Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.
详细描述
Background: Since the establishment of transcatheter aortic valve implantation (TAVI) in Romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. In 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis.
Objective
This is a national quality assurance initiative to improve patient care and outcomes. It further serves as a database for the assessment of the safety and efficacy of TAVI and its financial implications (e.g. reimbursement).
Design: National, prospective, observational, multi-center registry. All centers performing TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population: All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked valve of any manufacturer given that they provide written informed consent.
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
- •severe symptomatic aortic valve stenosis
- •high risk or patients deemed amenable for TAVI by a multidisciplinary team
- •signed informed consent to participate in the study
排除标准
- •inadequate annulus size (<18 mm, >29 mm)
- •left ventricle thrombus
- •active endocarditis
- •high risk of coronary ostium obstruction
- •plaques with mobile thrombi in the ascending aorta, or arch
- •hemodynamic instability
- •estimated life expectancy <1 year
- •comorbidity suggesting lack of improvement of quality of life
- •other situations adjudicated by the local HeartTeam
结局指标
主要结局
Mortality
时间窗: 1-year
All cause mortality
次要结局
- Arrhythmia(1-year)
- Bleeding(1-year)
- Myocardial ischemia(1-year)
- Acute kidney injury(1-year)
- Stroke(1-year)
- Vascular complications(1-year)