Status:

ENROLLING_BY_INVITATION

Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement

Lead Sponsor:

Maastricht University Medical Center

Conditions:

Degeneration Mitral Bioprosthesis

Eligibility:

All Genders

18+ years

Brief Summary

It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (describ...

Detailed Description

It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (describ...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years;
  • Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
  • Signed informed consent, inclusive of release of medical information where required by local governance.

Exclusion

  • \- Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
  • Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
  • Previous cardiac surgery of any kind;
  • Surgery for acute endocarditis
  • Surgery for Type A aortic dissection
  • Participation in another clinical trial that could interfere with the endpoints of this study.
  • Pregnant or breastfeeding at time of screening.

Key Trial Info

Start Date :

January 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

3500 Patients enrolled

Trial Details

Trial ID

NCT07151989

Start Date

January 1 2024

End Date

May 1 2026

Last Update

September 3 2025

Active Locations (1)

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Maastricht UMC+

Maastricht, Maastricht, Netherlands