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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Safety, Adverse Events
time frame: 6 months

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Cardiac Regeneration Technologies, LLC.