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This Study Will Evaluate if the Field Force Pulsed Field Ablation System is Safe and Effective for Treating Sustained Monomorphic Ventricular Tachycardia, a Potentially Serious Fast Heart Rhythm of the Heart. The Treatment Uses Short Pulses of Energy to Target and Destroy the Heart Tissue Causing VT
Sponsor: Field Medical
Summary
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.
Official title: Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program (VERITAS SCAR VT)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-12
Completion Date
2028-02
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT
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.