AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment (ICE-AFIB)

AtriCure

Status: Active, not recruiting

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation; Atrial Fibrillation (AF)

Treatments: Device: AtriCure CryoICE & AtriClip LAA Exclusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT03732794

CP2018-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is greater than or equal to 18 years of age
2. 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
3. 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
4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
5. Subject is willing and able to provide written informed consent
6. Subject has a life expectancy of at least 5 years
7. Subject is willing and able to return for scheduled follow-up visits.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

AtriCure CryoICE & AtriClip LAA Exclusion

Experimental group

Description:

AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

Treatment:

Device: AtriCure CryoICE & AtriClip LAA Exclusion