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Clinical Trials/NCT05627973
NCT05627973
Completed
Not Applicable

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

Medical University of Vienna0 sites991 target enrollmentJanuary 1, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Disease
Sponsor
Medical University of Vienna
Enrollment
991
Primary Endpoint
Overall mortality
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hendrik Jan Ankersmit

Univ. Prof. , MD, MBA

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • isolated surgical aortic valve replacement in Austria

Exclusion Criteria

  • below 18 years of age
  • above 50 years of age
  • concomitant heart surgery

Outcomes

Primary Outcomes

Overall mortality

Time Frame: 10 years

all cause mortality after aortic valve replacement

Secondary Outcomes

  • reoperation(10 years)
  • stroke(10 years)
  • heart insufficiency(10 years)
  • heart attack(10 years)
  • MACE(10 years)

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