This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility\[TM\] Ablation Catheter, Sensor Enabled\[TM\] (FlexAbility SE) catheter to obtain an indication to treat monomorphic ventricular tachycardia (MMVT) in the United States of America (US). The clinical trial has two cohorts: one is a randomized ischemic cardiomyopathy (ICM) cohort and the second is a concurrent single-arm non-ischemic cardiomyopathy (NICM) cohort. Four hundred ten (410) subjects with drug refractory sustained MMVT and ICM and 182 subjects with drug refractory sustained MMVT and NICM will be enrolled at up to 35 centers worldwide. Study subjects who have drug refractory sustained MMVT and ICM will be randomized 1:1 to treatment with the FlexAbility SE catheter ablation system in the Treatment group, or the ThermoCool, ThermoCool NaviStar, or ThermoCool SmartTouch Ablation Catheter from Biosense Webster in the Control group. Since at study start there was no approved device for VT ablation in patients with NICM to use as a comparator, subjects who have drug refractory MMVT and NICM will be treated with the FlexAbility SE catheter ablation system only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
592
Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.
Subjects receive ablation treatment using an ablation system that is not FDA approved.
Rate of complications
The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure.
Time frame: 7 days
Freedom from recurrence of VT
The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
Time frame: 6 months
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