AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

The AtriCure CryoICE Ablation System is being studied to ablate cardiac tissue during surgery for the treatment of Persistent and Long-standing Persistent atrial fibrillation in open concomitant cardiac surgery.

The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

Inclusion criteria

• Subject is greater than or equal to 18 years of age
• Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/ European Cardiac Arrhythmia Society (ECAS) Guidelines
• Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, and Coronary artery bypass procedures
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
• Subject is willing and able to provide written informed consent
• Subject has a life expectancy of at least 5 years
• Subject is willing and able to return for scheduled follow-up visits.

Exclusion criteria

• Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
• Previous surgical Maze procedure
• Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
• Prior cardiac surgery (Redo)
• Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
• Class IV New York Heart Association (NYHA) heart failure symptoms
• Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit
• Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
• Need for emergent cardiac surgery (i.e. cardiogenic shock)
• Known carotid artery stenosis greater than 80%
• Documented AF duration of greater than ten years
• LA diameter >7 cm by Transthoracic echocardiography (TTE)
• Current diagnosis of active systemic infection
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
• Renal failure requiring dialysis or hepatic failure
• A known drug and/or alcohol addiction
• Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
• Pregnancy or desire to get pregnant within 12-months of the study treatment
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes
• Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
• Subjects who have been treated with thoracic radiation
• Subjects in current chemotherapy
• Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
• Subjects with known connective tissue disorders
• Subjects with known hypertrophic obstructive cardiomyopathy
• Subjects with known cold agglutinin