NCT05627973

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 991 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Aortic Valve Replacement	Surgical replacement of aortic valves

Timeline

• Start date: 2010-01-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2022-11-28
• Last updated: 2022-11-28

Regulatory

• FDA-regulated device study