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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Globe Mapping and Ablation System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Globe Mapping and Ablation System | Device | Prospective, non-randomized, open-label clinical study. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Southlake Regional Health Centre | 596 Davis Dr, Newmarket ON L3Y 2P9, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Centre | Newmarket | Canada | ||||
| St. Paul's Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Vancouver |
| Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |