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

NCT00362401 | Completed Results

• 2 other identifiers: 2005021320050213 - 19/04-2006
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Valve Diseases

Keywords

Psychoacoustics; Quality of Life; Heart Valve Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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.

  10.06.2007

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator

Study Sites (1)

Herz- und Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Thais A. Pedersen, primary investigator
• Organization: Aarhus University Hospital, Skejby

thais.a.pedersen@ki.au.dk

+45 8949 5484

Study Officials

• Thais A. Pedersen, doctor

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: November 1, 2005
• Study Completion: January 1, 2009
• Last Updated: September 7, 2009
• Results First Posted: September 7, 2009

Record last verified: 2009-08

Locations

DE (1)