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:
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.
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)
- cTnI(1 week, 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)
- Angina level(6 months)
- NT-proBNP(N-terminal pro-brain natriuretic peptide)
- 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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