Acute Decompensated Heart Failure
Conditions
Keywords
Heart Failure
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
Detailed description
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)
Interventions
DEVICEAVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Health Care Utilizations | 30 days post-discharge | Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight Per Unit Change in Thoracic Impedance | 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. |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AVIVO™ PiiX Patch Monitor System Heart failure patients monitored continuously for 30 days post-discharge.
AVIVO™ PiiX Patch Monitor System: External monitoring for 30 days post-discharge. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | AVIVO™ PiiX Patch Monitor System |
|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Australia | 10 participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 70 |
| serious Total, serious adverse events | 14 / 70 |
Outcome results
Primary
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.
Time frame: 30 days post-discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AVIVO™ PiiX Patch Monitor System | Percentage of Participants With Health Care Utilizations | 28.6 percentage of participants |
Secondary
Change in Body Weight Per Unit Change in Thoracic Impedance
Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Time frame: Discharge to 30 days post discharge
Population: All subjects with changes of body weight and impedance from discharge to 30 days post discharge.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AVIVO™ PiiX Patch Monitor System | Change in Body Weight Per Unit Change in Thoracic Impedance | -0.03 lbs/Ohm |