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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Conditions
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Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: AtriCure CryoICE & AtriClip LAA Exclusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtriCure CryoICE & AtriClip LAA Exclusion<br>AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device. | Device: AtriCure CryoICE & AtriClip LAA Exclusion<br>* AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT) | Freedom from AF/AFL/AT lasting >30 seconds in duration 6 through 12-months following the ablation procedure in the absence of Class I or III antiarrhythmic drugs (AADs). | 12 months | 
| Safety Endpoint: composite acute major adverse event (MAE) rate | The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite post-procedure MAE rate (Safety). | Long-term safety based on MAE rate at 12-months post-procedure | 12 months | 
| Pacemaker implantation (Safety). | Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period. | 12 months | 
| Overall Serious Adverse Event (SAE) rate (Safety) | Long-term safety based on SAE rate at 12-months post-procedure | 12 months | 
| Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness) | Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in presence of previously failed Class I or III AADs. | 12 months | 
| Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness) | Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs. | 12 months | 
| Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness) | Based on composite score (0-100). A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). AFEQT Evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients The overall composite score and domains will be summarized by presenting the means, medians, standard deviations, interquartile ranges, minimum, and maximum | 12 months | 
| Acute procedural success (Effectiveness) | Absence of AF at end of procedure | Intra-operative period |