RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Surgical Ablation using the AtriCure Bipolar System
University Community Hospital/Dr. Kiran C. Patel Research Institute
Tampa, Florida, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Oklahoma Cardiac Arrythmia Research Institute
Oklahoma City, Oklahoma, United States
Sacred Heart Medical Center Endovascular Research
Eugene, Oregon, United States
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
Time frame: Perioperatively
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
Time frame: Discharge/30 Days
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Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
Dallas, Texas, United States