Tricuspid Regurgitation
Conditions
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.
Interventions
DEVICETricuspid transcatheter edge-to-edge repair
Transcatheter tricuspid leaflets approximation
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Heart failure hospitalization | During 6 months after intervention | Incidence of heart failure hospitalization during 6 months after intervention |
| Death | During 6 months after intervention | Incidence of death during 6 months after intervention |
Countries
Italy
Contacts
Primary ContactLuca Grappiolo
Outcome results
None listed