Women's INternational Transcatheter Aortic Valve Implantation Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,019
- 试验地点
- 10
- 主要终点
- VARC 2
研究概览
简要总结
The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.
详细描述
WINTAVI is an international, multi-centre, prospective, observational registry. The purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available Transcatheter Aortic Valve Implantation (TAVI) devices for percutaneous aortic valve implantation in female patients with severe Aortic Stenosis (AS) requiring treatment. Data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe AS. This will include Quality of Life questionnaires (KCCQ).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Severe AS determined by echocardiogram and Doppler, defined as: mean gradient >40 mmHg or peak jet velocity >4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
- •Symptomatic AS demonstrated by angina, congestive heart failure, NYHA functional class ≥ II, or syncope
- •Logistic EuroSCORE suitable for TAVI
- •Patient must have other conditions (such as severe airways disease, porcelain aorta, previous thoracic radiotherapy, Childs Pugh class B and C liver disease) such that the multi-disciplinary team (interventional cardiologists, cardiothoracic surgeons and cardiac anaesthesiologists) agree that co-morbidities render SAVR of high or prohibitive risk.
- •Patient has been informed of the nature of the registry and has provided full written informed consent according to hospital practise
排除标准
- •Patient is not an eligible candidate for TAVI
- •Untreated clinically significant (> 70% obstruction) coronary artery disease in the proximal segments of main branches suitable for revascularization
- •Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- •Hemodynamic instability (e.g. requiring inotropic support)
- •Active endocarditis or sepsis within 6-months prior to the study procedure
- •Use of investigational device without CE mark
结局指标
主要结局
VARC 2
时间窗: 30 days
The primary study endpoint is the VARC 2 early safety endpoint at 30-days (all-cause mortality, all stroke \[disabling and non disabling\], life-threatening bleeding, stage 2 or 3 acute kidney injury \[AKI\], coronary artery obstruction requiring intervention, major vascular complications, repeat procedure for valve-related dysfunction).
次要结局
- VARC 2(up to 2 years)
- BARC(up to 2 years)
- NYHA(up to 2 years)
- KCCQ-12(up to 2 years)