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

NCT01574144 | Completed Results

• 1 other identifier: READMIT-HF
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 8

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

Conditions

Acute Decompensated Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Health Care Utilizations

  Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.

  30 days post-discharge

Secondary Outcomes (1)

• Change in Body Weight Per Unit Change in Thoracic Impedance

  Discharge to 30 days post discharge

Study Arms (1)

AVIVO™ PiiX Patch Monitor System

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

Device: AVIVO™ PiiX Patch Monitor System

Interventions

AVIVO™ PiiX Patch Monitor System DEVICE

External monitoring for 30 days post-discharge.

AVIVO™ PiiX Patch Monitor System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients who are admitted to the hospital.

You may qualify if:

• Subject with acute decompensated heart failure
• Subject (or legal guardian) willing to give consent for their participation
• Subject ≥18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Bay Area Cardiology

Tampa, Florida, 33511-5908, United States

Location

United Heart and Cardiovascular

Saint Paul, Minnesota, 55102-2568, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Mohawk Valley Heart Institute

Utica, New York, 13501-5930, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219-2364, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amy Lautenbach
• Organization: Medtronic, Inc

amy.a.lautenbach@medtronic.com@medtronic.com

7633609163

Study Officials

• READMIT-HF Study Team

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 30, 2022
• Results First Posted: October 29, 2018

Record last verified: 2022-12

Locations

US (7); AU (1)