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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 Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Globe Mapping and Pulsed Field Ablation System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Globe Mapping and Pulsed Field Ablation System (Globe PF System) | Device | 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 pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects presenting with primary safety events which are device- or procedure-related | up to 3-month visit |
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Key Inclusion Criteria:
Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
Subjects between 18 and 75 years of age, inclusive
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | Contact | +1 (604) 248 8891 | Clinical.Affairs@kardium.com |
| Name | Affiliation | Role |
|---|---|---|
| Motol and Homolka University Hospital | V Úvalu 84/1, 150 00 Prague 5, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motol and Homolka University Hospital | Recruiting | Prague | 150 00 | Czechia |
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|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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