Back to resultsAtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment (ICE-AFIB)
Primary Purpose
Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AtriCure CryoICE & AtriClip LAA Exclusion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation (AF)
Eligibility Criteria
Inclusion Criteria:
- 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 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
- Subjects with known cold agglutinin
Sites / Locations
- UCLA Medical Center
- Washington Adventist Hospital
- Northwestern Medicine
- Franciscan Health
- Deaconess Gateway Hospital
- University Of Maryland
- University of Michigan
- Mayo Clinic
- St. Luke's Hospital
- Mount Sinai Icahn School of Medicine
- NYP-Weill Cornell
- Northwell Health Systems
- St. Joseph Hospital Health Center
- St Thomas West Hospital
- West Virginia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AtriCure CryoICE & AtriClip LAA Exclusion
Arm Description
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Composite post-procedure MAE rate (Safety).
Long-term safety based on MAE rate at 12-months post-procedure
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.
Overall Serious Adverse Event (SAE) rate (Safety)
Long-term safety based on SAE rate at 12-months post-procedure
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.
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.
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
Acute procedural success (Effectiveness)
Absence of AF at end of procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732794
Brief Title
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
Acronym
ICE-AFIB
Official Title
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AtriCure CryoICE & AtriClip LAA Exclusion
Arm Type
Experimental
Arm Description
AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Intervention Type
Device
Intervention Name(s)
AtriCure CryoICE & AtriClip LAA Exclusion
Intervention Description
AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Description
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).
Time Frame
12 months
Title
Safety Endpoint: composite acute major adverse event (MAE) rate
Description
The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite post-procedure MAE rate (Safety).
Description
Long-term safety based on MAE rate at 12-months post-procedure
Time Frame
12 months
Title
Pacemaker implantation (Safety).
Description
Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.
Time Frame
12 months
Title
Overall Serious Adverse Event (SAE) rate (Safety)
Description
Long-term safety based on SAE rate at 12-months post-procedure
Time Frame
12 months
Title
Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)
Description
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.
Time Frame
12 months
Title
Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)
Description
Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.
Time Frame
12 months
Title
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)
Description
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
Time Frame
12 months
Title
Acute procedural success (Effectiveness)
Description
Absence of AF at end of procedure
Time Frame
Intra-operative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Subjects with known cold agglutinin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niv Ad, MD
Organizational Affiliation
Washington Adventist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Washington Adventist Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20912
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Franciscan Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Deaconess Gateway Hospital
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
University Of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mount Sinai Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NYP-Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Northwell Health Systems
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
St. Joseph Hospital Health Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
St Thomas West Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
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