US-based medical device firm HLT has started patient enrolment in a feasibility clinical study (RADIANT) of its Meridian transcatheter aortic valve and Pathfinder II delivery system to treat severe aortic stenosis.
The Meridian transcatheter aortic valve is designed to adapt to the heart's natural structure and the Pathfinder II delivery system allows control of the valve placement in a heart prior to release.
The prospective, non-randomised, single-arm, multicentre RADIANT trial will evaluate the safety and performance outcomes of the valve and system in 20 patients who are at high risk for surgery.
HLT general manager Kevin Bassett said: "The RADIANT clinical study will provide evidence regarding the safety and performance of a third-generation transcatheter aortic valve replacement therapy.
"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 ideal positioning of a valve is expected to aid in good hemodynamics, decrease leakage around the valve's base and promote optimal patient outcomes.
The self-expanding Meridian transcatheter aortic valve features a flexible wire to support its leaflets to enable good flow characteristics as well as minimise stress on the tissue of leaflet for long-term performance.
The trial's endpoint will examine all-cause mortality at 30 days following the implant of the Meridian valve.
Patient follow-ups will be performed at one, six and 12 months and also annually up to five years.
Image: Meridian valve. Photo: courtesy of HLT.