Heart Failure Clinical Trial
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Summary
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
Full Description
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)
Eligibility Criteria
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.
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There are 8 Locations for this study
La Jolla California, 92037, United States
Tampa Florida, 33511, United States
Saint Paul Minnesota, 55102, United States
Morristown New Jersey, 07962, United States
Utica New York, 13501, United States
Cincinnati Ohio, 45219, United States
Nashville Tennessee, 37232, United States
Melbourne Victoria, 3004, Australia
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