NCT05627973

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
991

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

11 years

First QC Date

November 16, 2022

Last Update Submit

November 16, 2022

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    all cause mortality after aortic valve replacement

    10 years

Secondary Outcomes (5)

  • reoperation

    10 years

  • stroke

    10 years

  • heart attack

    10 years

  • heart insufficiency

    10 years

  • MACE

    10 years

Study Arms (2)

Aortic valve replacement with mechanical valves

Device: Aortic Valve Replacement

Aortic valve replacement with bioprostheses

Device: Aortic Valve Replacement

Interventions

Aortic Valve ReplacementDEVICE

Surgical replacement of aortic valves

Aortic valve replacement with bioprosthesesAortic valve replacement with mechanical valves

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years and below 50 years of age with no other concomitant heart surgery were included.

You may qualify if:

  • isolated surgical aortic valve replacement in Austria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. , MD, MBA

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 28, 2022

Study Start

January 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share