NCT05642650

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	novel wearable device	Patients with a novel wearable device for monitoring and uploading data daily to collect monitoring data such as jugular vein pressure and exercise steps after discharge.

Timeline

• Start date: 2023-02-07
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-12-08
• Last updated: 2023-02-08