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Safety and effectiveness of artificial intelligence technology for wearable limb Single lead electrocardiogram

Safety and effectiveness of artificial intelligence technology for wearable limb Single lead electrocardiogram

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053980
Enrollment
Unknown
Registered
2021-12-05
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

arrhythmia

Interventions

Gold Standard:GE MARS three-channel dynamic ECG recorder
Index test:Kardia&#32
Mobile,&#32
Omron&#32
Model&#32
BP7900&#32
Blood&#32
Pressure&#32
Monitor&#32
+&#32
EKG,&#32
HUAWEI&#32
WATCH&#32
GT&#32
2&#32
Pro&#32
ECG,&#32
CHERO&#32
Single-lead&#32
ECG&#32

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years; 2. People with a definite diagnosis of sinus rhythm, atrial fibrillation, or other arrhythmias can be verified by 12-lead ECG; 3. Agree and cooperate to participate in this study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of the use of antiarrhythmic drugs, pacemaker implantation, ICD implantation and CRT (D) implantation; 2. Hemodynamically unstable arrhythmia patients; 3. Patients with severe Parkinson's disease and amputation.

Design outcomes

Primary

MeasureTime frame
rhythm;Accuracy, specificity, sensitivity, ROC curve;—

Secondary

MeasureTime frame
Heart rate;amplitude of R wave;—

Countries

China

Contacts

Public ContactZhang Ping

Beijing Tsinghua Changgung Hospital

zhpdoc@126.com+86 13910036632

Outcome results

None listed

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