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This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vernakalant | Experimental |
| |
| Amiodarone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vernakalant | Drug | Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization | Up to 12 hours from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants admitted to hospital directly from the ER after randomization | Day 1 (time of ramdomization) |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| C524581 | vernakalant |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Amiodarone | Drug | Administered IV as per product label |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |