AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AtriCure, Inc.
- Enrollment
- 150
- Locations
- 15
- Primary Endpoint
- Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Intervention: AtriCure CryoICE & AtriClip LAA Exclusion (Device)
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Time Frame: 12 months
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).
Safety Endpoint: composite acute major adverse event (MAE) rate
Time Frame: 30 days
The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.
Secondary Outcomes
- Pacemaker implantation (Safety).(12 months)
- Composite post-procedure MAE rate (Safety).(12 months)
- Overall Serious Adverse Event (SAE) rate (Safety)(12 months)
- Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)(12 months)
- Acute procedural success (Effectiveness)(Intra-operative period)
- Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)(12 months)
- Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)(12 months)