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

Maastricht University Medical Centre (MUMC)

Status: Invitation-only

Conditions: Aortic Bioprosthesis Degeneration

Treatments: Procedure: Aortic valve replacement

Study type: Observational

Funder types: Other

Identifiers

NCT06964035

METC 2023-0326

Details and patient eligibility

About

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Full description

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study. These patients will be contacted to provide information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and to perform a postoperative echocardiography if not performed in the previous year. Once consent is given, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age ≥ 18 years; 9
• Patients who underwent isolated aortic and mitral valve replacement for stenosis or regurgitation
• Signed informed consent, inclusive of release of medical information.

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

10,000 participants in 1 patient group

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or a

Description:

All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated session) will be enrolled in the study

Treatment:

Procedure: Aortic valve replacement