SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
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Purpose
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 (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions.
The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Tachycardia, Ventricular |
Procedure: ICD Ablation plus VT-ablation Device: ICD Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Substrate Modification Study in Patients Getting an ICD |
- Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Number of hospital readmissions due to a cardiac indication [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Severe clinical events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
| Enrollment: | 116 |
| Study Start Date: | May 2002 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ICD Therapy plus VT-Ablation
|
Procedure: ICD Ablation plus VT-ablation
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
|
|
Active Comparator: 2
ICD Therapy only
|
Device: ICD Therapy
ICD Therapy for the Treatment of unstable VT´s
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Denmark | |
| Skejby Skygehus | |
| Aarhus, Denmark, 8200 | |
| Germany | |
| Herz- und Gefäßklinik GmbH | |
| Bad Neustadt / Saale, Germany, 97616 | |
| Berufsgenossenschaftliche Kliniken Bergmannsheil | |
| Bochum, Germany, 44789 | |
| Klinikum der J.W. Goethe Universität | |
| Frankfurt, Germany, 60590 | |
| Allgemeines Krankenhaus St. Georg | |
| Hamburg, Germany, 20099 | |
| Universitätsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, 20251 | |
| Klinikum der Stadt Ludwigshafen am Rhein | |
| Ludwigshafen, Germany, 67063 | |
| Principal Investigator: | Karl-Heinz Kuck, MD | Allgemeines Krankenhaus St. Georg |
More Information
No publications provided
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00170287 History of Changes |
| Other Study ID Numbers: | CEN_G_CA_3 |
| Study First Received: | September 9, 2005 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Medtronic Bakken Research Center:
|
Unstable Ventricular Tachycardia |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013