Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06009718

Deep Learning-Based Wearable Device Study Using Heart Sound and ECG Data for Screening Depressed Heart Function

Led by Ruijin Hospital · Updated on 2025-01-16

3000

Participants Needed

3

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a new wearable device that combines synchronized phonocardiography (PCG) and electrocardiogram (ECG) to help diagnose depressed left ventricular ejection fraction (dLVEF), a form of heart failure where the heart's pumping ability is reduced (ejection fraction less than 50%). This device aims to speed up diagnosis, reduce the need for costly ultrasound tests, and improve access to life-saving therapies by using artificial intelligence (AI) to analyze the collected heart sound and electrical data. The wearable cardiac patch wirelessly pairs with the WenXin Mobile application, allowing simultaneous recording and viewing of PCG and ECG signals. This study is a case-control design involving adults aged 18 to 100 years who are scheduled for ultrasound cardiography (UCG). The AI system will be developed by creating machine learning algorithms that learn from the synchronized PCG and ECG data of patients with dLVEF and then use these algorithms to identify such patients in clinical practice. Participants will have their heart failure status assessed once at the start of the study. The device collects acoustic and electrical heart data during regular care visits, and participants must have completed UCG and be able to record at least 8 consecutive cycles of sinus rhythm. The study involves cooperation with research procedures and informed consent. The main outcome is the determination of heart failure disease using the wearable device and AI analysis.

CONDITIONS

Official Title

Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Attendance at RuiJin hospital for UCG
  • Signed dated informed consent
  • Commitment to follow all research procedures and cooperate throughout the study
  • Completion of ultrasound cardiography (UCG)
  • Age 18 years or older
  • Ability to record at least 8 consecutive cycles of sinus rhythm
Not Eligible

You will not qualify if you...

  • Presence of a pacemaker
  • Complete left bundle branch block or QRS wave widening greater than 120 milliseconds
  • Damage or allergy to the skin on the left chest that would prevent patch use
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Ruijin Hospital, Shanghai Jiaotong School of Medicine

Shanghai, China, 200025

Actively Recruiting

2

Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine

Shanghai, China, 200030

Actively Recruiting

3

Shanghai East Hospital

Shanghai, China, 200123

Actively Recruiting

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Research Team

W

Wenli Zhang, MD

B

Bei Song, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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