Who may be eligible for the A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation trial?

Inclusion criteria: * Genetic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site with AI-Echo analysis indicating high risk for a genetic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment * Ischemic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for ischemic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment. * Cardiac amyloidosis arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for cardiac amyloidosis. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment. * Hypertrophic cardiomyopathy (HCM) arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff caring for patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site, with AI-Echo analysis indicating high risk for HCM. A high-risk score will be defined by a specific threshold determined during model development to maximize sensitivity while maintaining adequate positive predictive value for clinical deployment. Exclusion criteria: * Genetic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known or suspected diagnosis of genetic cardiomyopathy under evaluation, on hospice care, or who have an expected non-cardiac life expectancy \<1 year, and patients who have opted out of institutional and state research authorizations. * Ischemic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known CAD; prior myocardial infarction; revascularization with PCI or CABG; ischemic testing within the past 12 months; hospice care or expected non-cardiac life expectancy \<1 year, and patients who have opted out of institutional and state research authorizations. * Cardiac amyloidosis arm: Studies performed within the past 2 years at a Mayo site or in those patients with prior amyloid-specific testing (e.g., technetium pyrophosphate scan, cardiac MRI with late gadolinium enhancement suggestive of amyloid) or biopsy-proven systemic amyloidosis, on hospice care, or have expected non-cardiac life expectancy \<1 year, and patients who have opted out of institutional and state research authorizations. * Hypertrophic cardiomyopathy (HCM) arm: Studies performed within the past 2 years at a Mayo site or patients with a known diagnosis of HCM documented in the medical record prior to the index TTE, prior septal reduction therapy (surgical myectomy or alcohol septal ablation), or patients on hospice care or with an expected non-cardiac life expectancy \<1 year, and patients who have opted out of institutional and state research authorizations.

ClinicalTrials.gov record NCT07308704

A Study Of Deep Learning For Echo Analysis, Tracking, And Evaluation

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

DELINEATE-Deploy: Deep Learning for Echo Analysis, Tracking, and Evaluation - Prospective Deployment Platform IRB

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study that deploys AI algorithms to analyze transthoracic echocardiograms (TTEs) in routine care. It measures clinician usability, interpretive consistency, and how the tools fit into clinical workflow. The study also includes a pragmatic, stepped-wedge comparison (using EHR notifications and cluster-level randomization) to evaluate diagnostic AI algorithms for several heart diseases and their effects on diagnostic testing and time to diagnosis.

What it is studying. Whether informational AI-Echo algorithms can assist clinicians in interpreting core echocardiogram measures and stratifying disease risk, and whether deploying these algorithms changes diagnostic testing patterns and time to diagnosis.

What the researchers hope to learn. To evaluate clinician usability, interpretive consistency, and workflow integration of AI-Echo tools. To assess diagnostic performance of AI algorithms for genetic cardiomyopathy, ischemic heart disease, cardiac amyloidosis, and hypertrophic cardiomyopathy, including counts of confirmed diagnoses and time from index TTE to confirmed diagnosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The purpose of this study is to deploy and evaluate informational AI-Echo algorithms that assist echo clinicians in interpreting core echocardiographic parameters (e.g., LV/RV size and function, valvular disease severity) and stratifying disease progression risk. The primary outcome is clinician usability, interpretive consistency, and workflow integration. Second, we will conduct a pragmatic, stepped-wedge clinical trial with multiple arms evaluating diagnostic AI-Echo algorithms designed to identify specific cardiovascular diseases- such as genetic cardiomyopathy, ischemic heart disease, and cardiac amyloidosis-and assess whether AI deployment increases diagnostic testing and shortens time to diagnosis. Trials will be conducted using EHR-based notification systems with cluster-level randomization.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: Transthoracic Echocardiography (TTE)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Genetic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site with AI-Echo analysis indicating high risk for a genetic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment
Ischemic cardiomyopathy arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for ischemic cardiomyopathy. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment.
Cardiac amyloidosis arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff taking care of patients aged ≥18 years who are undergoing a comprehensive TTE with AI-Echo analysis indicating high risk for cardiac amyloidosis. A high-risk score will be defined by a specific threshold determined in model development to maximize sensitivity while maintaining an adequate positive predictive value to support clinical deployment.
Hypertrophic cardiomyopathy (HCM) arm: Clinicians who order, perform, and interpret echocardiograms and act on echocardiogram results, including both physicians and allied health staff caring for patients aged ≥18 years who are undergoing a comprehensive TTE at a participating Mayo Clinic site, with AI-Echo analysis indicating high risk for HCM. A high-risk score will be defined by a specific threshold determined during model development to maximize sensitivity while maintaining adequate positive predictive value for clinical deployment.

Exclusion criteria

Genetic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known or suspected diagnosis of genetic cardiomyopathy under evaluation, on hospice care, or who have an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Ischemic cardiomyopathy arm: Studies performed within the past 2 years at a Mayo site or in those patients with known CAD; prior myocardial infarction; revascularization with PCI or CABG; ischemic testing within the past 12 months; hospice care or expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Cardiac amyloidosis arm: Studies performed within the past 2 years at a Mayo site or in those patients with prior amyloid-specific testing (e.g., technetium pyrophosphate scan, cardiac MRI with late gadolinium enhancement suggestive of amyloid) or biopsy-proven systemic amyloidosis, on hospice care, or have expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.
Hypertrophic cardiomyopathy (HCM) arm: Studies performed within the past 2 years at a Mayo site or patients with a known diagnosis of HCM documented in the medical record prior to the index TTE, prior septal reduction therapy (surgical myectomy or alcohol septal ablation), or patients on hospice care or with an expected non-cardiac life expectancy <1 year, and patients who have opted out of institutional and state research authorizations.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Clinicians' routine comprehensive TTEs will be processed by the study's AI‑Echo algorithms and clinicians may receive EHR‑based notifications or AI output during normal care. The study collects clinical and diagnostic data from medical records to evaluate usability, interpretive consistency, workflow integration, changes in downstream diagnostic testing, and time to diagnosis. Depending on clinical judgment, downstream tests ordered as part of usual care (for example, genetic testing, coronary imaging or angiography, stress testing, amyloid imaging, cardiac MRI, or biopsy) may occur and will be recorded. Deployment is done in a stepped‑wedge, cluster‑randomized way, so clinician teams may start receiving AI notifications at different times as part of the study design.

How the study is structured. A prospective observational deployment study that watches how AI tools perform and are used in real clinical settings. Nested within this deployment is a pragmatic stepped-wedge comparison where clinics receive the AI at different times (cluster-level randomization) and EHR-based alerts are used to study effects across disease-specific arms.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Cardiomyopathy; Ischemic Heart Disease; Cardiac Amyloidosis. Does it apply to my diagnosis?
This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Feb 26, 2026
Primary completion: February 2028 (estimated)
Study completion: February 2028 (estimated)
Target enrollment: 10040000 participants (estimated)
Last updated on registry: Apr 16, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Mayo Clinic
Principal investigator: Tim Poterucha, Principal Invetigator
Mayo Clinic

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Tim Poterucha, M.D. 📞 507-284-2129 ✉ poterucha.timothy@mayo.edu

Participating sites (1)

Mayo ClinicRecruiting
Rochester, Minnesota, 55905 · United States
- Tim Poterucha, M.D. · 507-284-2129 · poterucha.timothy@mayo.edu
- Tim Poterucha, M.D.

Terms used on this page · explanations by MedicalUpdates.ai

primary outcome: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
clinical trial: A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
randomization: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
echocardiogram: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
life expectancy: Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biopsy-proven: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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