Trial Outcomes & Findings for Surveillance Monitoring as an Alternative to Telemetry (NCT NCT03039738)

NCT ID: NCT03039738

Last Updated: 2019-05-13

Results Overview

LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 206 participants
• Primary outcome timeframe: Baseline to end of hospital stay (or up to 30 day post enrollment)
• Results posted on: 2019-05-13

Participant Flow

Participant milestones

Measure	Telemetry Monitoring Arm The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Overall Study STARTED	206	0
Overall Study COMPLETED	152	0
Overall Study NOT COMPLETED	54	0

Reasons for withdrawal

Measure	Telemetry Monitoring Arm The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Overall Study Incomplete data sets	54	0

Baseline Characteristics

Surveillance Monitoring as an Alternative to Telemetry

Baseline characteristics by cohort

Measure	Telemetry Monitoring Arm n=206 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.	Total n=206 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 15.6 • n=5 Participants	—	55.3 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	—	107 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants	—	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	202 Participants n=5 Participants	—	202 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants	—	134 participants n=5 Participants
Body Mass Index (BMI)	28.8 kg/m^2 STANDARD_DEVIATION 9.2 • n=5 Participants	—	28.8 kg/m^2 STANDARD_DEVIATION 9.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 day post enrollment)

Population: The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected.

LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.

Outcome measures

Measure	Telemetry Monitoring (TM) Arm n=152 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring (SM) Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Hospital Length of Stay (LOS) as Assessed by Review of Medical Records	79.9 hrs Standard Deviation 73.0	—

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed.

Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.

Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.

Outcome measures

Measure	Telemetry Monitoring (TM) Arm n=152 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring (SM) Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records	143 Participants	—

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data. Only participants who were admitted to ICU, were assessed for this Outcome.

Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.

Outcome measures

Measure	Telemetry Monitoring (TM) Arm n=5 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring (SM) Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Length of Stay (LOS) in the ICU as Determined by Review of Medical Records	4.4 hrs Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.

CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.

Outcome measures

Measure	Telemetry Monitoring (TM) Arm n=152 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring (SM) Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records	14 Participants	—

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The study was prematurely terminated; this outcome was for Surveillance Monitoring arm only. The data were not collected, and no outcome measure analysis was performed.

Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: The patient and clinical team satisfaction questionnaires were designed to be collected for the SM arm only. The study enrolled control arm only prior to termination. The questionnaires were not collected, and no outcome measure analyses were performed.

Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of hospital stay (or up to 30 days post enrollment)

Population: All clinicians (e.g. ED physicians, nurses, critical care nurses) involved in the care of study participants at each hospital (not study subjects.) The study was prematurely terminated; no conclusion should be drawn from the reported data. The data for SM Arm were not collected, and no outcome measure analyses were performed.

Number of clinicians "very familiar" and "somewhat familiar" with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.

Outcome measures

Measure	Telemetry Monitoring (TM) Arm n=259 Participants The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring (SM) Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires	118 Participants	—

Adverse Events

Telemetry Monitoring Arm

Serious events: 40 serious events

Other events: 8 other events

Deaths: 0 deaths

Surveillance Monitoring Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telemetry Monitoring Arm n=206 participants at risk The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Psychiatric disorders AGITATED DELIRIUM	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Psychiatric disorders ALTERED MENTAL STATUS	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Nervous system disorders APHASIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders ASPIRATION PNEUMONIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders CARDIAC ARREST	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Nervous system disorders EXPRESSIVE APHASIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
General disorders FACIAL EDEMA (CONCERN FOR ALLERGIC REACTION VS. ATYPICAL ANGIOEDEMA)	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Gastrointestinal disorders GASTROINTESTINAL HEMORRHAGE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Renal and urinary disorders GROSS HEMATURIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Vascular disorders HEMORRHAGIC SHOCK (GI BLEED SOURCE)	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders HYPERCAPNIC RESPIRATORY FAILURE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders HYPERCARBIC RESPIRATORY FAILURE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders HYPERGLYCEMIA	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders HYPOGLYCEMIA	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders HYPOKALEMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Vascular disorders HYPOTENSION	1.5% 3/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders HYPOXEMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Nervous system disorders LETHARGY	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders NEW ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders NEW ONSET ATRIAL FIBRILLATION/FLUTTER	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders NON ST ELEVATION MYOCARDIAL INFARCTION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders NON STEMI	1.5% 3/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders NON SUSTAINED VENTRICULAR TACHYCARDIA	1.5% 3/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders RECURRENT HYPOGLYCEMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders RESPIRATORY ARREST	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders SYMPTOMATIC BRADYCARDIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders TRANSFUSION-INDUCED PULMONARY EDEMA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders UNRESPONSIVENESS/HYPOGLYCEMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders UNRESPONSIVENESS/RESPIRATORY FAILURE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Renal and urinary disorders WORSENING ACUTE KIDNEY INJURY	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Blood and lymphatic system disorders WORSENING ANEMIA	1.9% 4/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Infections and infestations WORSENING AV FISTULA INFECTION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders WORSENING CONGESTIVE HEART FAILURE	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Respiratory, thoracic and mediastinal disorders WORSENING COPD EXACERBATION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING DIABETIC KETOACIDOSIS	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Gastrointestinal disorders WORSENING GASTROINTESTINAL BLEED	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING HYERKALEMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING HYPERGLYCEMIA	1.5% 3/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING HYPERKALEMIA	1.5% 3/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Vascular disorders WORSENING HYPERTENSION	1.9% 4/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING HYPOKALEMIA	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING HYPONATREMIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Vascular disorders WORSENING HYPOTENSION	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Metabolism and nutrition disorders WORSENING METABOLIC ACIDOSIS	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Investigations WORSENING QT PROLONGATION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Infections and infestations WORSENING SEVERE SEPSIS	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders WORSENING SINUS BRADYCARDIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders WORSENING SINUS TACHYCARDIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders WORSENING TACHYCARDIA	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio

Other adverse events

Measure	Telemetry Monitoring Arm n=206 participants at risk The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.	Surveillance Monitoring Arm Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Vital Sync IM \& VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Psychiatric disorders AGITATION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
General disorders CHEST PAIN	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Vascular disorders HYPOTENSION	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Psychiatric disorders INCREASED ALTERED MENTAL STATUS	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Cardiac disorders VENTRICULAR TACHYCARDIA	0.97% 2/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio
Nervous system disorders WORSENING LETHARGY	0.49% 1/206 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio	— 0/0 • The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing 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. Only the following adverse events were collected for this study: * 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 serious adverse event, of any relationship, meeting the protocol definitio

Additional Information

Anne Kinney

Medtronic

Phone: +1-303-876-8904

Email: anne.r.kinney@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place