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A Multicenter, Open-Label, Paired-Design Clinical Trial to Evaluate the Efficacy, Safety, and Stability of Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System.

A Multicenter, Open-Label, Paired-Design Clinical Trial to Evaluate the Efficacy, Safety, and Stability of Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107178
Enrollment
Unknown
Registered
2025-08-05
Start date
2025-08-05
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Syncopepostural hypotensionorthostatic intolerancepostural tachycardia syndrome( POTS)chronic coronary syndrome( CCS)chronic heart failure( CHF)cardiac neurosis

Interventions

Gold Standard:Cardiovascular Autonomic Reflex Tests (CARTs)
Index test:The Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000)

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18 years and above, regardless of gender. 2. Having one of the indications for cardiac autonomic function examination: syncope, postural hypotension, orthostatic intolerance, postural tachycardia syndrome, chronic coronary syndrome, chronic heart failure, cardiac neurosis, etc. 3. Voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. A history of proliferative retinopathy (also known as proliferative stage retinopathy, i.e., stages IV-VI, retinal detachment, or glaucoma; 2. Within 3 months prior to signing the informed consent form, electrocardiogram (ECG) examination indicates any of the following: ectopic beats >= 5 beats per minute; various types of tachyarrhythmias (including but not limited to atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia); bradyarrhythmias with a non-1:1 P/R ratio (degree II-III atrioventricular block); or pacemaker rhythm. 3. Poorly controlled hypertension (sitting systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg before testing); 4. Acute coronary syndrome (including unstable angina pectoris, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) occurring within 3 months prior to signing the informed consent form; 5. Being in a state of stress such as severe infection or surgery, or in the acute or unstable phase of any disease, within 1 month prior to signing the informed consent form; 6. Pregnant women; 7. Inability to attach a dynamic electrocardiogram (ECG) recorder due to extensive skin burns, ulceration, inflammatory reactions, severe desquamation in the precordial area, or severe thoracic deformities; 8. Any other individuals whom the researchers consider unsuitable for this trial or unable to cooperate with the examination;

Design outcomes

Primary

MeasureTime frame
The sensitivity of the investigational device for diagnosing CAN;The specificity of the investigational device for diagnosing CAN;Accuracy;

Secondary

MeasureTime frame
Device-related adverse events and serious adverse events;

Countries

China

Contacts

Public ContactQinghua Hou

The Seventh Affiliated Hospital Sun Yat-sen University

houqinghua@sysush.com+86 755 8120 6847

Outcome results

None listed

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