NCT06782620

Brief Summary

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer: Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,761

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 13, 2025

Last Update Submit

January 17, 2025

Conditions

Aortic Valve Replacement

Keywords

aortic valve replacementmechanical AVRbiological AVR

Outcome Measures

Primary Outcomes (1)

  • Survival

    overall Survival

    up to 12 years

Secondary Outcomes (7)

  • reoperation-free survival

    up to 12 years

  • reoperation

    up to 12 years

  • MACEs

    up to 12 years

  • heart failure

    up to 12 years

  • embolic stroke or ICH

    up to 12 years

  • +2 more secondary outcomes

Study Arms (2)

sB-AVR

Patients with biological Aortic valve replacement

sM-AVR

Patients with mechanical Aortic valve replacement

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* age between 50 and 65 years * st. p. isolated biological or mechanical aortic valve replacement

You may qualify if:

  • age between 50 and 65 years
  • st. p. isolated biological or mechanical aortic valve replacement

You may not qualify if:

  • transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
  • age \<50 or \>65 years
  • concomitant heart surgery or additional procedures during the index operation
  • patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Study Officials

  • Hendrik J Ankersmit, Univ. Prof. Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alissa Florian

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 20, 2025

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)