Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: Safety and Efficacy Results of a Phase I First-in-man Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 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 hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.
详细描述
Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract 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 ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients is 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and 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
Resting left ventricle outflow tract gradients \< 30 mmHg, provoked left ventricle outflow tract gradients \< 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.
All-cause mortality
时间窗: 3 months
Death from any cause during the observation period.
次要结局
- Left ventricle mass(3 months)
- Cardiac diastolic function(7 days and 3 months)
- Left ventricular outflow tract gradient(7 days and 3 months)
- Left ventricular outflow tract diameter(7 days and 3 months)
- Device success(1 day)
- Left ventricle volume(7 days and 3 months)
- Heart function-associated quality of life(7 days and 3 months)
- Septal thickness(7 days and 3 months)
- Left atria volume(7 days and 3 months)
- New York Heart Association class(7 days and 3 months)
- Major adverse cardiovascular and cerebral events(3 months)
- 6-minute walking test(3 months)
- Evaluation of the mitral valve(7 days and 3 months)
研究者
Xiang Wei
Professor and Director
Tongji Hospital