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Clinical Trials in the USA / NCT03732794
Active, not recruiting Not applicable

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

NCT03732794 · tracked via the Priya Life Science USA tracker
Sponsor
AtriCure, Inc.
Phase
Not applicable
Started
2019-01-30
Last updated
2024-10-15

Condition(s) studied

Atrial Fibrillation (AF)Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

AtriCure CryoICE & AtriClip LAA Exclusion

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03732794 on ClinicalTrials.gov ↗ ← All trials in the USA