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Not Yet Recruiting NCT07714876

Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Kardium Inc.

Summary

This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.

Eligibility Criteria

Key Inclusion Criteria: * A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation * Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key Exclusion Criteria: * Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is 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 any pulmonary vein stents * Body mass index (BMI) \>40 kg/m\^2 * Left ventricular ejection fraction (LVEF) \55mm

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07714876). StuddyBuddy aggregates publicly available trial information.