NCT03021356已完成不适用
Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Transprosthetic pressure gradient at stress exercise echocardiography
研究概览
简要总结
The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years
- •Elective aortic valve replacement in patients with predominant aortic stenosis
- •including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
- •Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
- •Native German speakers (quality of life questionnaire in German language)
排除标准
- •Isolated aortic regurgitation
- •Concomitant aortic regurgitation > 2°
- •Endocarditis
- •LVEF <40%
- •Concomitant other valve surgery
- •s/p valve surgery
- •Contraindication for stress echocardiography
研究组 & 干预措施
Trifecta aortic xenograft
Active Comparator
The Trifecta aortic xenograft is implanted in these patients.
干预措施: Aortic xenograft (Device)
Magna Ease aortic xenograft
Active Comparator
The Magna Ease aortic xenograft is implanted in these patients.
干预措施: Aortic xenograft (Device)
结局指标
主要结局
Transprosthetic pressure gradient at stress exercise echocardiography
时间窗: Echo at follow up stress echo (at 10 months)
次要结局
- Quality of life using the EQ-5D-3L questionnaire(1 to 5 days before surgery and at follow up (10 months))
- Left ventricular mass regression calculated by echocardiography (gram)(Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months))
- BNP plasma level(1 to 5 days before surgery and at follow up (10 months))
- Transprosthetic pressure gradient at discharge echo(Echo at discharge (usually postoperative day 5 to 7))
研究者
研究点 (1)
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