Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Right ventricular fractional area change
研究概览
简要总结
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40. Echocardiographic parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
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
- •≥ 18 years of age
- •Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
- •Referred for medically indicated aortic valve replacement
- •Sinus rhythm
- •Provide written informed consent
排除标准
- •Left ventricular ejection fraction less than 0.45
- •Presence of any coexisting severe valvular disorder
- •Previous cardiac surgery
- •Urgent or emergent surgery
结局指标
主要结局
Right ventricular fractional area change
时间窗: Preoperatively and postoperatively at day 4 and 40
Pulsed wave tissue Doppler right venricular velocity
时间窗: Preoperatively and postoperatively at day 4 and 40
Tricuspid Annular Peak Systolic Excursion (TAPSE)
时间窗: Preoperatively and postoperatively at day 4 and 40
Right ventricular dimensions
时间窗: Preoperatively and postoperatively at day 4 and 40
次要结局
未报告次要终点
研究者
Peter Svenarud
MD, PhD
Karolinska University Hospital