Remote-CO-1: Assess Measurements of Wireless Cardiac Output Device
Study Details
Study Description
Brief Summary
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate, stroke volume, cardiac output, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation. Programs for chronic heart failure that include remote monitoring have been shown to have a positive effect on clinical outcomes in community dwelling patients with chronic heart failure.
In preparation for a study evaluating the effectiveness of mobile monitoring, the value of Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are available in a hospital or clinic setting. This study covers the validation of the measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or MRI
Study Design
Outcome Measures
Primary Outcome Measures
- Measuring Cardiac Output for wireless transmission as per discharge guideline [2 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects of either gender above the age of 18 years
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The subject is able and willing to provide written informed consent prior to enrollment in the study
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One or more of the following diagnosis
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New York Heart Association (NYHA) classification class of I-IV or Stages A-D
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Symptoms of dyspnea
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Chronic renal failure on renal replacement therapy
Exclusion Criteria:
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Patients who may not come for follow up or likely to drop out of the study
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Any illness which may preclude regular follow up
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Patient is unable or not willing to wear electrode patches as required
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Patient has skin sensitivity to adhesive or hydrogel materials used in electrode patches
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Patient is considered by the PI to be medically unsuitable for study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scottsdale Cardiovascular Center | Scottsdale | Arizona | United States | 85251 |
Sponsors and Collaborators
- Aventyn, Inc.
- Baxter Healthcare Corporation
- BMS Hospital Trust
- Intel Corporation
Investigators
- Principal Investigator: Kris Vijay, MD, MS, FACC, Scottsdale Healthcare
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. Epub 2007 Apr 10. Review.
- Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD007228.
- AV.CO.v0-01