RecruitingNot ApplicableNCT06203262

Ventricular Catheter Ablation Study (VCAS)

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

Sponsor

Field Medical

Enrollment

60 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Ventricular Tachycardia Ventricular Arrythmia PVC - Premature Ventricular Contraction Ventricular Tachyarrhythmia PVC - Premature Ventricular Complex

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human pilot study evaluates the safety and feasibility of a new pulsed field ablation (PFA) device called FieldForce™ for treating ventricular arrhythmias — abnormal heart rhythms originating in the lower chambers of the heart, including ventricular tachycardia (VT) and frequent premature ventricular contractions (PVCs). PFA uses short bursts of electrical energy rather than heat to destroy abnormal heart tissue, which may offer a safer profile than traditional ablation. Adults aged 18–80 with confirmed VT or frequent PVCs (more than 15% of all heartbeats) who meet guidelines for catheter ablation and do not have a recent heart attack, severe heart failure, or active infection may be eligible. Participation involves the catheter ablation procedure and follow-up visits to assess heart rhythm and safety outcomes. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFieldForce™ 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.

DEVICEFieldForce™ Ablation System Premature Ventricular Contractions