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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 16, 2014