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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00486928
First received: June 14, 2007
Last updated: July 22, 2011
Last verified: July 2011
  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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00486928     History of Changes
Other Study ID Numbers: 06/8009
Study First Received: June 14, 2007
Last Updated: July 22, 2011
Health Authority: Norway: The Data Inspectorte

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

ClinicalTrials.gov processed this record on April 17, 2014