CoreValve® Expanded

Investigator: Neal Kleiman, MD

Study Coordinator: Deena Victor

Status: Open Not Enrolling Number: NCT01675440

Phone: 713.441.4536

Protocol Number: Pro00008027


The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValveĀ® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of ?50% at 30 days associated with surgical aortic valve replacement.
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