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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ICD Therapy plus VT-Ablation |
|
| 2 | Active Comparator | ICD Therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD Ablation plus VT-ablation | Procedure | ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) | 12 Months | |
| Quality of life | 12 Months | |
| Number of hospital readmissions due to a cardiac indication |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, MD | Allgemeines Krankenhaus St. Georg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skejby Skygehus | Aarhus | 8200 | Denmark | |||
| Herz- und Gefäßklinik GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28292751 | Derived | Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, Willems S; SMS Investigators. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004422. doi: 10.1161/CIRCEP.116.004422. |
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| ICD Therapy | Device | ICD Therapy for the Treatment of unstable VT´s |
|
| 12 Months |
| Severe clinical events | 12 Months |
| Bad Neustadt / Saale |
| 97616 |
| Germany |
| Berufsgenossenschaftliche Kliniken Bergmannsheil | Bochum | 44789 | Germany |
| Klinikum der J.W. Goethe Universität | Frankfurt | 60590 | Germany |
| Allgemeines Krankenhaus St. Georg | Hamburg | 20099 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen | 67063 | Germany |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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