Cryoablation + LAA Closure for Atrial Fibrillation
(ICE-AFIB Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on long-term treatment with oral or injected steroids, you may not be eligible to participate.
What data supports the effectiveness of the treatment AtriCure CryoICE & AtriClip LAA Exclusion for Atrial Fibrillation?
Research shows that combining cryoablation (a technique that uses extreme cold to destroy tissue) and left atrial appendage closure is effective in managing stroke risk in patients with atrial fibrillation. Additionally, cryoballoon ablation has been effective in maintaining stable heart rhythms in patients with persistent atrial fibrillation.12345
Is cryoablation combined with left atrial appendage closure safe for treating atrial fibrillation?
How is the Cryoablation + LAA Closure treatment for atrial fibrillation different from other treatments?
This treatment is unique because it combines cryoablation (a technique that uses extreme cold to destroy abnormal heart tissue) with left atrial appendage (LAA) closure, which helps prevent blood clots. This combination aims to both manage the irregular heartbeat and reduce the risk of stroke, offering a comprehensive approach for high-risk atrial fibrillation patients.358910
What is the purpose of this trial?
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.
Research Team
Niv Ad, MD
Principal Investigator
Washington Adventist Hospital
Eligibility Criteria
This trial is for adults over 18 with persistent or long-standing atrial fibrillation who need non-emergency heart surgery, like valve repair/replacement or bypass. They must be able to consent and follow up, have a life expectancy of at least 5 years, and an ejection fraction ≥30%. Excluded are those with severe carotid artery stenosis, active infections, mental impairments affecting study comprehension, pregnancy plans within a year, certain steroid treatments, previous Maze procedures or cardiac surgeries (Redo), ventricular arrhythmia drug therapy needs, specific cardiomyopathies or blood disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the AtriCure CryoICE system procedure to perform the Cox-Maze III lesion set and LAA exclusion using the AtriClip device during cardiac surgery
Follow-up
Participants are monitored for safety and effectiveness, including freedom from AF/AFL/AT and quality of life assessments
Treatment Details
Interventions
- AtriCure CryoICE & AtriClip LAA Exclusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
AtriCure, Inc.
Lead Sponsor