Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Completed

Conditions studied: Aortic Stenosis

In brief

According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every 1-2 years for moderate disease and every 3-5 years for mild disease. This results in a multitude of screening studies in the investigators patient population. 3M has developed a new stethoscope and phonocardiography software capable of identifying the peak intensity of the AS murmur and tracking it as it moves towards the second heart sound potentially indicating increasing severity of disease. Currently there exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates to disease severity or progression of disease. The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. In this study the investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis severity.

Key facts

Study ID

NCT01605669

Run by

United States Naval Medical Center, San Diego

People needed

50

Starts

2012-05-01

Expected to finish

2013-06-01

Last updated by the study team

2016-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 18 years of age and older.
• Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
• Subjects must be able to sit for auscultation examination.
• Subject must be able to complete a TTE .
• Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.

You may not qualify if…

• Subjects with significant additional valvular heart disease.
• Subjects with unrecordable heart sounds.
• Subjects with known or who may have been previously diagnosed with congenital heart disease.
• Subjects with atrial fibrillation.
• Subjects with history of cardiac surgery.
• Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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