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
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).
• Signed patient informed consent form (ICF).
• Female and male participants between 18 and 80 years.
• For VCAS-I group, patients with VT meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
• For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
• For VCAS-II, documentation of frequent PVCs by 24 hours Holter with \>15% PVC burden for asymptomatic patients and \>5% PVC burden for symptomatic patients within the last 60 days.