Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2026-03-02
Last updated
2026-08-21
Condition(s) studied
Heart Valve Diseases
Study summary
This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans.
The primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 18 years.
2. Complete electronic health record.
3. Non-contrast chest CT performed between Nov 1, 2025 - Nov 1, 2026 in any medical context (including physical exam, outpatient, inpatient, or emergency).
4. AI-predicted moderate or severe valvular heart disease, or deemed to require clinical intervention, or selected negative cases from sampling verification.
Exclusion Criteria:
1. Poor-quality non-contrast chest CT images.
2. Incomplete clinical records, involving severe deficiencies in critical diagnostic results, treatment records, imaging data, surgical records, medical history summaries, laboratory test results, or other essential medical information.
3. Presence of prosthetic valve implants, including aortic valves (mechanical valves, bioprosthetic valves), mitral valves (transcatheter edge-to-edge repair, bioprosthetic valves, mechanical valves, annuloplasty rings), tricuspid valves (TEER clipping, bioprosthetic valves, mechanical valves, annuloplasty rings), pulmonary valves (bioprosthetic valves), etc.
4. Abnormalities or conditions deemed by the investigator to warrant exclusion from the study enrollment.
Primary outcome measure(s)
Sensitivity — 1 year Sensitivity: Measures the proportion of patients with moderate-to-severe disease that the model correctly identifies.
Trial sites (3)
Facility
City
Region
Status
Renmin Hospital of Wuhan University
Wuhan
Hubei
Recruiting
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi
Xinjiang
Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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