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AtriCure Bipolar System · 1 trial · 1 indication
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...
AtriCure Bipolar System is used for the treatment of atrial fibrillation, a condition characterized by irregular and often rapid heart rate. It is a surgical device designed for use in cardiac ablation procedures to treat this arrhythmia. The system is currently in clinical development for this indication.
AtriCure Bipolar System is developed by AtriCure, Inc., a company publicly traded under the ticker symbol ATRC. The company is focused on surgical ablation technologies for the treatment of atrial fibrillation and related conditions.
AtriCure Bipolar System is in Phase 3 clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the device is not currently in active clinical trials.
AtriCure Bipolar System has one completed Phase 3 clinical trial, identified by the identifier NCT00560885. This trial, titled 'AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation,' enrolled 55 participants in the United States. The trial was uncontrolled and not randomized or double-blinded.
AtriCure Bipolar System is associated with the AtriCure Bipolar Radiofrequency Ablation procedure, as indicated by the clinical trial title. The system uses bipolar radiofrequency energy for ablation, but the specific product name is AtriCure Bipolar System.