AtriCure, a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced that the first patient was enrolled and treated in the Box Lesion Creation with Left Atrial Appendage Exclusion to Reduce the Occurrence of New-onset Atrial Fibrillation (BoxX-NoAF) clinical trial. The first patient was treated by Dr. Anthony Rongione, Cardiothoracic Surgeon at Orlando Health Heart and Vascular Institute in Orlando, Florida.
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New onset or post-operative Afib (POAF) is the most common complication following cardiac surgery, occurring in as many as 50% of patients presenting immediately or in the months following surgery. These arrhythmias are associated with increased mortality, morbidity, cerebrovascular accidents, Afib recurrence, hospital length of stay, and total hospital costs. BoxX-NoAF is a prospective, multicenter, randomized, FDA-approved investigational device exemption (IDE) clinical trial of up to 960 subjects at up to 75 sites worldwide. This seminal trial will ultimately define clinical practice and treatment guidelines for reducing the occurrence of POAF and longer-term clinical Afib in elevated risk cardiac surgery patients.
“The BoxX-NoAF trial, together with our LeAAPS trial that completed enrollment in July 2025, reflects AtriCure’s vision to advance standards of care by expanding the benefits of surgical ablation and LAA exclusion to a broader population of cardiac surgery patients,” said Michael Carrel, President and Chief Executive Officer. “We expect results of these trials to demonstrate that use of AtriCure devices can safely and effectively improve outcomes for cardiac surgery patients worldwide by reducing the prevalence of new-onset Afib, stroke, and systemic embolization. These studies reinforce our commitment to pioneering clinical science to expand our addressable markets.”
“POAF remains one of the most challenging complications for patients who have undergone cardiac surgery, undermining patient recovery and consuming significant hospital resources,” said Edward G. Soltesz, MD, MPH, Cleveland Clinic cardiovascular and thoracic surgeon. “We believe the BoxX procedure, combining a box lesion and LAA exclusion, could meaningfully lower the occurrence of new-onset Afib and significantly improve the quality of care for these patients.”
The BoxX-NoAF trial is the first randomized controlled trial designed to demonstrate superiority of concomitant surgical ablation with LAA management for reducing the occurrence of new-onset Afib POAF compared to no treatment. If successful, trial results would position AtriCure to pursue expanded labeling for the EnCompass clamp and AtriClip systems when used together in a BoxX procedure, and the only FDA-approved devices for the prevention of post-operative and longer-term clinical Afib.
