Status:
COMPLETED
Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Heart and Diabetes Center North Rhine-Westphalia
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare the sound pressure levels (SPLs) from three of the most frequently implanted mechanical heart valve prostheses, in order to determine whether there was any sign...
Detailed Description
Patient's perception of mechanical heart valve sounds: psychoacoustics and quality of life Background: Approximately 90.000 mechanical prosthetic heart valves are implanted every year all over the wo...
Eligibility Criteria
Inclusion
- Adult patients (18 years of age and older) with an aortic mechanical heart valve which belongs to one of the three investigated valve types and have been implanted from three months to four years before the investigation.
Exclusion
- Patients with severe hearing impairment (evaluated by a conventional audiogram inside the sound-insulated chamber) or who use hearing aid;
- patients with severe cardiac arrhythmias;
- patients with claustrophobia;
- patients who are not capable of cooperating to the experimental conditions at a sound-insulated chamber;
- patients who are unable to fulfil the quality of life questionnaire.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00362401
Start Date
November 1 2005
End Date
January 1 2009
Last Update
September 7 2009
Active Locations (1)
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1
Herz- und Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen, Germany, 32545