Artificial Intelligence in Aortic Regurgitation

March 17, 2026 updated by: Dr Alex PW Lee, Chinese University of Hong Kong

Artificial Intelligence in Aortic Regurgitation: A Multicenter Randomised Controlled Trial

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, measurement, and diagnosis, addressing challenges like variability in echocardiographic interpretations and the need for specialized expertise. It will integrate multiple echocardiographic parameters to provide accurate, standardized, and efficient AR diagnoses, reducing human error and improving consistency. This tool will enhance diagnostic precision and accessibility, improving clinical outcomes and extending advanced diagnostic capabilities to a broader range of healthcare environments, including resource-limited settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • New Territories
      • Hong Kong, New Territories, Hong Kong, Sha Tin
        • Recruiting
        • Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed AR diagnosis via TTE and Doppler imaging per guidelines.
  • Age ≥ 18 years.
  • Adequate acoustic window for AR quantification.

Exclusion Criteria:

  • Prior cardiac transplant or implanted cardiac devices.
  • Poor image quality.
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AI-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.
Diagnostic test: AI-Assisted Group
Participants in this group will undergo aortic regurgitation assessment using an advanced artificial intelligence tool.
Other: Manual 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.
Other: Manual measurement group
Participants in this group will receive a traditional diagnostic assessment for aortic regurgitation, performed by trained sonographers following standard protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Outcomes
Time Frame: This will be recorded from baseline to study completion (20 months)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing Accuracy in Differentiating AR Severity Levels
Time Frame: This will be recorded from baseline to study completion (20 months)
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)
Time Frame: This will be recorded from baseline to study completion (20 months)
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)
Time Frame: This will be recorded from baseline to study completion (20 months)
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)
Time Frame: This will be recorded from baseline to study completion (20 months)
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
Time Frame: This will be recorded from baseline to study completion (20 months)
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)
Time Frame: This will be recorded from baseline to study completion (20 months)
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
Time Frame: The time taken for each method to reach a diagnosis will be recorded from baseline to study completion (20 months)
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
Time Frame: Participants will be followed up at 6 and 12 months to monitor outcomes, including 1-year all-cause mortality and HFH.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Semmelweis University
The University of New South Wales
The Prince Charles Hospital
Us2.ai
Toho University

Investigators

  • Principal Investigator: Alex PW Lee, Professor, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.689-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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