DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.

Detailed Description
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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.

Official Title
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DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting

Conditions
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Reduced Left Ventricular Function Defined as LVEF < 50%, Regional Left Ventricular Wall Motion Abnormalities

Intervention / Treatment
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* Procedure: Direct Epicardial Shock Wave Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Adverse Events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting, Myocardial Regeneration