AtriCure, a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management announced the first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn, MI.
This company-sponsored trial will evaluate intraoperative cryoanalgesia therapy using cryoablation in conjunction with standard of care (SOC) pain management compared to SOC alone.
The design of the trial is a prospective, 3:1 randomized trial including a total of up to 100 patients. The randomization will include up to 75 patients in the treatment arm (intraoperative cryoablation plus SOC), and up to 25 patients in the control arm (SOC alone).
The study will include patients undergoing unilateral thoracotomy cardiac procedures and will evaluate pain scores and lung function recovery during hospital stay.
"FROST is the first prospective study of the cryoICE system evaluating its ability to manage post-operative pain, enabling faster and more complete patient recovery," said Michael Carrel, President and Chief Executive Officer of AtriCure
"Since we launched our temporary pain management indication under 510(k) clearance in early 2015, adoption of this therapy has been solid, as surgeons see the positive effects on their patients. This study is designed to provide further clinical and scientific evidence."
The primary objective of the study is to demonstrate that intraoperative intercostal cryoanalgesia in conjunction with SOC provides improved analgesic efficacy and faster, more complete recovery in patients undergoing unilateral thoracotomy cardiac procedures as compared to current SOC.
Additional endpoints, such as ICU length of stay, total hospital length of stay, opioid consumption, and long-term neurologic recovery will be gathered.
"In my experience, cryoanalgesia appears to result in improved pain management," said Dr Steven F. Bolling, Professor of Cardiac Surgery at University of Michigan Medical Center. "Perhaps more importantly, patients seem to extubate sooner and seem to be ready for an earlier discharge. FROST will seek to confirm this effect at multiple cardiac surgery institutions."
"I have continued to see the benefits of cryoanalgesia therapies in conjunction with minimally invasive mitral valve surgery," stated Dr. Francis Shannon, cardiothoracic surgeon, Beaumont Health System. "The benefit for patients is quite significant, and I look forward to developing further evidence through participation in the FROST study."
Participating centers in the study are the William Beaumont Hospital, the University of Michigan Medical Center, as well as Cleveland Clinic Foundation.
The coordinating investigators for the FROST study are Dr. Wei Lau and Dr. Francis Shannon at William Beaumont Hospital. Dr. Andrea Trescot, past president of the American Society of Interventional Pain Physicians is serving as Scientific Advisor for this trial.
"Today’s pain management options offer relief while patients are hospitalized, but do little to address pain post-discharge," said Dr. Wei Lau, Professor of Anesthesiology at Oakland University William Beaumont School of Medicine. "We have seen cryoanalgesia control pain and improve recovery post-operatively."
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation.
AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures.