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

Completed

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

• Registration Number: NCT05627973
• 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 2010-2020 in under 50 year old patients.

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, 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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-11
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Study First Posted: 2022-11-28
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 991

Inclusion Criteria

• isolated surgical aortic valve replacement in Austria

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Exclusion Criteria

• below 18 years of age
• above 50 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	10 years	all cause mortality after aortic valve replacement

Secondary Outcome Measures

Name	Time	Method
stroke	10 years	incidence of stroke after aortic valve replacement
reoperation	10 years	incidence of reoperation after aortic valve replacement
heart insufficiency	10 years	incidence of heart insufficiency after aortic valve replacement
heart attack	10 years	incidence of heart attack after aortic valve replacement
MACE	10 years	incidence of MACE after aortic valve replacement