Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
NCT ID: NCT01605669
Last Updated: 2016-09-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
50 participants
OBSERVATIONAL
2012-05-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aortic stenosis patients
Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study. All participants will recieve a transthoracic echocardiogram and recorded cardiac auscultation.
Tranthoracic Echocardiogram
standard measurement
Cardiac Ascultation Recordings with Electronic stethoscope
3M device
Interventions
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Tranthoracic Echocardiogram
standard measurement
Cardiac Ascultation Recordings with Electronic stethoscope
3M device
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
3. Subjects must be able to sit for auscultation examination.
4. Subject must be able to complete a TTE .
5. Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.
Exclusion Criteria
2. Subjects with unrecordable heart sounds.
3. Subjects with known or who may have been previously diagnosed with congenital heart disease.
4. Subjects with atrial fibrillation.
5. Subjects with history of cardiac surgery.
6. Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
The Geneva Foundation
OTHER
United States Naval Medical Center, San Diego
FED
Responsible Party
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Principal Investigators
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William E Bennett, MD
Role: PRINCIPAL_INVESTIGATOR
United States Naval Medical Center, San Diego
Locations
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Naval Medical Center San Diego
San Diego, California, United States
Countries
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References
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BRAUNWALD E, GOLDBLATT A, AYGEN MM, ROCKOFF SD, MORROW AG. Congenital aortic stenosis. I. Clinical and hemodynamic findings in 100 patients. II. Surgical treatment and the results of operation. Circulation. 1963 Mar;27:426-62. doi: 10.1161/01.cir.27.3.426. No abstract available.
Bonner AJ Jr, Sacks HN, Tavel ME. Assessing the severity of aortic stenosis by phonocardiography and external carotid pulse recordings. Circulation. 1973 Aug;48(2):247-52. doi: 10.1161/01.cir.48.2.247. No abstract available.
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26. No abstract available.
Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.
Other Identifiers
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NMCSD.2011.0123
Identifier Type: -
Identifier Source: org_study_id
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