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

Recruiting

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Age> 18 years
Severe STR, amenable to percutaneous treatment with T-TEER
Acceptance to be part of this study by signing the informed consent
Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
Availability for clinical, CCT and, echocardiography follow-up visits

Exclusion Criteria

Pregnancy
Severe chronic kidney disease (GFR <30 mL/min)
Hypersensitivity reactions to contrast media
Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
Bad acoustic window with inadequate echocardiographic images.

Primary Outcome Measures

Name	Time	Method
Inverse remodeling of right heart chambers	At baseline and at 6 months after intervention	Change in inverse remodeling of right heart chambers at 6 months after intervention
Death	During 6 months after intervention	Incidence of death during 6 months after intervention
Heart failure hospitalization	During 6 months after intervention	Incidence of heart failure hospitalization during 6 months after intervention

Secondary Outcome Measures

Name	Time	Method

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