Trial Outcomes & Findings for Patients Perception of Mechanical Heart Valve Sounds: Psychoacoustics and Quality of Life (NCT NCT00362401)

Last Updated: 2009-09-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

10.06.2007

Results posted on

2009-09-07

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15	29	40
Overall Study COMPLETED	15	29	40
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATS (Open Pivot® Standard) n=15 Participants 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 n=29 Participants 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 n=40 Participants 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 n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0.0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants	36.0 Participants n=4 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	48.0 Participants n=4 Participants
Age Continuous	65 years STANDARD_DEVIATION 7 • n=5 Participants	64 years STANDARD_DEVIATION 9 • n=7 Participants	63 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	21.0 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	23 Participants n=7 Participants	32 Participants n=5 Participants	63.0 Participants n=4 Participants
Region of Enrollment Germany	15 participants n=5 Participants	29 participants n=7 Participants	40 participants n=5 Participants	84.0 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 - ATS n=15 Participants 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.	Group 2- Medtronic Hall n=29 Participants 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.	Group 3 - St Jude Medical n=40 Participants 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.
Intensity (Highness) of the Sound From Mechanical Heart Valves	43 dB (decibel) Standard Deviation 5	41 dB (decibel) Standard Deviation 4	40 dB (decibel) Standard Deviation 4

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thais A. Pedersen, primary investigator

Aarhus University Hospital, Skejby

Phone: +45 8949 5484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place