REducing 30-day ADMIssions in posT-discharge Subjects (READMIT) (READMIT-HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01574144 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
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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
Condition or disease | Intervention/treatment |
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Acute Decompensated Heart Failure | Device: AVIVO™ PiiX Patch Monitor System |
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)
Study Type : | Observational |
Actual Enrollment : | 70 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study of Reducing 30-day Admissions in Post-discharge Subjects |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | August 2013 |

Group/Cohort | Intervention/treatment |
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AVIVO™ PiiX Patch Monitor System
Heart failure patients monitored continuously for 30 days post-discharge.
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Device: AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge. |
- Percentage of Participants With Health Care Utilizations [ Time Frame: 30 days post-discharge ]Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
- Change in Body Weight Per Unit Change in Thoracic Impedance [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574144
United States, California | |
Scripps Green Hospital | |
La Jolla, California, United States, 92037 | |
United States, Florida | |
Bay Area Cardiology | |
Tampa, Florida, United States, 33511-5908 | |
United States, Minnesota | |
United Heart and Cardiovascular | |
Saint Paul, Minnesota, United States, 55102-2568 | |
United States, New Jersey | |
Morristown Memorial Hospital | |
Morristown, New Jersey, United States, 07962 | |
United States, New York | |
Mohawk Valley Heart Institute | |
Utica, New York, United States, 13501-5930 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45219-2364 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 |
Study Director: | READMIT-HF Study Team | Medtronic |
Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
ClinicalTrials.gov Identifier: | NCT01574144 |
Other Study ID Numbers: |
READMIT-HF |
First Posted: | April 10, 2012 Key Record Dates |
Results First Posted: | October 29, 2018 |
Last Update Posted: | October 29, 2018 |
Last Verified: | February 2018 |
Heart Failure |
Heart Failure Heart Diseases Cardiovascular Diseases |