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OpenTrials
Completed

NCT Number: NCT05627973

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

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.

Completed

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • isolated surgical aortic valve replacement in Austria

Exclusion criteria

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

Treatment and study plan

Aortic Valve Replacement

Device

Surgical replacement of aortic valves

Primary outcomes

  1. Overall mortality

    Time frame: 10 years

    all cause mortality after aortic valve replacement

Secondary outcomes

  1. reoperation

    Time frame: 10 years

    incidence of reoperation after aortic valve replacement

  2. stroke

    Time frame: 10 years

    incidence of stroke after aortic valve replacement

  3. heart attack

    Time frame: 10 years

    incidence of heart attack after aortic valve replacement

  4. heart insufficiency

    Time frame: 10 years

    incidence of heart insufficiency after aortic valve replacement

  5. MACE

    Time frame: 10 years

    incidence of MACE after aortic valve replacement

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Landesklinikum Sankt Polten
  • Sicknessfund Burgenland

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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