Vivio AS (Aortic Stenosis) Detection Study

Completed · Not applicable

Conditions studied: Aortic Stenosis

In brief

Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.

Key facts

Study ID

NCT04066634

Run by

Ventric Health, LLC

People needed

200

Starts

2019-04-02

Expected to finish

2019-10-29

Last updated by the study team

2021-08-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult subjects (21 years of age or older).
• Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
• Willing and able to participate in all study evaluations and allow access to medical testing and records.
• Signed informed consent or have a legally authorized representative who provides informed consent on behalf of the subject.

You may not qualify if…

• Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
• Need for bedside echocardiogram (inpatient).
• Prosthetic device previously implanted at aortic valve position.
• Inability to palpate carotid pulse (e.g. due to severe obesity)
• History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
• History of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy).
• Open skin lesions at target site of electronic stethoscope/Vivio device examination.

Where it is running

• Morristown Medical Center — Morristown, New Jersey, United States
• St. Francis Hospital — Roslyn, New York, United States
• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.