The VERITAS VT Study is a prospective, multicenter, international, single-arm clinical investigation designed to evaluate the safety and effectiveness of the FieldForce™ Pulsed Field Ablation System for the treatment of sustained monomorphic ventricular tachycardia (VT). Eligible patients undergoing catheter ablation for VT will receive treatment with the investigational pulsed field ablation system according to the study protocol. The study will assess acute and chronic outcomes including major adverse events, freedom from recurrent ventricular tachycardia, need for antiarrhythmic drug escalation, repeat ablation procedures, and other clinically relevant outcomes through 180 days following the index ablation procedure.
Ventricular tachycardia remains a significant source of morbidity and mortality among patients with structural heart disease. Although catheter ablation is an established therapeutic option, long-term recurrence rates remain substantial and procedural challenges continue to exist. The VERITAS VT Study is a prospective, multicenter, single-arm clinical investigation evaluating the safety and effectiveness of the Field Force Pulsed Field Ablation System in subjects with sustained monomorphic ventricular tachycardia. Eligible participants will undergo mapping and ablation using the Field Force Pulsed Field Ablation System during the index procedure. Subjects will be followed for 180 days after the index procedure to assess safety and effectiveness outcomes. The primary safety objective is to evaluate the incidence of device- and procedure-related major adverse events. The primary effectiveness objective is to evaluate freedom from recurrence of sustained monomorphic ventricular tachycardia through 180 days following the index ablation procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
The Field Force Pulsed Field Ablation System is an investigational device that delivers non-thermal pulsed electric field energy through a catheter-based platform to ablate targeted cardiac tissue. The system is intended for use during catheter ablation procedures in patients with sustained monomorphic ventricular tachycardia (VT) to treat tissue involved in the initiation and maintenance of the arrhythmia.
Primary Safety Endpoint - Freedom from casual or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. (Or within 90 days for esophageal events (fistula/perforation)
A pre-defined list of device - or procedure-related MAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event
Time frame: As applicable within 7 days or 90 days after the index ablation procedure
Primary Effectiveness: Freedom from recurrence of sustained monomorphic VT
Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) for any ventricular arrhythmia through 6 months after the index ablation procedure
Time frame: Through 6 months most the index ablation procedure
Secondary Effectiveness Endpoint: Percentage of patients with reduced ventricular tachycardia burden
Percentage of patients with reduced ventricular tachycardia burden
Time frame: 6 months post index procedure
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