Why is this study important? 

Transcatheter edge-to-edge repair (t-TEER) for the tricuspid valve using the TriClip device is a relatively new FDA approved technology for treating symptomatic patients suffering from severe or greater tricuspid regurgitation. Data from the TRILUMINATE Pivotal Study of the TriClip System demonstrated a favorable efficacy and safety profile. Continued study through subsequent patient enrollment is important to ensure safety of this new device. 

What question was being studied? 

Does the TriClip device for t-TEER continue to show favorable safety profiles over time? 

What did the study show? 

Safety profiles of the TriClip device improve over time with operator experience. Major bleeding and single leaflet detachment (SLDA) both decreased significantly from the primary analysis cohort to the subsequent enrollment cohort. Other safety endpoints such as cardiovascular death, device embolization, and new pacemaker implantation all remained low on follow up. Finally, t-TEER using the TriClip device was safe in patients with cardiac implantable electronic devices (CIED) and did not require lead revision, replacement, or removal.