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

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: Aortic Valve Replacement

• Registration Number: NCT04900909
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13993

Inclusion Criteria

• isolated surgical aortic valve replacement in Austria

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Exclusion Criteria

• below 18 years of age
• concomitant heart surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic valve replacement with mechanical valves	Aortic Valve Replacement	-
Aortic valve replacement with bioprostheses	Aortic Valve Replacement	-

Primary Outcome Measures

Name	Time	Method
Overall mortality	8 years	all cause mortality after aortic valve replacement

Secondary Outcome Measures

Name	Time	Method
heart insufficiency	8 years	incidence of heart insufficiency after aortic valve replacement
reoperation	8 years	incidence of reoperation after aortic valve replacement
stroke	8 years	incidence of stroke after aortic valve replacement
heart attack	8 years	incidence of heart attack after aortic valve replacement