NCT06224621Unknown不适用
Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial
China National Center for Cardiovascular Diseases2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in LVOT gradiant/midventricular gradient
研究概览
简要总结
This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:
- the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
- the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of hypertrophic cardiomyopathy;
- •At least 18 years old;
- •The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
- •Willing to receive PESA treatment;
- •LVEF≥55%;
- •Signed and dated written informed consent and willing to return for clinical follow-up.
排除标准
- •Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
- •Complete right bundle branch block;
- •Acute decompensation heart failure with NYHA IV;
- •Previous septal reduction therapy including surgical and interventional procedures;
- •Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
- •Contraindications of radiofrequency ablation procedure;
- •Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
- •Currently enrolled in another investigational device or drug trial;
- •Combining any other clinical condition with a life expectancy less than 1 year.
结局指标
主要结局
Change in LVOT gradiant/midventricular gradient
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
- Change in Maximal wall thickness (MWT)(6 months,9 months and 12 months)
- Change in 6 minute walking test(6 months,9 months and 12 months)
- Change in NYHA cardiac function class(6 months,9 months and 12 months)
- Change in cTnT(6 months,9 months and 12 months)
- Change in cTnI(6 months,9 months and 12 months)
- Change in Left ventricular end-diastolic diameter (LVEDD)(6 months,9 months and 12 months)
- Change in Left atrial diameter (LAD)(6 months,9 months and 12 months)
- Change in Cardiac index (CI)(6 months,9 months and 12 months)
- Change in Late gadolinium enhancement (LGE)(6 months,9 months and 12 months)
- Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score(6 months,9 months and 12 months)
- Change in NT-proBNP(6 months,9 months and 12 months)
- Change in Left ventricular ejection fraction (LVEF)(6 months,9 months and 12 months)
- Change in Left ventricular mass index (LVMi)(6 months,9 months and 12 months)
研究者
研究点 (2)
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