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

AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation (AF); Longstanding Persistent Atrial Fibrillation
• Intervention / Treatment: Device: AtriCure CryoICE & AtriClip LAA Exclusion

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20912
      • Washington Adventist Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health
    • Newburgh, Indiana, United States, 47630
      • Deaconess Gateway Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Icahn School of Medicine
    • New York, New York, United States, 10065
      • NYP-Weill Cornell
    • New York, New York, United States, 10075
      • Northwell Health Systems
    • Syracuse, New York, United States, 13203
      • St. Joseph Hospital Health Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St Thomas West Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)	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).	12 months
Safety Endpoint: composite acute major adverse event (MAE) rate	The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite post-procedure MAE rate (Safety).	Long-term safety based on MAE rate at 12-months post-procedure	12 months
Pacemaker implantation (Safety).	Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.	12 months
Overall Serious Adverse Event (SAE) rate (Safety)	Long-term safety based on SAE rate at 12-months post-procedure	12 months
Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)	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.	12 months
Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)	Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.	12 months
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)	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	12 months
Acute procedural success (Effectiveness)	Absence of AF at end of procedure	Intra-operative period

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Niv Ad, MD, Washington Adventist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): June 27, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2018-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, Statistical Analysis Plan (SAP), and Informed Consent (ICF) will be shared at the completion of the study.
• IPD Sharing Time Frame: Information will be available in accordance with clinical trials.gov requirements.
• IPD Sharing Access Criteria: Publicly available through clinical trials.gov

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes