Ventricular Tachycardia Clinical Trial
Official title:
A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack
and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an
implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's
rhythm back to normal by electrically stimulating the heart but in doing so gives the patient
painful and debilitating shocks. The first ICD shock after implantation appears to be a
powerful predictor of subsequent shock therapy as well as being a predictor of of increased
mortality in patients with primary prevention ICDs. In patients who receive repeated shocks
VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem.
However, it is often only performed as a last resort as it is technically challenging. We
believe that performing VT ablation using the robotic system early after the first episode of
VT after ICD implantation, may reduce the number of painful shocks received by the patient
and possibly increase life expectancy and quality of life.
200 patients from 5 european countries will be recruited in a prospective, open, randomised
trial. Eligible, consenting patients who have experienced their first episode of VT since ICD
implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or
standard 'conventional' therapy and followed-up every 4 months over two years to assess the
number of subsequent ICD shocks, hospitalisation, mortality and quality of life.
n/a
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