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

NCT06875154 | Enrolling By Invitation DMC

• 1 other identifier: 2023-0324
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Degeneration of Tricuspid Surgical Bioprosthesis

Keywords

tricuspid valve; Tricuspid bioprosthesis; Durability

Outcome Measures

Primary Outcomes (1)

• Long term durability

  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.

  20 years

Secondary Outcomes (1)

• Long term survival

  20 years

Study Arms (1)

Surgical Tricuspid bioprosthesis

All patients undergoing elective tricuspid valve replacement from 2000 to 2020. All operations were performed through median longitudinal sternotomy, mini-sternotomy or mini- thoracotomy.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. Beating heart procedure can be performed without the use of aortic clamp. The prosthesis were be implanted with 2-0 U-shaped sutures.

Procedure: Valve replacement

Interventions

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.

Surgical Tricuspid bioprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

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

Maastricht, Netherlands

Location

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD PhD

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

NL (1)