Evaluating Safety and Effectiveness of the TruGamma Transcatheter Tricuspid Valve Replacement System in Patients 65 and Older with Severe Tricuspid Regurgitation

What this Trial Is About

Researchers are conducting a pivotal clinical trial to evaluate the safety and performance of the TruGamma transcatheter tricuspid valve replacement system in patients aged 65 and older with severe tricuspid regurgitation. This study compares the TruGamma System combined with optimal medical therapy OMT to OMT alone. The trial is randomized and multi-center, focusing on patients assessed as high-risk and ineligible for surgery. Participants in the trial will either receive the TruGamma System device along with their OMT or continue with OMT alone. The OMT involves medications such as diuretics managed by a local heart team. The study follows patients at discharge, 30 days, 3 months, 6 months, and annually up to 5 years to assess the outcomes of both treatment approaches. During the study, participants will undergo various assessments including the Kansas City Cardiomyopathy Questionnaire KCCQ, New York Heart Association NYHA functional class evaluation, and a 6-minute walk test. Researchers will monitor tricuspid regurgitation severity, major adverse events, procedural success, quality of life, hospitalizations due to heart failure, and mortality rates. Follow-up visits will help track device performance and patient health over time.

A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement