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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL125001-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Evaluate the performance of the CorBand product when used to monitor patients.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management. |
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| Arm 2 | Other | Adult (≥ 18 years of age) patients undergoing chronic hemodialysis. |
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| 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. |
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| Arm 4 | Other | Adult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorBand | Device | The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Experience |
INCLUSION:
Arm 1:
Arm 2:
Arm 3:
Arm 4:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Kennedy, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Satellite Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26811276 | Background | 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. | |
| 23741058 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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Multi-Arm study with different patient populations evaluating the CorBand.
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| Activity Monitor | Other | commercially available accelerometer to be worn on wrist |
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| Bioimpedance spectrometer | Other | Commercially available bioimpedance monitor. |
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| ECG | Other | Commercially available electrocardiogram machine |
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| respiratory rate sensor | Other | Commercially available respiratory rate sensor. |
|
| 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 |
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 |
| San Jose |
| California |
| 95128 |
| United States |
| 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. |
| 21080835 | 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. |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |