NCT05912660

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18,882

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
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

11 years

First QC Date

June 10, 2023

Last Update Submit

June 10, 2023

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    all cause mortality after aortic valve replacement

    10 years

Secondary Outcomes (4)

  • reoperation

    10 years

  • myocardial infaction

    10 years

  • heart failure

    10 years

  • stroke

    10 years

Study Arms (2)

Aortic valve replacement with surgically implanted bioprostheses

Device: Aortic Valve Replacement

Aortic valve replacement with TAVI

Device: Aortic Valve Replacement

Interventions

Aortic Valve ReplacementDEVICE

Aortic Valve Replacement (surgically or TAVI)

Aortic valve replacement with TAVIAortic valve replacement with surgically implanted bioprostheses

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.

You may qualify if:

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

You may not qualify if:

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

June 10, 2023

First Posted

June 22, 2023

Study Start

January 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share