Tissue Regeneration Technologies, LLC (TRT), is planning to complete the clinical study entitled DESWT (Direct epicardial shock wave therapy) for the product Cardiogold by February 2010. The study aim is to examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting. The trial is currently recruiting participants in Austria.
The treatment, open label, single group assignment, safety/efficacy study will enroll approximately 10 subjects. 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, (subsidiary of TRT) 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.
Cardiogold increases myocardium performance by direct epicardial shock wave therapy in combination with coronary artery bypass grafting. Its shockwave therapy directly on the surface of the heart shows preliminary results of increased blood flow, increase in the ejection fraction and a marked improvement in cardiac performance.
The official title of the trial is “Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting”.