RecruitingNot ApplicableNCT06452589

The Field PULSE Study

A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Patients With Atrial Fibrillation

Sponsor

Field Medical

Enrollment

40 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Arrhythmias

Summary

This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a heart procedure called pulsed field ablation (PFA) to treat atrial fibrillation (AF) — an irregular heartbeat that can cause stroke and heart failure. PFA uses rapid electrical pulses to scar the heart tissue causing the abnormal rhythm, with the goal of being safer than older heat-based ablation methods. **You may be eligible if...** - You are aged 18–80 with symptomatic atrial fibrillation confirmed by an ECG - You have had at least 2 AF episodes in the past 6 months - This would be your first catheter ablation procedure for AF - At least one antiarrhythmic medication has not worked for you **You may NOT be eligible if...** - You have had previous ablation or surgery for AF - You have persistent AF (lasting more than 7 days) - You have severe heart failure (NYHA Class IV), a blood clot in the heart, or certain heart device implants - Your AF is caused by thyroid disease or other reversible causes Talk to your doctor to see if this trial is right for you.

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

The FieldForce Ablation System is indicated for cardiac electrophysiologic mapping, delivery of diagnostic pacing stimuli, and pulse field ablation of cardiac tissue. When used with the FieldForce Ablation Catheter, the FieldForce System is intended to be used in the right/left atria and/or left/right ventricle to deliver PFA ablation lesions in the selected areas of the chamber.

Locations(1)

Na Homolce Hospital

Prague, Czechia

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NCT06452589

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