Clinical 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.
Official title: Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degeneration of Tricuspid Surgical Bioprosthesis
Keywords: tricuspid valve
Tricuspid bioprosthesis
Durability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing elective tricuspid valve replacement from 2000 to 2020 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study

Brief summary: The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, ruptures and perforations of leaflets. In the great majority of cases SVD consists of leaflet calcium deposits and can be clinically associated with young age, hypercholesterolemia, hypertension, diabetes mellitus, renal failure. The long term durability of these bioprosthesis is still missing.

Detailed description: 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 the rising demand of bioprosthetic valve implantation, even a few years increase in the expected durability of the BHV, although limited to a defined population of patients, will have a very relevant clinical impact.

We aim to perform a retrospective, multi-center, observational study. All patients undergoing elective tricuspid valve replacement from 2000 to 2020 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.

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.

Primary outcomes:
measure: Long term durability
timeFrame: 20 years
Secondary outcomes:
measure: Long term survival
timeFrame: 20 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Cardio-Thoracic Surgery Department - Heart & Vascular Centre - Maastricht University Medical Centre (MUMC+)
Study officials:
References: