Status:
UNKNOWN
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Lead Sponsor:
Cardiac Regeneration Technologies, LLC
Conditions:
Reduced Left Ventricular Function Defined as LVEF < 50%
Regional Left Ventricular Wall Motion Abnormalities
Eligibility:
All Genders
18+ years
Phase:
NA
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 Re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00741065
Start Date
September 1 2008
End Date
February 1 2010
Last Update
February 11 2010
Active Locations (1)
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1
Clinical Department for Cardiothoracic Surgery, General Hospital Vienna
Vienna, Austria, 1090