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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Global mapping and ablation device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Global mapping and ablation device<br> | Device: Global mapping and ablation device<br>* 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.<br>* Other names: Globe® Mapping and Ablation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects presenting with adverse events | Subjects presenting with primary serious adverse events up to 1 year Subjects presenting with adverse events or serious adverse events up to 1 year | Up to 1 year | 
| Acute procedural success | Acute device performance in achieving entrance block of the pulmonary veins | Intra-procedurally | 
| Rate of freedom from documented atrial fibrillation | Rate of freedom from electrocardiographically documented atrial fibrillation between 3 months and 1 year post-ablation | Between 3 months and 1 year | 
| Change in Quality of life and AF symptom frequency and severity scores | 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 | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, global, radiofrequency RF ablation, left atrium anatomical and electrophysiological mapping