Reduced Left Ventricular Function Defined as LVEF < 50% Clinical Trial
Official title:
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment