Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
研究概览
简要总结
This randomised, controlled clinical trial aims to evaluate the safety and efficacy of Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring surgical revascularization. The main questions to answer are:
- Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular ejection fraction?
- Is cardiac shockwave therapy in addition to CAGB surgery safe?
Participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.
详细描述
This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The masking is performed using opaque envelopes that are opened by an assistant at the end of the CABG procedure after the bypasses are fully established.
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting
- •Presentation with reduced left ventricular function, defined as LVEF ≤ 40% measured by cardiac MRI
- •Presentation with regional left ventricular wall motion abnormalities
- •Written informed consent from the patient for participation in the study
排除标准
- •Significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery)
- •Serious radiographic contrast allergy
- •Patient in cardiogenic shock or presenting with acute myocardial infarction (STEMI or NSTEMI)
- •Patient with a contraindication for cardiac MRI
- •History of significant ventricular arrhythmia, other than MI-associated arrhythmia
- •Comorbidity reducing life expectancy to less than one year
- •Presence of a ventricular thrombus
- •Presence of a cardiac tumour
- •Pregnancy
结局指标
主要结局
The primary efficacy endpoint is the improvement in LVEF measured by cardiac MRI from baseline to 360 days.
时间窗: 360 days
The primary efficacy objective is to assess the efficacy of cardiac shock wave therapy in patients undergoing primary coronary artery bypass grafting and suffering from reduced left ventricular function ≤ 40%
The primary safety endpoint is the occurrence of device-related complications (adverse device effects or serious adverse device effects) within 360 days.
时间窗: 360 days
The primary safety objective is to assess the safety profile of the cardiac shock wave therapy device.
次要结局
- Secondary efficacy-related endpoints include patient-reported outcomes.(360 days)
- Secondary safety-related endpoints include patient-reported outcomes.(6 Days)