AtriCure has treated the first subject in the randomised Box Lesion Creation with Left Atrial Appendage Exclusion to Reduce the Occurrence of New-onset Atrial Fibrillation (BoxX-NoAF) trial.
The study will assess the effectiveness and safety of the AtriCure IsolatorSynergy EnCompassclamp, as well as the AtriClip聽left atrial appendage exclusion system, to minimise the new-onset atrial fibrillation (Afib) occurrence in patients undergoing cardiac surgery.
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The treatment was carried out by Orlando Health Heart and Vascular Institute聽cardiothoracic surgeon Dr聽Anthony Rongione.
Approved by the US Food and Drug Administration (FDA), the seminal, multicentre, prospective, investigational device exemption study aims to include up to 960 participants across as many as 75 global locations.
It is designed to establish treatment guidelines for decreasing the incidence of new-onset or post-operative Afib (POAF) and chronic clinical Afib in high-risk patients undergoing cardiac surgery.
The occurrence of POAF after cardiac surgery is a common issue, with up to 50% of individuals experiencing this complication either immediately or in the months post-surgery.
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By GlobalDataThe condition is linked to morbidity, mortality, strokes, recurrent Afib, prolonged hospital stays, and total healthcare expenditures.
This trial claims to be the first randomised controlled study designed to show the benefits of concomitant surgical ablation with left atrial appendage (LAA) management in decreasing the new-onset POAF occurrence, as opposed to no intervention.
A successful outcome from the trial could position the company to expand the indications for the combined use of EnCompass clamp and AtriClip systems, specifically for the BoxX procedure, potentially making them the exclusive devices approved by the FDA for preventing post-operative and long-term clinical Afib.
AtriCure CEO and president Michael Carrel said: 鈥淭he BoxX-NoAF trial, together with our LeAAPS trial that completed enrolment in July 2025, reflects AtriCure鈥檚 vision to advance standards of care by expanding the benefits of surgical ablation and LAA exclusion to a broader population of cardiac surgery patients.
鈥淲e 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 embolisation. These studies reinforce our commitment to pioneering clinical science to expand our addressable markets.鈥�
Last year, the company launched the cryoSPHERE+ cryoablation probe, designed to aid in managing post-operative pain.
