Results from the 130-patient Cryo4Persistent AF trial, presented at the annual meeting of the European Heart Rhythm Assn. in Barcelona, is an open-label, single-arm study with a primary outcome of single-procedure success at 12 months. Single-procedure success is defined as “absence of adjudicated AF/atrial flutter/atrial tachyarrhythmias” of 30 or more seconds, clocked after a 90-day blanking period following the cryoablation procedure, according to ClinicalTrials.gov.
Medtronic said the study showed a 60.7% rate of freedom from all atrial arrhythmias of 30 seconds or more. For the secondary outcome, acute procedural success, the study showed a 4% procedure-related complication rate.
“Similar to what we saw with the Fire and Ice clinical trial, the Cryo4Persistent AF findings demonstrate the significant benefits of cryo energy for the treatment of AF,” AF solutions GM Rebecca Seidel said in prepared remarks. “As more and more physicians around the world adopt cryoablation, we are committed to providing the technology and expertise to help them bring better, more efficient care for their patients.”
“The findings demonstrate the benefits of cryoablation therapy in reducing the significant burden patients experience once AF progresses and hold promise for physicians to realize efficient procedure times and a low rate of adverse events for their persistent AF patients,” added co-principal investigator Dr. Serge Boveda of Toulouse’s Clinique Pasteur. “These results are encouraging and demonstrate the reproducibility of the cryoballoon procedure even in patients with persistent AF.”
“This is the first study of its kind to closely observe patients with persistent AF using a PVI-only strategy with the cryoballoon,” co-principal investigator Dr. Pascal Defaye, of the Grenoble-Alpes University Hospital, said in a press release. “The results are noteworthy and provide valuable insights for the physician community.”