The Amplatzer Amulet IDE trial, which will assess the safety and effectiveness of the company’s Amplatzer  Amulet Left Atrial Appendage Occluder used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular AF.

It will recruit patients at around 100 sites in the US and an additional 50 sites worldwide.

The patients in the study will be randomly assigned to secure either the firm’s Amulet device or an FDA approved LAA closure device in the control arm of the study.

St. Jude Medical will use data from the trial to receive FDA approval for the Amplatzer amulet occluder.

The company received CE mark approval for the Amplatzer Amulet device. It is currently commercially available in the Europe.

According to the World Health Organization (WHO), around 15 million strokes occur across the globe each year.

St. Jude Medical chief medical officer and medical affairs vice president Dr Mark Carlson said: “The Amplatzer Amulet device, which is the current market leader among left atrial appendage occluders in Europe, was developed to provide physicians additional treatment options to improve patient care.

“Enrollment in the Amplatzer Amulet IDE trial will take us one step closer to bringing this important technology to patients in the United States who are at an increased risk of stroke due to atrial fibrillation.”

Image: The Amplatzer Amulet left atrial appendage occluder. Photo: courtesy of St. Jude Medical.