Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2009
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.
- Procedure: Direct Epicardial Shock Wave Therapy
- performed in adjunct to a standard coronary artery bypass grafting procedure Prior to aortic cross clamping direct epicardial shock wave therapy – applied directly to the myocardium
Clinical Trial Outcome Measures
- Safety, Adverse Events
- Time Frame: 6 months
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Cardiac Regeneration Technologies, LLC
- Provider of Information About this Clinical Study
- Reiner Schultheiss MD, Cardiac Regeneration Technologies LLC
- Overall Official(s)
- Michael Grimm, Prof. MD, Principal Investigator, Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
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