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

NCT ID: NCT00741065

Last Updated: 2010-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-02-28

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

CardioGold® CG050: CG05000001; CardioGold® CG050: CG05000002; Applikator CA01

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiac Regeneration Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Cardiac Regeneration Technologies LLC

Principal Investigators

Michael Grimm, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria

Locations

Clinical Department for Cardiothoracic Surgery, General Hospital Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

DESWT,Version:02; May 21,2008

Identifier Type: -

Identifier Source: org_study_id