Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Left ventricular outflow tract gradient variability
研究概览
简要总结
This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:
Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.
Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.
Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.
Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.
详细描述
This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with hypertrophic cardiomyopathy (HCM);
- •age ≥18 years old;
- •presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
- •left ventricular ejection fraction (LVEF) ≥55%;
- •signed informed consent, willing and able to return to the hospital for follow-up.
排除标准
- •previously underwent septal reduction therapy (including surgical or interventional procedures);
- •received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
- •individuals with concomitant conditions requiring simultaneous surgical intervention;
- •New York Heart Association (NYHA) functional class IV;
- •unwilling to undergo surgical treatment;
- •pregnant or lactating or planning pregnancy;
- •previously participated in other clinical trials before enrollment;
- •individuals with concurrent diseases with an expected lifespan of less than 1 year.
结局指标
主要结局
Left ventricular outflow tract gradient variability
时间窗: 6 months,9 months and 12 months
Change in Left ventricular outflow tract gradient pre- and post- intervention
次要结局
- Echocardiographic indicator(6 months,9 months and 12 months)
- 6-minute walk distance(6 months,9 months and 12 months)
- Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score(6 months,9 months and 12 months)
- Cardiac magnetic resonance indicator(6 months,9 months and 12 months)
- New York Heart Association Functional Classification of Heart Failure(6 months,9 months and 12 months)
- Marker of myocardial injury(6 months,9 months and 12 months)