Why is this study important?

This study provides the longest available randomized follow-up data of the tricuspid edge-to-edge repair (TEER) with the TriClip device.

What question was this study supposed to answer?

Initial data from the TRILUMINATE Pivotal trial confirmed that TriClip TEER is a durable, effective, and safe option for patients with severe tricuspid regurgitation (TR), leading to sustained clinical benefits and improved quality of life at one year. The question remains, are these benefits sustainable on long-term follow-up?

What did the study show?

Taking into account the high rates of crossover from the treatment arm to the control arm and the non-blinded study design, the results highlight the long-term durability of tricuspid TEER with the TriClip device. The initial benefits—TR reduction, improved health status, and procedural safety—persisted through two years of follow-up. The majority of patients maintained moderate or less TR, with an average Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement exceeding 15 points. The TriClip's strong safety profile remained consistent, with no cases of device embolization, thrombosis, or conduction disturbances requiring permanent pacing.