Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quantification of obstructive severity
研究概览
简要总结
Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of tumors are hard to completely resect. Also, as thoracoscopic surgeries induce great operation trauma, some patients cannot tolerate or do not will to take the operation. Therefore, new methods and techniques are in urgent need.
Our center have a 12-year experience of intervention treatment for solid tumors and has conducted several animal experiments to verify the effectiveness of transthoracic puncture ablation and radiofrequency ablation for ventricular muscle.
The purpose of this study is to conduct new method of direct transthoracic cardiac tumor-targeted Radiofrequency Ablation (RFA) or Laser induced Interstitial Thermotherapy (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the safety and validity of intervention treatment in long term.
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
- •Cardiac tumors not suitable for surgical removal
- •Subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence
- •Cardiac tumors in ventricular chambers, myocardium, or pericardium
- •Subject who cannot tolerate thoracoscopic removal or volunteer for the operation
- •Subject Over 12 years old
排除标准
- •Subject who has other cardiac diseases must receive surgical removal
- •Subject has end-stage heart failure
- •Subject has poor physical conditions and cannot tolerate the operation
研究组 & 干预措施
Cardiac tumors
干预措施: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy (Procedure)
Cardiac tumors
干预措施: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy (Procedure)
结局指标
主要结局
Quantification of obstructive severity
时间窗: 24 months
Investigators use the peak velocity and of stenosis (by echocardiography) to quantify obstructive severity caused by the tumor. If the peak velocity increases, the symptom gets deteriorated; if the peak velocity decreases, the symptom gets relieved.
Mortality
时间窗: 24 months
Tumor size
时间窗: 24 months
If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.
次要结局
- Quantification of cardiac function(24 months)
- Quantification of tumor blood perfusion(24 months)
研究者
Liu Liwen
MD,PhD
Xijing Hospital