Novel Wearable Device for Heart Failure Management

Clinical Translational Research of Novel Wearable Device Based on Patented Sensing Technology in Non-Invasive Management of Heart Failure

Heart failure (HF) is a major cardiovascular disease with high readmission and mortality rate. A wearable device that could remotely monitor and detect the worsening HF early before the symptoms appear will help reduce HF readmissions effectively. The purpose of the current study is to examine the efficiency of a novel wearable device based on flexible strain sensor comparing to the clinical 'gold standard,' and then transform it into a clinical application.

The prospective cohort study aims to examine the efficiency of a novel wearable device based on a flexible strain sensor to improve the outcomes of patients with HF compared to the standard-of-care without wearable device monitoring.

The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography,NYHA functional class,left ventricular ejection fraction,natriuretic peptide,additional co-morbidities,and others.

Inclusion Criteria:

1. Diagnosis of HF ≥ 3 months
2. Diagnosis of NYHA Class III HF
3. Subjects with age ≥ 18 years
4. At least 1 HF hospitalization within 12 months prior to enrollment
5. Subjects with elevated ambulatory levels of BNP/NT-proBNP

Exclusion Criteria:

1. Subjects unable to cooperate to complete the trial.
2. Subjects with severe arrhythmia.
3. Subjects with cardiac shock.
4. Subjects with acute myocardial infarction.
5. Subjects with local skin infections and injuries in the jugular vein area
6. Subjects with active uncontrolled infections
7. Subjects with eGFR < 25 mL/min/1.73m2
8. Pregnant women, or women likely to undergo pregnancy
9. Subjects with life expectancy less than 6 months