Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
研究概览
简要总结
In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.
详细描述
The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.
Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.
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 aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- •Qualification for TAVI by decision of the local Heart Team
- •Patient provided written informed consent
排除标准
- 未提供
结局指标
主要结局
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
时间窗: From 30 days post procedure to completion of at least 2 years of follow up
* All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA (New York Heart Association) class III or IV functional classification of heart failure * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) \<0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation
次要结局
- VARC defined 'Device success' composite endpoint(30 days)
- VARC defined "Early Safety" composite endpoint(30 days)
- VARC defined "Time-related valve safety" composite endpoint(From device implant to completion of at least 2 years of follow up)