Clinical trial launches for new treatment of congenital heart disease

St. Jude Medical announced the launch of a pediatric trial for the Amplatzer Duct Occluder II Additional Sizes device, which is designed for the closure of the small patent ductus arteriosus, according to a company press release.

Patent ductus arteriosus is one of the most common congenital heart anomalies. Currently, many children receive treatment with adult-sized devices, according to the release.

“The patients who would be eligible for this study are the tiniest and most fragile we care for — severely premature newborns who in many cases are critically ill from the presence of a [patent ductus arteriosus],” Evan M. Zahn, MD, director of the Guerin Family Congenital Heart Program in the Cedars-Sinai Heart Institute and pediatric cardiologist at CedarsSinai Medical Center in Los Angeles, stated in the release. “The Amplatzer Duct Occluder II [Additional Sizes] will provide an experimental option to surgery. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed for this fairly common and often quite serious problem.”

The Amplatzer Duct Occluder II Additional Sizes (ADO II AS) device is designed to fit to the smallest ducts while achieving complete closure.

The study will be enrolling up to 50 pediatric patients at up to 10 sites in the United States. Patients in the trial will fall within two study groups: a minimum of 15 patients 2 kg (approximately 4.4 lb) or a minimum of 25 patients > 2 kg, according to the release.

The ADO II AS device is currently approved for use in more than 50 countries outside of the United States.