Clinical trial NCT00741065: DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Official title: DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduced Left Ventricular Function Defined as LVEF < 50%
Regional Left Ventricular Wall Motion Abnormalities
Keywords: Coronary Artery Bypass Grafting
Myocardial Regeneration
Lead sponsor: Cardiac Regeneration Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety, Adverse Events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clinical Department for Cardiothoracic Surgery, General Hospital Vienna
Study officials:
affiliation: Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
name: Michael Grimm, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: