Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.
详细描述
The study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery 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
- •Qualification for TAVI through common carotid artery 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 "Time-related valve safety" composite endpoint(From device implant to completion of at least 2 years of follow up)
- VARC defined "Early Safety" composite endpoint(30 days)
- VARC defined 'Device success' composite endpoint(30 days)