NCT06309524

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

Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 17 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Tricuspid transcatheter edge-to-edge repair	Transcatheter tricuspid leaflets approximation

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study