Clinical trial NCT06309524: Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair
Official title: Valutazione Del Rimodellamento Delle Camere Destre Dopo Trattamento Transcatetere Edge-to-edge Dell'Insufficienza Tricuspidale Severa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic tricuspid regurgitation that fulfill Guidelines criteria for transcatheter tricuspid valve repair

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.


Eligibility criteria: 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 \&lt;30 mL/min)
* Hypersensitivity reactions to contrast media
* Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
* Bad acoustic window with inadequate echocardiographic images.

Primary outcomes:
measure: Inverse remodeling of right heart chambers
timeFrame: At baseline and at 6 months after intervention
measure: Heart failure hospitalization
timeFrame: During 6 months after intervention
measure: Death
timeFrame: During 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
state: Lombardia
Study officials:
References: