AtriCure, a provider of atrial fibrillation solutions, has announced that the first patient was enrolled for its ICE-AFIB trial, which received Investigational Device Exemption approval from the US Food and Drug Administration (FDA).
The first patient enrolled for the ICE-AFIB clinical trial has been treated by Dr. Niv Ad at Washington Adventist Hospital in Takoma Park, Maryland.
Dr. Niv Ad said: “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.”
The ICE-AFIB trial is a potential, multicenter, single-arm study conducted on approximately 150 patients at 20 centers across the US. It is expected to evaluate the cryoICE Ablation System for the treatment of long-standing persistent atrial fibrillation during concomitant open-chest cardiac surgery.
Under the study, patients with persistent and long-standing persistent atrial fibrillation undergoing cardiac surgical procedures for heart valve repair or replacement and/or coronary artery bypass procedures are enrolled.
Furthermore, the study defines their medical condition in accordance with the Heart Rhythm Society (HRS) 2017 AF expert consensus statement.
The cryoICE system in combination with an AtriClip left atrial appendage occlusion device is used to perform the Cox-Maze III lesion in the trial. The freedom from atrial fibrillation (Afib), atrial flutter, or atrial tachycardia is defined as the primary effectiveness.
The primary effectiveness lasting greater than 30 seconds is evaluated for 12 months after the procedure and the long-term effectiveness is evaluated for three years post 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 ICE-AFIB trial is yet another testament to AtriCure’s commitment to and leadership in improving the lives of atrial fibrillation patients undergoing cardiac surgery.”
The company said that its cryoICE ablation system was cleared by the FDA 510(k) in 2009 for the cryosurgical treatment of cardiac arrhythmias.
The treatment involves freezing of the target tissues to create an inflammatory response that blocks the electrical conduction pathway.