Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Transvalvular Mean Pressure Gradient (mPG)
研究概览
简要总结
The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.
详细描述
This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are going to undergo aortic valve replacement with bioprosthesis
排除标准
- •heart failure with severe LV dysfunction (LV EF <30%)
- •active infective endocarditis
- •with other critical cardiovascular disease (e.g. acute aortic dissection)
- •with other critical comorbities by which the expected life span is less than 1 year
- •inadequate participant by the researcher's discretion
结局指标
主要结局
Transvalvular Mean Pressure Gradient (mPG)
时间窗: at postoperative 1 year
transvalvular mean pressure gradient measured by trans-thoracic echocardiography
次要结局
- Number of Participants With Op Morbidities(at postoperative 1 year)
- Effective Orifice Area (EOA)(at postoperative 1 year)
- Number of Participants With Op Mortality(at postoperative 30 days or at the time of discharge)
- Number of Participants With All-cause Mortality(at postoperative 1 year)
- Number of Participants With Cardiac Death(at postoperative 1 year)
- Number of Participants With Aortic Valve-related Events(at postoperative 1 year)
研究者
Ho Young Hwang
Professor
Seoul National University Hospital