Study of Patient Profiles and Outcomes After Transcatheter Tricuspid Valve Repair in Severe Tricuspid Regurgitation

What this Trial Is About

This research aims to better understand patients with severe tricuspid regurgitation who are considered for transcatheter tricuspid valve interventions TTVI. It seeks to describe patient profiles, reasons for disqualification from TTVI, and to evaluate both the immediate and long-term effectiveness and safety of these procedures. The study is observational and enrolls patients referred to specialized centers for evaluation and potential treatment of tricuspid valve disease. Participants may be qualified or disqualified for various interventions based on detailed heart imaging and clinical assessments. Those qualified might receive transcatheter tricuspid valve edge-to-edge repair T-TEER or other procedures like mitral valve repair, aortic valve implantation, or device implantations. Patients disqualified from TTVI receive medical therapy and follow-up. The enrollment lasts 36 months with each patient followed for 12 months or longer, including multiple clinical and imaging assessments at defined intervals. During the study, participants undergo clinical exams, echocardiography, laboratory tests, and assessments of heart function and aerobic capacity. Data on symptoms, heart failure status, and treatment outcomes are collected regularly, both in clinics and remotely if needed. The main outcomes include mortality and heart failure hospitalizations over 24 months, with additional measures of valve function, aerobic capacity, and quality of life. The study follows strict ethical guidelines and informed consent is obtained from all patients.

ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation