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临床试验/NCT01161732
NCT01161732已完成不适用

Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

Asan Medical Center8 个研究点 分布在 2 个国家目标入组 145 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
8
主要终点
Cardiac mortality

研究概览

简要总结

The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.

详细描述

Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated AV replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College of Cardiology/American Heart Association guidelines recommend surgery as a class IIb indication only in patients with extremely severe AS and who are at low operative risk. Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and asymptomatic patients with very severe AS are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe AS, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe AS is associated with an improved long-term survival in a prospective, observational study. However, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe AS. We sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.
  • According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.

排除标准

  • Exertional dyspnea
  • Left ventricular ejection fraction < 50%
  • Significant aortic regurgitation
  • Significant mitral valve disease
  • Pregnancy
  • Age < 20 years or > 80 years
  • Coexisting malignancies
  • Positive exercise test

结局指标

主要结局

Cardiac mortality

时间窗: Entire follow-up ( a minimum of 10 years)

defined as death from complications of myocardial infarction, heart failure, shock, complications of cardiac surgery or intervention, other cardiovascular diseases including sudden cardiac death

Operative mortality

时间窗: up to 30 days after surgery

Operative mortality is defined as death within 30 days of surgery.

次要结局

  • All-cause death(Entire follow-up (a minimum of 10 years))
  • Repeat aortic valve surgery(Entire follow-up (a minimum of 10 years))
  • Clinical thromboembolic events(Entire follow-up (a minimum of 10 years))
  • Hospitalization due to congestive heart failure(Entire follow-up (a minimum of 10 years))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duk-Hyun Kang

Professor

Asan Medical Center

研究点 (8)

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