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CompletedNCT00486928Hall-KasterUpdated Jul 25, 2011

Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

An observational study in Aortic Valve Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2011-07-25.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
816
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Aortic Valve Disease

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Keywords

  • Valves, heart disease, prosthesis.
03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 816 is above the median of 200 across 112 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All consecutive patients undegoing AVR during inclusion period

Eligibility criteria

Inclusion Criteria:

  • All patients with aortic valve replacement 1977-87
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
816 participants (actual)

Groups and cohorts

  • AVR

    All consecutive patients in the study period

06

Study locations

1 site
  • Rikshospitalet
    Oslo, 0027, Norway
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00486928
Lead sponsor
Oslo University Hospital
First posted
Jun 15, 2007
Start date
May 2004
Completion
May 2005
Last update
Jul 25, 2011

Study contacts

Jan L Svennevig, MD,PhD
principal investigator · Rikshospitalet, Oslo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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