DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
This trial is active, not recruiting.
|Conditions||reduced left ventricular function defined as lvef < 50%, regional left ventricular wall motion abnormalities|
|Treatment||direct epicardial shock wave therapy|
|Sponsor||Cardiac Regeneration Technologies, LLC|
|Start date||September 2008|
|End date||June 2009|
|Trial size||10 participants|
|Trial identifier||NCT00741065, DESWT,Version:02; May 21,2008|
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Safety, Adverse Events
time frame: 6 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
|Official title||DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting|
|Principal investigator||Michael Grimm, Prof. MD|
|Description||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.|
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