Anteris Technologies (ASX:AVR) said the first patients in the DurAVR transcatheter heart valve global pivotal trial for patients with severe calcific aortic stenosis were enrolled and treated in Denmark, according to a Tuesday Australian bourse filing.

The trial seeks to evaluate the safety and effectiveness of the DurAVR transcatheter heart valve compared to commercially available transcatheter aortic valve replacements, the filing said. The company plans to enroll around 1,000 patients in the "All-Comers Randomized Cohort," and it will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization one year after the procedure.

The trial builds on the firm's existing clinical data set of 130 patients successfully treated with the transcatheter heart valve, including de novo aortic stenosis cases, valve-in-valve patients, as well as those with complex anatomies such as bicuspid aortic valve patients.

The company plans to expand the trial into the US, Europe, and Canada.

Anteris Technologies' shares fell past 3% in recent Tuesday trade.