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

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.

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).