Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Death, CVI and/or renal failure requiring any dialysis
研究概览
简要总结
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
详细描述
The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.
The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).
Heart centres in the Nordic region with experience (>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.
Study hypothesis:
As compared to conventional aortic valve substitution in patients aged >75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant aortic valve stenosis (valve area < 1cm2)
- •Age > 75 (years Aarhus University Hospital, Skejby)
- •Age > 80 years (other participating centres)
- •Operable by conventional surgery AND transapical stent valve implantation
- •Expected survival > 1 year following successful treatment
- •Accept of participation and in follow-up investigations after adequate information
- •Informed consent
排除标准
- •Coronary artery disease requiring PCI or CABG
- •Earlier cardiac surgery
- •Myocardial infarction within 24 hours
- •Kidney failure requiring any dialysis
- •Ongoing infection
- •Acute surgery
- •Allergy to ASA or Clopidogrel
研究组 & 干预措施
Conventional Aortic Valve Surgery
Insertion of a biological valve
干预措施: Conventional Aortic Valve Surgery (Procedure)
Transapical Aortic Valve Implantation
Transapical implantation of an Edwards SAPIENtm valve
干预措施: Transapical Aortic Valve Implantation (Procedure)
结局指标
主要结局
Death, CVI and/or renal failure requiring any dialysis
时间窗: 1 month
次要结局
- Echocardiographic results, valve performance(1 month with subseguent followup)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby