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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06309524
Study type Observational
Source Istituto Auxologico Italiano
Contact Luca Grappiolo
Phone +390261911
Email luca.grappiolo@auxologico.it
Status Recruiting
Phase
Start date February 15, 2023
Completion date January 1, 2025

See also
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Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
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Not yet recruiting NCT05848284 - Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) Phase 1
Active, not recruiting NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
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