Skip to content

Clinical equivalence study of digital multi-channel electrocardiograph

Clinical equivalence study of digital multi-channel electrocardiograph

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105711
Enrollment
Unknown
Registered
2025-07-09
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

cardiovascular disease

Interventions

Observation group:NA

Sponsors

Wuhan Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Over 3 years old, gender not limited; 2.The subjects meet any one of the following criteria: (1) Roughly normal; (2)Arrhythmia: atrial and ventricular premature beats; Atrial flutter/fibrillation or first-degree atrioventricular block and complete left/right bundle branch block; (3) There are two adjacent leads with ST segments elevated by >= 0.2mV or depressed by >=0.1mV. 3. Good compliance, able to cooperate independently to complete this research; 4.Voluntarily participate and have signed the informed consent form..

Exclusion criteria

Exclusion criteria: 1. Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICDs); 2.Patients with tremor disorders or chorea, etc., who have difficulty cooperating quietly to complete the examination; 3. Patients with bullous diseases or extensive rashes all over the body, etc., who are not suitable for surface electrode recording; 4.Patients whose skin is allergic to ethanol; 5.Patients with infectious skin diseases; 6.Patients with a history of mental illness or cognitive dysfunction; 7.Patients who have participated in other clinical trials that may affect this trial within 30 days; 8.Other circumstances where the researcher deems it inappropriate to participate in the trial..

Design outcomes

Primary

MeasureTime frame
Evaluation of the accuracy of equipment parameter measurement;

Secondary

MeasureTime frame
Evaluation of equipment usage safety;

Countries

China

Contacts

Public ContactZhang Bo

Wuhan Sixth Hospital

499308381@qq.com+86 139 7119 0936

Outcome results

None listed

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