Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting (CAST-HF)
Heart Failure Patients, Cardiac Ischemia
About this trial
This is an interventional treatment trial for Heart Failure Patients
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Sites / Locations
- Medical University of Innsbruck - Competence Center for Clinical Trials
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Arm
Sham Control Arm
In the intervention arm, 300 shockwave impulses per coronary supply territory, at an energy flux density of 0.38mJ/mm2 and a frequency 3Hz, are applied in direct contact with the ischaemic myocardium of the left ventricle. The intervention is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass.
In the sham control arm, the same manipulations are performed with an inactive shockwave applicator in direct contact with the ischaemic myocardium of the left ventricle as in the intervention arm. The sham treatment is performed during CABG surgery after bypasses are fully established while still on cardiopulmonary bypass.