A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring

Study Overview
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Brief Summary
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Evaluate the performance of the CorBand product when used to monitor patients.

Detailed Description
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The goal of the study is to demonstrate the validity and reliability of the CorBand across a suite of six clinical measures by comparing the measurements to similar outputs of FDA cleared devices: CorBand heart rate and heart rate variability will be compared to an electrocardiogram. CorBand bioimpedance will be compared to recorded extracted fluid and a bioimpedance measurement device. CorBand respiration rate will be compared to an respiratory rate sensor. CorBand skin temperature will be compared to a skin temperature monitoring device. CorBand activity will be compared to an activity monitor. CorBand outputs will be compared to the outputs of the CardioMEMS system. Device safety, comfort, and ease-of-use will also be evaluated as part of this study. Adverse events and serious adverse events will be documented throughout the study duration.

Official Title
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A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring

Conditions
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Heart Failure, Chronic Kidney Diseases

Intervention / Treatment
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* Device: CorBand
* Other: Activity Monitor
* Other: Bioimpedance spectrometer
* Other: ECG
* Other: respiratory rate sensor


Participation Criteria
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Eligibility Criteria
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INCLUSION: Arm 1: Subject is ≥ 18 years of age (legal age to give informed consent). Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center. Arm 2: Subject is ≥ 18 years of age (legal age to give informed consent). Subject receives chronic hemodialysis. Subject undergoes at least two hemodialysis sessions per week. Willing and capable of participating in all study visits and comply with medication/treatment requirements associated with this clinical study at an approved clinical study center. Arm 3: Subject is ≥ 18 years of age (legal age to give informed consent). Subject is implanted with the CardioMEMS HF device. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center. Arm 4: Subject is ≥ 18 years of age (legal age to give informed consent). Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment. Subject is stabilized during (and not yet discharged from) a hospitalization for exacerbation of symptomatic heart failure or a clinic visit for symptomatic heart failure associated with unscheduled treatment with IV diuretics. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center. EXCLUSION: The subject is unable or refuses to sign the informed consent. Subject is pregnant or planning to become pregnant during the study. A life expectancy of less than 6 months per clinician discretion. Subject has an implanted pacemaker or pacing device (Arm 1 and Arm 2 only). Poor healthcare literacy that would prevent the subjects from using the CorBand and/or completing questionnaires. Physical or mental impairment preventing use of the CorBand or compliance with study requirements. Material sensitivity to wearable devices, including the CorBand device. Additional Exclusion Criteria for Arm 4 Only: Home use of intravenous continuous inotropes or planned outpatient weekly inotrope infusions. Subject has been implanted with a ventricular assist device. Subject is listed on heart transplant list. Subject has a glomerular filtration rate (GFR) less than 30 mL/min. Subject has uncontrolled hypertension defined as 160/100 mmHg on two consecutive readings taken 15 min apart after subject has been resting for 15 min. Subject is undergoing or expected to undergo chronic hemodialysis (regularly scheduled sessions unrelated to a worsening heart failure event) during the study. Subject is incompatible with CorBand (e.g., skin type resulting in poor data measurements).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Multi-Arm study with different patient populations evaluating the CorBand.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management. | Device: CorBand<br>* The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.<br>Other: ECG<br>* Commercially available electrocardiogram machine<br>Other: respiratory rate sensor<br>* Commercially available respiratory rate sensor.<br>|
| Other: Arm 2<br>Adult (≥ 18 years of age) patients undergoing chronic hemodialysis. | Device: CorBand<br>* The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.<br>Other: Activity Monitor<br>* commercially available accelerometer to be worn on wrist<br>Other: Bioimpedance spectrometer<br>* Commercially available bioimpedance monitor.<br>|
| Other: Arm 3<br>Adult (≥ 18 years of age) patients (i) implanted with the CardioMEMS HF device and (ii) diagnosed with heart failure and/or undergoing cardiac management. | Device: CorBand<br>* The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.<br>|
| Other: Arm 4<br>Adult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management. | Device: CorBand<br>* The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Endpoint: Heart Rate | To evaluate the accuracy of the heart rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 
| Study Endpoint: Heart Rate Variability | To evaluate the accuracy of the heart rate variability data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 
| Study Endpoint: Respiration Rate | To evaluate the accuracy of the respiration rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 
| Study Endpoint: Activity | To evaluate the accuracy of the activity (steps/movement) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 
| Study Endpoint: Skin Temperature | To evaluate the accuracy of the skin temperature data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 
| Study Endpoint: Bioimpedance (Extracellular fluid differences) | To evaluate the accuracy of the bioimpedance (extracellular fluid differences) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.) | Through study completion, an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis