NCT04900909

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 2010-2018.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13,993

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
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

9 years

First QC Date

May 20, 2021

Last Update Submit

November 16, 2022

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    all cause mortality after aortic valve replacement

    8 years

Secondary Outcomes (4)

  • reoperation

    8 years

  • stroke

    8 years

  • heart attack

    8 years

  • heart insufficiency

    8 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+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • isolated surgical aortic valve replacement in Austria

You may not qualify if:

  • below 18 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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/Univ. Prof. , MD, MBA

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share