VARC-TAVI (VASCULAR CONTROL in TRANSCATHETER AORTIC VALVE IMPLANTATION)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- ACCESS RELATED OR BLEEDING COMPLICATIONS
研究概览
简要总结
SUMMARY:
The investigators are planning a clinical study to compare two methods of performing a procedure called TAVI, used in patients with severe aortic stenosis. In this procedure, the aortic valve is replaced in a less invasive way. Traditionally, access through the groin (femoral) is used, but now radial access (through the wrist) is being considered as an alternative.
Reasons for the Study:
- Currently, there is not enough solid evidence to support the choice between these two accesses.
- The investigators want to understand if radial access could be safer and have fewer complications compared to femoral access.
What the Investigators Will Measure:
- Major complications, such as bleeding or vascular injuries.
- Other important outcomes, such as functional recovery and quality of life.
How the Investigators Will Do It:
- The investigators will randomize patients to receive radial or femoral access.
- The investigators will record which type of access is used and assess complications and outcomes.
- The investigators will compare the results to understand if there are significant differences between the two groups.
Ultimate Goal:
- The investigators aim to improve the safety and efficacy of this procedure for patients.
- The results of this study will help doctors make informed decisions on how to perform TAVI.
Conclusion:
- This study is crucial for enhancing care for patients with aortic stenosis and ensuring the procedure is performed in the safest and most effective manner. The results will benefit patients and guide doctors in choosing the best approach for each individual.
详细描述
INTRODUCTION:
The TAVI procedure has been established as a safe and effective alternative for aortic valve replacement in patients with severe aortic stenosis. Vascular access plays a crucial role during the TAVI procedure, allowing the introduction of necessary devices for valve implantation, as well as protection and resolution of potential complications. Traditionally, femoral access has been the preferred approach for both main access (through which the valve navigates) and secondary access (serving as a guide during implantation and protection of the main access) due to its familiarity and technical ease. However, in recent years, radial access has gained popularity due to its theoretical potential to reduce vascular complications and improve participant recovery and quality of life. In this study, the investigators aim to demonstrate if there are differences between radial and femoral secondary access in transfemoral TAVI implantation.
JUSTIFICATION:
Conducting a clinical trial comparing radial and femoral secondary access in transfemoral TAVI implantation is crucial for several fundamental reasons. The main aspects supporting the need for such a clinical trial are outlined below.
- Limited and Heterogeneous Evidence:
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
- 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
- •Adult patients with severe aortic stenosis and candidates for transfemoral TAVI.
- •Secondary access possible through both radial and femoral routes.
- •Capacity to provide informed consent.
排除标准
- •Specific contraindications for radial or femoral access.
结局指标
主要结局
ACCESS RELATED OR BLEEDING COMPLICATIONS
时间窗: From the enrollment to 4 weeks after the procedure.
Major and minor access-related complications (VARC-3) and major or greater (VARC ≥2) bleeding complications (BARC)
次要结局
- MACE(From the enrollment to 4 weeks after the procedure.)
- Quality of life scale(4 weeks after the procedure)
- bleeding(From the enrollment to 4 weeks after the procedure.)
- Complications not directly TAVI procedure-related(From the enrollment to 4 weeks after the procedure.)
研究者
Daniel Tébar Márquez
Doctor of medicine
Hospital Universitario La Paz