N/A
Completed N=84
Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
Source: ClinicalTrials.gov NCT00362401 ↗Enrolled (actual)
84
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Intensity (Highness) of the Sound From Mechanical Heart Valves — 43; 41; 40 dB (decibel) — p=<0.05
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 significant difference between the intensities of the valve sounds
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intensity (Highness) of the Sound From Mechanical Heart Valves |
43; 41; 40 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00362401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.