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

Inclusion Criteria

• •INCLUSION:
• •Arm 1:
• •1. Subject is ≥ 18 years of age (legal age to give informed consent).
• •2. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
• •3. 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:
• •1. Subject is ≥ 18 years of age (legal age to give informed consent).
• •2. Subject receives chronic hemodialysis.
• •3. Subject undergoes at least two hemodialysis sessions per week.
• •4. 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:
• •1. Subject is ≥ 18 years of age (legal age to give informed consent).
• •2. Subject is implanted with the CardioMEMS HF device.
• •3. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
• •4. 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:
• •1. Subject is ≥ 18 years of age (legal age to give informed consent).
• •2. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
• •3. 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.
• •4. 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:
• •1. The subject is unable or refuses to sign the informed consent.
• •2. Subject is pregnant or planning to become pregnant during the study.
• •3. A life expectancy of less than 6 months per clinician discretion.
• •4. Subject has an implanted pacemaker or pacing device (Arm 1 and Arm 2 only).
• •5. Poor healthcare literacy that would prevent the subjects from using the CorBand and/or completing questionnaires.
• •6. Physical or mental impairment preventing use of the CorBand or compliance with study requirements.
• •7. Material sensitivity to wearable devices, including the CorBand device.