Reduced Left Ventricular Function Defined as LVEF < 50%, Regional Left Ventricular Wall Motion Abnormalities
Conditions
Keywords
Coronary Artery Bypass Grafting, Myocardial Regeneration
Brief summary
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
Detailed 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.
Interventions
PROCEDUREDirect 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
Sponsors
Cardiac Regeneration Technologies, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Adverse Events | 6 months |
Countries
Austria
Outcome results
None listed