The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Decision 2- Valve size decision after knowledge of the computer simulation results
研究概览
简要总结
Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.
The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.
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
- •Native severe aortic valve stenosis
- •Planned for TAVI with the Evolut R Valve
排除标准
- •Bicuspid aortic valve
- •Extensive subannular calcifications
- •Non-transfemoral access
- •Poor CT quality
- •Lack of written informed consent
结局指标
主要结局
Decision 2- Valve size decision after knowledge of the computer simulation results
时间窗: an average of 1 day before TAVI, before TAVI but after computer simulation
Valve size decision after availability of the results of computer simulation
Decision 1- Valve size decision based on pre TAVI MSCT
时间窗: an average of 2 days before TAVI, before TAVI and computer simulation
Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting
次要结局
- Depth of implantation target 2(an average of 1 day before TAVI, before TAVI but after computer simulation)
- Correlation between predicted contact pressure and observed new conduction abnormality(an average of 4 days after TAVI, at hospital discharge)
- Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed(an average of 4 days after TAVI, at hospital discharge)
- MACCE(an average of 4 days after TAVI, at hospital discharge)
- Decision 3- Change of initial valve size decision during TAVI(an average of 5 minutes after TAVI, directly after TAVI)
- Decision 3- Change of initial depth of implantation strategy during TAVI(an average of 5 minutes after TAVI, directly after TAVI)
- Depth of implantation target(an average of 2 days before TAVI, before TAVI and computer simulation)
- Aortic regurgitation(an average of 4 days after TAVI, at hospital discharge)
研究者
P de Jaegere
MD, PhD, Professor
Erasmus Medical Center