Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Tranthoracic Echocardiogram

Other

standard measurement

Cardiac Ascultation Recordings with Electronic stethoscope

Device

3M device

Primary outcomes

Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity

Time frame: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.

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. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

3M
The Geneva Foundation

Registry information

Acronym: Cassette

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: May 25, 2012
Registry last updated: Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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