The device maker said the heart valve -- which replaces the heart's aortic valve -- will be implanted in roughly 500 adult patients.

The trial will be conducted at approximately 22 medical centers in the United States and Canada, St. Jude said.

"The promise of the Trifecta tissue valve to potentially deliver superior hemodynamic performance to currently available stented or stentless aortic valves is very exciting," said study investigator Tirone David, head of the division of cardiovascular surgery at Toronto General Hospital.

About 170,000 patients worldwide have aortic tissue heart valve replacements annually, the company said, usually in patients with a narrowing of the aortic valve, or aortic stenosis, or aortic regurgitation, where the valve does not close tightly and blood flows back into the heart's left ventricle.