REPRISE III: REPOSITIONABLE PERCUTANEOUS REPLACEMENT OF STENOTIC AORTIC VALVE THROUGH IMPLANTATION OF LOTUS VALVE SYSTEM - RANDOMIZED CLINICAL TRIAL EVALUATION
To evaluate the safety and effectiveness of the Lotus Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
Heart & Vascular,
Heart & Vascular - Structural Heart Trials
Ming Zhang, MD, PhD
Patients who have an aortic valve that needs to be replaced because it has been diagnosed as having too narrow of an opening (called stenosis), and who are judged to be high or extreme risk for traditional surgical valve replacement. A recent heart attack (within 1 month), stroke (within 6 months), other recent cerebrovascular event, severe kidney disease, or other diagnoses may exclude potential subjects.