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

Cardiac Regeneration Technologies

Status

Unknown

Conditions

Regional Left Ventricular Wall Motion Abnormalities

Reduced Left Ventricular Function Defined as LVEF < 50%

Treatments

Procedure: Direct Epicardial Shock Wave Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00741065

DESWT,Version:02 May 21,2008;

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.