Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Valve-related long-term clinical efficacy
研究概览
简要总结
This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.
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
- •Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
- •Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
- •Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
- •Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form
排除标准
- •Patients who cannot provide informed consent
- •Patients who are participating in other clinical trials
结局指标
主要结局
Valve-related long-term clinical efficacy
时间窗: 5 years
* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
All-casuse mortality
时间窗: 5 years
All-casuse mortality including cardiac death and non-cardiac death
次要结局
- Rate of technical success(at exit from procedure room)
- Combined early safety and clinical efficacy outcomes(30 days)
- Rate of device success(discharge or 30 days)
- Combined clinical efficacy outcomes(5 years and 10 years)
- Valve-related long-term clinical efficacy(10 years)
研究者
LingTao
Professor in Cardiology, Director of the department of Cardiology
Xijing Hospital