DELINEATE-Prospective

Recruiting now

Conditions studied: Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease, Tricuspid Regurgitation (TR), Aortic Regurgitation

In brief

Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease. Valve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers. Recent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions. At Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.

Key facts

Study ID

NCT07197736

Run by

Columbia University

People needed

50

Starts

2026-04-15

Expected to finish

2028-10-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory
• Provided informed consent to take part in the questionnaires or pivotal study

You may not qualify if…

• Physician in training (cardiology fellow or advanced imaging fellow)

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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