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

About

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

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