Follow-up Study of Patients Treated With TricValve Transcatheter Bicaval Valves System for Severe Tricuspid Regurgitation

What this Trial Is About

Researchers are conducting a multicenter observational study to follow up on patients with severe tricuspid regurgitation who have been treated with the TricValve4 Transcatheter Bicaval Valves System. This study aims to monitor the long-term outcomes and health status of these patients after receiving this specific valve treatment. It includes patients who have undergone this procedure and focuses on assessing their heart function and related complications over time. Participants in the study have already been treated with the TricValve device in both the Inferior Vena Cava and Superior Vena Cava. The study involves a follow-up period lasting up to five years, with scheduled clinical visits at discharge, 1 month, 6 months, 1 year, and annually thereafter up to 5 years. During these visits, routine tests such as blood counts, kidney function tests, electrocardiograms, and echocardiograms are performed to evaluate the valves function and the hearts hemodynamic status. Throughout the follow-up, researchers will track important health outcomes, including hospital readmissions for heart failure, mortality rates, adverse events, changes in heart function and valve performance, and patient functional status using the New York Heart Association NYHA classification. The study will also assess biomarkers related to heart function and medication adjustments. These comprehensive evaluations help researchers understand the safety and durability of the TricValve system over time.

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®