Although cryothermal energy has been used for surgical ablation for more than 30 years, there has been no prospective study to assess its safety and efficacy. Niv Ad, MD, from the University of Maryland and Washington Adventist Hospital, presented the latest information on the ICE-AFIB IDE trial, designed to bridge this evidence gap. The intent of the trial is to assess the safety and sustained effectiveness of cryothermal ablation as a standalone energy source for surgical atrial fibrillation (AF) ablation.
The ICE-AFIB trial will enroll up to 150 persistent and long standing persistent AF patients undergoing concomitant cardiac surgery. The study subjects will undergo a biatrial Cox Maze III lesion set using cryothermal energy and exclusion of the left atrial appendage. The patients will be followed at 30 days, 3, 6, 9, 12, 24 and 36 months, with a 24-hr holter at all study visits starting at month 3, said Dr. Ad. The primary safety endpoint is a composite of major adverse events within 30 days, and the primary efficacy endpoint is freedom from AF/ AFL/AT lasting more than 30 seconds at 12 months.
ICE AFIB is an IDE US FDA trial designed to establish a specific indication to treat AF concomitant to cardiac surgery. The first enrollment began in February 2019. Performance goals for the trial were developed from a systematic meta-analysis of published literature on the safety and effectiveness of this procedure. Assuming an effectiveness rate of 72%, the trial has at least 90% power to demonstrate that the primary effectiveness exceeds the 58% performance goal. For the primary safety endpoint, the upper bound of the confidence interval will not exceed 15%. For the trial to be successful, both endpoints must meet their respective performance goals.
“The ICE-AFIB multicenter IDE trial is the first of its kind designed to demonstrate safety and effectiveness of surgical cryoablation for the treatment of concomitant persistent and longstanding AF,” said Dr. Ad, the National primary investigator of the trial.