NCT05648825进行中（未招募）不适用
Transapical Beating-Heart Septal Myectomy for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Xiang Wei1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 myectomy for the treatment of apical hypertrophic cardiomyopathy. This is a prospective, single-arm, single-center study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed as nonobstructive hypertrophic cardiomyopathy, with maximal apical wall thickness ≥ 15 mm.
- •Patients with heart function of New York Heart Association ≥ class II.
- •Presenting with severe symptoms, e.g. angina, dyspnea, or fatigue, that were unresponsive or intolerant to pharmaceutical therapies;
- •Kansas City Cardiomyopathy Questionnaire (KCCQ) score < 80;
- •Presenting with one of the following conditions: midventricular obstruction with gradient ≥ 50 mmHg; grade II or higher diastolic dysfunction; apical aneurysm; ventricular tachycardia that needed an ICD implantation; pulmonary hypertension.
- •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-chamber cardiac surgery.
- •Patients who had severe heart failure with left ventricle ejection fraction < 50%.
- •Patients whose estimated life expectancy < 12 months.
- •Patient who were non-compliant.
- •peak VO2 of cardiopulmonary exercise test ≥ 90% of predicted.
- •LVOT obstruction.
- •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.
研究组 & 干预措施
Transapical beating-heart septal myectomy
Experimental
Transapical beating-heart myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy
干预措施: Transapical beating-heart septal myectomy (Device)
结局指标
主要结局
Procedural success
时间窗: 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement of ≥10 points, New York Heart Association (NYHA) improvement ≥ 1 grade, stroke volume increased by ≥10 mL, and diastolic function grading at normal or grade I (of III) .
次要结局
- Left ventricular end-diastolic pressure(1 day)
- Pulmonary artery wedge pressure(3 days)
- Stroke volume(3 days)
- NT-proBNP(N-terminal pro-brain natriuretic peptide)
- cTnI(1 week, 6 months)
- Angina level(6 months)
- Left ventricular end-diastolic pressure(1 day)
- Left ventricular end-systolic volume(7 days and 6 months)
- Left ventricular end-diastolic volume(7 days and 6 months)
- Obliteration(6 months)
- Peak oxygen consumption(6 months)
- pVO2(6 months)
- Pulmonary artery wedge pressure(3 days)
- Stroke volume(3 days)
- Left ventricle mass(6 months)
- Cardiac diastolic function(6 months)
- Left atria volume(6 months)
- Ventricular wall thickness(6 months)
- LVOT gradient(1 week, 6 months)
- Midventricular gradient(1 week, 6 months)
- Device success(6 months)
- New York Heart Association class(6 months)
- 6-minute walking test(6 months)
- Heart function-associated quality of life(6 months)
- Major adverse cardiovascular and cerebral events(6 months)
- All cause mortality(6 months)
研究者
Xiang Wei
Division of Cardiothoracic and Vascular Surgery
Tongji Hospital
研究点 (1)
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