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CompletedNCT04900909Updated Nov 18, 2022

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

An observational study in Aortic Valve Disease, sponsored by Medical University of Vienna. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13,993
Ages
18 Years and older
Sex
All
01

Study 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 2010-2018.

Read the 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 (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.

02

Conditions studied

  • Aortic Valve Disease

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03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 13,993 is above the median of 200 across 112 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years of age with no other concomitant heart surgery were included.

Inclusion criteria

  • isolated surgical aortic valve replacement in Austria

Exclusion criteria

Exclusion Criteria:

  • below 18 years of age
  • concomitant heart surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13,993 participants (actual)
Patient registry
No

Groups and cohorts

  • Aortic valve replacement with mechanical valves

    Device: Aortic Valve Replacement

  • Aortic valve replacement with bioprostheses

    Device: Aortic Valve Replacement

Interventions

  • DeviceAortic Valve Replacement

    Surgical replacement of aortic valves

06

What researchers measure

Primary outcomes

  1. Overall mortality

    all cause mortality after aortic valve replacement

    Time frame: 8 years

Secondary outcomes

  1. reoperation

    incidence of reoperation after aortic valve replacement

    Time frame: 8 years

  2. stroke

    incidence of stroke after aortic valve replacement

    Time frame: 8 years

  3. heart attack

    incidence of heart attack after aortic valve replacement

    Time frame: 8 years

  4. heart insufficiency

    incidence of heart insufficiency after aortic valve replacement

    Time frame: 8 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04900909
Lead sponsor
Medical University of Vienna
Collaborators
Landesklinikum Sankt Polten, Sicknessfund Burgenland (BGKK), A.ö. Krankenhaus St. Josef Braunau GmbH
Responsible party
Hendrik Jan Ankersmit (Principal Investigator/Univ. Prof. , MD, MBA, Medical University of Vienna) — Principal investigator
First posted
May 25, 2021
Start date
Jan 1, 2010
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Nov 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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