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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04900909
Other study ID # AUTHEARTVISIT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2018

Study information

Verified date November 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.


Description:

The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. We aim to compare those outcomes between mechanical valves and bioprostheses. Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2018.


Recruitment information / eligibility

Status Completed
Enrollment 13993
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - isolated surgical aortic valve replacement in Austria Exclusion Criteria: - below 18 years of age - concomitant heart surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Aortic Valve Replacement
Surgical replacement of aortic valves

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Medical University of Vienna A.ö. Krankenhaus St. Josef Braunau GmbH, Landesklinikum Sankt Polten, Sicknessfund Burgenland (BGKK)

Outcome

Type Measure Description Time frame Safety issue
Primary Overall mortality all cause mortality after aortic valve replacement 8 years
Secondary reoperation incidence of reoperation after aortic valve replacement 8 years
Secondary stroke incidence of stroke after aortic valve replacement 8 years
Secondary heart attack incidence of heart attack after aortic valve replacement 8 years
Secondary heart insufficiency incidence of heart insufficiency after aortic valve replacement 8 years
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