FREEZE-AFIB Post-Market Study

Prior treatment

• Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
• Previous left sided ablation procedures procedure.
• Known carotid artery stenosis greater than 80% prior to index ablation procedure.
• Prior history of ischemic stroke or hemorrhagic stroke
• History of MI with ST elevation within 6 weeks prior to the index ablation
• Large left atrial size i.e., LA diameter \>7 cm prior to the index ablation procedure.
• Subjects with active systemic infection prior to index ablation procedure.
• Subjects who had documented severe peripheral arterial occlusive disease defined as claudication with minimal exertion prior to the ablation procedure.
• Subjects with history of renal failure requiring dialysis or hepatic failure prior to the ablation procedure.
• A known drug and/or alcohol addiction.
• Subjects in currently undergoing chemotherapy.
• Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
• Subjects undergoing aortic dissection surgery as index procedure.
• Cardiac surgical re-intervention since the index cardiac surgery with concomitant AF ablation procedure

Other illness

• Mental impairment or other conditions which may not allow the subject to understand the nature, significance, and scope of the study.
• Subjects who are on anti-arrhythmic drug therapy for the treatment of another arrhythmia.
• Subjects who had known connective tissue disorders at the time of index ablation procedure
• Subjects who had or tested positive for COVID-19
• Subjects with bleeding disorders and/or inability to receive anticoagulation

Other

• Untreated atrial flutter and symptomatic ventricular arrythmia
• Documented AF duration of greater than 10 years.
• Subjects who are pregnant
• Subjects who had preoperative need for mechanical circulatory support or intravenous inotropes.
• Subjects who had known hypertrophic obstructive cardiomyopathy at the time of index ablation procedure
• Subjects with known cold agglutinin.

• Subject is greater than or equal to 18 years of age.
• Subject has documented history of atrial fibrillation.
• Subjects who received surgical ablation for their atrial fibrillation using CRYOF and on whom at least the following lesions were performed: Left and right pulmonary vein isolation, roof and floor lines, mitral annulus line and a connecting lesion from left atrial appendage to left pulmonary vein coronary sinus lesion and LAA exclusion , with a lesion duration of at least 2 minutes.
• Stable subject that underwent non-emergent cardiac surgical procedure(s) 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, or coronary artery bypass procedures, or atrial septal defect (ASD) repair
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to return for scheduled follow-up visits.