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

NCT03993886 | Completed FDA Device

• 2 other identifiers: P 0055R44HL125001-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Heart Failure; Chronic Kidney Diseases

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (6)

• 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

Other Outcomes (2)

• Incidence of investigational device related adverse events

  Through study completion, an average of 1 week

• Patient Experience

  Through study completion, an average of 1 week

Study Arms (4)

Arm 1

OTHER

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

Device: CorBand; Other: ECG; Other: respiratory rate sensor

Arm 2

OTHER

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

Device: CorBand; Other: Activity Monitor; Other: Bioimpedance spectrometer

Arm 3

OTHER

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

Arm 4

OTHER

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

Device: CorBand

Interventions

CorBand DEVICE

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

Arm 1; Arm 2; Arm 3; Arm 4

Activity Monitor OTHER

commercially available accelerometer to be worn on wrist

Arm 2

Bioimpedance spectrometer OTHER

Commercially available bioimpedance monitor.

Arm 2

ECG OTHER

Commercially available electrocardiogram machine

Arm 1

respiratory rate sensor OTHER

Commercially available respiratory rate sensor.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• ReThink Medical: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Satellite Healthcare

San Jose, California, 95128, United States

Location

Related Publications (3)

• Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez 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. No abstract available.

  PMID: 26811276 BACKGROUND

• 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. No abstract available.

  PMID: 23741058 BACKGROUND

• 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.

  PMID: 21080835 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Jamie Kennedy, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-Arm study with different patient populations evaluating the CorBand.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: June 21, 2019
• Study Start: January 17, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 14, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)