NCT07168889

Brief Summary

The goal of this observational study is to learn about the long-term effects of mechanical versus biological mitral valve replacement in patients aged 70 years or younger. The main question it aims to answer is: Do patients who receive a mechanical mitral valve live longer and need fewer repeat operations compared with those who receive a biological valve? Participants are patients in Austria who already had mitral valve surgery between 2010 and 2020 as part of their regular medical care. Information about their surgeries, health conditions, and outcomes was collected from national health insurance records. Researchers will follow these patients for up to 10 years to compare survival, reoperation rates, and other heart-related events between mechanical and biological valve recipients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,520

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
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

11 years

First QC Date

September 4, 2025

Last Update Submit

September 11, 2025

Conditions

Mitral Valve Replacement

Keywords

mitral valvebioprosthesesmechanical prostheses

Outcome Measures

Primary Outcomes (1)

  • all-cause death

    rate of all-cause death

    10 years

Secondary Outcomes (8)

  • major adverse cardiac events

    10 years

  • reoperation-free survival

    10 years

  • reoperation

    10 years

  • myocardial infarction

    10 years

  • heart failure

    10 years

  • +3 more secondary outcomes

Study Arms (2)

SBMVR

biological mitral valve replacement

SMMVR

mechanical mitral valve replacement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Austria. The data included 3,520 patients aged ≤70 years who underwent mitral heart valve surgery between 1.1.2010 and 31.12.2020 in Austria.

You may qualify if:

  • Mitral valve surgery between 01.01.2010 and 31.12.2020

You may not qualify if:

  • concomitant procedures on other valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 11, 2025

Study Start

January 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share