Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01574144




Registration number
NCT01574144
Ethics application status
Date submitted
3/04/2012
Date registered
10/04/2012
Date last updated
30/12/2022

Titles & IDs
Public title
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Scientific title
Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
Secondary ID [1] 0 0
READMIT-HF
Universal Trial Number (UTN)
Trial acronym
READMIT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Decompensated Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - AVIVO™ PiiX Patch Monitor System

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


Treatment: Devices: AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Health Care Utilizations
Timepoint [1] 0 0
30 days post-discharge
Secondary outcome [1] 0 0
Change in Body Weight Per Unit Change in Thoracic Impedance
Timepoint [1] 0 0
Discharge to 30 days post discharge

Eligibility
Key inclusion criteria
* Subject with acute decompensated heart failure
* Subject (or legal guardian) willing to give consent for their participation
* Subject =18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT01574144
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
READMIT-HF Study Team
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01574144