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

Running, not enrolling · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03732794

Run by

AtriCure, Inc.

People needed

150

Starts

2019-01-30

Expected to finish

2026-06-01

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Washington Adventist Hospital — Washington D.C., District of Columbia, United States
• Northwestern Medicine — Chicago, Illinois, United States
• Franciscan Health — Indianapolis, Indiana, United States
• Deaconess Gateway Hospital — Newburgh, Indiana, United States
• University Of Maryland — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Mount Sinai Icahn School of Medicine — New York, New York, United States
• NYP-Weill Cornell — New York, New York, United States
• Northwell Health Systems — New York, New York, United States
• St. Joseph Hospital Health Center — Syracuse, New York, United States
• St Thomas West Hospital — Nashville, Tennessee, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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