The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.
This prospective, open label, multi-center, observational, single arm registry is designed to monitor the AtriCure Synergy Ablation System continued safety and efficacy during the peri-procedural and long-term phase during commercial use in patients being treated for non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump cardiac surgical procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
365
Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following: * Coronary Artery Bypass Grafting (CABG) * Mitral valve repair or replacement * Aortic valve repair or replacement * Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.
The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.
The number of participants free from atrial fibrillation (AF), i.e., episodes lasting \>30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.
Time frame: 36 months post-operatively
Secondary Efficacy Outcome
The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting \> 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.
Time frame: 12, 24, and 36 months post-operatively
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