AtriCure (Nasdaq:ATRC) today announced the first patient enrolled in its BoxX-NoAF clinical trial evaluating its cardiac therapy technologies.
With the Box Lesion Creation with Left Atrial Appendage Exclusion to Reduce the Occurrence of New-onset Atrial Fibrillation (BoxX-NoAF) trial, Mason, Ohio-based AtriCure hopes to define clinical practice and treatment guidelines for reducing the occurrence of post-operative AFib (POAF) and longer-term clinical AFib in elevated-risk cardiac surgery patients. Dr. Anthony Rongione treated the first patient at Orlando Health Heart and Vascular Institute.
The study looks at concomitant surgical ablation with left atrial appendage (LAA) management. Investigators seek to see if this reduces the occurrence of new-onset AFib POAF compared to no treatment. If successful, results would position the company to pursue expanded labeling for its EnCompass clamp and AtriClip systems. Used together in a BoxX procedure, they could prevent post-operative and longer-term AFib.
Investigators plan to enroll up to 960 subjects across up to 75 sites worldwide. They hope to address new onset POAF, which can lead to increased mortality, morbidity, cerebrovascular accidents, AFib recurrence, hospital length of stay and total hospital costs.
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.
AtriCure designed EnCompass for the ablation of cardiac tissue during cardiac surgery to make concomitant surgical ablations more efficient. The company’s AtriClip portfolio excludes and electrically isolates the LAA during cardiac surgery. LAA can cause blood clots in patients with AFib.
“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 CEO. “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.”
