Heart Valve DiseasesNCT00362401
Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
An observational study of Heart Valve Diseases, run by University of Aarhus at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to Jan 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients are expected to be included. They all must have a mechanical heart valve in the aortic position implanted between 3 months and 4,5 years prior to the investigation. The patients will be divided into tree main groups, which correspond to the type of valve they have acquired - ATS (ATS Medical Inc, Minneapolis, MN, USA), Medtronic-Hall™ (Medtronic, Minneapolis, MN, USA) and St. Jude Medical Standard (St. Jude Medical Inc, St. Paul, MN, USA). With the purpose of recruiting a greater number of patients than those available in the geographic region of Denmark, we have established an agreement with The Heart Center in Bad Oeynhausen, Germany, who will contribute to the study with all 150 patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen, 32545
About this study
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
Read the 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.
- Conditions
- Heart Valve Diseases
- Keywords
- Psychoacoustics, Quality of Life, Heart Valve Prosthesis
- Medical subject headings
- Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10.06.2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startNov 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Investigators
- Thais A. Pedersen, doctor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362401
- Sponsor's protocol ID
- 20050213
- Other IDs
- 20050213 - 19/04-2006
- Status last verified
- Aug 2009
- First submitted
- 9 Aug 2006
- Last updated
- 7 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life
- ClinicalTrials.gov ID
- NCT00362401
- Acronym / sponsor ID
- 20050213
- Conditions
- Heart Valve Diseases
- Keywords
- Psychoacoustics, Quality of Life, Heart Valve Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Study start
- Nov 2005
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 7 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients are expected to be included. They all must have a mechanical heart valve in the aortic position implanted between 3 months and 4,5 years prior to the investigation. The patients will be divided into tree main groups, which correspond to the type of valve they have acquired - ATS (ATS Medical Inc, Minneapolis, MN, USA), Medtronic-Hall™ (Medtronic, Minneapolis, MN, USA) and St. Jude Medical Standard (St. Jude Medical Inc, St. Paul, MN, USA). With the purpose of recruiting a greater number of patients than those available in the geographic region of Denmark, we have established an agreement with The Heart Center in Bad Oeynhausen, Germany, who will contribute to the study with all 150 patients.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensity (Highness) of the Sound From Mechanical Heart Valves
Time frame: 10.06.2007
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais A. Pedersen, doctor principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by University of Aarhus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity (Highness) of the Sound From Mechanical Heart Valves (time frame: 10.06.2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2009.