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

NCT07151989 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2025-09-03

No results posted yet for this study

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

Interventions

PROCEDURE

Mitral valve replacement

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.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-11-01
Completion
2026-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151989 on ClinicalTrials.gov