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A Prospective Clinical Study of Concordance, Performance Evaluation, and Algorithm Training for Arrhythmia Diagnosis: A Contactless, Unobtrusive Cardiopulmonary Monitoring System Versus Holter Monitoring

A Prospective Clinical Study of Concordance, Performance Evaluation, and Algorithm Training for Arrhythmia Diagnosis: A Contactless, Unobtrusive Cardiopulmonary Monitoring System Versus Holter Monitoring

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125860
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

ECG monitoring

Interventions

Observation group:None

Sponsors

the First People’s Hospital of Kunshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years. 2. Patients with confirmed or suspected arrhythmias (e.g., atrial flutter, atrial fibrillation, supraventricular tachycardia, premature ventricular contractions, bradycardia, etc.). 3. Able to complete a resting monitoring session lasting from 2 hours to overnight. 4. Willing to participate in the study and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of an implantable cardiac electronic device (e.g., pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device, cardiac contractility modulation device, or implantable cardiac monitor). 2. Behavioral factors that may interfere with data acquisition (e.g., agitation). 3. Patients whose contact with the mattress is unavoidably obstructed (e.g., bandage wrapping, use of absorbent underpads). 4. Burns, trauma, allergies, or other physiological/pathological conditions that preclude electrode placement or compromise data acquisition. 5. Any other condition that, in the investigator’s opinion, may affect the efficacy or safety assessment of the study and renders the subject unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
heartbeat agreement;event time agreement ;diagnostic classification;

Countries

China

Contacts

Public ContactZhongliang Yu

Cardiology Department, Kunshan First People's Hospital

1390857287@qq.com+86 512 5702 9079

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026