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临床试验/NCT05625607
NCT05625607招募中不适用

Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry

Medical University of Warsaw7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
7
主要终点
Rate of myocardial infarction

研究概览

简要总结

In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. Significantly burdened ones are oftentimes disqualified or not referred to surgery redo. An emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. This technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (TAVI). Recent papers prove that transcatheter mitral valve replacement (TMVR) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. However, data regarding the Polish population are limited. Therefore, the aim of the study is to create a nationwide registry, collecting data from all Polish centers performing TMVR in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after TMVR as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.

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

  • Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  • Qualification for TMVR by decision of the local Heart Team
  • Patient provided written informed consent

排除标准

  • Disqualification from TMVR

结局指标

主要结局

Rate of myocardial infarction

时间窗: 1 year

Endpoint described as n=x (y%).

Rate of all-cause mortality

时间窗: 1 year

Endpoint described as n=x (y%).

Rate of hospitalization

时间窗: 1 year

Hospitalization for valve-related symptoms or worsening congestive heart failure. Endpoint described as n=x (y%).

Rate of neurological events

时间窗: 1 year

All stroke, transient ischemic attack (TIA). Endpoint described as n=x (y%).

Rate of valve-related dysfunction

时间窗: 1 year

Mean transvalvular gradient ≥5mmHg; ≥mitral regurgitation; ≥mild paravalvular leak; left ventricle outflow tract obstruction (LVOTO)- (acute hemodynamic deterioration associated with imaging evidence of LVOTO; mean LVOT pressure gradient increasement ≥10 mmHg compared to the baseline value). Endpoint described as n=x (y%).

次要结局

  • Rate of procedural success(30 days)
  • Rate of technical success(at 24 hours)
  • Rate of device success(30 days, 6 month, 1 year)
  • Rate of patient success(1 year)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (7)

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