Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Differences in mid term trans prosthetic gradients
研究概览
简要总结
Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of:
- 6 -month hemodynamic performance.
- 6 month clinical outcomes including all cause mortality, stroke, myocardial infarction, valve reoperation and major/life threatening bleeding
- Cost effectiveness
详细描述
This study is aimed to compare clinical and hemodynamic performance of conventional sutured stented bio-prostheses among patients undergoing a surgical aortic valve replacement. The prostheses are not pre specified to be provided by a specific manufacturer, so that any bio prosthesis but transcatheter and scentless aortic valves can be implanted.
The estimated sample size is 350 patients. They will be randomised 1:1 to any of the two arms of the study (standard Vs. sutureless prostheses). The randomisation will be stratified according to the need for a concomitant coronary artery bypass grafting procedure.
Six hospitals in Madrid (Spain) will take part in the study. The period of recruitment will start as soon as June 2019 and is supposed to finish by June 2020 or earlier.
The main outcomes of the study will be measured 6 months after the aortic valve implantation
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18
- •Pure aortic stenosis or combined aortic stenosis/regurgitation
- •Aortic annulus >18 mm and < 27 mm
排除标准
- •Pregnancy
- •Willing to receive some other prosthesis
- •Concomitant surgery of the ascending aorta or left ventricle outflow tract
- •Endocarditis
- •Emergency
- •Some other concomitant procedure
- •Participation in any other study
- •Previous surgery
结局指标
主要结局
Differences in mid term trans prosthetic gradients
时间窗: 6 month
The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure
次要结局
- Differences in quality if life according to the KCCQ12 questionnaire(6 month)
- Survival from Combined major adverse cardiovascular event(6 month)
研究者
Manuel Carnero Alcazar
Adult Cardiac Surgeon, MD, PhD
Hospital San Carlos, Madrid