NCT00486928

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
816

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

First QC Date

June 14, 2007

Last Update Submit

July 22, 2011

Conditions

Aortic Valve Disease

Keywords

Valves, heart disease, prosthesis.

Study Arms (1)

AVR

All consecutive patients in the study period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients undegoing AVR during inclusion period

You may qualify if:

  • All patients with aortic valve replacement 1977-87

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Aortic Valve DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Heart Valve DiseasesCardiovascular Diseases

Study Officials

  • Jan L Svennevig, MD,PhD

    Rikshospitalet, Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 15, 2007

Study Start

May 1, 2004

Study Completion

May 1, 2005

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

NO(1)