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

Completed

Brief 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

Detailed 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)

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
AVIVO™ PiiX Patch Monitor System	AVIVO™ PiiX Patch Monitor System	Heart failure patients monitored continuously for 30 days post-discharge.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Health Care Utilizations	30 days post-discharge	Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight Per Unit Change in Thoracic Impedance	Discharge to 30 days post discharge	Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.

Locations (8): United Heart and Cardiovascular
🇺🇸
Saint Paul, Minnesota, United States
Scripps Green Hospital
🇺🇸
La Jolla, California, United States
Bay Area Cardiology
🇺🇸
Tampa, Florida, United States
Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
Mohawk Valley Heart Institute
🇺🇸
Utica, New York, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States