Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to obtain observational data allowing for the preliminary assessment of the utility of a noninvasive physiologic monitor for monitoring of patients with congestive heart failure.

Detailed Description
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The study proposes to utilize the CoVa™ Monitoring System, a novel body-worn sensor that remotely monitors thoracic fluid, heart rate, heart rate variability, respiration rate, skin temperature, posture, and, using transmitted waveforms, stroke volume and cardiac output to evaluate the system's monitoring capabilities in individuals recently hospitalized for congestive heart failure. The data acquired through this study will play a critical roll in developing future interventional studies that will allow patients with HF to potentially receive better and more timely treatment in the home setting, decreasing hospitalizations and improving quality of life.

Official Title
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Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure

Conditions
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Congestive Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over age 18 Have wireless internet access within their homes. Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following: Symptoms: Onset or worsening of dyspnea within the past 2 weeks Physical exam (at least 1 present): Rales/ Crackles on auscultation Elevated JVP > 8 cmH2O Weight gain LE edema Diagnostic imaging/ labs (at least 1 present): Evidence of pulmonary congestion or edema on chest X-ray/ chest CT Elevated NT-pro-BNP (age-adjusted) (>1000) Patients of particular interest will be those who already have a Medtronic Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy device with the OptiVol feature that tracks transthoracic impedance. Exclusion Criteria: Allergy to ECG electrodes Psychological or social situation that would make the study difficult for the patient Inability to consent Pregnant women Pneumonia - currently, or within the past 30 days Non-cardiogenic pulmonary edema (e.g. ARDS) Interstitial lung disease End-stage renal disease and on hemodialysis For any reason unable to wear or place the CoVa™ device, e.g. pectus excavatum, fragile skin, severe arthritis.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF. | To track on a daily basis important physiologic parameters among patients with a primary diagnosis of acute decompensated heart failure (ADHF) beginning at the time of their hospitalization and then continued for up to 60 days after discharge, in order to better understand their inter- and intra- individual variability and compare this to standard monitoring including daily weights. To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization. | 65 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology. | Compare transthoracic impedance measured noninvasively with the CoVa and invasively in individuals who already have a Medtronic implanted device with OptiVol technology. | 65 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute decompensated heart failure (ADHF), noninvasive physiologic monitoring