741065
Last Update Posted: 2010-02-11
Recruiting status is unknown
All Genders accepted | 18 Years + |
10 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
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.
Eligibility
Relevant conditions:
Reduced Left Ventricular Function Defined as LVEF < 50%
Regional Left Ventricular Wall Motion Abnormalities
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov