ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Mercy Heart Institute
Sacramento, California, United States
Sutter Health
Sacramento, California, United States
Heart Center of Indiana
Indianapolis, Indiana, United States
Spectrum Health
Grand Rapids, Michigan, United States
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
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.
Time frame: 30 days Post Procedure
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Time frame: 6 Months Post Procedure
Composite 6-month Post-procedure Major Adverse Event Rate.
Time frame: 6 Months Post Procedure
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Munson Medical Center
Traverse City, Michigan, United States
Baylor Heart Hospital
Dallas, Texas, United States
Inova Fairfax
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States