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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
ICD Therapy for the Treatment of unstable VT´s
Skejby Skygehus
Aarhus, Denmark
Herz- und Gefäßklinik GmbH
Bad Neustadt / Saale, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Allgemeines Krankenhaus St. Georg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany
Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period
Time frame: 12 Months
All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)
Time frame: 12 Months
Quality of life
Time frame: 12 Months
Number of hospital readmissions due to a cardiac indication
Time frame: 12 Months
Severe clinical events
Time frame: 12 Months
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