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

Primary Purpose

Heart Failure, Chronic Kidney Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CorBand

Activity Monitor

Bioimpedance spectrometer

ECG

respiratory rate sensor

About this trial

This is an interventional device feasibility trial for Heart Failure focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of California, San Francisco
Satellite Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.)

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.)

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.)

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.)

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.)

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.)

Secondary Outcome Measures

Full Information

NCT ID

NCT03993886

First Posted

April 24, 2019

Last Updated

July 15, 2020

Sponsor

ReThink Medical

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03993886

Brief Title

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

Acronym

ZENITH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReThink Medical

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Chronic Kidney Diseases

Keywords

Hemodialysis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Other

Arm Description

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

Arm Title

Arm 2

Arm Type

Other

Arm Description

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

Arm Title

Arm 3

Arm Type

Other

Arm 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.

Arm Title

Arm 4

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CorBand

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Activity Monitor

Intervention Description

commercially available accelerometer to be worn on wrist

Intervention Type

Other

Intervention Name(s)

Bioimpedance spectrometer

Intervention Description

Commercially available bioimpedance monitor.

Intervention Type

Other

Intervention Name(s)

ECG

Intervention Description

Commercially available electrocardiogram machine

Intervention Type

Other

Intervention Name(s)

respiratory rate sensor

Intervention Description

Commercially available respiratory rate sensor.

Primary Outcome Measure Information:

Title

Study Endpoint: Heart Rate

Description

Time Frame

Through study completion, an average of 1 week

Title

Study Endpoint: Heart Rate Variability

Description

Time Frame

Through study completion, an average of 1 week

Title

Study Endpoint: Respiration Rate

Description

Time Frame

Through study completion, an average of 1 week

Title

Study Endpoint: Activity

Description

Time Frame

Through study completion, an average of 1 week

Title

Study Endpoint: Skin Temperature

Description

Time Frame

Through study completion, an average of 1 week

Title

Study Endpoint: Bioimpedance (Extracellular fluid differences)

Description

Time Frame

Through study completion, an average of 1 week

Other Pre-specified Outcome Measures:

Title

Incidence of investigational device related adverse events

Description

Adverse events and serious adverse events will be documented throughout the study duration.

Time Frame

Through study completion, an average of 1 week

Title

Patient Experience

Description

Arm 2 and 3 Subjects will complete an end of study questionnaire to evaluate comfort and ease of use of the investigational device

Time Frame

Through study completion, an average of 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamie Kennedy, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Satellite Healthcare

City

San Jose

State/Province

California

ZIP/Postal Code

95128

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26811276

Citation

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.

Results Reference

background

PubMed Identifier

23741058

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. No abstract available.

Results Reference

background

PubMed Identifier

21080835

Citation

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.

Results Reference

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

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