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The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSEâ„¢ catheter and the TRUPULSEâ„¢ generator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation | Other | This is a non-randomized one arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation (PFA) | Device | PFA using Irreversible Electroporation (IRE) Ablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early onset primary adverse events (PAEs) | within seven (7) days of an ablation procedure | |
| Freedom from documented atrial tachyarrhythmia episodes | effectiveness evaluation period (Day 91-Day 365) | |
| Freedom from acute procedural failure | during ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernard's Heart and Vascular Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Beth Israel Deaconess Medical Center | Active, not recruiting | Boston | Massachusetts | 02215 | United States |
| Mount Sinai Hospital | Not yet recruiting | New York | New York | 10029 | United States |
|
| Montefiore Medical Center | Not yet recruiting | New York | New York | 10467 | United States |
|
| Texas Cardiac Arrhythmia Institute/Research Foundation | Recruiting | Austin | Texas | 78705 | United States |
|
| 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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