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

NCT ID: NCT01574144

Last Updated: 2022-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-08-31

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)

Conditions

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Acute Decompensated Heart Failure

Keywords

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AVIVO™ PiiX Patch Monitor System

Heart failure patients monitored continuously for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System

Intervention Type DEVICE

External monitoring for 30 days post-discharge.

Interventions

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AVIVO™ PiiX Patch Monitor System

External monitoring for 30 days post-discharge.

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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READMIT-HF Study Team

Role: STUDY_DIRECTOR

Medtronic

Locations

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Scripps Green Hospital

La Jolla, California, United States

Site Status

Bay Area Cardiology

Tampa, Florida, United States

Site Status

United Heart and Cardiovascular

Saint Paul, Minnesota, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Mohawk Valley Heart Institute

Utica, New York, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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READMIT-HF

Identifier Type: -

Identifier Source: org_study_id