Medtronic announces new study to evaluate CoreValve Evolut PRO valve
Medtronic announced a new post-market clinical study to evaluate its CoreValve Evolut PRO valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO Clinical Study will evaluate longer-term performance (out to five years) of the next-generation self-expanding TAVI system, which was recently approved for commercial use in Europe and United States. The multi-center, prospective single-arm study will enroll 600 patients across 35 sites in Europe, and will evaluate safety including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. Patients will be followed out to five years.