Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+. A Randomized, Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Achievement commissural alignment.
研究概览
简要总结
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve material after implantation.
Method The study will include patients undergoing TAVI. Participants will be randomized, meaning that it will be determined by chance which of two established implantation techniques is used. Both techniques are already part of routine clinical practice.
Examinations After the procedure, a CT scan will be performed to evaluate the position of the valve in relation to the coronary arteries. This CT scan is the only additional examination beyond today's standard clinical practice.
Significance If one of the techniques proves to provide better positioning of the valve, this method may be recommended as standard practice in future treatment. The study will therefore contribute to improved patient safety and treatment quality, as well as increase knowledge about optimal positioning and implantation techniques in TAVI.
详细描述
The purpose of the present study is to prospectively evaluate the efficacy and safety of a novel patient-specific rotation of the Evolut FX+ TAVI valve and the delivering system during the transfemoral (TF) procedure. Specifically, it aims to evaluate and compare the commonly used fluoroscopic (X-ray) LAO degree for rotation of the delivery system and more patient-specific LAO degree achieved by CT analysis prior to the procedure. The degree of alignment and coronary overlap will be measured with ECG-gated CT after the procedure. Thus, it will prospectively explore if these two techniques differ in obtaining commissural alignment, coronary overlap and safety outcomes following implantation of latest-generation Evolut FX+ valve.
We intend to include 40 patients with severe aortic stenosis and in whom TF-TAVI with Evolut FX+ is planned after heart team meeting. Preprocedure CT scan and postprocedure CT scan will be evaluated for commissural alignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe aortic stenosis indicated for TAVI after heart team meeting.
- •Age ≥65 years.
- •Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).
- •Patients providing informed consent.
排除标准
- •Severe peripheral vascular disease preventing transfemoral access.
- •Prior aortic valve replacement or bicuspid valve.
- •Severely reduced kidney function (estimated glomerular filtration rate <30).
结局指标
主要结局
Achievement commissural alignment.
时间窗: Day 1 (post-procedure CT).
Proportion of patients achieving commissural alignment post-TAVI (measured by CT-analysis after TAVI).
Commissural alignment after TAVI measured in degrees.
时间窗: Day 1 (post-procedure CT)
Commissural alignment following TAVI, assessed by computed tomography (CT) analysis. Native commissures (measured before TAVI from CT) will serve as the reference. We will measure the number of degrees of all three commissures from the center of the left main artery before and after TAVI to estimate alignment.
次要结局
未报告次要终点
研究者
Ahmed Al-Ani
MD
Oslo University Hospital