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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

RecruitingNAAges 18 Years - 80 YearsAllKardium Inc.
NCT06973031 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Globe Pulsed Field System
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Where

1 site
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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