Actively Recruiting

Age: 18Years +
All Genders
ID07197736

Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)

Led by Columbia University · Updated on 2026-04-16

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

Heart disease is the leading cause of death in the United States, and echocardiography (echo) is the most common method doctors use to examine the heart. Valve diseases such as aortic stenosis and mitral regurgitation are common in older adults but often go undiagnosed. This research aims to test whether artificial intelligence (AI) can help cardiologists analyze echocardiograms more quickly and consistently by providing real-time AI analysis during echo reading. Researchers at Columbia University have developed deep learning algorithms that interpret echocardiograms by classifying views, identifying structures, measuring heart dimensions, and diagnosing valve disease. This study will continue to develop these AI models using patient data and evaluate an automated system that delivers AI analyses to cardiologists while they review echocardiograms. The goal is to improve the accuracy and efficiency of echo readings. Participants are attending cardiologists who read transthoracic echocardiograms at Columbia University facilities and have consented to participate. The study involves reviewing echocardiograms with AI support and comparing physician and AI assessments, especially for cases of moderate to severe valve leakage or narrowing. Outcomes measured include how often AI changes clinical decisions or leads to referrals for specialists or further testing over an 18-month period. Expert panel reviews and follow-up assessments will monitor the impact of AI on clinical management.

CONDITIONS

Brief Title

DELINEATE-Prospective

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 18 months

Participants undergo echocardiogram assessments that are analyzed by deep learning algorithms and expert cardiologists to evaluate valvular regurgitation severity.

Visits as needed for echocardiogram assessments and expert panel adjudication

Long-term Monitoring

Duration - Up to 18 months

Participants are observed over time to track clinical management changes and outcomes based on AI and physician assessments.

Follow-up visits scheduled based on clinical needs

Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

H

Heidi S Hartman, MD

M

Michelle Castillo, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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