Real-World Evaluation of Eko Algorithms in a Point of Care Setting

Status Recruiting

Clinical Trial Summary

The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.

Clinical Trial Description

Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. In November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late. Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021. This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05459545
Study type	Observational
Source	Eko Devices, Inc.
Contact	Doug Van Pelt
Phone	1-844-356-3384
Email	doug.vanpelt@ekohealth.com
Status	Recruiting
Phase
Start date	April 15, 2022
Completion date	May 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Completed	`NCT04571385` - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)	Phase 2
Completed	`NCT05366803` - Women's Health Initiative Silent Atrial Fibrillation Recording Study	N/A
Completed	`NCT02864758` - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting	`NCT05442203` - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease	N/A
Completed	`NCT05599308` - Evaluation of Blood Pressure Monitor With AFib Screening Feature	N/A
Completed	`NCT03790917` - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation	`NCT05890274` - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO	N/A
Recruiting	`NCT05266144` - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting	`NCT05316870` - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation	N/A
Not yet recruiting	`NCT06023784` - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT04087122` - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures	N/A
Completed	`NCT06283654` - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04546763` - Study Watch AF Detection At Home
Completed	`NCT03761394` - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.