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OpenTrials
Completed

NCT Number: NCT05912660

Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis

The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Exclusion criteria

  • below 65 years of age
  • coronary revascularization within 4 months before the index procedure
  • concomitant heart surgery

Treatment and study plan

Aortic Valve Replacement

Device

Aortic Valve Replacement (surgically or TAVI)

Primary outcomes

  1. all-cause 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. myocardial infaction

    Time frame: 10 years

    incidence of myocardial infaction after aortic valve replacement

  3. heart failure

    Time frame: 10 years

    incidence of heart failure after aortic valve replacement

  4. stroke

    Time frame: 10 years

    incidence of stroke 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
Jun 22, 2023
Registry last updated
Jun 22, 2023

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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