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Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04900909
Enrollment
13993
Registered
2021-05-25
Start date
2010-01-01
Completion date
2018-12-31
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Brief 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.

Detailed 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.

Interventions

DEVICEAortic Valve Replacement

Surgical replacement of aortic valves

Sponsors

Landesklinikum Sankt Polten
CollaboratorOTHER
Sicknessfund Burgenland (BGKK)
CollaboratorUNKNOWN
A.ö. Krankenhaus St. Josef Braunau GmbH
CollaboratorOTHER
Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* isolated surgical aortic valve replacement in Austria

Exclusion criteria

* below 18 years of age * concomitant heart surgery

Design outcomes

Primary

MeasureTime frameDescription
Overall mortality8 yearsall cause mortality after aortic valve replacement

Secondary

MeasureTime frameDescription
reoperation8 yearsincidence of reoperation after aortic valve replacement
stroke8 yearsincidence of stroke after aortic valve replacement
heart attack8 yearsincidence of heart attack after aortic valve replacement
heart insufficiency8 yearsincidence of heart insufficiency after aortic valve replacement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026