An observational study in Tricuspid Regurgitation, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Istituto Auxologico Italiano · Observational
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's planned enrollment of 17 is below the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic tricuspid regurgitation that fulfill Guidelines criteria for transcatheter tricuspid valve repair
Exclusion Criteria:
Transcatheter tricuspid leaflets approximation
Inverse remodeling of right heart chambers
Change in inverse remodeling of right heart chambers at 6 months after intervention
Time frame: At baseline and at 6 months after intervention
Heart failure hospitalization
Incidence of heart failure hospitalization during 6 months after intervention
Time frame: During 6 months after intervention
Death
Incidence of death during 6 months after intervention
Time frame: During 6 months after intervention
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Tricuspid Valve Insufficiency→
Istituto Auxologico Italiano