A Multi-Center Study of Detection of Low Ventricular Ejection Fraction

This is a multi-site, retrospective study to evaluate the performance of a locked AI-based algorithm for detection of left ventricular systolic dysfunction. A prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ECG paired with an echocardiogram with LVEF information within 30 days of the date of the ECG. The AI-ECG LVSD algorithm will be applied on all ECGs and diagnostic performance features for the detection of LVSD will be estimated using the provided paired LVEF value (Low LVEF as the reference label). Performance will also be assessed in subgroups of subjects determined by demographic and clinical factors.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deacon Medical Center, Boston, Massachusetts, United States

About this study

Following institutional review board approval, 12,000 12-lead ECG's paired with an echocardiogram with LVEF information within 30 days of the date of the ECG will be collected across three enrolled sites. Each site will provide data from up to 4000 enrolled subjects that meet the inclusion criteria. No other demographic characteristics or enrichment will be considered in the selection of subjects in order to best represent the general population for that site. Sites will securely transfer the data to a centralized repository for processing.

Once data is collected, the device will be used to analyze the ECG data for all enrolled subjects without reference or access to the echocardiogram data. The device will display a binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.

Exclusion criteria

No research authorization provided
An ECG signal shorter than 10 seconds or that is not interpretable
An echocardiogram is considered technically challenging
Only qualitative interpretation of left ventricular systolic function available (i.e., "decreased EF") without a numerical value.
A paced rhythm

Treatment and study plan

AI Algorithm to detect LVEF in ECG

Diagnostic Test

A clinical decision support software as a medical device that detects whether a patient has LVEF less than or equal to 40% based upon the input of one or more ECG vectors at the point-of-care.

Primary outcomes

Established Diagnostic Performance

Time frame: 1 month

Number of participants with presence of EF less than of equal to 40% identified by 12-lead AI ECG algorithm

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Anumana, Inc.

Registry information

Official study title

A Multicenter Study of Detection of Low Ventricular Ejection Fraction (LVEF) ≤ 40% Based on Point-of-Care 12- Lead ECG Data

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 15, 2021
Registry last updated: Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed