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Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

NCT ID: NCT04900909

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13993 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2018-12-31

Brief Summary

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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 2010-2018.

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Detailed Description

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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 (secondary outcomes) after aortic valve replacement. 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 2010-2018.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aortic valve replacement with mechanical valves

Aortic Valve Replacement

Intervention Type DEVICE

Surgical replacement of aortic valves

Aortic valve replacement with bioprostheses

Aortic Valve Replacement

Intervention Type DEVICE

Surgical replacement of aortic valves

Interventions

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Aortic Valve Replacement

Surgical replacement of aortic valves

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* isolated surgical aortic valve replacement in Austria

Exclusion Criteria

* below 18 years of age
* concomitant heart surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landesklinikum Sankt Polten

OTHER

Sponsor Role collaborator

Sicknessfund Burgenland (BGKK)

UNKNOWN

Sponsor Role collaborator

A.รถ. Krankenhaus St. Josef Braunau GmbH

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Hendrik Jan Ankersmit

Principal Investigator/Univ. Prof. , MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AUTHEARTVISIT

Identifier Type: -

Identifier Source: org_study_id

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