N/A
N=70
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Acute Decompensated Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01574144 ↗Enrolled (actual)
70
Serious AEs
20.0%
Results posted
Oct 2018
Primary outcome: Primary: Percentage of Participants With Health Care Utilizations — 28.6 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AVIVO™ PiiX Patch Monitor System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Health Care Utilizations |
28.6 | — |
| SECONDARY Change in Body Weight Per Unit Change in Thoracic Impedance |
-0.03 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01574144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.