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RECRUITING
NCT06203262
NA

Ventricular Catheter Ablation Study (VCAS)

Sponsor: Field Medical

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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