Reduced Left Ventricular Function Defined as LVEF < 50%DESWTNCT00741065
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
A study testing Direct Epicardial Shock Wave Therapy in people with Reduced Left Ventricular Function Defined as LVEF < 50% and Regional Left Ventricular Wall Motion Abnormalities, run by Cardiac Regeneration Technologies, LLC at 1 site in Austria.
Trial summary
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduced Left Ventricular Function Defined as LVEF < 50%, Regional Left Ventricular Wall Motion Abnormalities
- What is being tested?
- Direct Epicardial Shock Wave Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Clinical Department for Cardiothoracic Surgery, General Hospital Vienna
Vienna, 1090
About this study
Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.
Read the 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
- Being tested
- Direct Epicardial Shock Wave Therapy
- Keywords
- Coronary Artery Bypass Grafting, Myocardial Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Epicardial Shock Wave TherapyProcedure or surgery
Also called CardioGold® CG050: CG05000001, CardioGold® CG050: CG05000002, Applikator CA01
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduced Left Ventricular Function Defined as LVEF < 50%Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiac Regeneration Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Grimm, Prof. MD, Principal investigator, Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741065
- Sponsor's protocol ID
- DESWT,Version:02; May 21,2008
- Acronym
- DESWT
- Status last verified
- Feb 2010
- First submitted
- 25 Aug 2008
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT00741065
- Acronym / sponsor ID
- DESWT / DESWT,Version:02; May 21,2008
- Conditions
- Reduced Left Ventricular Function Defined as LVEF < 50%, Regional Left Ventricular Wall Motion Abnormalities
- Keywords
- Coronary Artery Bypass Grafting, Myocardial Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cardiac Regeneration Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Epicardial Shock Wave TherapyAlso: CardioGold® CG050: CG05000001, CardioGold® CG050: CG05000002, Applikator CA01performed 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 | Procedure or surgery | – |
Primary outcome
Safety, Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Grimm, Prof. MD principal investigator
Vienna General Hospital, Clinical department for Cardiothoracic Surgery, Währinger Gürtel 18-20,1090 Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Epicardial Shock Wave Therapy in people with Reduced Left Ventricular Function Defined as LVEF < 50% and Regional Left Ventricular Wall Motion Abnormalities, run by Cardiac Regeneration Technologies, LLC at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2010.