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CoreValve® U.S. Pivotal Trial
|Principal Investigator:||Jon R. Resar, M.D.|
Kathleen Citro, R.N.
|Study Long Title:|
Medtronic CoreValve® U.S. Pivotal Trial | High Risk Patients
|Study Short Title:||Medtronic CoreValve® U.S. Pivotal Trial|
|Funding Source:||Medtronic CardioVascular|
|Summary of Trial:||High Risk Surgical Patients: To demonstrate that the safety and effectiveness of the Medtronic CoreValve® System (MCS) is non-inferior to surgical aortic valve replacement (SAVR) in the treatment of severe aortic stenosis in patients who have a predicted high risk for aortic valve surgery. Patients in the High Risk study will be randomized on a 1:1 basis to either transcatheter aortic valve implant (TAVI) or SAVR.|
|High Risk Surgical Patients: Patients with symptomatic severe aortic stenosis (AS) necessitating aortic valve replacement whose predicted risk of operative mortality is > 15% as determined by a cardiologist and two cardiac surgeons.|
|Evidence of a heart attack within past month, any percutaneous coronary or peripheral interventions within the past month, bleeding disorders, untreated significant coronary artery disease requiring revascularization, stroke within the past six months, active peptic ulcer or GI bleeding within the past six months, severe kidney disease, dementia, patient would refuse a blood transfusion, need for emergency surgery for any reason, cardiogenic shock, sepsis, severe left ventricular dysfunction with left ventricular ejection fraction < 20%, symptomatic carotid or vertebral artery disease. In the High Risk study, patients who have been offered surgery but declined. There are several other exclusions that can only be evaluated during the screening process.|
|Clinical Trial Site:|
Johns Hopkins Hospital
|Compensation for Participating:||No|
|Anticipated End Date:||12/2018|