Enrollment for this trial is now closed.
| 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® U.S. Pivotal Trial (High Risk Inoperable Patients) and (High Risk Surgical Patients) |
| Study Short Title: | Medtronic CoreValve® U.S. Pivotal Trial |
| IRB Number: | NA_00041009 |
| 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). 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. |
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. 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. |
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 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 |
| Start Date: | 03/2011 |
| Anticipated End Date: | 12/2018 |
Facebook
Twitter
Sharecare
Blogs
YouTube
RSS
Podcasts
