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Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis (Hall-Kaster)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486928
First Posted: June 15, 2007
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose
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.

Condition
Aortic Valve Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Further study details as provided by Oslo University Hospital:

Enrollment: 816
Study Start Date: May 2004
Study Completion Date: May 2005
Groups/Cohorts
AVR
All consecutive patients in the study 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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients undegoing AVR during inclusion period
Criteria

Inclusion Criteria:

  • All patients with aortic valve replacement 1977-87
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Norway
Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Jan L Svennevig, MD,PhD Rikshospitalet, Oslo
  More Information

ClinicalTrials.gov Identifier: NCT00486928     History of Changes
Other Study ID Numbers: 06/8009
First Submitted: June 14, 2007
First Posted: June 15, 2007
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Oslo University Hospital:
Valves, heart disease, prosthesis.