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

Maastricht University Medical Centre (MUMC)

Status: Invitation-only

Conditions: Degeneration Mitral Bioprosthesis

Treatments: Procedure: Mitral valve replacement

Study type: Observational

Funder types: Other

Identifiers

NCT07151989

METC 2023-0324-A-1

Details and patient eligibility

About

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 (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Full 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 (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• - 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.

Trial design

3,500 participants in 1 patient group

Patients treated with mitral bioprosthesis replacement

Description:

All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Treatment:

Procedure: Mitral valve replacement