NCT02054221已完成不适用
Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
研究概览
简要总结
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
详细描述
Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Able to sign Informed Consent and Release of Medical Information forms
- •Age ≥ 18 years
- •obstructive hypertrophic cardiomyopathy
- •surgically significant mitral insufficiency
- •II-IV (NYHA),
- •average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
- •basal or medium ventricular obstruction
排除标准
- •Related defect of the aortic valve;
- •Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
- •Surgically significant coronary artery lesions;
- •Patients requiring implantation of a cardioverter-defibrillator
结局指标
主要结局
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
时间窗: one year
次要结局
- The pressure gradient in the output section of the left ventricle(one year)
研究者
研究点 (2)
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