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Medical-engineering transformation and risk early warning model construction of multiple wearable products for heart failure and sudden cardiac death

Medical-engineering transformation and risk early warning model construction of multiple wearable products for heart failure and sudden cardiac death

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099993
Enrollment
Unknown
Registered
2025-04-01
Start date
2024-09-06
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Arrhythmia

Interventions

Gold Standard:Heart failure: echocardiogram, blood tests
arrhythmias: electrocardiogram, holter
sleep apnea: PSG.
Index test:Diagnostic test
Wearable heart rhythm monitor
Cardiovascular event smartwatch (PPG or piezoelectric).

Sponsors

Beijing hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Wearable Heart Failure Monitor (WHFM) and Cardiovascular Event Smartwatch Verification: 1. Medium- and high-risk patients who were screened by heart failure and SCD risk early warning models and admitted to Beijing Hospital, including 34 patients with acute heart failure. 2. Control group: 10 patients with non-heart failure who visited Beijing Hospital were included. without any indication for a diagnosis of heart failure; Blood tests and echocardiography are performed as clinically indicated. Wearable Electrocardiogram Monitor (WCM) and Cardiovascular Event Smartwatch Validation: 1. Disease group: 34 patients with premature ventricular contractions/ventricular tachycardia were included in the intermediate- and high-risk patients who were screened by heart failure and SCD risk early warning models and visited Beijing Hospital. Diagnostic criteria: short burst ventricular tachycardia or premature ventricular holter >= 2000 premature beats/day. 2. Control group: 10 patients with non-ventricular premature contractions/ventricular tachycardia who visited Beijing Hospital were included. Diagnosis of premature ventricular contractions/ventricular tachycardia; Holter examination is performed 1-3 days according to its clinical indications.

Exclusion criteria

Exclusion criteria: 1. The bust is too small or too large to wear WCM/WHFM; 2. Clinically unstable; 3. Known pregnancy, recent cardiothoracic surgery, recent chest trauma; 4. Age< 18 years old.

Design outcomes

Primary

MeasureTime frame
Premature ventricular contractions;Cardiac output;Ejection fraction;AHI;ODI;BNP/ProBNP;

Secondary

MeasureTime frame
Respiratory effort;Symptom;Fluid balance;Awakening frequency;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