Status:
COMPLETED
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Tachycardia, Ventricular
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator...
Eligibility Criteria
Inclusion
- Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.
- Left ventricular ejection fraction \< 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.
- Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:
- Hypotensive VT without major neurologic dysfunction;
- Syncope; or
- Cardiac arrest.
Exclusion
- Age \< 18 years or \> 80 years
- Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram
- Acute myocardial infarction within the preceding 2 months
- Class IV New York Heart Association (NYHA) heart failure
- Valvular heart disease or mechanical heart valve precluding access to the left ventricle
- Unstable angina
- Cardiac surgery within the past 2 months
- Serum creatinine \> 220 mmol/L (2.5 mg/dL)
- Thrombocytopenia or coagulopathy
- Contraindication to heparin
- Pregnancy
- Acute illness or active systemic infection
- Other disease process likely to limit survival to less than 12 months
- Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study
- Participation in another investigational study
- Unwillingness to participate or lack of availability for follow-up
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00170287
Start Date
May 1 2002
End Date
August 1 2011
Last Update
July 3 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Skejby Skygehus
Aarhus, Denmark, 8200
2
Herz- und Gefäßklinik GmbH
Bad Neustadt / Saale, Germany, 97616
3
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
4
Klinikum der J.W. Goethe Universität
Frankfurt, Germany, 60590