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NCT05627973 Clinical Trial

Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

Aortic Valve Disease Clinical Trial

Official title:
Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05627973
Other study ID # AUTHEARTVISIT < 50
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2020

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 2010-2020 in under 50 year old patients.

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, MACE (secondary outcomes) after aortic valve replacement in under 50 year olds. 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 2010-2020.

Recruitment information / eligibility
Status Completed
Enrollment 991
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - isolated surgical aortic valve replacement in Austria Exclusion Criteria: - below 18 years of age - above 50 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 (3)
Lead Sponsor Collaborator
Medical University of Vienna Landesklinikum Sankt Polten, Sicknessfund Burgenland

Outcome
Type Measure Description Time frame Safety issue
Primary Overall mortality all cause mortality after aortic valve replacement 10 years
Secondary reoperation incidence of reoperation after aortic valve replacement 10 years
Secondary stroke incidence of stroke after aortic valve replacement 10 years
Secondary heart attack incidence of heart attack after aortic valve replacement 10 years
Secondary heart insufficiency incidence of heart insufficiency after aortic valve replacement 10 years
Secondary MACE incidence of MACE after aortic valve replacement 10 years
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