Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation
研究概览
简要总结
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects.
There is limited experience for the balloon expandable Edwards THV on the need for predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case series.
The investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.
详细描述
Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:
- Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia.
- In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality.
- BAV has been identified as a major source of thrombotic and valvular material, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke.
- The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.
The investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Signed informed consent
- •Males or females
- •At least 18 years of age
排除标准
- •Logistic EuroSCORE I >40%
- •Mitral or tricuspid valvular insufficiency (> grade II)
- •Previous aortic valve replacement
- •Uncontrolled atrial fibrillation
- •Left ventricular or atrial thrombus by echocardiography
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Patients with mobile structures on the leaflets
- •Need for a cerebral protection device
结局指标
主要结局
Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation
时间窗: within 30 days after TAVI
次要结局
- Non-fatal myocardial infarction(within 30 days after TAVI)
- pacemaker implantation(within 30 days after TAVI)
- acute kidney injury(within 30 days after TAVI)
- Stroke(within 30 days after TAVI)
- All-cause mortality(within 30 days after TAVI)