AtriCure Announces the First Patient Enrolled in the ICE-AFIB™ Clinical Trial
Trial will evaluate the safety and effectiveness of AtriCure’s cryoICE® Ablation System for the treatment of persistent and long-standing persistent atrial fibrillation in open concomitant cardiac surgery
The ICE-AFIB trial is a prospective, multicenter, single-arm study of up
to 150 patients at up to 20 U.S. centers. The study will enroll patients
with persistent and long-standing persistent atrial fibrillation
undergoing cardiac surgical procedure(s) for heart valve repair or
replacement and/or coronary artery bypass procedures. The study defines
persistent and long-standing persistent atrial fibrillation in
accordance with the
The cryoICE system in conjunction with an AtriClip® left atrial appendage (LAA) occlusion device will be used to perform the Cox-Maze III lesion set in this trial. Primary effectiveness is defined as freedom from Afib, atrial flutter, and/or atrial tachycardia lasting greater than 30 seconds and will be evaluated 12 months after the procedure. Long-term effectiveness will be evaluated three years post procedure.
“Cryothermal energy has been a mainstay of surgical ablation for a long
time. The ICE-AFIB IDE trial is the first of its kind designed to assess
the safety and sustained effectiveness of cryothermal ablation as a
standalone energy source for surgical AF ablation,” said Dr.
“While AtriCure’s ABLATE™ clinical trial confirmed that the usage of the
Isolator® Synergy™ Ablation System (radiofrequency ablation
(heat)) when supplemented with select lesions created with cryothermal
energy (cold) is an effective treatment for persistent and long-standing
persistent Afib during cardiac surgery, the ICE-AFIB trial is a unique
opportunity to generate systematic clinical evidence on the safety and
effectiveness of cryosurgery for the treatment of such patients,” said
The cryoICE ablation system was 510(k) cleared by the
About
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Source:
Valerie Storch-Willhaus
Media Relations
Senior Director,
Corporate Marketing and Communications
(612) 605-3311
vstorch-willhaus@AtriCure.com
Andy Wade
Investor Relations
Senior Vice President and Chief
Financial Officer
(513) 755-4564
awade@AtriCure.com