Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis (Hall-Kaster)
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|ClinicalTrials.gov Identifier: NCT00486928|
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : July 25, 2011
|Condition or disease|
|Aortic Valve Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||816 participants|
|Official Title:||Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||May 2005|
All consecutive patients in the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486928
|Oslo, Norway, 0027|
|Principal Investigator:||Jan L Svennevig, MD,PhD||Rikshospitalet, Oslo|