Minimally Invasive Transapical Beating-Heart Septal Myectomy in Patients With Nonobstructive Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Procedural success
研究概览
简要总结
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
详细描述
Medical therapy is first recommended for patients with nonobstructive hypertrophic cardiomyopathy administrated at onset of heart failure symptoms. As the disease progresses, patients with global ejection fraction < 50% should be evaluated with respect to eligibility and motivation for heart transplant. However, for those with preserved ejection fraction and drug-refractory heart failure symptoms, there is still no optimal therapy. Some patients with increased left atrial volume and/or diastolic dysfunction can be recognized as a result of excessive myocardial hypertrophy, and the septal resection for these patients may be beneficial. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient resection of hypertrophied septal myocardium while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricular morphology and hemodynamics are evaluated each time after resection. Multiple resections are performed to tailor sufficient enlargement of left ventricular end-diastolic volume and improvement of mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients are scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose maximal ventricular septal wall thickness ≥ 15 mm.
- •Patients with heart function of New York Heart Association ≥ class II.
- •Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
- •Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form
排除标准
- •Patients who were pregnant.
- •Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
- •Patients who had severe heart failure with left ventricle ejection fraction < 40%.
- •Patients whose estimated life expectancy < 12 m.
- •Patient who were non-compliant.
- •Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.
结局指标
主要结局
Procedural success
时间窗: 3 months
A reduction of ≥1 New York Heart Association (NYHA) class and a decrease of ≥ 20% of left atrial volume
All-cause mortality
时间窗: 3 months
Death from any cause during the observation period.
次要结局
- Septal thickness(7 days and 3 months)
- Left atrial volume(7 days and 3 months)
- New York Heart Association class(7 days and 3 months)
- Evaluation of the mitral valve(7 days and 3 months)
- Left ventricular end-diastolic volume(3 months)
- Device success(1 day)
- 6-minute walking test(3 months)
- Left ventricle mass(7 days and 3 months)
- Major adverse cardiovascular and cerebral events(3 months)
- Heart function-associated quality of life(7 days and 3 months)
- Left ventricular outflow tract diameter(7 days and 3 months)
研究者
Xiang Wei
Professor and Director
Tongji Hospital