Low Ejection Fraction
Conditions
Keywords
low ejection fraction
Brief summary
The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.
Interventions
DEVICEEko digital stethoscopes
Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.
Sponsors
Eko Devices, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 years and older * Able and willing to provide informed consent * Complete a clinical echocardiogram within 7 days before or after study procedures
Exclusion criteria
* Unwilling or unable to provide informed consent * Patients who are hospitalized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm | 15-16 months | The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures. |
Countries
India
Contacts
CONTACTClinical Research Associate
Outcome results
None listed