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Chinese University of Hong KongArtificial Intelligence in Aortic Regurgitation 540 Randomized
Clinical Trial NCT07486271 is an interventional study for Aortic Regurgitation Disease that is recruiting. It started on 1 December 2025 with plans to enroll 540 participants. Led by Chinese University of Hong Kong, it is expected to complete by 31 March 2028. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief Summary
This research project aims to develop and validate a tool that uses artificial intelligence (AI) to automatically detect and quantify aortic regurgitation (AR). The clinical efficacy of this tool will be established by comparing it to manual diagnostic methods in a multicenter randomized controlled trial. By leveraging deep learning (DL) techniques, the AI system will automate aortic regurgitation (AR) detection, mea...Show More
Official Title
Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial
Conditions
Aortic Regurgitation DiseaseOther Study IDs
- 2024.689-T
NCT ID Number
Start Date (Actual)
2025-12-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2028-03-31
Enrollment (Estimated)
540
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Aortic Regurgitation
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Artificial Intelligence
Echocardiography
Automated Diagnosis
Clinical Efficacy
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorAI-Assisted Group AR severity will be assessed using an AI tool that evaluates grading and key echocardiographic parameters (e.g., EROA, VC, PISA, jet width, and RegVol), along with the time required for assessments. | AI-Assisted Group Participants in this group will undergo aortic regurgitation assessment using an advanced artificial intelligence tool. |
OtherManual Measurement Group AR severity will be assessed manually by trained sonographers following standard protocols. Cardiologists (ASE level III or equivalent), blinded to patient history and group assignment, will review both AI-generated and manual outputs to make final diagnoses and treatment decisions based solely on the initial assessments. | Manual measurement group Participants in this group will receive a traditional diagnostic assessment for aortic regurgitation, performed by trained sonographers following standard protocols. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Study Outcomes | To compare the accuracy of the AI group and the manual group in distinguishing severe from non-severe AR, using expert cardiologists' (ASE level III or equivalent) assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Comparing Accuracy in Differentiating AR Severity Levels | To compare the accuracy of the AI group and the manual group in differentiating trace, mild, moderate, and severe aortic regurgitation, using cardiologists' assessments as the reference standard. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Effective Regurgitant Orifice Area (EROA) | The Effective Regurgitant Orifice Area (EROA) assesses the size of a valve opening that leads to backward blood flow in the heart. It is an important metric for evaluating valvular regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Vena Contracta (VC) | The Vena Contracta (VC) is an important measurement in echocardiography used to evaluate how severe mitral regurgitation is and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Proximal Isovelocity Surface Area (PISA) | Proximal Isovelocity Surface Area (PISA) is a method used in echocardiography to evaluate mitral regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in jet width | The jet width is a critical measurement used to assess the severity of aortic regurgitation and will be measured during echocardiography. | This will be recorded from baseline to study completion (20 months) |
Assessing deviations in Regurgitant Volume (RegVol) | Regurgitant Volume assesses how much blood leaks back into the left atrium during mitral regurgitation and will be measured using Doppler echocardiography. | This will be recorded from baseline to study completion (20 months) |
Comparing Assessment Completion Time | To compare the time taken by the AI group, the manual group, and the cardiologists to complete their assessments. | The time taken for each method to reach a diagnosis will be recorded from baseline to study completion (20 months) |
Tracking 1-Year Outcomes | To track 1-year all-cause mortality and heart failure hospitalizations (HFH), comparing outcomes for patients with severe aortic regurgitation identified by the AI and manual groups, separately. | Participants will be followed up at 6 and 12 months to monitor outcomes, including 1-year all-cause mortality and HFH. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.
- Age ≥ 18 years.
- Adequate acoustic window for AR quantification.
- Prior cardiac transplant or implanted cardiac devices.
- Poor image quality.
- Pregnancy or lactation.
Chinese University of Hong Kong474 active studies to explore- 🎓Semmelweis U...
Study Responsible Party
Dr Alex PW Lee, Principal Investigator, Professor, Chinese University of Hong Kong
Study Central Contact
Contact: Xueting Wang, (852) 3505 3840, [email protected]
1 Study Locations in 1 Countries
New Territories
Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, New Territories, Sha Tin, Hong Kong
Xueting PW Wang, Professor, Contact, (852) 3505 3840, [email protected]
Recruiting