Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation | NCT07714876

NCT07714876

Overview

NCT ID: NCT07714876
Lead Sponsor: Kardium Inc.INDUSTRY
Official Title: A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Study
Brief 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.
Conditions: Paroxysmal Atrial Fibrillation
Interventions: Globe Pulsed Field System

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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) <35%

Anterior-posterior left atrial (LA) diameter >55mm

Central Contacts: Clinical AffairsContact
Clinical.Affairs@kardium.com+1 (604) 248 8891