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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
UCLA Medical Center
Los Angeles, California, United States
Washington Adventist Hospital
Washington D.C., District of Columbia, United States
Northwestern Medicine
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).
Time frame: 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.
Time frame: 30 days
Composite post-procedure MAE rate (Safety).
Long-term safety based on MAE rate at 12-months post-procedure
Time frame: 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.
Time frame: 12 months
Overall Serious Adverse Event (SAE) rate (Safety)
Long-term safety based on SAE rate at 12-months post-procedure
Time frame: 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.
Time frame: 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.
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Chicago, Illinois, United States
Franciscan Health
Indianapolis, Indiana, United States
Deaconess Gateway Hospital
Newburgh, Indiana, United States
University Of Maryland
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Mount Sinai Icahn School of Medicine
New York, New York, United States
...and 5 more locations
Time frame: 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
Time frame: 12 months
Acute procedural success (Effectiveness)
Absence of AF at end of procedure
Time frame: Intra-operative period