Maastricht UMC+
Maastricht, Netherlands
NCT Number: NCT07151989
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.
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Request Info18 year and older
All sexes
Observational
Maastricht, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 20 years
Echocardiographic paramters will be used.
Quantitative and qualitative measurments swill be implied. The measurment used are listed below:
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.
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
Time frame: 20 years
How long is the survival after the operation
Maastricht University Medical Center
Other
Acronym: DURABLE-Mitral
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.