| Title: |
Pivotal Study of a Dual Epicardial and Endocardial Procedure (DEEP) Approach For Treatment of Subjects With Persistent or Long-Standing Persistent Atrial Fibrillation With Radiofrequency Ablation |
| Description: |
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF-based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure. |
| Device: |
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation |
| NCT Number: |
02393885 |
| Notes: |
The primary outcome for a patient is freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12-month follow-up visit, in the absence of Class I or III AADs. |
| Start Date: |
4/27/16 |
| Status: |
On hold per FDA |
| Principal Name: |
Margot Vloka, MD |
| Contact Name: |
Jennifer Yehle, CRC |
| Phone: |
(208)302-0066 |
