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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).
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Summary:
Ventricular arrythmias are common but often undertreated. The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia (VT) and ventricular fibrillation (VF). However, the efficacy of antiarrhythmic drugs (AADs) has been proven to be low, and implantable cardioverter defibrillators (ICDs) treat VT but do not prevent it. Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative. Despite overwhelming evidence that catheter ablation is superior, there are many technical barriers that prevent widespread application of this therapy. Furthermore, non-fatal ventricular arrythmias such as premature ventricular contractions (PVCs) are treatable by catheter ablation. The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle.
Pulsed field ablation (PFA) is a new ablation method for the therapy of arrhythmias. PFA is considered as a non-thermal and low-energy method of ablation. This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury. The very strong electric fields put strain on cellular compartmentalization. These changes can be reversible, and cells can recover with no consequences; however, if compartmentalization is disrupted for an extended period of time, it results in metabolic injury and cell death. This mechanism is also known as electroporation. Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart. Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation. However, there is less data on the application of PFA for VT.
Therefore, this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce™ Ablation system in patients with ventricular tachycardia divided into two groups: ventricular tachycardia (VCAS-I) and unifocal premature ventricular complex (VCAS-II).
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60 participants in 2 patient groups
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Steven R Mickelsen, MD
Data sourced from clinicaltrials.gov
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