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Search / Trial NCT06875154

INFLUENCE of ORIGINAL NATIVE TRICUSPID VALVE LESION (STENOSIS or STENO-INSUFFICIENCY or INSUFFICIENCY) on POST-IMPLANT STRUCTURAL BIOPROSTHETIC DEGENERATION AFTER TRICUSPID VALVE REPLACEMENT.

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Mar 7, 2025

Trial Information

Current as of April 29, 2025

Enrolling by invitation

Keywords

Tricuspid Valve Tricuspid Bioprosthesis Durability

ClinConnect Summary

It is not clear if the same biochemical, hemodynamic and immunological mechanisms leading to native valve calcification can cause bioprosthetic SVD. We hypothesize that the mechanisms protecting the native valve from calcification in the insufficiency disease may subsequently protect also the bioprosthetic valve from calcific SVD. In such a case, considering also the reduced incidence in insufficiency patients of prosthesis-patient mismatch, supposedly associated with increased risk of SVD, indication for bioprosthetic valve use could be expanded in patients with insufficiency. Because of t...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Age ≥ 18 years; 6
  • - Patients who underwent isolated tricuspid valve replacement for stenosis, regurgitation or steno-regurgitation
  • - Signed informed consent, inclusive of release of medical information where required by local governance.
  • Exclusion Criteria:
  • Tricuspid valve replacement associated with other surgical procedures (CABG or other)
  • Previous cardiac surgery of any kind;
  • - Surgery for acute endocarditis
  • - Participation in another clinical trial that could interfere with the endpoints of this study.
  • - Pregnant or breastfeeding at time of screening.

About Maastricht University Medical Center

Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.

Locations

Maastricht, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported