Compare the Results for the Extended Myoectomy and Standard Morrow's Myoectomy in Patients With Ventricular Obstruction of the Left Ventricular Output
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The pressure gradient in the output section of the left ventricle
研究概览
简要总结
The purpose of this study is to determine whether the application of the extended myoectomy in patients with obstruction of the left ventricular output more efficient than standard myoectomy by Morrow.
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. Use of extended myomectomy eliminates mitral insufficiency due to SAM syndrome. The question remains whether it is possible at hypertrophic cardiomyopathy basal part and mediated mitral insufficiency use only myoectomy by Morrow is achieved regression SAM syndrome and release output of the left ventricle. Planned to create two equal groups of 30 people that will use two methods of surgical treatment of obstructive hypertrophic cardiomyopathy. The study will be terminated in the event of complete AV block more than 2% and unsatisfactory results of a myoectomy requiring perform mitral valve replacement in more than 15% of the patients studied. The study assumed crossover: in case of failure elimination SAM syndrome and mediated mitral insufficiency myoectomy by Morrow for patients will perform extended myoectomy in the case of a good result in patients are moved to the second group.
Planned studies the long-term and immediate results of operations:
- Quantitative determination of enzymes of myocardial injury: creatine phosphokinase MB and troponin I.
- Determination of atrial natriuretic peptide (ANP) and brain natriuretic peptide (VNP).
- MRI with contrast heart to assess remodeling of the heart chambers and heart weight measurements.
- TEE evaluation function and mitral valve gradient at the output of the left ventricle.
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
- •mediated mitral insufficiency by SAM syndrome
- •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 pressure gradient in the output section of the left ventricle
时间窗: one year
次要结局
- The function of the mitral valve(one year)