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

Reduced Left Ventricular Function Defined as LVEF < 50% Clinical Trial

— DESWT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00741065
• Other study ID #: DESWT,Version:02; May 21,2008
• Status: Active, not recruiting
• Phase: N/A
• First received: August 25, 2008
• Last updated: February 10, 2010
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Cardiac Regeneration Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Reduced Left Ventricular Function Defined as LVEF < 50%
• Regional Left Ventricular Wall Motion Abnormalities

Intervention

Procedure:
• Direct Epicardial Shock Wave Therapy
performed in adjunct to a standard coronary artery bypass grafting procedure Prior to aortic cross clamping direct epicardial shock wave therapy - applied directly to the myocardium

Locations

Country	Name	City	State
Austria	Clinical Department for Cardiothoracic Surgery, General Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Cardiac Regeneration Technologies, LLC

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, Adverse Events		6 months	Yes