Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
研究概览
简要总结
To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.
详细描述
Patients will undergo elective transfemoral TAVR with the Evolut THV. The operators will attempt to selectively engage both the right and left coronary arteries through standardized angiographic views. The CCI-CIC CoreLabs will adjudicate angiographic views, post-TAVR CT scan, and determine if the coronaries were selectively engaged. Catheter choice, adjunctive tools if needed (e.g guide extension, wires etc) and engagement technique will be at the discretion of the operator. All images and fluoroscopic views will be anonymized, saved and imported to the CCI-CIC Angiographic and CT CoreLabs.
Statistical analysis
Patient baseline and outcome data will be presented as mean and standard deviation (SD) for normally distributed variables, median and interquartile range (IQR) for non-normally distributed variables, and frequency and proportion for categorical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
- •Written informed consent to participate in the study.
排除标准
- •Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.
- •Advanced chronic kidney disease, defined as a GFR <30 ml/min.
- •Valve-in-valve TAVR
- •Aorto-ostial coronary artery disease.
- •Prior PCI of the left main or right coronary ostium
结局指标
主要结局
The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
时间窗: Immediately post-TAVR
Coronary engagement will be classified as: 1. Partially successful if non-selective engagement is achieved (catheter is unable to be placed in the coronary ostia) and there is adequate opacification of the coronary vessels. 2. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels. 3. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels.
次要结局
- Total contrast use (ml) from catheter insertion to selective coronary engagement.(During TAVR procedure)
- Total number and types of wires and catheters used.(During TAVR procedure)
- Description of type of technique utilized to achieve selective coronary engagement.(During TAVR procedure)
- Type of wire and catheter used for successful right and left coronary engagement(During TAVR procedure)
- Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement.(During TAVR procedure)
研究者
David Wood
Interventional and Structural Cardiologist
University of British Columbia