Benefits of Microcor in Ambulatory Decompensated Heart Failure

Study Overview
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Brief Summary
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To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Detailed Description
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Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days. During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μCor wear, and any health care utilization since the end of μCor wear.

Official Title
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Benefits of Microcor in Ambulatory Decompensated Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: μCor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge. 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1 4.1.3 Subjects 21 years of age or older on the day of screening. Exclusion Criteria: 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD) 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease. 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives. 4.2.4 Subjects anticipated to start dialysis within 90 days. 4.2.5 Subjects currently implanted with an S-ICD system. 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization. 4.2.7 Subjects who are unable to participate in all follow up visits. 4.2.8 Subjects participating in research other than a registry at the time of enrollment. 4.2.9 Subjects currently implanted with an LVAD. 4.2.10 Subjects with self-reported pregnancy. 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Ages Eligible for Study
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Minimum Age: 21 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Data Engagement Assessment<br>This arm will assess the endpoints of investigator engagement with the device data. | Device: μCor<br>* μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Engagement of Device Data | Quantification of investigator actions after viewing device data. | Through study completion, an average of 2.5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations of the μCor measured thoracic fluid index to heart failure related clinical events. | Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance). Clinical heart failure events will be collected in the Case Report Forms. | 90 days. | 
| Correlations of cardiac rhythm μCor measurements to heart failure related clinical events. | Reading: cardiac rhythm measured as heart rate (beats per minute)Clinical heart failure events will be collected in the Case Report Forms. | 90 days | 
| Correlations of respiration rate μCor measurements to heart failure related clinical events. | Reading: respiration rateClinical heart failure events will be collected in the Case Report Forms. | 90 days | 
| Correlations of the μCor measured thoracic fluid index and heart failure related symptoms. | Reading: thoracic impedance index (relative value that is normalized to a baseline radar impedance).Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms. | 90 days | 
| Correlations of cardiac rhythm μCor measurements and heart failure related symptoms. | Reading: cardiac rhythm measured as heart rate (beats per minute)Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms. | 90 days. | 
| Correlations of respiration rate μCor measurements and heart failure related symptoms. | Reading: respiration rate. Heart Failure symptoms assessed through subject reported symptoms captured in the Case Report Forms. | 90 days | 
| Incident Rate; Hospital Readmission | Rate of hospital readmission captured in the Case Report Forms. | 90 days, 6 months, 1 year | 
| Incident Rate; Physician Visit | Rate of physician visits captured in the Case Report Forms. | 90 days, 6 months, 1 year | 
| Incident Rate; Outpatient Clinic Visit | Rate of outpatient clinic visits captured in the Case Report Forms. | 90 days, 6 months, 1 year | 
| Mortality; Rate | Mortality Rate; number of subject deaths captured in the Case Report Forms | 90 days, 6 months, 1 year | 
| Mortality; Cause of Death | Cause of Death; clinical history captured in the Case Report Forms | 90 days, 6 months, 1 year | 
| Quality of Life by Patient Security Questionnaire | Quality of Life; measured through and Patient Health Security Questionnaire. | 90 days, 6 months, 1 year | 
| Quality of Life by Kansas City Heart Questionnaire | Quality of Life; measured through Kansas City Heart Failure Questionnaire. | 90 days, 6 months, 1 year | 
| Health Care Utilization by Cost Estimate | Health Care Utilization; measured through cost estimates of prescription medications. | 90 days, 6 months, 1 year | 
| Health Care Utilization by Frequency of Prescription Medication Use. | Health Care Utilization; measured through frequency of prescription medication use reported on the Case Report Forms. | 90 days, 6 months, 1 year | 
| Health Care Utilization by Frequency of Hospital Visits. | Health Care Utilization; measured through frequency of hospital visits reported on the Case Report Forms. | 90 days, 6 months, 1 year | 
| Health Care Utilization by Frequency of ER visits. | Health Care Utilization; measured through frequency of emergency room visits reported on the Case Report Forms. | 90 days, 6 months, 1 year | 
| Health Care Utilization by Frequency of physician visits. | Health Care Utilization; measured through frequency of physician visits reported on the Case Report Forms. | 90 days, 6 months, 1 year |