NCT05873387 · Eko Devices, Inc.
Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
What this study is about
The major goal of the study is to determine whether phonocardiography (using the Eko DUO stethoscope which can capture a three lead ECG reading) can present features that relate to the presence of PH diagnosed by echocardiography or right heart catheterization (RHC), and therefore have a potential to assist the provider to suspect PH.
View original scientific description
The major goal of the study is to determine whether phonocardiography (using the Eko DUO stethoscope which can capture a three lead ECG reading) can present features that relate to the presence of PH diagnosed by echocardiography or right heart catheterization (RHC), and therefore have a potential to assist the provider to suspect PH.
Interventions
DEVICE
Use of Eko DUO stethoscope (paired ECG/PCG)
Auscultation of heart sounds using electronic stethoscope
Primary outcome measures
Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms
Time frame: Up to 2 years to complete database
Create a training/validation dataset composed of ECG/PCG recordings by enrolling at least 2200 subjects undergoing echocardiography and at least 220 subjects who have undergone right heart catheterization (RHC)
Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity
Time frame: Up to 3 years to complete algorithm development
Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients, ages \>18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion.
Exclusion criteria
- Patients undergoing limited echocardiography
- Intubated patients
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations