Comparing Allograft and Stented Biological Valve Replacements for Primary Tricuspid Valve Disease Evaluating Safety, Effectiveness, and Long-Term Outcomes

What this Trial Is About

Researchers are evaluating the early safety, clinical effectiveness, and long-term outcomes of mitral allografts compared to stented biological prostheses in tricuspid valve replacement for patients with primary tricuspid valve diseases. The study focuses on key outcomes such as survival, freedom from reoperation, repeat endocarditis, and other valve-related complications. Echocardiographic assessments and MSCT scans will also be used to monitor both patient groups. The treatments being studied include mitral allograft implantation and biological stented valve replacement for primary tricuspid valve disease. Patients receive either complete or partial tricuspid valve replacement with a mitral allograft or complete tricuspid valve replacement with a biological prosthesis. These procedures aim to compare the outcomes of these two types of valve replacements. Participants will be monitored for mortality and stroke within 30 days after surgery. Further evaluations of valve function, freedom from prosthetic endocarditis, reoperation, and new pacemaker implantation will occur annually for up to three years. Secondary measures include transvalvular gradient, transprosthetic regurgitation, and right atrial remodeling. This comprehensive follow-up will assess the long-term safety and efficacy of both valve replacement methods.

Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)