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Medtronic shift in strategic direction for study device
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The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.
This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetry Monitoring Arm | Active Comparator | The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. |
|
| Surveillance Monitoring Arm | Experimental | Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vital Sync IM & VPMP (Surveillance Monitoring) | Device | The Vital Syncâ„¢ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay (LOS) as Assessed by Review of Medical Records | LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms. | Baseline to end of hospital stay (or up to 30 day post enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Associated Health Care Costs (HCC) as Determined by Review of Billing Records | Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms | Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey House, MD, PhD | Washington University in Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in Saint Louis | St Louis | Missouri | 63130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 Syncâ„¢ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Surveillance Monitoring Arm did not initiate as the study was terminated following the completion of the TM phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Surveillance Monitoring Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay (LOS) as Assessed by Review of Medical Records | LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms. | The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected. | Posted | Mean | Standard Deviation | hrs | Baseline to end of hospital stay (or up to 30 day post enrollment) |
|
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:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGITATION | Psychiatric disorders | Systematic Assessment |
This study was terminated early, no conclusions should be drawn from the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Kinney | Medtronic | +1-303-876-8904 | anne.r.kinney@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2017 | Jan 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2017 | Jan 2, 2019 | SAP_001.pdf |
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| Telemetry Monitoring | Device | Continuous ECG monitoring for hospitalized patients at-risk for cardiac events. |
|
Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms. |
| Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Length of Stay (LOS) in the ICU as Determined by Review of Medical Records | Length of Stay in the ICU will be determined by comparing numbers between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records | CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only | Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm) | Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires | Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) |
| Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires | 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. | Baseline to end of hospital stay (or up to 30 days post enrollment) |
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 Syncâ„¢ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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 Syncâ„¢ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. |
|
|
| Secondary | Associated Health Care Costs (HCC) as Determined by Review of Billing Records | Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms | The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed. | Posted | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
| Secondary | Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records | Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms. | 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. | Posted | Count of Participants | Participants | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
|
| Secondary | Length of Stay (LOS) in the ICU as Determined by Review of Medical Records | Length of Stay in the ICU will be determined by comparing numbers between monitoring arms. | 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. | Posted | Mean | Standard Deviation | hrs | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
|
| Secondary | Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records | CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms. | 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. | Posted | Count of Participants | Participants | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
|
| Secondary | Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only | Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm) | 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. | Posted | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
| Secondary | Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires | Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms. | 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. | Posted | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
| Secondary | Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires | 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. | 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. | Posted | Count of Participants | Participants | Baseline to end of hospital stay (or up to 30 days post enrollment) |
|
|
|
| 0 |
| 206 |
| 40 |
| 206 |
| 8 |
| 206 |
| EG001 | 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 Syncâ„¢ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. | 0 | 0 | 0 | 0 | 0 | 0 |
| AGITATED DELIRIUM | Psychiatric disorders | Systematic Assessment |
|
| ALTERED MENTAL STATUS | Psychiatric disorders | Systematic Assessment |
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| APHASIA | Nervous system disorders | Systematic Assessment |
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| ASPIRATION PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
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| EXPRESSIVE APHASIA | Nervous system disorders | Systematic Assessment |
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| FACIAL EDEMA (CONCERN FOR ALLERGIC REACTION VS. ATYPICAL ANGIOEDEMA) | General disorders | Systematic Assessment |
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| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
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| GROSS HEMATURIA | Renal and urinary disorders | Systematic Assessment |
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| HEMORRHAGIC SHOCK (GI BLEED SOURCE) | Vascular disorders | Systematic Assessment |
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| HYPERCAPNIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| HYPERCARBIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPOKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | Systematic Assessment |
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| HYPOXEMIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| LETHARGY | Nervous system disorders | Systematic Assessment |
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| NEW ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE | Cardiac disorders | Systematic Assessment |
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| NEW ONSET ATRIAL FIBRILLATION/FLUTTER | Cardiac disorders | Systematic Assessment |
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| NON ST ELEVATION MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
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| NON STEMI | Cardiac disorders | Systematic Assessment |
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| NON SUSTAINED VENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| RECURRENT HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| SYMPTOMATIC BRADYCARDIA | Cardiac disorders | Systematic Assessment |
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| TRANSFUSION-INDUCED PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| UNRESPONSIVENESS/HYPOGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| UNRESPONSIVENESS/RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| WORSENING ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment |
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| WORSENING ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
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| WORSENING AV FISTULA INFECTION | Infections and infestations | Systematic Assessment |
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| WORSENING CONGESTIVE HEART FAILURE | Cardiac disorders | Systematic Assessment |
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| WORSENING COPD EXACERBATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| WORSENING DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING GASTROINTESTINAL BLEED | Gastrointestinal disorders | Systematic Assessment |
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| WORSENING HYERKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING HYPERGLYCEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING HYPERKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING HYPERTENSION | Vascular disorders | Systematic Assessment |
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| WORSENING HYPOKALEMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING HYPONATREMIA | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING HYPOTENSION | Vascular disorders | Systematic Assessment |
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| WORSENING METABOLIC ACIDOSIS | Metabolism and nutrition disorders | Systematic Assessment |
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| WORSENING QT PROLONGATION | Investigations | Systematic Assessment |
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| WORSENING SEVERE SEPSIS | Infections and infestations | Systematic Assessment |
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| WORSENING SINUS BRADYCARDIA | Cardiac disorders | Systematic Assessment |
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| WORSENING SINUS TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| WORSENING TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| CHEST PAIN | General disorders | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | Systematic Assessment |
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| INCREASED ALTERED MENTAL STATUS | Psychiatric disorders | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
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| WORSENING LETHARGY | Nervous system disorders | Systematic Assessment |
|
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