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This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Globe Pulsed Field System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Globe Pulsed Field System | Device | Ablation and atrial mapping with the Globe Pulsed Field System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness endpoint | Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure. | 12 months |
| Safety endpoint | Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure. | 7 days |
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Key inclusion criteria:
Key exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| St. Bernards Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41563170 | Background | Reddy VY, Kottkamp H, Calkins H, Nair DG, Sommer P, Hussein AA, Schumacher B, Dukkipati S, Neuzil P, Oza S, Woods C, Deyell MW, Osorio J, Verma A; PULSAR Investigators. Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2026 Apr 14;87(14):1747-1761. doi: 10.1016/j.jacc.2025.10.084. Epub 2026 Jan 21. |
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| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Sutter Health - California Pacific Medical Center | San Francisco | California | 94109 | United States |
| St. Vincent's Medical Center | Jacksonville | Florida | 32204 | United States |
| Mercy Hospital | Miami | Florida | 33133 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Mt. Sinai Hospital, Guggenheim Pavilion | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| St.Paul's Hospital | Vancouver | British Columbia | V6E 1M7 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Motol and Homolka University Hospital | Prague | Czechia |
| Heart and Diabetes Center NRW | Bad Oeynhausen | Germany |
| Charité Campus Virchow Clinic | Berlin | Germany |
| Westpfalz-Klinikum GmbH Kaiserslautern | Kaiserslautern | 67655 | Germany |
| 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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