Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Eko Devices, Inc.
Study ID
NCT05873387
Status
Recruiting
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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Use of Eko DUO stethoscope (paired ECG/PCG) — DEVICE
    Auscultation of heart sounds using electronic stethoscope

Study Details

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.

Key Dates

Start date
Jul 12, 2023
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
2,420 participants (estimated)

Arms

  • Arm: Echocardiography ground-truth
    Subjects with ECG/PCG recordings labeled against echocardiography
  • Arm: Right heart catheterization ground-truth
    Subjects with ECG/PCG recordings labeled against right heart catheterization

Primary Outcome Measure

Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms [ Time Frame: Up to 2 years to complete database ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Providence VA Medical CenterProvidenceRhode Island02908
Pamela Brewer, PhD, RN
[email protected]
401-273-71oo
Rhode Island HospitalProvidenceRhode Island02903
Kelly Franchetti
[email protected]
The Miriam HospitalProvidenceRhode Island02906
Lori-Ann Desimone
[email protected]
Guarav Choudhary, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Providence VA Medical Center· Providence, RIRhode Island Hospital· Providence, RIThe Miriam Hospital· Providence, RI

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