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

Heart Failure Clinical Trial

— ZENITH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993886
• Other study ID #: P 005
• Secondary ID: 5R44HL125001-03
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: July 14, 2020

Study information

• Verified date: July 2020
• Source: ReThink Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 14, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Heart Failure
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• CorBand
The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.

Other:
• Activity Monitor
commercially available accelerometer to be worn on wrist
• Bioimpedance spectrometer
Commercially available bioimpedance monitor.
• ECG
Commercially available electrocardiogram machine
• respiratory rate sensor
Commercially available respiratory rate sensor.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California
United States	Satellite Healthcare	San Jose	California

Sponsors (3)

Lead Sponsor	Collaborator
ReThink Medical	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. Erratum in: N Engl J Med. 2011 Feb 3;364(5):490. N Engl J Med. 2013 Nov 7;369(19):1869. — View Citation

WRITING COMMITTEE MEMBERS, Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. — View Citation

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of investigational device related adverse events	Adverse events and serious adverse events will be documented throughout the study duration.	Through study completion, an average of 1 week
Other	Patient Experience	Arm 2 and 3 Subjects will complete an end of study questionnaire to evaluate comfort and ease of use of the investigational device	Through study completion, an average of 1 week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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