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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 (DESWT)

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Direct Epicardial Shock Wave Therapy
Sponsored by
Cardiac Regeneration Technologies, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduced Left Ventricular Function Defined as LVEF < 50% focused on measuring Coronary Artery Bypass Grafting, Myocardial Regeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Department for Cardiothoracic Surgery, General Hospital Vienna

Outcomes

Primary Outcome Measures

Safety, Adverse Events

Secondary Outcome Measures

Full Information

First Posted
August 25, 2008
Last Updated
February 10, 2010
Sponsor
Cardiac Regeneration Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00741065
Brief Title
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cardiac Regeneration Technologies, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduced Left Ventricular Function Defined as LVEF < 50%, Regional Left Ventricular Wall Motion Abnormalities
Keywords
Coronary Artery Bypass Grafting, Myocardial Regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Direct Epicardial Shock Wave Therapy
Other Intervention Name(s)
CardioGold® CG050: CG05000001, CardioGold® CG050: CG05000002, Applikator CA01
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety, Adverse Events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Grimm, Prof. MD
Organizational Affiliation
Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Department for Cardiothoracic Surgery, General Hospital Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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