Novel Wearable Device for Heart Failure Management

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Nov 30, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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