Skip to content

Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life

Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00362401
Enrollment
90
Registered
2006-08-10
Start date
2005-11-30
Completion date
2009-01-31
Last updated
2009-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

Psychoacoustics, Quality of Life, Heart Valve Prosthesis

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 significant difference between the intensities of the valve sounds

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 world. They generate a clicking sound at closure, which can be a major problem for some patients. About 12% of them all experience annoyance, concentration disturbance, sleeping disorders and social embarrassment. All those factors could affect patients' quality of life. Aim: 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. Material and Methods: We intended to include 150 patients with an implanted mechanical heart valve (ATS Medical, Medtronic-Hall or St. Jude Medical) in the aortic position between 3 months and 4 years before the analysis. For logistical reasons, the actual number of the patients included was 84. The total conducted valve sound was measured (by a method designed by the authors) for each patient. The measures took place in a bioacoustical laboratory built with a sound-insulated chamber with a very low background noise, designed for the purposes of the study. The measures were performed in German patients followed by The Heart Centre in Bad Oeynhausen (Herz- und Diabeteszentrum Nordrhein Westfalen, University of Bochum), where the mentioned laboratory is constructed. The sound analysis of the present study was conducted in a specially designed soundproof bioacoustic laboratory, which isolates the outside sound and vibration from the environment indoors. Inside the laboratory, heavy soundinsulated curtains were placed between the patient and the investigator chambers. The total background noise inside the patient chamber was 19 dB(A), and this was reduced further to 9 dB(A) by using a 250 Hz high-pass filter. The sounds were recorded with the patient in the supine position, and without clothes covering the chest. The valve closing sounds were recorded using a microphone (Brüel and Kjær 4179) placed 5 cm above the patient's chest. This sound was then preamplified (Brüel and Kjær 2660), amplified (Brüel and Kjær 2610) and 250 Hz high-pass filtered (Krohn-Hite 3944) (see Fig. 1). All valve sounds were recorded by the same experienced investigator and stored on an instrumentation recorder (TEAC 510) for later off-line analysis. The data acquisition time for each patient was approximately 10 min. The patients were asked to fuldill a quality of life questionnaire (SF-36), which will be assessed in a future study regarding psychoacoustics for mechanical heart valve sounds. Perspectives: The results obtained from this analysis will contribute to expand knowledge concerning the sound produced by these three different types of mechanical heart valve prosthesis. The study can add one important parameter in the choice of the implanted valve: patient's pleasantness. It will assess some of the most sold mechanical heart valve worldwide and the final results can contribute to elucidate which type, among those valves, that should be chosen to a specific patient.

Interventions

None listed

Sponsors

Heart and Diabetes Center North Rhine-Westphalia
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intensity (Highness) of the Sound From Mechanical Heart Valves10.06.2007The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient's chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.

Countries

Germany

Participant flow

Recruitment details

All 84 included patients were recruited from the same out patient clinic at the Heart Center, Bad Oeynhausen, Germany. They have been recruited between november 2005 and april 2006.

Pre-assignment details

3 previously included patients were excluded from the analysis due to double mechanical heart valve prosthesis (in both mitral and aortic position).

Participants by arm

ArmCount
ATS (Open Pivot® Standard)
patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
15
Medtronic Hall
patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
29
St Jude Medical
patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
40
Total84

Baseline characteristics

CharacteristicMedtronic HallSt Jude MedicalATS (Open Pivot® Standard)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0.0 Participants
Age, Categorical
>=65 years
18 Participants22 Participants8 Participants48.0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants18 Participants7 Participants36.0 Participants
Age Continuous64 years
STANDARD_DEVIATION 9
63 years
STANDARD_DEVIATION 10
65 years
STANDARD_DEVIATION 7
63 years
STANDARD_DEVIATION 9
Region of Enrollment
Germany
29 participants40 participants15 participants84.0 participants
Sex: Female, Male
Female
6 Participants8 Participants7 Participants21.0 Participants
Sex: Female, Male
Male
23 Participants32 Participants8 Participants63.0 Participants

Outcome results

Primary

Intensity (Highness) of the Sound From Mechanical Heart Valves

The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient's chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.

Time frame: 10.06.2007

Population: Patients with a mechanical heart valve prosthesis recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.

ArmMeasureValue (MEAN)Dispersion
Group 1 - ATSIntensity (Highness) of the Sound From Mechanical Heart Valves43 dB (decibel)Standard Deviation 5
Group 2- Medtronic HallIntensity (Highness) of the Sound From Mechanical Heart Valves41 dB (decibel)Standard Deviation 4
Group 3 - St Jude MedicalIntensity (Highness) of the Sound From Mechanical Heart Valves40 dB (decibel)Standard Deviation 4
Comparison: The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026