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Enrolling by Invitation

NCT Number: NCT06875154

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardio-Thoracic Surgery Department - Heart & Vascular Centre - Maastricht University Medical Centre (MUMC+)

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valve replacement

Procedure

All operations were performed through median longitudinal sternotomy or mini-sternotomy or minitoracothomy 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 or from peripheral access. 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.. All the prosthesis were be implanted with supranular technique and 2-0 U-shaped pledgeted sutures.

Primary outcomes

  1. Long term durability

    Time frame: 20 years

    Long term durability of the tricuspid bioprosthesis in terms of structural valve deterioration or /and associated complications.

    Echocardiographic parameters will be used. Continous variables will be implied.

Secondary outcomes

  1. Long term survival

    Time frame: 20 years

    Long term survival, event free survival, freedom from reoperations and hospitalization.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: DURABLE-TRIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.