AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB (RESTORE SR IIB)
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).
|Official Title:||Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation|
- Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.
- The primary safety endpoint will be determined by assessing the rate of serious adverse events.