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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

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.

Interventions

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Safety, Adverse Events
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardiac Regeneration Technologies, LLC
  • Provider of Information About this Clinical Study
    • Reiner Schultheiss MD, Cardiac Regeneration Technologies LLC
  • Overall Official(s)
    • Michael Grimm, Prof. MD, Principal Investigator, Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria

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