Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis (Hall-Kaster)
|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|
|Study Completion Date :||May 2005|
All consecutive patients in the study period
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|