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Ventricular Catheter Ablation Study (VCAS)
Sponsor: Field Medical
Summary
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
Official title: A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-04-12
Completion Date
2027-06-30
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
FieldForce™ Ablation System Ventricular Tachycardia
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
FieldForce™ Ablation System Premature Ventricular Contractions
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
Locations (2)
Na Homolce Hospital
Prague, Czechia
IKEM
Prague, Czechia