Expired Study
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San Diego, California 92037


Purpose:

The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02343523


Primary Contact:

Principal Investigator
Steven Steinhuble, MD
STSI


Backup Contact:

N/A


Location Contact:

San Diego, California 92037
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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