Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).

Official Title
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Evaluation of the Acute Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Globe Mapping and Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old and ≤75 years old Symptomatic AF with at least one AF episode electrocardiographically documented within one (1) year prior to enrolment. Documentation may include diagnosis in the patient medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter monitor or telemetry strip. Selected for catheter ablation for the treatment of atrial fibrillation Exclusion Criteria: History of previous left atrial ablation or surgical treatment for AF/AFL/AT Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy) Presence of LA thrombus by TEE, CT scan, MRI, or angiography Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity) Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others) Uncontrolled heart failure or NYHA Class III or IV heart failure Valve repair or replacement or presence of a prosthetic valve Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months MI or PCI procedure within 3 months before screening Left Ventricular Ejection Fraction (LVEF) < 40% Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD) Severe pulmonary hypertension or prior pulmonary stenting History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment Contraindication to anticoagulation (e.g., heparin) History of blood clotting or bleeding disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Globe Mapping and Ablation System<br> | Device: Globe Mapping and Ablation System<br>* Prospective, non-randomized, open-label clinical study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block |  | start to end of the procedure | 
| Procedure time |  | start to end of the procedure | 
| Catheter dwell time |  | start to end of the procedure | 
| Fluoroscopy time |  | start to end of the procedure | 
| Fluoroscopy dose area product |  | start to end of the procedure | 
| Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure |  | start to seven days after the end of the procedure | 
| Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure |  | start to seven days after the end of the procedure |