NCT01574144

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DEVICE	AVIVO™ PiiX Patch Monitor System	External monitoring for 30 days post-discharge.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-04-01
• Completion: 2013-08-01
• First posted: 2012-04-10
• Last updated: 2022-12-30
• Results posted: 2018-10-29

Locations

8 sites across 2 countries: United States, Australia