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

NCT ID: NCT00486928

Last Updated: 2011-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

816 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AVR

All consecutive patients in the study period

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients with aortic valve replacement 1977-87
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jan L Svennevig, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Oslo

Locations

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Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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06/8009

Identifier Type: -

Identifier Source: org_study_id

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