Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486928
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2007-06-14
Brief Title:
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hall-Kaster
Brief Summary:
Background- The Medtronic-Hall MH valve was developed and for the first time implanted in Oslo in 1977 A total of 1104 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
Detailed 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 1104 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None