AVIVO™ PiiX Patch Monitor System
DeviceExternal monitoring for 30 days post-discharge.
NCT Number: NCT01574144
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
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Notify Me18 year and older
All sexes
Observational
The Alfred Hospital, Melbourne, Victoria, Australia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
External monitoring for 30 days post-discharge.
Time frame: 30 days post-discharge
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
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.
Medtronic Cardiac Rhythm and Heart Failure
Industry
Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
Acronym: READMIT-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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