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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Cardiac Regeneration Technologies, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cardiac Regeneration Technologies, LLC
ClinicalTrials.gov Identifier:
NCT00741065
First received: August 25, 2008
Last updated: February 10, 2010
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention
Reduced Left Ventricular Function Defined as LVEF < 50%
Regional Left Ventricular Wall Motion Abnormalities
 Procedure: Direct Epicardial Shock Wave Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiac Regeneration Technologies, LLC:

Primary Outcome Measures:
  • Safety, Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Names:
    • CardioGold® CG050: CG05000001
    • CardioGold® CG050: CG05000002
    • Applikator CA01
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741065

Locations
Austria
Clinical Department for Cardiothoracic Surgery, General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Cardiac Regeneration Technologies, LLC
Investigators
Principal Investigator: Michael Grimm, Prof. MD Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
  More Information

No publications provided

Responsible Party: Reiner Schultheiss MD, Cardiac Regeneration Technologies LLC
ClinicalTrials.gov Identifier: NCT00741065     History of Changes
Other Study ID Numbers: DESWT,Version:02; May 21,2008
Study First Received: August 25, 2008
Last Updated: February 10, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Cardiac Regeneration Technologies, LLC:
Coronary Artery Bypass Grafting
Myocardial Regeneration

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 21, 2013