 
Platform (VPMP) 
The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) 
 
(Medtronic, Boulder) is a software only device that provides mobile and centralized remote monitoring. 
The Vital Sync™ IM is intended to route and store medical device data from connected medical devices to 
the electronic medical record (eMR), clinical information system (CIS) and/or the VPMP. The Vital Sync™ 
VPMP displays information received from the IM on any web-enabled device. The product is a Class II 
device and 510(k) cleared by the FDA. 
 
The Vital Sync™ IM & VPMP routes and displays parameters, waveforms and alarms for the connected 
medical devices in near-real time. The Vital Sync™ IM & VPMP allows users to set up a new default alarm 
priority across device types and allows for institutions to modify alarm priorities per their internal 
protocols. The Vital Sync™ IM & VPMP provides for the setting or adjusting of thresholds on supported 

 
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devices where this capability is not available on the device itself; the platform can also act as the primary 
display for patient data and alerts where this capability is not available or enabled on the device itself. 
Vital Sync™ IM & VPMP includes Turn Time functionality which allows position and posture of the patient 
to be monitored. The Vital Sync™ IM & VPMP allows the user the capability, via the software, to perform 
simple calculations from processed parameters, or from manual input by the user. 
 
The Vital Sync™ IM & VPMP will receive and display vital sign data from the BioModule wearable 
physiological monitor (see Section 8.1.2). 
 
The indications for use are as follows: 
 
The Vital Sync™ IM is software that is intended to route and store medical device data and device 
diagnostic information from supported devices to the VPMP, 3rd Party Annunciation Systems, Electronic 
Medical Record (eMR) and Clinical Information System (CIS). 
 
The Vital Sync™ VPMP is a display system that provides visual and audible renderings of physiologic data, 
waveforms, alarms and alerts routed through the Vital Sync™ IM from supported devices. The Vital 
Sync™ VPMP is intended to be used by healthcare professionals in a hospital or hospital-type facility for 
the following purposes: 
 
• 
To remotely view and review patient data, waveforms, alerts and alarm information from 
supported devices and clinical information systems to facilitate clinical management. 
• 
To facilitate remote collaboration with other healthcare professionals regarding patient data from 
supported devices. 
• 
To access additional processed parameters to facilitate patient monitoring, assessment and 
clinical management.  
• 
To set and adjust alert thresholds on supported devices where this capability is not available on 
the device itself. 
• 
To access data, waveforms and alerts from supported devices where these capabilities are not 
enabled or available on the device itself. 
 
WARNING: The Vital Sync™ IM & VPMP is a notification system and is not a replacement for direct 
patient observation, patient assessment or clinical judgment. 
8.1.2. 
Wearable Physiological Monitor 
The BioModuleTM BH3-M2 sensor is a wearable physiological monitoring device intended for monitoring 
adults in hospitals and alternate care settings. When combined with the BioModule Holder and snap ECG 
electrodes, it becomes the BioPatch™ wireless device. It continuously collects a patient’s physiologic data 
including ECG, HR, RR, body orientation, and activity and transmits data to the Vital Sync™ VPMP every 
. The BioModuleTM sensor provides a
, single-lead ECG that records either 
automatically or on demand when a patient’s heart or respiration rate crosses clinician-assigned 
thresholds. 
The BioModuleTM sensor is a Class II device and 510(k) cleared by the FDA. 
 
 
 
 
BioModuleTM 

 
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8.2. 
Packaging 
Research conducted for this study will utilize devices cleared through the 510(k) regulatory process. FDA 
cleared devices do not require special labeling. Labeling and package for all products used in this study 
will follow the local and regional regulatory requirements. Labeling, user guides, and instructions for use 
will be provided to the site. 
8.3. 
Intended Population 
The intended study population is adult patients hospitalized and scheduled for telemetry monitoring but 
do not meet AHA criteria for telemetry monitoring. 
8.4. 
Product Use 
The Vital Sync™ IM & VPMP will be used to allow clinicians  to remotely view patient information collected 
from the BioModule and enable clinicians to be notified of clinical distress via color coded alarms and 
audible alerts.  The BioModule will be attached to each subject and placed on the lower section of the 
sternum via two electrodes. 
 
User guides and instructions for use of the Vital Sync™ IM & VPMP and BioModule™ will be provided to 
the study team prior to or at the Site Initiation Visit. 
ECG Electrodes 
BioModule Holder 

 
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8.5. 
Product Training Requirements 
Prior to investigation site activation or subsequent involvement in clinical study activities, Medtronic will 
provide product and clinical study training relevant and pertinent to the involvement of personnel 
conducting clinical study activities and investigator responsibilities. 
 
As a minimum, Investigators and coordinators will be trained on their responsibilities, on the CIP, on the 
use of data collection tools as well as applicable local regulations. Study-specific training will be 
documented prior to investigation site activation. Hospital staff will be trained on the surveillance 
monitoring system prior to start of the SM phase of the study. 
 
The support and training of the hospital units using the study product will be performed by employees of 
Medtronic.  
8.6. 
Product Receipt and Tracking 
The following records will be maintained at minimum for product delivery, receipt and tracking at the 
site: dates, quantities received, lot/serial numbers, and expiration dates, as applicable. Traceability of 
devices will be achieved during and after the clinical investigation by means of recording lot numbers, 
batch numbers or serial numbers, as applicable, on the Product Accountability Log (PAL). There are no 
investigational devices/supplies being utilized in this study.  All non-investigational devices/supplies 
associated with Vital Sync™ IM & VPMP and the BioModule will be maintained on the PAL as instructed 
during the Site Initiation Visit training. 
8.7. 
Product Return  
The investigator will return used and unused study supplies and maintain documentation of return as 
instructed during the Site Initiation Visit training. Study supplies should be returned to: 
 
 
8.8. 
Product Storage and Accountability  
The investigator will store the study product per the instructions for use and product manual. The storage 
area should be locked/secure with access limited only to approved hospital and study staff. Devices 
should be stored in a way that they will not be mixed with standard clinical inventory. 
 
Use of the study devices by each participant will be recorded on the PAL as instructed during the Site 
Initiation Visit training. 
8.9. 
Recalls 
In the event of a recall, Medtronic will immediately inform investigator to cease the use of the product or 
other study equipment and make arrangements for the return/disposition of the recalled product. 
 
Medtronic will notify the FDA and all reviewing IRBs/ECs, within 30 working days after the request is 
made to cease the use of the device, as applicable. 

 
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9. 
Selection of Subjects 
9.1. 
Study Population 
The target population consists of hospitalized patients aged ≥18 who are scheduled for admission to 
telemetry but do not meet AHA criteria for telemetry.  
9.2. 
Subject Enrollment 
Subject is considered enrolled once they sign the informed consent form. Subject will be considered a 
screen failure and immediately exited from the study if: 
• 
The subject signs the informed consent form but fails to meet study inclusion/exclusion criteria. 
• 
The subject signs the informed consent form, meets the study inclusion/exclusion criteria but 
does not start telemetry or surveillance monitoring for any reason. 
The investigator will maintain a log of all subjects enrolled in the clinical investigation called the Subject 
Identification Log for internal use to track subject identification numbers, subject names, and contact 
information. This log will be kept updated in real time during enrollment and stored in the ISF. 
A Screening and Enrollment Log described in Section 10.3 will also be maintained by the investigator. 
Individual subject enrollment will be complete when the subject is discharged from the hospital, 
completes 30 days (± 2 days) of enrollment, or is withdrawn from the study, whichever comes first. 
9.3. 
Inclusion Criteria 
Each subject must meet the following criteria to be enrolled in the study: 
1. Signed and dated informed consent by subject   
2. Male or female 18 years of age or older  
3. Expected hospitalized admission on the general care floor or medical surgical unit for at least one 
overnight stay and/or > 12 hours 
4. Scheduled for telemetry monitoring 
5. Diagnosis indicates AHA telemetry Class III or none and therefore not indicated for telemetry 
monitoring  
6. For SM group subjects, treating provider who scheduled subject for telemetry agrees to 
alternative monitoring plan of surveillance monitoring    
7. Willingness to have study devices attached and hair shaved at sensor location as needed during 
study participation 
8. Willingness to participate in all aspects of the study 
9.4. 
Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from the study: 
1. Implanted pacemaker or automatic defibrillator  
2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads 
3. Current AHA Class I or II indication/prescription for telemetry monitoring  
4. Prescription for other continuous condition monitoring such as capnography or pulse oximetry 
5. Ongoing opioid therapy by PCA, by epidural or intrathecal infusions or by intravenous analgesia, 
per Investigator discretion 
6. Ventilated or intubated patients at the time of enrollment 
7. Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for 
women with childbearing potential (see Section 9.5) 

 
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8. Condition that, in the opinion of the investigator, may prevent completion of the study or protocol 
requirements 
9. Subject is considered as being morbidly obese (defined as BMI >50.0) 
9.5. 
Childbearing Potential and Pregnancy Testing 
Pregnancy testing will only be performed in women with childbearing potential. Women of 
nonchildbearing potential are defined of self report of any female who meets one of the following 
condition. 
• 
Postmenopausal defined as amenorrhea for at least 2 years. 
• 
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise 
be incapable of pregnancy) 
• 
Abstinent (at the discretion of the investigator) 
• 
Having other congenital or medical condition that prevents subject from becoming pregnant 
 
Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) 
pregnancy test or a negative urine pregnancy test prior to placement of any monitoring devices. 
10. Study Procedures 
Each enrolled subject will be assigned to one of two types of monitoring arms:  telemetry monitoring 
(TM) OR surveillance monitoring (SM) and then followed for the duration of their hospital stay up to 30 
days (± 2 days). The monitoring groups described in Section 10.1 will be enrolled in two prospective 
phases. The enrollment phase of the TM group will occur first. After TM subjects have completed study 
participation, the SM phase  will initiate.  
 
The SM phase will begin with a tuning period to educate the hospital staff so they can obtain experience 
using the SM system within their workflow.  No subjects will be enrolled in the study during this time as 
hospital staff will be able to pilot the SM system within hospitalized patients. 
 
Study flowchart is reported in Figure 1. 
10.1. Monitoring Group Assignment  
Telemetry Monitoring (TM) Group, Control  
The TM group will serve as the control group and will be monitored via the site’s standard of care 
telemetry practice/protocol. Subjects will continue to be enrolled in the study if subjects are transferred 
to medical-surgical unit after initial period of TM. Subjects will be tracked daily to confirm continuing 
eligibility for the study. Temporary alternate monitoring modalities will be allowed per the discretion of 
the Investigator. If subject no longer meets eligibility criteria, the subject should be withdrawn and study 
completion date will be the date the subject became ineligible not the date the study team discovered the 
ineligibility. 
 
If a subject is transferred to another hospital unit or telemetry is discontinued, subject will continue to be 
enrolled in the study.  
 
If subject is transferred to ICU, there will be an exception to the requirement of tracking daily continuing 
eligibility. It is expected for additional care and monitoring to be administered during the ICU stay and 
AHA indication to change. Once subject is transferred from the ICU back to a lower acuity unit, eligibility 
criteria will be reassessed and documented. If subject no longer meets eligibility criteria upon return to 

 
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lower acuity unit, the subject should be withdrawn from the study. If subject meets eligibility criteria 
daily, subject will resume SM procedures and daily tracking of eligibility criteria 
 
Surveillance Monitoring (SM) Group 
Subjects in the SM group will alternatively be admitted to a medical surgical unit and placed with the 
study device following study enrollment. Hospital staff will utilize SM for the duration of study enrollment.  
 
The sponsor and investigator will collaborate to implement the SM strategy. This implementation could 
include a variety of strategies based on the site’s facilities, staffing resources, and IT infrastructure. The 
Vital Sync™ IM & VPMP conveys physiologic data, waveforms, and will provide visual alerts and 
annunciation alarms. Alert and alarm thresholds will be customized as needed to align with the hospital’s 
protocols.  Data from the remote monitoring platform will be accessed at a central workstation, a 
workstation on wheels, a bedside tablet, and/or smartphones/tablets. 
 
Subjects will be tracked daily to confirm continuing eligibility for the study. Temporary alternate 
monitoring modalities will be allowed per the discretion of the Investigator. If subject no longer meets 
eligibility criteria, the subject should be withdrawn and study completion date will be the date the subject 
became ineligible not the date the study team discovered the ineligibility.  
 
If a subject is transferred to another hospital unit, subject will continue to be enrolled in the study. 
However, the subject will be removed from SM during the transfer including placement of BioModule. 
When the subject transfers back to the medical-surgical unit, SM should resume as soon as reasonably 
possible per discretion of the Investigator until discharge from the hospital or end of study enrollment.   
 
If subject is transferred to ICU, there will be an exception to the requirement of tracking daily continuing 
eligibility. It is expected for additional care and monitoring to be administered during the ICU stay and 
AHA indication to change. Once subject is transferred from the ICU back to a lower acuity unit, eligibility 
criteria will be reassessed and documented. If subject no longer meets eligibility criteria upon return to 
lower acuity unit, the subject should be withdrawn from the study. If subject meets eligibility criteria 
daily, subject will resume SM procedures and daily tracking of eligibility criteria. 
 

 
 
 
  
 
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Figure 1. Study Flowchart. 
 

 
 
 
  
 
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10.2. Data Collection and Schedule of Events 
The Schedule of Events (Table 1) summarizes the intervals and data collection procedures.  Table 1 
outlines the events that occur during both study phases and events that occur during only the TM and SM 
phase.   
 
Applicable clinical data will be collected from the eMR or source documentation and entered into the 
eCRF. Clinical data will be entered electronically through two different secure systems: 
• 
(EDC, Oracle Clinical): Enrollment, Baseline Assessments, Monitoring Group Assignment, Hospital 
History, Patient and HCP satisfaction, Adverse Events, Protocol Deviations, Device Deficiencies, 
will be collected through eCRF.  
• 
Vital Sync™ IM & VPMP : Raw vital sign data from the SM system may be utilized to determine 
the time that the SM system detected a protocol defined activation threshold and thus activated 
an alarm notification. This will occur post-completion of each subject’s enrollment and will occur 
only in subjects who had a RRT intervention and/or code blue. Alternately, alarm notifications 
generated by the Vital Sync™ IM & VPMP system may be utilized to determine changes in patient 
data relative to protocol defined thresholds and associated timing for those changes. Raw de-
identified vital sign data will be collected throughout the duration of the study.  All data may be 
used for future product development.  
 
Healthcare economic and resource utilization data will be collected separately via hospital and billing 
records. 

 
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Table 1. Schedule of Events 
Event/Activity to Occur Across All Phases 
Event/Activity 
Screening/ 
Enrollment 
Inpatient 
Days  
End of  
Study 
Informed Consent  
X 
  
  
Inclusion/Exclusion Criteria 
• 
Pregnancy test, if applicable 
X 
X 
 
Baseline Assessments 
• Demographics 
• Medical history  
• Primary diagnosis 
• Hospital admission data 
• Pregnancy test, if applicable 
X 
  
  
Monitoring Group Assignment 
X 
 
 
Inpatient Tracking Form (daily eligibility) 
 
X 
 
Hospital History data 
 
 
X 
Healthcare Economic data   
 
 
X 
Resource Utilization data 
 
 
X 
Adverse Events   
 
X 
X 
Protocol Deviations 
 
X 
X 
Device Deficiencies  
 
X 
X 
eCRF Data Entry  
X 
X 
X 
Event/Activity to Occur During TM Phase Only 
Event/Activity 
Screening/ 
Enrollment 
Inpatient 
Days  
End of  
Study 
Telemetry Utilization Questionnaire for 
Clinicians (PRE) 
X 
 
 
Perception Questionnaire for Prescribing 
Clinicians (PRE) 
X 
 
 
Event/Activity to Occur During SM Phase Only 
Event/Activity 
Screening/ 
Enrollment 
Inpatient 
Days  
End of  
Study 
BioModule Placement 
X 
 
 
BioModule Replacement (~every 24 hrs) 
 
X 
 
Patient Satisfaction Questionnaire 
 
 
X 
Clinical Team Satisfaction Questionnaire 
 
 
X 
Telemetry Utilization Questionnaire for 
Clinicians (POST) 
 
 
X 
Perception Questionnaire for Prescribing 
Clinicians (POST) 
 
 
X 
 

 
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10.2.1. 
Screening/Enrollment Visit 
The first visit is the screening and enrollment visit. Patients considered potential candidates for the study 
based on pre-screening will sign informed consent form prior to participating in any study activities. 
 
The following procedures and assessments will be performed during both phases of the study on the 
day of study enrollment and the results will be recorded on the subject eCRFs. 
• 
Signed and dated informed consent 
• 
Pregnancy test if applicable 
• 
Verify that the subject meets all inclusion/exclusion criteria and collect the following: 
o 
Demographics 
o 
Medical history 
o 
Hospital admission data 
• 
Assignment to monitoring group 
• 
Assignment of study number 
o 
SM group will be a consecutive number beginning with 1001 
o 
TM group will be a consecutive number beginning with 2001 
• 
Verify data and enter into eCRF within 5 preferred  business days of collection 
 
During the TM Phase only, the following procedures and assessments will be performed. 
• 
Eligible clinicians complete Telemetry Utilization Questionnaire for Clinicians (PRE) 
• 
Eligible clinicians complete Perception Questionnaire for Prescribing Clinicians (PRE) 
 
During the SM Phase only, the following procedures and assessments will be performed. 
• 
Attach BioModule to subject according to user manual instructions and keep device attached to 
subject for the duration of the evaluation or until fully charged BioModule is needed  
• 
Link subject to BioModule using the Vital Sync™ VPMP 
• 
Confirm that BioModule is communicating to Vital Sync™ VPMP by observing flashing green light 
on BioModule AND that HR, RR, and activity parameters are displayed on the central station 
10.2.2. 
Inpatient Data Collection  
Data collected during the course of the hospital stay will be limited to daily reviews of the subject status 
to assess continuing eligibility and to assess for AEs/SAEs, protocol deviations, and device deficiencies as 
applicable per Section 12. 
 
The following procedures and assessments will be performed during both phases of the study on 
inpatient days and the results will be recorded on the subject eCRFs. 
• 
Complete inpatient tracking form to confirm continuing eligibility for the study 
• 
Check and record daily AEs/SAEs and protocol deviations 
• 
Verify data and enter into eCRF within 5 preferred business days of collection 

 
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During the SM Phase only, the following procedures and assessments will be performed. 
• 
Change-out BioModule as battery limits are reached, return the BioModule to the charging station 
• 
Apply a new fully charged BioModule to the subject and link subject to new BioModule using the 
Vital Sync™ VPMP 
• 
Clean reusable BioModule and return to the charging station 
• 
Perform daily checks to confirm BioModule and the Vital Sync™ VPMP are communicating and 
operating properly 
• 
Assess for and document any device deficiencies 
10.2.3. 
End of Study Visit 
The last visit will be on the day the subject is discharged from the hospital or at day 30 (± 2 days) of 
hospital admission. Subject participation ends at this visit or if the subject is withdrawn from the study for 
any reason. The following procedures and assessments will be performed during both phases of the 
study at the end of the study and will be recorded on the subject eCRFs. 
• 
Check and record AEs/SAEs and protocol deviations 
• 
Collect the following from the medical and billing records (UB04): 
o 
Hospital History data 
o 
Healthcare Economic data   
o 
Resource Utilization data 
• 
Verify data and enter into eCRF within 5 preferred business days of collection 
 
During the SM Phase only, the following procedures and assessments will be performed.  
• 
Remove BioModule, BioModule holder and electrodes. Discard disposable BioModule holder and 
electrodes. 
• 
Clean reusable BioModule and return to the charging station 
• 
Assess for and document any device deficiencies 
• 
Subject complete Patient Satisfaction Questionnaire  
• 
Eligible clinicians complete Clinical Team Satisfaction Questionnaire 
• 
Eligible clinicians complete Telemetry Utilization Questionnaire for Clinicians (POST) 
• 
Eligible clinicians complete Perception Questionnaire for Prescribing Clinicians (POST) 
10.2.4. 
Clinician Focused Qualitative Assessments 
A series of questionnaires will be administered to the clinicians involved in the care of study participants 
across the hospital. Each questionnaire will be focused on a subset of clinicians. It is likely that the same 
clinician may provide care for multiple study participants over the course of the study. Eligible clinicians 
should complete the focused questionnaire(s) only once if they provide care to more than one study 
participant. If the questionnaire has a Pre/Post component, both the Pre and the Post should be 
completed only one by each eligible clinician. 
 
Eligible clinicians will be provided with the clinical team questionnaire information sheet during the 
informed consent process. If the clinician is willing to consider participation, the clinician will provide 
consent by completing the questionnaire and returning to the study team.  A Clinician Participant Log will 
be used to capture clinicians who participated in the clinician focused qualitative assessments. 

 
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Perception Questionnaire for Prescribing Clinicians (PRE) 
Eligible clinicians will be any clinician who ordered telemetry monitoring for the study participant. The 
questionnaire should be administered to the clinician after enrollment of the subject, but if the clinician is 
not available at the time of enrollment it is acceptable to administer the questionnaire during the 
inpatient period.  
 
Perception Questionnaire for Prescribing Clinicians (POST) 
Eligible clinicians will be any clinician who ordered telemetry monitoring for the study participant. The 
POST questionnaire should be administered at the end of the SM phase after all subjects have completed 
study participation. 
 
Telemetry Utilization Questionnaire for Clinicians (PRE) 
Eligible clinicians will be any telemetry clinician who provides inpatient care for the study participant.  
Other eligible clinicians who may not provide direct care to participants but have visibility into hospital 
resource utilization impacting the flow of patients during the study period will be eligible. Examples 
clinicians include ED physicians/nurses, intensivists, critical care nurses, and hospitalists. The PRE 
questionnaire should be administered to the clinician after enrollment of the subject, but if the clinician is 
not available at the time of enrollment it is acceptable to administer the questionnaire during the 
inpatient period. 
 
Telemetry Utilization Questionnaire for Clinicians (POST) 
Eligible clinicians will be any telemetry clinician who provides inpatient care for the study participant. 
Other eligible clinicians who may not provide direct care to participants but have visibility into hospital 
resource utilization impacting the flow of patients during the study period will be eligible. Examples 
clinicians include ED physicians/nurses, intensivists, critical care nurses, and hospitalists. The POST 
questionnaire should be administered at the end of the SM phase after all subjects have completed study 
participation.  
 
Clinical Team Satisfaction Questionnaire 
Eligible clinicians will be any clinician who provides inpatient care to the study subject participating during 
the SM phase of the study and interacts with the study devices, the Vital Sync™ IM & VPMP and the 
BioModule. The satisfaction questionnaire should be administered to clinicians at the end of the SM phase 
after all subjects have completed study participation.  
10.3. Subject Screening  
Subjects who have an order placed for telemetry monitoring at the study site will be pre-screened as 
potential subjects for the study. In order to do so, only the existing information obtained per standard 
routine medical procedures will be used. No study-specific screening procedures, activities or 
questionnaires will be performed during the pre-screening. The Screening and Enrollment Log will capture 
both pre-screened and screened subjects. The log will also capture reasons why eligible pre-screened 
subjects did not participate in the study. 
 
Potentially eligible subjects will be provided with detailed information about the study during the informed 
consent process. If the subject is willing to consider participation, written informed consent must be 
obtained.  
 

 
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After informed consent, if a subject does not meet the inclusion/exclusion criteria, the subject will be 
considered a screening failure and may not participate in the study. If the subject is determined to be 
ineligible for the study, the reason will be documented on the Screening and Enrollment Log. 
10.4. Subject Consent 
Informed consent must be obtained before a subject is enrolled in the study and/or before any study-
specific procedures are initiated.  
 
Potential subjects expressing an interest in participating in the study will be given written and oral 
information about the study, their rights as a subject in a research project, as well as a copy of the 
subject informed consent form. The potential subject will be encouraged to discuss participation in the 
study with their support network (family, friends, ordering physician). Any study-related questions posed 
by the potential subject will be answered. Potential subjects are given adequate time to consider their 
participation.  
 
Potential subjects who then wish to participate and who appear to meet the inclusion/exclusion criteria 
will be asked to sign and personally date the Informed Consent Form. The investigator and or an 
authorized designee will also sign and personally date the Informed Consent Form  The signed original 
informed consent is maintained in the investigator’s records, and a copy given to the subject.  
 
The Informed Consent Form should cover all essential information per the protocol, Good Clinical 
Practices (GCP), release of hospital billing data, and the applicable regulatory requirements.  
 
If the Informed Consent Form is amended/updated throughout the life-cycle of the study, study subjects 
may be asked to re-consent by reviewing, signing and personally dating the updated Informed Consent 
Form. A copy of the amended/updated Informed Consent Form will be provided to the subject. 
10.5. Blinding 
No blinding will occur during the course of the study.  
10.6. Randomization  
No randomization will be used during the course of the study. Assignment to a monitoring arm will be 
determined by the phase status of the study. During the TM phase, all subjects will be assigned to the 
TM group. During the SM phase, all subjects will be assigned to the SM group. 
10.7. Assessment of Safety 
Methods and timing for assessing, recording, and analyzing safety parameters, including adverse events 
are described in section 12. 
10.8. Recording Data 
The investigator will clearly mark the clinical records to indicate that the subject is enrolled in this clinical 
study. 

 
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Subject’s medical record will be used as source documents. Additional source worksheets will serve as 
supplemental source documentation when a data field is not in the subject’s medical record. 
 
The investigator will allow inspections of the study site and documentation by Clinical Research and audit 
personnel from Medtronic or designee, IRB, external auditors, or representatives of regulatory 
authorities. The purpose of these inspections is to verify and corroborate the data collected on the eCRFs. 
In order to do this, direct and secure access to medical or clinical records and billing databases will be 
necessary. 
 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs which are derived from source documents, 
such as patient medical records, must be consistent with the source documents or the discrepancies need 
to be justified in a documented rationale, signed and dated by the Principal Investigator, to be filed in the 
subject file. All baseline and medical history data must be derived from source documents. Only 
authorized persons can complete eCRFs and record observation. Training will be provided to site 
personnel on the use of data collection tools, as described in section 8.5. A final version of eCRFs will be 
provided to the investigation site when the investigational site has been declared ready for the study. 
 
Sponsor study personnel will review collected data and create data queries for missing data that impacts 
data analysis. Queries will be sent to the investigator or appropriate support staff for resolution within a 
preferred 5 business day period. Where copies of the original source document as well as print outs of 
original electronic source documents are retained, these shall be signed and dated by a member of the 
investigation site team with a statement that it is a true reproduction of the original source document. 
10.9. Deviation Handling 
The investigator is required to conduct this study in accordance with the CIP, IRB requirements and 
applicable regulations. 
 
A CIP deviation is defined as an event when the investigator or site personnel did not conduct the study 
according to the CIP or the clinical trial agreement. Thorough documentation of all deviations in source 
documents and transcription to eCRF is required, along with notification to your sponsor contact.  
Additionally, the site must complete the Deviation Log found in the ISF. 
 
Major deviations are associated with subject safety or data integrity. They are defined as deviations with 
respect to: 
• 
Patient informed consent procedure 
• 
Patient eligibility criteria at the time of initial screening/enrollment 
o 
Deviations of daily tracking of eligibility procedures are not a major deviation  
• 
Study data collection and reporting 
• 
SADE reporting 
 
All deviations and reasons to deviate from the study protocol must be reported prior to deviation when 
planned or promptly after occurrence when unplanned to the sponsor regardless of whether medically 
justifiable, pre-approved by the sponsor, or taken to protect the subject in an emergency. 

 
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10.10. 
Subject Withdrawal or Discontinuation  
During the course of this study, subjects may elect to be or may be withdrawn from further treatment for 
any of the following reasons: 
• 
The subject may withdraw from the study for any reason without prejudice 
• 
The clinician or investigator may terminate the study at their discretion 
• 
Subject is prescribed additional continuous monitoring after enrollment 
• 
Within the first 12 hours of study participation, subject is discharged from hospital or removed 
from the study for any reason  
• 
Subject no longer meet study inclusion/exclusion criteria 
• 
Technical issues that prevent continuous data collection from the Vital Sync™ IM & VPMP  
• 
Sponsor terminates the study 
• 
Other 
Subjects may withdraw from the study at any time and for any reason. If a subject officially withdraws 
from the study, the investigator will document the reason and collect final outcomes data from the 
subject’s medical record. No additional follow-up will occur for withdrawn subjects. 
 
Subjects may only be replaced if the they are a screen failure OR are withdrawn from the study during 
the first 12 hours of enrollment for any reason. 
 
Withdrawal or discontinuation from the study will not affect the subject’s regular care/hospitalization in 
any way. 
10.11. 
Role of Sponsors Representatives 
Sponsor’s representatives may provide support as required for the clinical study, including technical 
support or training staff in the different hospital units. The sponsor will collaborate with investigator to 
implement the SM strategy which may include a sponsor implementation team to assist the site with 
adopting the SM strategy into their clinical workflow.  
11. Risks and Benefits 
11.1. Potential Risks 
Risks under this protocol relate to both study devices and study procedures. The devices in this study are 
non-invasive, post-market products with FDA clearance, and will be used in accordance with their 
labeling. The clinical protocol design is minimal risk to the subject.  
 
Following is a list detailing potential risks from the Vital Sync™ IM & VPMP, the BioModule, and the 
clinical study protocol.   
 
Risk associated with the Vital Sync™ IM & VPMP 
 
• 
Use errors could cause delay in treatment or incorrect treatment. Potential use errors include 
manually entering incorrect parameter values, adjusting the alarm priority for the incorrect alarm, 
or an unauthorized user disassociating devices from patients. Multiple design mitigations such as 

 
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data validation, administrator account, and user interface acknowledgement messages have been 
implemented to reduce the possibility of hazardous situations arising from use errors. 
 
• 
Use of the Vital Sync™ IM & VPMP by clinicians remotely viewing patient data in a non-secure 
environment presents potential risk of breaches of patient confidential data from clinicians 
remotely viewing patient data. Mitigations for patient privacy risks include security on the 
software server architecture, providing instructions for users on how to lock down the bedside 
displays’ operating system, and instructing users to utilize a secure network for remote viewing of 
patient data. 
 
• 
Environmental risks could cause delay in treatment. Potential environmental risks includes radio 
interference, patient being out of range, and network failure. This would result in delay in 
treatment since the  patient would experience a loss of monitoring, sending stale data over the 
network, or having the clinician unable to receive the alert notification. Environmental risk 
mitigations include an aged data indicator, message time stamps, disconnect and performance 
notifications. 
 
  
 
 
 
  
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
 
  
 
Risks associated with clinical study protocol:  
There are no known risks associated specifically with the clinical study protocol. 
 

 
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Inclusion and exclusion criteria have been described to recruit only appropriate subjects into the study. 
Potential subjects who may be at increased risk from the devices will not be enrolled. For example, 
subjects with implanted pacemaker or defibrillator will not be included. If there is any question of the 
subject meeting inclusion/exclusion for enrollment, Medtronic should be contacted to discuss first. 
11.2. Potential Benefits 
Subjects’ participation in this study may offer no additional benefit in respect to the same monitoring 
provided outside of the study. 
 
Possible benefits for participating in this study include the following (although others are possible): 
• 
Subjects in SM arm may benefit from the alternative surveillance monitoring strategy via 
detection of clinical deterioration during the course of hospital stay. 
 
There is, however, the potential for benefiting future patients should this study lead to the development 
of safer, more accurate, more cost-effective, and easier-to-use medical monitoring devices.  
 
Since this is not a treatment study, the alternative is to not participate in the study. 
11.3. Risk-Benefit Rationale 
Medtronic believes that the potential risks associated with the conduct of this trial are minimal using 
nonsignificant risk, non-invasive study devices for the following reasons: 
• 
All the devices used in the study are cleared by FDA and available in the hospitals and used 
within their intended use. 
• 
Surveillance monitoring will be performed in addition to standard patient “spot-check” monitoring 
performed by hospital staff. 
• 
The “Instructions for Use” and product labeling for the devices which will be provided to 
investigator prominently include statements that clearly advise users about how to properly use 
the system and interpret the output. Thus, users will clearly be instructed how to avoid and 
prevent many of these risks.  
• 
The expected likelihood that any of these failure modes could occur during conceivable use of the 
BioModule on a patient is very small. The likelihood that an actual injury would occur if a rare 
failure mode of the BioModule occurs simultaneously is vanishingly small. This analysis is based 
upon clinical experience as well as a wide body of published knowledge on the magnitude and 
impact of changes in physiology of low acuity patients possibly monitored with the BioModule.  
• 
Risk of injury is further mitigated because routine clinical observation is frequently deployed in 
addition to any monitoring. Based on the results of the risk benefit analysis, the benefits 
outweigh the risks for basic physiologic monitoring. 
12. Adverse Event Assessments 
Only the following adverse events will be collected for this study: 

 
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• 
Any adverse events noting mild or moderate physiological deterioration  
• 
Any adverse event whose relationship to the study device is: possible, probable, definite, or 
unknown/ impossible to determine, regardless of what the event may be. 
• 
All SAEs, of any relationship, meeting definition in section 12.2 of the CIP must be reported. 
The recording of adverse events for all enrolled subjects begin after the study devices are attached and 
ends with the subject’s completes study enrollment. Completion is defined by when a subject is 
discharged from the hospital, completes 30 day (± 2 days) enrollment period, or if the subject is 
withdrawn from the study for any reason. 
12.1. Anticipated Adverse Events 
Types of anticipated clinical signs, symptoms or conditions that could occur during this study, include the 
following:  
• 
Redness of skin  
• 
Skin burn  
• 
Allergic reaction to ECG lead adhesives  
12.2. Definitions/Classifications 
For the purposes of the clinical report, the sponsor will classify each adverse.  
 
• 
Adverse Events (AE): Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or 
not related to the medical device.  
NOTE 1:  This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2:  This definition includes events related to the procedures involved. 
NOTE 3:  For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
 
• 
Adverse Device Effect (ADE): Adverse event related to the use of a medical device.  
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device 
 
• 
Serious Adverse Event (SAE): Adverse event that  
1. led to death,  
2. led to serious deterioration in the health of the subject, that either resulted in  
a. a life-threatening illness or injury, or  
b. a permanent impairment of a body structure or a body function, or  
c. in-patient or prolonged hospitalization, or  
d. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function,  
3. led to fetal distress, fetal death or a congenital abnormality or birth defect  

 
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NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, 
without serious deterioration in health, is not considered a serious adverse event.  
 
• 
Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.  
 
• 
Device Deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. Device deficiencies include malfunctions, use errors, and 
inadequate labelling.  
12.3. Recording and Reporting Adverse Events and Device Deficiencies 
Adverse Event and Device Deficiency information will be collected throughout the study on the source, 
eCRF, AE log, or the Device Deficiency form located in the Investigator Site File (ISF).  
 
Information reported on the CRF will include:  
• 
Adverse Event diagnosis term to be determined by investigator 
• 
A detailed description of the event  
• 
The date of event onset  
• 
The relatedness of the event to the device  to be determined by investigator 
• 
The relatedness of the event to the procedure to be determined by investigator 
• 
Severity to be determined by investigator 
• 
Actions taken as a result of the event  per investigator  
• 
The outcome of the event  
• 
The date the event was first noticed by the investigator  
• 
For device deficiency, determine if it could have led to a SADE  
 
The investigator must report any SADE/SAE to the sponsor and IRB as soon as possible, but no later than 
10 working days after the investigator learns of the effect.  
 
Medtronic will conduct an evaluation of any SADE/SAE after first receiving notice of the event and report 
the results to all reviewing IRBs, the participating investigator and, if the effect is determined to be 
device-related, to the FDA.  
 
12.3.1. 
Product Complaint Reporting 
In geographies where devices are market-released, product complaint reporting is applicable. This 
includes when an AE is related to a market-released device during the study. The reporting of product 
complaints is not part of the clinical study and should be done in addition to the AE reporting 
requirements. Refer to local regulations for reporting requirements. 
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 

 
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the product. Any complaints should be reported to Medtronic via written, electronic, or oral reporting 
method in a timely manner to your Medtronic contact. Medtronic will notify the regulatory authorities 
(e.g. FDA, Competent Authority) for applicable incidents immediately upon learning of them. 
12.3.2. 
Emergency Contact Information in case of SAE/SADE  
 
  
 
  
 
 
   
  
  
 
 
13. Statistical Design and Methods 
13.1. Sample Size Justification 
The study sample size is based on the primary non-inferiority objective of comparing hospital length of 
stay (LOS) between the surveillance monitoring (SM) and telemetry monitoring (TM) period on subjects 
without AHA telemetry indication. From similar study data published in the literature, we assume a similar 
LOS distribution for both monitoring groups with a common coefficients of variation of 0.65. With a pre-
specified non-inferiority margin of 0.2 for the mean ratio, a sample size of 132 in each group will provide 
more than 80% power to assess the objective at the significance level of 0.05. Assuming at least 30% 
attrition from withdrawals and screen failures, up to 220 recruited  subjects in each monitoring group will 
be used for this study. 
13.2. Hypotheses and Endpoints 
The primary study endpoint is hospital of length of study (LOS), which is calculated from date of 
admission and discharge. The primary objective is to demonstrate that LOS of the SM group is similar 
(non-inferior) to the TM group. 
  
 
  

 
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Additionally, if the non-inferiority objective is met, superiority will also be assessed (without statistical 
penalty) to further understand the effectiveness of SM versus TM. The corresponding superiority 
hypothesis 
  
e., SM has shorter LOS duration than TM).  
 
Secondary clinical and qualitative endpoints include:  
• 
number of RRT interventions between monitoring groups 
• 
survival rates post RRT interventions between monitoring groups 
• 
Time of RRT activation to time of threshold notifications from SM system following clinical 
deterioration events  
• 
code blue rates between monitoring groups 
• 
unplanned intubations between monitoring groups 
• 
clinical team satisfaction with surveillance monitoring and study product 
• 
patient satisfaction with surveillance monitoring and study product 
• 
perceptions of clinicians who prescribe telemetry to patients without AHA indication 
• 
Clinicians’ perceptions on telemetry utilization and impact on hospital resource utilization and 
patient flow 
Additionally, healthcare economic and resource utilization data will be collected to evaluate:  
• 
telemetry bed, ED, and ICU bed availability between monitoring periods 
• 
associated health care costs between monitoring periods 
• 
the number of ICU, ED, PACU, and telemetry delays in transfer between monitoring periods 
• 
the number of hospital unit transfers between monitoring groups 
• 
the number of unplanned ICU transfers between monitoring groups 
• 
ICU LOS for subjects who have an unplanned transfer to the ICU between monitoring groups 
• 
the number of unnecessary diagnostic tests and therapeutic procedures generated by artifacts 
and/or misdiagnosis between monitoring groups 
13.3. Statistical Analysis 
In general, descriptive statistics will be used to summarize baseline and study outcomes. For continuous 
variables, number of available observations, mean, standard deviation, median, minimum and maximum 
values will be provided.  For categorical variables, frequency and percentage will be used. Unless 
otherwise specified, statistical assessments will be based on 2-sided tests at an alpha level of 0.05, which 
include Student-t or Wilcoxon rank-sum or ANOVA test for continuous variables, and Chi-square or 
Fisher’s exact test for categorical variables. Multivariate regression models will be used to assess impacts 
of potential confounding variable. 
 
.  
 
The primary effectiveness analysis will be based on all evaluable data from this study. A per protocol 
analysis will be performed based on all subjects who are compliant with the study protocol, i.e. who 
provide valid informed consents.  
 
For safety assessments, adverse events (AEs) will be summarized using frequency counts and 
percentages. Descriptive statistics will be provided by monitoring group and by severity and relationship. 
Additionally, differences between the two monitoring groups will be summarized along with 95% 
confidence intervals. Individual listings of adverse events, including event type, start date, duration, 

 
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severity, and device-relatedness will be provided as appropriate. The safety analysis will be based on all 
patients participated in the study. 
 
Further, a health economic analysis will be performed based on healthcare economic and resource 
utilization data collected in this study. A separate health economic data collection plan will be developed 
outside of this CIP. Monitoring effectiveness, QoL in the form of Quality-Adjusted Life-Years (QALYs), life-
years gained and other data collected in this study may be used as inputs to the model.  
 
Any deviations from the original statistical plan will be justified and documented appropriately.  
14. Ethics 
14.1. Statements of Compliance 
This clinical study will be conducted in compliance with 21 CFR 803, laws and regulations of the countries 
in which the clinical study is conducted, including data protection laws, the Clinical Investigation 
Agreement, and the Clinical Investigation Plan. 
 
All principles of the Declaration of Helsinki have been implemented in this clinical study by means of the 
informed consent process, IRB approval, and clinical study training. 
 
If the regulatory authority imposes any additional requirements (e.g. safety reports, progress reports 
etc.), Medtronic will prepare the required documents and send them to the respective authority. 
 
Patient Monitoring & Recovery is a business unit of Covidien LP, an indirect wholly owned subsidiary of 
Medtronic plc, which as the parent company of such entity maintains appropriate clinical study liability 
insurance coverage as required under applicable laws and regulations and will comply with applicable law 
and customs concerning specific insurance coverage. If required, a Clinical Trial Insurance 
statement/certificate will be provided to the IRB. 
14.2.  Subject Compensation 
 
15. Study Administration 
15.1. Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of the study per regulations. 
Appropriately trained Medtronic personnel or delegates appointed by Medtronic will perform study 
monitoring at the study center in order to ensure that the study is conducted in accordance with the 
Clinical Investigation Plan (CIP), the Clinical Trial Agreement, and applicable regulatory requirements. 
Medtronic must therefore be allowed access to the subject’s clinic and hospital records when so 
requested as per the Informed Consent Form and Clinical Trial Agreement. 
 

 
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Monitoring visits will be conducted at the start, during and at the closure of the clinical study in 
accordance with Medtronic internal SOPs and the Monitoring Plan. An interim monitoring visit may be 
combined with the closing monitoring visit. 
 
Frequency of monitoring visits will occur based on subject enrollment, duration of the study, study 
compliance, findings from previous monitoring visits and any suspected inconsistency in data that 
requires investigation. Regulatory documents (e.g., Informed Consent Form, IRB approval letters and 
Clinical Trial Agreements, etc.) will be reviewed at the study center. 
 
Monitoring visits will be conducted periodically to assess site study progress, the investigator’s adherence 
to the CIP, regulatory compliance including but not limited to IRB review and approval of the study, 
maintenance of records and reports, and review of source documents against subject eCRFs. Monitors 
facilitate site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel. This may be done in collaboration with the study management and the local field personnel, if 
available. Communication with the site personnel occurs during the visit and following the visit via a 
written follow-up letter. Monitors may work with study personnel to determine appropriate corrective 
action recommendations and to identify trends within the study or at a particular center. Study closure 
visits will be conducted via telephone, letter, or on site at the enrolling study center. 
15.2. Data Management 
The investigator must ensure accuracy, completeness, and timeliness of the data reported in the CRFs 
and in all other required reports. Data reported on the eCRFs which are derived from source documents 
must be consistent with the source documents and discrepancies need to be justified in a documented 
rationale, signed and dated by the Principal Investigator, and filed in the subject medical file. 
 
Only authorized persons can complete eCRFs. eCRFs shall be signed by the investigator (physicians only) 
as specified on the Delegated Tasks List included in the Investigator Site File. 
 
The Electronic Data Capture (EDC) system maintains an audit trail on entries, changes or corrections in 
eCRFs. If a person is only authorized to complete eCRFs or make changes to an already signed eCRF, the 
investigator shall re-sign this eCRF. 
 
The following data will be recorded directly on the eCRF and is considered as source data: 
• 
Patient hospital billing data 
• 
Hospital resource utilization data 
 
Reports generated by Vital Sync™ IM & VPMP and raw data from the BioModule will be the source to 
determine the time of when a subject crossed protocol defined activation thresholds for clinical 
deterioration. 
 
It is preferred that eCRFs will be completed within 5 business days from the performed visit or as soon as 
source documents are available, except for Serious Adverse Events that require immediate reporting  
and for Protocol Deviation requiring pre-approval. A delayed completion of the eCRF will not be 
considered a Protocol Deviation. 
 
Data management will be done according to Medtronic SOPs that will be made available on request. 
 

 
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All collected data will be reviewed for completeness, correctness and consistency. In case of issues, 
queries will be sent to the investigator or appropriate support staff  to complete, correct or comment on 
the data. Corrections are preferred within 5 business days. 
15.3. Accessibility of Investigation Site Staff and Study Materials 
The principal investigator(s), his/her delegate(s) and the study coordinator(s) shall be accessible to 
Medtronic field personnel and the Clinical Study Manager. This accessibility is of particular importance for 
reviewing data in the eCRF. Individual, secure, and direct access to patient medical files for source data 
verification (if applicable) will need to be granted and prepared prior to any monitoring visits. 
15.4.  Audits and Investigation Site Inspections 
In addition to regular monitoring visits, Medtronic may conduct audits at the participating investigation 
site. The purpose of an audit is to verify the adequate performance of the clinical study related activities 
independent of the employees involved in the clinical study. Regulatory authorities may also perform 
inspections at the participating investigation site. Any regulatory authority inspection announcements 
shall be forwarded immediately to Clinical Study Manager. 
 
The investigator and/or institution shall permit Medtronic and regulatory bodies direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study 
related monitoring, audits, IRB review (if applicable), and regulatory inspections. 
15.5. Confidentiality 
Access to subject's records is restricted to the clinical investigator and clinical site support staff, to the 
sponsor and to other researchers involved. Regulatory authorities and IRB may also be granted direct 
access to the medical records/ study files in order to comply with legal and regulatory requirements. 
Physical study documents will be stored in secure, access-controlled locations at the clinical site. 
 
Study results reported by the investigator or the sponsor will be in aggregate form with individual 
identities not publicly disclosed. It is possible that legal authorities may request detailed clinical 
information regarding specific subjects. In these situations, information will be provided by study 
identification number. 
15.6.  IRB Approval 
Prior to enrolling subjects in this clinical study, the investigation site’s IRB will be required to approve the 
current Clinical Investigation Plan, the Patient Information and Informed Consent form, including any 
other written information to be provided to the subjects and materials used to recruit subjects. IRB 
approval of the clinical study must be received in the form of a letter and provided to Medtronic before 
commencement of the clinical study at an investigation site. The approval letter must contain enough 
information to identify the version or date of the documents approved. If this information is not contained 
in the approval letter, it must be retrievable from the corresponding submission letter. In addition, the 
approval letter needs to be accompanied by an IRB roster or letter of compliance, to allow verification 
that the investigator, other investigation site personnel, and/or Medtronic personnel are not members of 
the IRB. If they are members of the IRB, written documentation is required stating that he/she did not 
participate in the approval process. If the IRB imposes any additional requirements (e.g. safety reports, 
progress reports etc.), Medtronic will prepare the required documents and send them to the investigator 

 
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for reporting to the IRB. The investigator must inform Medtronic of any change in status of IRB approval 
once the investigation site has started enrollment. If any action is taken by an IRB with respect to the 
investigation, that information will be forwarded to Medtronic by the respective investigator 
15.7. CIP Amendments 
The investigator will propose any appropriate modification(s) of the Clinical Investigation Plan.  Medtronic 
will review this proposal and decide whether the modification(s) will be implemented. 
 
Medtronic will submit any significant amendment to the Clinical Investigation Plan, including a justification 
for this amendment, to the appropriate regulatory authorities and to the investigator to obtain approval 
from their IRB, if applicable. Administrative amendments to the Clinical Investigation Plan will be 
submitted to the IRB and appropriate regulatory authorities for notification, if applicable. 
15.8. Reporting Requirements and Record Retention 
Investigator records 
At a minimum, the following records must be kept by the investigator: 
• 
Clinical Investigation Plan and, if applicable, any amendments 
• 
Medtronic and IRB approved Informed Consent 
• 
Regulatory Authority approval or notification, if applicable 
• 
Fully signed clinical investigation agreement and confidentiality agreement (if not included in the 
clinical investigation agreement) 
• 
Financial disclosures, if applicable 
• 
Insurance certificates 
• 
Completed Delegated Task List and Curriculum Vitae of Primary Investigator 
• 
Training documentation of all investigation site personnel 
• 
Relevant communications 
• 
Screening and Enrollment Log 
• 
Subject Identification Log 
• 
Product Accountability Log 
• 
Clinician Participant Log 
• 
Signed, dated and fully executed informed consent forms 
• 
Fully executed CRFs and corrections 
Investigator reporting responsibilities  
Report 
Submitted to 
Description 
Adverse Events 
Sponsor, IRB, and local 
regulatory authority, where 
applicable 
Refer to section 12.3 for reporting 
requirements. 
Withdrawal of IRB 
approval 
Sponsor 
Investigator will inform Medtronic in case 
IRB approval is withdrawn. 

 
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Report 
Submitted to 
Description 
Final Clinical Study 
Report 
IRB 
A copy of the Final Clinical Study Report 
will be provided to the IRB. 
Deviations from Investigational Plan 
Emergency Use 
Sponsor, IRB, regulatory 
authority 
Investigator will report deviation as soon 
as possible to the sponsor and IRB. 
Planned deviation 
Sponsor, IRB, regulatory 
authority 
Prior approval from Medtronic must always 
be obtained from Medtronic. If the 
deviation affects scientific soundness of 
the clinical study or the rights, safety, or 
welfare of the subject and is not an 
emergency, prior approval must be 
obtained from the IRB and regulatory 
authority. 
Other Deviations 
Sponsor 
Deviations that are beyond the control of 
the investigator or deviations that do not 
affect the scientific soundness of the 
clinical study or the rights, safety, or 
welfare of the subject and are not an 
emergency, should be submitted as they 
are identified by the investigation site or 
Medtronic staff. 
 
Sponsor records 
At a minimum, the sponsor will keep the following records: 
• 
All essential study documents and correspondence that pertains to the clinical study 
• 
CIP and, if applicable, any amendments 
• 
Curriculum vitae of Primary investigator Delegated Task Lists and training records of 
investigators and site staff 
• 
IRB approvals/notifications and regulatory approvals/notifications 
• 
Signed Clinical Investigation Agreements and signed agreements with third parties 
• 
Insurance certificates 
• 
Medtronic and IRB approved Informed Consents 
• 
Site selection reports, site initiation reports and monitoring visit reports 
• 
Adverse event reports 
• 
Financial disclosures, if applicable 
• 
Fully executed CRFs and corrections 
 
 

 
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Sponsor reporting responsibilities 
Report 
Submit to 
Description 
Adverse Events 
IRB, Investigator, 
and regulatory 
authorities, where 
applicable 
Medtronic will report adverse events as 
required and in compliance with local 
regulatory requirements, as applicable. 
Withdrawal of IRB 
approval 
IRB, Investigator, 
and regulatory 
authorities, where 
applicable 
In case of withdrawal of IRB approval 
Medtronic will suspend the clinical study 
as described below. 
Premature termination or 
suspension of study 
IRB, Investigator, 
and regulatory 
authorities, where 
applicable 
Medtronic will provide prompt notification 
of termination or suspension and 
reason(s) to investigator and where 
required to IRB and regulatory 
authorities. 
Final Report 
Investigator, and 
regulatory 
authorities, where 
applicable 
Medtronic will provide the investigator 
with a copy of the Final Clinical Study 
Report of the clinical study.  
IRBs and regulatory authorities will be 
informed when required. 
Emergency Deviations 
from Investigational Plan 
Regulatory 
authorities, where 
applicable 
If required, Medtronic will inform 
regulatory authorities as soon as possible 
about any emergency deviations that 
affect scientific soundness of the clinical 
study or the rights, safety, or welfare of 
the subject. 
 
Study related documents must be maintained for a minimum of two years after latter of the following two 
dates in a limited access location: The date on which the study is terminated or completed, or the date 
that the records are no longer required for the purposed of supporting a premarket approval application 
or a notice of completion of a product development protocol. Prior to the destruction of the study related 
data, the investigator should notify the sponsor. 
 
The investigator should take measures to prevent accidental or early destruction of the clinical study 
related materials. 

 
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Protocol #: COVMOPO0561 
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15.9. Publication and Use of Information 
The results of this clinical study are planned for publication. Publication/Presentation statement will be 
included in the clinical trial agreement between Medtronic and the site. 
 
The study will be recorded on www.clinicaltrials.gov by Medtronic before the first enrollment. 
15.10. 
Suspension or Early Termination 
Medtronic or Regulatory Authority may decide to suspend or prematurely terminate the clinical study 
(e.g. if information becomes available that the risk to study subject is higher than initially indicated). If 
the clinical study is terminated prematurely or suspended, Medtronic shall promptly inform the clinical 
investigator of the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing IRB and the study subjects or their legal representative. 
 
Medtronic, IRB or Regulatory Authority may decide to suspend or prematurely terminate an 
investigation site (e.g. in case of expiring approval of the reviewing IRB, non-compliance to the 
Clinical Investigation Plan, or lack of enrollment). If an investigation site is suspended or prematurely 
terminated, Medtronic shall promptly inform the investigator(s) of the termination or suspension and the 
reason(s) for this. The investigator shall then promptly inform the reviewing IRB, if required, the 
study subjects or their legal representative. 
 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definite 
outcomes, the investigator must assess whether to continue, modify or immediately stop the clinical 
study in 
the respective investigation site and immediately inform the sponsor and IRB, if applicable. 
 
In case of early investigation site suspension or termination subjects will be followed-up as per standard 
of care. 
 
In case of close out, the investigator will be notified and notification/report to Medtronic and Regulatory 
Authority will be done, if required. 
16. Advisory Committees 
16.1. Data Monitoring Committee 
A Data Monitoring Committee (DMC) will not be utilized for this clinical study as no interventions intended 
to prolong life or reduce risk of a major adverse health outcome (e.g., cardiovascular events) are 
evaluated, for which favorable or unfavorable study results suggest study termination. Additionally, there 
are no safety concerns suggesting the need for a DMC. This study is considered non-significant risk for 
study participants, thus the need for additional safety oversight beyond Medtronic’s already rigorous 
safety monitoring processes is not required.  Finally, this study does not have a pre-specified interim 
analysis. 

 
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Protocol #: COVMOPO0561 
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