AtriCure has announced that the first patient was recently enrolled and treated in the BoxX-NoAF clinical trial, which is assessing the safety and effectiveness of box lesion creation with the company’s Isolator Synergy EnCompass clamp and AtriClip left atrial appendage (LAA) exclusion system to reduce the occurrence of new-onset atrial fibrillation (AF). The first patient was treated by Anthony Rongione (Orlando Health Heart and Vascular Institute, Orlando, USA).
“POAF [postoperative AF] remains one of the most challenging complications for patients who have undergone cardiac surgery, undermining patient recovery and consuming significant hospital resources,” said Edward Soltesz (Cleveland Clinic, Cleveland, USA). “We believe the BoxX procedure, combining a box lesion and LAA exclusion, could meaningfully lower the occurrence of new-onset AF and significantly improve the quality of care for these patients.”
BoxX-NoAF is a prospective, multicentre, randomised, US Food and Drug Administration (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 AF in elevated-risk cardiac surgery patients, as stated in an AtriCure press release.
“The BoxX-NoAF trial, together with our LeAAPS trial that completed enrolment 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,” commented Michael Carrel, president and chief executive officer (CEO) of AtriCure. “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 AF, stroke, and systemic embolisation. These studies reinforce our commitment to pioneering clinical science to expand our addressable markets.”
The BoxX-NoAF trial is claimed by the company to be the first randomised controlled trial designed to demonstrate superiority of concomitant surgical ablation with LAA management for reducing the occurrence of new-onset AF/POAF compared to no treatment.
If successful, trial results would position AtriCure to pursue expanded labelling for the EnCompass clamp and AtriClip systems when used together in a BoxX procedure, potentially making them the only US FDA-approved devices for the prevention of postoperative and longer-term clinical AF.
