The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Catheter ablation of ventricular tachycardia
Herzzentrum Leipzig
Leipzig, Saxony, Germany
NOT_YET_RECRUITINGAmsterdam UMC
Amsterdam, Netherlands
RECRUITINGHagaZiekenhuis
The Hague, Netherlands
NOT_YET_RECRUITINGPrimary Efficacy Endpoint
Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0
Time frame: Perioperative/Periprocedural
Primary Safety Endpoint
Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
Time frame: 7 days
Secondary Efficacy Endpoint
Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
Time frame: 6 months
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