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

ReThink Medical

Status: Completed

Conditions: Chronic Kidney Diseases; Heart Failure

Treatments: Device: CorBand; Other: Activity Monitor; Other: Bioimpedance spectrometer; Other: ECG; Other: respiratory rate sensor

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03993886

P 005

5R44HL125001-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Evaluate the performance of the CorBand product when used to monitor patients.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

   Additional Exclusion Criteria for Arm 4 Only:

8. Home use of intravenous continuous inotropes or planned outpatient weekly inotrope infusions.

9. Subject has been implanted with a ventricular assist device.

10. Subject is listed on heart transplant list.

11. Subject has a glomerular filtration rate (GFR) less than 30 mL/min.

12. 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.

13. Subject is undergoing or expected to undergo chronic hemodialysis (regularly scheduled sessions unrelated to a worsening heart failure event) during the study.

14. Subject is incompatible with CorBand (e.g., skin type resulting in poor data measurements).

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 4 patient groups

Arm 1

Other group

Description:

Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management.

Treatment:

Other: respiratory rate sensor

Other: ECG

Device: CorBand

Arm 2

Other group

Description:

Adult (≥ 18 years of age) patients undergoing chronic hemodialysis.

Treatment:

Other: Activity Monitor

Other: Bioimpedance spectrometer

Device: CorBand

Arm 3

Other group

Description:

Adult (≥ 18 years of age) patients (i) implanted with the CardioMEMS HF device and (ii) diagnosed with heart failure and/or undergoing cardiac management.

Treatment:

Device: CorBand

Arm 4

Other group

Description:

Adult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management.

Treatment:

Device: CorBand