Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00560885 | AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation | PHASE3 | COMPLETED | 55 | — | — | Nov 1, 2007 | Dec 1, 2012 | Mar 29, 2013 | 9 | United States |
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
| Arm | Type | Description |
|---|---|---|
| AtriCure Bipolar System | EXPERIMENTAL | The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure. |
| Name | Type | Description |
|---|---|---|
| AtriCure Bipolar System | DEVICE | Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System |
Inclusion Criteria: 1. Subject is greater than or equal to 18 years of age 2. Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines 3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: * Mitra...