A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease

Overview

About this study

The purpose of this study is to identify patients presenting to the echocardiogram laboratroy for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. These patients will undergo a cardiac physical examination using the ©CompuSteth stethoscope for the following 2 aims:

1) Collect computerized auscultation data to train the ©CompuSteth device on how a variety of cardiac pathologies "sound", including normal heart sounds, aortic stenosis, and mitral valve disease, after identifying these cardiac pathologies using gold-standard testing with echocardiography or invasive cardiac catheterization.

2)Prospectively determine the accuracy of the ©CompuSteth device as a tool to non-invasively screen for structural cardiac pathologies, by comparing the results in terms of structural cardiac pathologies ascertained from using the ©CompuSteth device with those derived from echocardiography or cardiac catheterization testing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Aged 18 years of age or older.

- Referred to the echocardiogram laboratory for routine clinically indicated
echocardiography, or to the cardiac catheterization laboratory for routine clinically
indicated catheterization procedures

- Individuals with normal heart sounds, isolated aortic stenosis (any degree of
severity), or isolated mitral regurgitation (any degree of severity)

Exclusion Criteria:

- Patients with unstable cardiovascular or pulmonary disease

- Patients with mixed valvular heart disease, corresponding to more than one type of
valve pathology (i.e.: Aortic stenosis and Aortic Regurgitation), or more than 1 valve
involved (i.e.: aortic stenosis and mitral regurgitation)

Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Gulati, M.D., Ph.D.

Open for enrollment

Contact information:

Faten Sebaali B.S.

(507) 266-3180

Sebaali.Faten@mayo.edu

More information

Publications

Publications are currently not available