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

NCT07151989 | Enrolling By Invitation DMC

• 1 other identifier: METC 2023-0324-A-1
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Degeneration Mitral Bioprosthesis

Keywords

Mitral bioprosthesis degeneration

Outcome Measures

Primary Outcomes (1)

• Prosthesis degeneration due to physiological deterioration

  Echocardiographic paramters will be used. Quantitative and qualitative measurments swill be implied. The measurment used are listed below: 1. Morphological Assessment (2D / 3D TTE \& TEE) Leaflet morphology: thickness, mobility, calcification, pannus, tears, perforations. Bioprosthetic ring/annulus: dehiscence, rocking motion, paravalvular defects. Presence of thrombus, pannus, or vegetation. Structural valve deterioration (SVD) features: leaflet thickening, restricted opening, abnormal motion. 2. Hemodynamic Assessment (Doppler Echocardiography) Mitral inflow pattern (continuous-wave Doppler across prosthesis): Peak velocity (m/s) Mean transprosthetic gradient (mmHg) - heart-rate dependent Pressure half-time (PHT, ms) - limited use in prosthetic valves, but can suggest stenosis Effective orifice area (EOA) (via continuity equation or PHT-derived, cautiously interpreted). Doppler Velocity Index (DVI) = LVOT VTI / Prosthetic MV VTI (helps detect obstruction independent of fl

  20 years

Secondary Outcomes (1)

• Long term survival

  20 years

Study Arms (1)

Patients treated with mitral bioprosthesis replacement

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.

Procedure: Mitral valve replacement

Interventions

Mitral valve replacement PROCEDURE

All operations were performed through median longitudinal sternotomy or mini-sternotomy. Intraoperative transesophageal echocardiography (TOE) was used in all patients. Arterial cannulation was central and venous cannulation was achieved with a common two-stage cannula in the right atrium. Left ventricle was vented through the right superior pulmonary vein. In minimally invasive procedures, venous cannulation was achieved percutaneously. Myocardial protection was achieved by administration of cold crystalloid or blood cardioplegia at the surgeon's discretion in an antegrade (indirect or selective) or retrograde fashion. The removal of the calcified cusps and the decalcification of the annulus was performed according to traditional techniques. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.

Patients treated with mitral bioprosthesis replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 4 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Maastricht, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD PhD

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: September 3, 2025
• Study Start: January 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

NL (1)