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Research and development and transformation of heart failure related early warning monitoring products and subcutaneous implantable automatic defibrillator series products

Research and development and transformation of heart failure related early warning monitoring products and subcutaneous implantable automatic defibrillator series products

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102554
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Gold Standard:Heart failure: echocardiogram, blood test
arrhythmia: electrocardiogram, 24-hour dynamic electrocardiogram.
Index test: Wearable cardiac monitor

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Wearable heart failure monitoring device (WHFM) and cardiovascular event smartwatch validation Study population selection: 1. Select 34 patients with acute heart failure who are at medium and high risk of seeking medical treatment in medical consortia and central hospitals. 2. Control group: 10 non heart failure patients who received treatment from medical consortia and central hospitals were included. The inclusion criteria for the control group are: 1. Any indication for the diagnosis of heart failure; 2. According to its clinical indications, blood tests and echocardiography examinations are required. WCM and cardiovascular event smartwatch verification Study population selection: 1. Ventricular premature beats/ventricular tachycardia group: Select medium and high-risk patients who seek medical treatment from medical consortia and central hospitals, and include them in the group 34 patients with ventricular premature beats/ventricular tachycardia. 2. Control group: 10 patients with non ventricular premature beats/ventricular tachycardia who visited medical consortia and central hospitals were included. Inclusion criteria for the control group: 1. No diagnosis of ventricular premature beats/ventricular tachycardia; 2. According to its clinical indications, a 1-3 day Holter examination is required.

Exclusion criteria

Exclusion criteria: Wearable heart failure monitoring device (WHFM) and cardiovascular event smartwatch validation a. The chest circumference is too small or too large to wear WHFM; b. Unstable clinical condition; c. Known pregnancy, recent cardiothoracic surgery, recent chest trauma; d. Age<18 years old. WCM and cardiovascular event smartwatch verification a. The chest circumference is too small or too large to wear WCM; b. Unstable clinical condition; c. Known pregnancy, recent cardiothoracic surgery, recent chest trauma; d. Age<18 years old.

Design outcomes

Primary

MeasureTime frame
Premature ventricular contractions;Cardiac output;BNP/ProBNP;Fluid balance;Symptom;Ejection fraction;Exercise tolerance;Recovery time after premature ventricular contraction;

Countries

China

Contacts

Public ContactZou Tong

Beijing Hospital

zoutong2001@163.com+86 136 0116 4422

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026