Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure

The QI Device is a self-contained, reusable, rechargeable, battery-powered, wrist-watch that
simultaneously tracks and records a number of physiological health related parameters such
as heart rate, blood pressure, respiratory rate, temperature, and motion/position. One
advantage of this device over current home diagnostic systems is the capability for
longitudinal monitoring.

Inclusion Criteria:

- Adults over age 18

- Own, and comfortable using, a home computer with internet access (Phase 2 only)

- Acute hospitalization with a primary diagnosis of acute decompensated heart failure
(ADHF) diagnosed on the basis of all of the following:

1. Symptoms:

- Onset or worsening of dyspnea within the past 2 weeks

2. Physical exam (at least 1 present):

- Rales/ Crackles on auscultation

- Elevated JVP > 10 cmH2O

- Weight gain

- LE edema

3. Diagnostic imaging/ labs (at least 1 present):

- Evidence of pulmonary congestion or edema on chest X-ray/ chest CT

- Elevated BNP or NT-pro-BNP (age-adjusted)

Exclusion Criteria:

- Psychological or social situation that would make the study difficult for the patient

- Inability to consent

- Chronic atrial fibrillation or other dysrhythmia with a high (>10%) burden of ectopic
beats.

- Pregnant women

- Pneumonia - currently, or within the past 30 days

- Non-cardiogenic pulmonary edema (e.g. ARDS)

- Interstitial lung disease

- End-stage renal disease and on Hemodialysis