AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment (ICE-AFIB)
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|ClinicalTrials.gov Identifier: NCT03732794|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : October 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation (AF) Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation||Device: AtriCure CryoICE & AtriClip LAA Exclusion||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||July 2024|
|Estimated Study Completion Date :||December 2026|
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.
- 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).
- 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.
- Composite post-procedure MAE rate (Safety). [ Time Frame: 12 months ]Long-term safety based on MAE rate at 12-months post-procedure
- 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.
- Overall Serious Adverse Event (SAE) rate (Safety) [ Time Frame: 12 months ]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) [ 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.
- 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.
- 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
- Acute procedural success (Effectiveness) [ Time Frame: Intra-operative period ]Absence of AF at end of procedure
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|Contact: Nfii K Ndikintum, PhD, MBAfirstname.lastname@example.org|
|Contact: Jess Lampertemail@example.com|
|Principal Investigator:||Niv Ad, MD||Washington Adventist Hospital|
|Responsible Party:||AtriCure, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 7, 2018 Key Record Dates|
|Last Update Posted:||October 3, 2022|
|Last Verified:||January 2022|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|