Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF) (GLOBAL-AF)

Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)

A Prospective, Non-randomized Clinical Study to Assess Safety and Performance of a Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.

Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF) ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed pre-procedure for screening and health assessment. During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI during the procedure. Echocardiography will be performed at discharge to assess cardiac function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented AF and adverse events. Subject-reported AF symptomology and quality of life will also be assessed during follow-up.

atrial fibrillation, global, radiofrequency RF ablation, left atrium anatomical and electrophysiological mapping

During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.

Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure

Rate of subjects presenting with one or more of the following serious adverse events occurring within 7-days of the procedure: Transient ischemic attack Cerebrovascular accident Major bleeding Cardiac tamponade Pulmonary vein stenosis Pericarditis Myocardial infarction Diaphragmatic paralysis Atrio-esophageal fistula Valvular damage Phrenic nerve palsy Intra-procedural device complication requiring open chest or heart surgery Death

Subjects presenting with primary serious adverse events up to 1 year Subjects presenting with adverse events or serious adverse events up to 1 year

Rate of freedom from electrocardiographically documented atrial fibrillation between 3 months and 1 year post-ablation

Change of quality of life (SF-36) and AF symptom frequency and severity (Bubien et al 1993) questionnaire scores from baseline to 1 year after ablation

Rate of procedures terminated or switched to a third-party ablation catheter due to Globe device failures

Inclusion Criteria: Patients indicated for ablation, with a documented history of symptomatic paroxysmal atrial fibrillation Between 18 and 80 years of age, inclusive Exclusion Criteria: Patients who have contraindications to open heart surgery Patients from an Intensive Care Unit Patients requiring concurrent right atrial ablation or who have had previous left atrial ablation Previous cardiac procedure or known abnormalities that would interfere with device delivery, position, or treatment efficacy History of a documented thromboembolic event or bleeding abnormalities Contraindication to anticoagulation therapy Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study Anatomy that would prevent safe and appropriate introduction or delivery of the Globe device into the patient

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