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St Jude Medical commences new FlexAbility ablation catheter study
St Jude Medical has announced the commencement of a landmark clinical study evaluating the effectiveness of ablation procedures for the treatment of ventricular tachycardia.
The Star-VT trial is a prospective, multicentre randomised study evaluating the safety and efficacy of the FlexAbility ablation catheter when used in ventricular tachycardia ablation procedures.
It aims to assess whether combining targeted ablation with either an implantable cardiac defibrillator (ICD) or cardiac resynchronisation therapy defibrillator (CRT-D) can be more effective than treatment with either an ICD or CRT-D and medication alone.
The first patient has been enrolled for the trial, with an estimated 1,450 participants at approximately 50 centres in the US to be involved. International centres will also be included.
Dr Srijoy Mahapatra, vice-president of clinical, medical and scientific affairs at St Jude Medical, said: "We look forward to gathering evidence that supports our belief that the addition of catheter ablation in this patient population is a safer, more efficacious and cost-effective option for patients."
The device was approved in Europe for use in the treatment of cardiac arrhythmias last year.
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