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

• Conditions: Aortic Bioprosthesis Degeneration

• Registration Number: NCT06964035
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-04-30
• Status Verified: 2025-05
• Study First Posted: 2025-05-09
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-11-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prosthetic valve deterioration and degenration	10-15 years	Echocardiographic analisys with multiparametric datas will be used. From quantitative to qualitative.

Secondary Outcome Measures

Name	Time	Method
Survival	15 years	Longitudinal analysis will be used to establish the surival rate at long term.

Trial Locations

Locations (1)

Maastricht UMC+ METC; 🇳🇱 Maastricht, Netherlands