EKO SENSORA: Detecting Clinically Significant Murmurs
ConditionHeart Murmurs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health South
About this trial
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).
The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.
The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography
Disqualifiers
Contact isolation patients
Pediatric patients under the age of 18
Trial design
Design model
Single group
Treatments tested in this trial
Eko Sensora
DeviceThe exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Eko DeviceOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of new clinically significant heart murmurs detected
Time frame
through study completion, an average of 90 daysSecondary outcomes
1
Number of echocardiograms ordered
Time frame
through study completion, an average of 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov