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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732794
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation (AF) Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation Device: AtriCure CryoICE & AtriClip LAA Exclusion Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Composite post-procedure MAE rate (Safety). [ Time Frame: 12 months ]
    Long-term safety based on MAE rate at 12-months post-procedure

  2. Pacemaker implantation (Safety). [ Time Frame: 12 months ]
    Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.

  3. Overall Serious Adverse Event (SAE) rate (Safety) [ Time Frame: 12 months ]
    Long-term safety based on SAE rate at 12-months post-procedure

  4. Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness) [ Time Frame: 12 months ]
    Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in presence of previously failed Class I or III AADs.

  5. Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness) [ Time Frame: 12 months ]
    Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.

  6. Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness) [ Time Frame: 12 months ]

    Based on composite score (0-100). A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).

    AFEQT Evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients The overall composite score and domains will be summarized by presenting the means, medians, standard deviations, interquartile ranges, minimum, and maximum


  7. Acute procedural success (Effectiveness) [ Time Frame: Intra-operative period ]
    Absence of AF at end of procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732794


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, District of Columbia
Washington Adventist Hospital
Washington, District of Columbia, United States, 20912
United States, Illinois
Northwestern Medicine
Chicago, Illinois, United States, 60611
United States, Indiana
Franciscan Health
Indianapolis, Indiana, United States, 46237
Deaconess Gateway Hospital
Newburgh, Indiana, United States, 47630
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, New York
Mount Sinai Icahn School of Medicine
New York, New York, United States, 10029
NYP-Weill Cornell
New York, New York, United States, 10065
Northwell Health Systems
New York, New York, United States, 10075
St. Joseph Hospital Health Center
Syracuse, New York, United States, 13203
United States, Tennessee
St Thomas West Hospital
Nashville, Tennessee, United States, 37205
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: Niv Ad, MD Washington Adventist Hospital
More Information
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT03732794    
Other Study ID Numbers: CP2018-1
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol, Statistical Analysis Plan (SAP), and Informed Consent (ICF) will be shared at the completion of the study.
Time Frame: Information will be available in accordance with clinical trials.gov requirements.
Access Criteria: Publicly available through clinical trials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes