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Sponsored by: |
Cardiac Regeneration Technologies, LLC |
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Information provided by: | Cardiac Regeneration Technologies, LLC |
ClinicalTrials.gov Identifier: | NCT00741065 |
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
Condition | Intervention |
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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: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Grimm, Prof. MD | +43 1 40400 ext 5620 | michael.grimm@meduniwien.ac.at |
Contact: Daniel Zimpfer, MD | +43 1 40400 ext 5630 | daniel.zimpfer@meduniwien.ac.at |
Austria | |
Clinical Department for Cardiothoracic Surgery, General Hospital Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Michael Grimm, Prof. MD +43 1 40400 ext 5620 michael.grimm@meduniwien.ac.at | |
Contact: Daniel Zimpfer, MD +43 1 40400 ext 5630 daniel.zimpfer@meduniwien.ac.at |
Principal Investigator: | Michael Grimm, Prof. MD | Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria |
Responsible Party: | Cardiac Regeneration Technologies LLC ( Reiner Schultheiss MD ) |
Study ID Numbers: | DESWT,Version:02; May 21,2008 |
Study First Received: | August 25, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00741065 |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Coronary Artery Bypass Grafting Myocardial Regeneration |
Shock Congenital Abnormalities |