Medical technologies developer AtriCure has started enrolment and treatment in the prospective ICE-AFIB clinical trial of its cryoICE Ablation System in atrial fibrillation (Afib) patients.
The first patient was treated at Washington Adventist Hospital in Maryland, US.
The cryoICE product has been developed for the cryosurgical treatment of cardiac arrhythmias through freezing of target tissues. The ablation system holds the US Food and Drug Administration (FDA) 510(k) clearance.
The multi-centre, single-arm ICE-AFIB trial will assess the safety and effectiveness of the device in up to 150 patients suffering from persistent and long-standing persistent Afib.
At 20 sites in the US, the trial will recruit patients who are set to receive cardiac surgery for repairing or replacing a heart valve and/or coronary artery bypass.
During the trial, cryoICE will be used along with AtriCure’s AtriClip left atrial appendage (LAA) occlusion device to carry out the Cox-Maze III lesion.
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The primary effectiveness in the trial will be measured as freedom from Afib, atrial flutter and/or atrial tachycardia lasting more than 30 seconds at 12 months following the treatment.
In addition, the trial will monitor long-term effectiveness at three years after the procedure.
AtriCure president and CEO Michael Carrel said: “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.”
The company offers a variety of cardiovascular products, including cardiac ablation devices for Afib treatment procedures and LAA occlusion devices for blocking the left atrial appendage.
Furthermore, AtriCure portfolio includes intraoperative testing equipment.