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A Multicenter Pragmatic Implementation Study of ECG-AI-Based Clinical Decision Support Software to Identify Low LVEF

NCT05867407 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11610

Last updated 2025-09-04

No results posted yet for this study

Summary

A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.

The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

Conditions

  • Ventricular Ejection Fraction

Interventions

DEVICE

Anumana Low EF AI-ECG Algorithm

Clinician will have access to the Anumana Low EF AI-ECG algorithm via a link in the patient's electronic health record which will display results applied to patients' ECGs, as well as supporting information. Using the results of the algorithm, combined with the clinician's knowledge of patient-specific risk factors, the clinician will determine whether further evaluation is warranted.

OTHER

Care-as-Usual

Clinicians will not have access to the Anumana Low EF AI-ECG algorithm and will provide care-as-usual.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Anumana, Inc.

    lead INDUSTRY

Principal Investigators

  • Francisco Lopez-Jimenez, MD, MSc, MBA · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867407 on ClinicalTrials.gov