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NCT00486928 Clinical Trial

Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Aortic Valve Disease Clinical Trial

— Hall-Kaster  

Official title:
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00486928
Other study ID # 06/8009
Secondary ID
Status Completed
Phase N/A
First received June 14, 2007
Last updated July 22, 2011
Start date May 2004
Est. completion date May 2005

Study information
Verified date July 2011
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: The Data Inspectorte
Study type Observational

Clinical Trial Summary

Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

Description:

The Medtronic-Hall (MH) tilting valve disk was first implanted in Oslo in June 1977. From 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department.

The MH valve is made of a single piece of titanium with no welds. The disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. The tungsten renders the disk radiopaque. In the aortic position the maximal opening is 75˚. A central aperture in the disk allows free rotation. The valve is rotatable in the sewing ring. The sewing ring is made of Teflon. Aortic sizes are 20-31 mm (outer diameter).

The initial clinical results were published in 1979 (1). The cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). In the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (AVR) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

Recruitment information / eligibility
Status Completed
Enrollment 816
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with aortic valve replacement 1977-87

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Rikshospitalet Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

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