First patients enrolled in study of novel TAVR system

HLT Inc. announced the first patients have been enrolled in a new trial to study the safety and performance outcomes of a transcatheter aortic valve replacement system in patients with severe aortic stenosis at high risk for surgery.

The study, RADIANT, is a prospective, non-randomized, single-arm study of a transcatheter aortic valve (Meridian, HLT) and delivery system (Pathfinder II, HLT), according to a press release issued by the company. The researchers aim to enroll up to 20 high-risk patients, who will be followed up at 1 month, 6 months, 12 months and annually up to 5 years.

The primary endpoint is all-cause mortality at 30 days, according to the release.

The valve is self-expanding with a flexible wire frame supporting its leaflets to promote flow and reduce stress, and the delivery system enables the operator to retrieve or reposition the valve if necessary, according to the release.

“The RADIANT clinical study will provide evidence regarding the safety and performance of a third-generation transcatheter aortic valve replacement therapy.” Kevin Bassett, general manager of HLT, said in the release. “We’re delighted to partner in the study with outstanding clinicians at the Quebec Heart and Lung Institute as well as the Sunnybrook Health Science Centre in Toronto.”

The system is not yet approved for sale anywhere.

Disclosure: Bassett is an employee of HLT Inc.