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Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (Cassette)

This study has been completed.
Sponsor:
Collaborators:
3M
The Geneva Foundation
Information provided by (Responsible Party):
William E Bennett, MD FACC, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01605669
First received: May 17, 2012
Last updated: November 1, 2013
Last verified: November 2013
Results First Received: May 17, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Aortic Stenosis
Interventions: Other: Tranthoracic Echocardiogram
Other: Cardiac Ascultation Recordings with Electronic stethoscope

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aortic Stenosis Patients Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.

Participant Flow:   Overall Study
    Aortic Stenosis Patients  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aortic Stenosis Patients Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.

Baseline Measures
    Aortic Stenosis Patients  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     36  
Gender  
[units: participants]
 
Female     15  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures

1.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients with significant concomitant valvular disease were not evaluated. The software does not provide immediate feedback on the severity of the stenosis. Multiple early recordings had artifact noise rquiring modificaiton of recording techniques.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: LCDR William Bennett MD FACC
Organization: Naval Medical Center San Deigo
phone: 619-532-7400
e-mail: william.bennett5@med.navy.mil


Publications:

Responsible Party: William E Bennett, MD FACC, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01605669     History of Changes
Other Study ID Numbers: NMCSD.2011.0123
Study First Received: May 17, 2012
Results First Received: May 17, 2013
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government