AtriCure Enrolls 1st Patient in BoxX-NOAF Trial

AtriCure announced that the first patient was enrolled and treated in its Box Lesion Creation with Left Atrial Appendage Exclusion to Reduce the Occurrence of New-onset Atrial Fibrillation (BoxX-NoAF) clinical trial.

The company lauds BoxX-NoAF as the first randomized controlled trial to show the superiority of concomitant surgical ablation with left atrial appendage (LAA) management to reduce new-onset post-operative atrial fibrillation (POAF) compared to no treatment. Successful trial results will spur AtriCure to chase expanded labeling for its EnCompass clamp and AtriClip systems used together in a BoxX procedure.

BoxX-NoAF is a prospective, multicenter, randomized, FDA-approved investigational device exemption (IDE) clinical trial of up to 960 patients at up to 75 global sites. The seminal trial aims to define clinical practice and treatment guidelines for reducing POAF occurrence, as well as longer-term AFib in patients with elevated risk cardiac surgery.

New-onset POAF is a challenging complication for cardiac surgery patients—it undermines recovery and consumes significant hospital resources, said Edward G. Soltesz, MD, MPH, a 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,” Dr. Soltesz told the press.

AtriCure president and CEO Michael Carrel said BoxX-NOAF and the company’s LeAAPS trial—which completed enrollment in July—hope to help extend surgical ablation and LAA exclusion to a wider cardiac surgery population.

“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,” said Carrel. “These studies reinforce our commitment to pioneering clinical science to expand our addressable markets.”

Earlier this year, AtriCure announced the first use of its new device for minimally invasive concomitant procedures, the AtriClip PRO-Mini LAA exclusion system.