CoreValve® U.S. Pivotal Trial - Continued Access Protocol

Principal Investigator:	Jon R. Resar, M.D. John V. Conte, M.D.
Study Coordinator:	Kathleen Citro, R.N.
Contact Phone:	410-955-7377
Contact Email:	kcitro@jhmi.edu
Study Long Title:	Medtronic CoreValve® Continued Access Protocol
Study Short Title:	Medtronic CoreValve® Continued Access Protocol
IRB Number:	NA_00070569
Funding Source:	Medtronic CardioVascular
Summary of Trial:	Extreme Risk Patients: To demonstrate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in the treatment of symptomatic, severe aortic stenosis in patients with predicted extreme risk for aortic valve surgery. In this registry, all patients will receive the Medtronic CoreValve® System (MCS).
Inclusions:	Extreme Risk Patients: Patients with symptomatic, severe aortic stenosis (AS) necessitating aortic valve replacement, whose predicted risk of operative mortality is > 50% as determined by a cardiologist and two cardiac surgeons.
Exclusions:	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 three 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. There are several other exclusions that can only be evaluated during the screening process.
Clinical Trial Site:	Johns Hopkins Hospital 1800 Orleans Street Zayed 7125N Baltimore, Maryland 21287
Compensation for Participating:	No
Start Date:	03/2012
Anticipated End Date:	12/2018