REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)

Study Overview
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Brief Summary
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The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF) Changes in physiologic data are expected to correlate with 30-day readmission rates in this population

Detailed Description
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This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia The study objectives are: Collect and characterize physiologic data from subjects with acute decompensated heart failure. Characterization of data related to health care utilizations within 30-days Post-discharge Correlation between patch monitor collected data and inpatient clinical data Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)

Official Title
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Observational Study of Reducing 30-day Admissions in Post-discharge Subjects

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: AVIVO™ PiiX Patch Monitor System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with acute decompensated heart failure Subject (or legal guardian) willing to give consent for their participation Subject ≥18 years of age Exclusion Criteria: Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation) Subject with known allergies or hypersensitivities to adhesives or hydrogels Subject with implantable devices with active minute ventilation sensors. Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AVIVO™ PiiX Patch Monitor System<br>Heart failure patients monitored continuously for 30 days post-discharge. | Device: AVIVO™ PiiX Patch Monitor System<br>* External monitoring for 30 days post-discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Health Care Utilizations | Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits. | 30 days post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight Per Unit Change in Thoracic Impedance | Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance. | Discharge to 30 days post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure