Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair - Trial NCT06309524

Timeline & Enrollment

Primary Outcome

Inverse remodeling of right heart chambers,Heart failure hospitalization,Death

Summary

In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its
 high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair
 represents novel and less invasive alternatives to surgery and has shown early promising
 results. Treatment options mimic surgical techniques such as leaflet approximation, direct
 annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially
 available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among
 leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER)
 using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the
 PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally
 invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate
 the effect of T-TEER on the geometry and function of the right heart chambers in patients
 with STR; ii. to identify the predictors of procedural success potentially related to
 features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE
 assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same
 parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome.

ICD-10 Classifications