NCT03993886|CompletedFDA Device
A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
ZENITH
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ZENITH
Sponsor study identifier
Secondary identifiers
interventional
80
1 country
2
Study Start
January 17, 2019
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
July 14, 2020
Actual (reported)Evaluate the performance of the CorBand product when used to monitor patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 14, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2019
Actual (reported)April 24, 2019
Actual (reported)June 21, 2019
Actual (reported)June 30, 2020
Actual (reported)July 14, 2020
Actual (reported)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
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
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.
The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.
University of California, San Francisco
San Francisco, California, 94143, United States
Satellite Healthcare
San Jose, California, 95128, United States
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.
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.
Jamie Kennedy, MD
University of California, San Francisco
80 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2019
First Posted
June 21, 2019
Study Start
January 17, 2019
Actual (reported)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
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.
commercially available accelerometer to be worn on wrist
Commercially available bioimpedance monitor.
Commercially available electrocardiogram machine
Commercially available respiratory rate sensor.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
July 14, 2020
Actual (reported)Last Updated
July 17, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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