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

Launched by KARDIUM INC. · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with paroxysmal or persistent atrial fibrillation (AF), which is a common heart rhythm problem that can cause symptoms like palpitations, shortness of breath, and fatigue. The researchers want to see how safe and effective the combination of a method called Pulmonary Vein Isolation along with Box Isolation of Fibrotic Areas (BIFA) works when using the Globe® Pulsed Field System. They will follow participants for 12 months to assess the results.

To participate in this study, individuals need to be between the ages of 65 and 74 and have been diagnosed with recurrent symptomatic AF. They should have also tried at least one heart medication that didn't work for them or that they couldn't tolerate. However, certain people won't be eligible, such as those with long-standing AF, recent heart problems, or specific heart conditions. If eligible, participants can expect to receive this innovative treatment and be monitored closely over the year to evaluate their heart health and how well the treatment works.

Gender

ALL

Eligibility criteria

• 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