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

This study has been completed.
Sponsor:
Collaborator:
Herz- und Diabeteszentrum Nordrhein Westfalen
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00362401
First received: August 9, 2006
Last updated: August 3, 2009
Last verified: August 2009
Results First Received: January 22, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Heart Valve Diseases

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 previously included patients were excluded from the analysis due to double mechanical heart valve prosthesis (in both mitral and aortic position).

Reporting Groups
  Description
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.
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.
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.

Participant Flow:   Overall Study
    ATS (Open Pivot® Standard)     Medtronic Hall     St Jude Medical  
STARTED     15     29     40  
COMPLETED     15     29     40  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    ATS (Open Pivot® Standard)     Medtronic Hall     St Jude Medical     Total  
Number of Participants  
[units: participants]
  15     29     40     84  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     7     11     18     36  
>=65 years     8     18     22     48  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 7     64  ± 9     63  ± 10     63  ± 9  
Gender  
[units: participants]
       
Female     7     6     8     21  
Male     8     23     32     63  
Region of Enrollment  
[units: participants]
       
Germany     15     29     40     84  



  Outcome Measures

1.  Primary:   Intensity (Highness) of the Sound From Mechanical Heart Valves   [ Time Frame: 10.06.2007 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thais A. Pedersen, primary investigator
Organization: Aarhus University Hospital, Skejby
phone: +45 8949 5484
e-mail: thais.a.pedersen@ki.au.dk


No publications provided


Responsible Party: University of Aarhus - Thais A. Pedersen, Thais A. Pedersen - University of Aarhus
ClinicalTrials.gov Identifier: NCT00362401     History of Changes
Other Study ID Numbers: 20050213, 20050213 - 19/04-2006
Study First Received: August 9, 2006
Results First Received: January 22, 2009
Last Updated: August 3, 2009
Health Authority: Denmark: Ethics Committee