Atrial Arrhythmias Clinical Trial
Official title:
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
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.
Atrial fibrillation (AF) is a cardiac rhythm disorder characterized by irregular and often abnormally fast contractions of the atrial cardiomyocytes resulting in various symptoms, including palpitations, dizziness, shortness of breath and tiredness. AF is the most common sustained cardiac arrhythmia, having a prevalence of about ≈2% in the general population. AF can be associated with increased morbidity and mortality in patients with cardiovascular disease, and increased risk of stroke in general population. Catheter ablation for the treatment of AF is primarily performed with radiofrequency (RF) or cryoballoon (CB) catheters to achieve anatomic pulmonary vein isolation (PVI). However, the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB. Pulsed field ablation (PFA) is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues. This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents, culminating in cell death. Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner. The FieldForce™ Ablation System utilizes PFA with an innovative electrode technology called FieldBending™ designed to improve safety, tolerability, and efficacy for focal deflectable catheters used for the treatment of AF. ;
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