DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
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
- Safety, Adverse Events
研究概览
简要总结
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
详细描述
Direct epicardial shock wave therapy: DESWT will be performed in adjunct to a standard CABG procedure. Prior to aortic cross clamping, DESWT will be performed using a CardioGold® CG050 (CRT Cardiac Regeneration Technologies, Woodstock, USA / manufactured by MTS-Europe GmbH, Konstanz, Germany) shock wave therapy device and a specially designed handheld applicator under sterile conditions. Depending on the localisation of the myocardial infarct scar, 290-310 impulses will be applied to the anterior, lateral, or posterior wall. Shock waves will be generated at 1 or 2 Hz in a non ECG triggered fashion, should DESWT result in significant ventricular arrhythmias, ECG gating will be initiated. After completion of DESWT, CABG will be continued in a regular fashion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients above 18 years of age undergoing primary coronary artery bypass grafting.
- •Patients have to present with reduced left ventricular function defined as LVEF < 50%.
- •Patients have to present with regional left ventricular wall motion abnormalities.
- •Patients have to give written informed consent to participate in the study.
排除标准
- •Significant concomitant valve disease(except significant valve disease not detected in preoperative cardiac ultrasound that is detected intra-operatively).
- •HIV positive patients.
- •Hepatitis C positive patients.
- •Patients in cardiogenic shock.
- •Patients with a contraindication for cardiac MRI.
- •Present contraindication for transoesophageal echocardiography (TEE).
- •History of significant ventricular arrhythmias, except arrhythmias associated with MI.
- •Highly reduced left ventricular function defined as LVEF <30%.
- •Present co-morbidity which reduces life expectancy to less than 6 months.
- •Presence of ventricular thrombus.
- •Presence of a cardiac tumor.
- •Pregnancy.
结局指标
主要结局
Safety, Adverse Events
时间窗: 6 months
次要结局
未报告次要终点