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RECRUITINGINTERVENTIONAL

A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.

Who May Be Eligible (Plain English)

Key Who May Qualify: - A diagnosis of recurrent symptomatic paroxysmal or persistent AF - Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key Who Should NOT Join This Trial: - Long-standing persistent AF (sustained \>12 months) - Atrial fibrillation secondary to a reversible cause or of non-cardiac origin - History of thromboembolic events within the past six months - Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months - Any cardiac surgery within the previous six months - Prior left atrial ablation or surgical procedure - Presence of an implanted cardiac device - Body mass index (BMI) \>40 kg/m\^2 - Left ventricular ejection fraction (LVEF) \<35% - Anterior-posterior left atrial (LA) diameter \>55mm Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key inclusion criteria: * A diagnosis of recurrent symptomatic paroxysmal or persistent AF * Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key exclusion criteria: * Long-standing persistent AF (sustained \>12 months) * Atrial fibrillation secondary to a reversible cause or of non-cardiac origin * History of thromboembolic events within the past six months * Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months * Any cardiac surgery within the previous six months * Prior left atrial ablation or surgical procedure * Presence of an implanted cardiac device * Body mass index (BMI) \>40 kg/m\^2 * Left ventricular ejection fraction (LVEF) \<35% * Anterior-posterior left atrial (LA) diameter \>55mm

Treatments Being Tested

DEVICE

Globe Pulsed Field System

Ablation and atrial mapping with the Globe Pulsed Field System

Locations (1)

Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany