AtriCure (NSDQ:ATRC) said today that it launched a new FDA investigational device exemption cleared trial of its CryoIce system exploring its use in treating persistent atrial fibrillation during concomitant open-chested cardiac surgery.
The first patient in the trial has already been treated, the Mason, Ohio-based company said. The initial procedure took place at Takoma Park, Md.’s Washington Adventist Hospital.
“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,” national principal investigator Dr. Niv Ad of the Washington Adventist Hospital said in a press release.
The ICE-AFIB study aims to enroll 150 patients with persistent or long-standing persistent AF who are undergoing cardiac surgical procedures for heart valve repair or replacement or coronary artery bypass procedures, AtriCure said.
The company’s CryoIce system, along with the AtriClip left atrial appendage occlusion device, will be used to perform the Cox-Maze III lesion set in the trial. Primary effectiveness endpoints are defined as freedom from AF, atrial flutter and/or atrial tachycardia lasting more than 30 seconds.
Patients in the trial will be evaluated at 12 months and monitored out to three years, Atricure 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 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,” prez & CEO Michael Carrel said in a prepared statement.
Last month, AtriCure shares took a fall despite preliminary results for the fourth quarter and 2018 that topped estimates.
