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

  • STATUS
    Recruiting
  • End date
    Jul 13, 2024
  • participants needed
    150
  • sponsor
    AtriCure, Inc.
Updated on 13 August 2020
Investigator
Nfii Ndikintum, PhD, MBA
Primary Contact
Washington Adventist Hospital (4.2 mi away) Contact
+14 other location
ejection fraction
arrhythmia
heart surgery
persistent atrial fibrillation
mitral valve repair
tricuspid valve repair

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.

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.

Details
Treatment AtriCure CryoICE & AtriClip LAA Exclusion
Clinical Study IdentifierNCT03732794
SponsorAtriCure, Inc.
Last Modified on13 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Arrhythmia or Dysrhythmia or Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation or Persistent Atrial Fibrillation or Atrial Fibrillati...?
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 five 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
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