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