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临床试验/NCT06309524
NCT06309524招募中不适用

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

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
17
试验地点
1
主要终点
Inverse remodeling of right heart chambers

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Inverse remodeling of right heart chambers

时间窗: At baseline and at 6 months after intervention

Change in inverse remodeling of right heart chambers at 6 months after intervention

Death

时间窗: During 6 months after intervention

Incidence of death during 6 months after intervention

Heart failure hospitalization

时间窗: During 6 months after intervention

Incidence of heart failure hospitalization during 6 months after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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