We're sorry, but this trial is no longer enrolling volunteers.
Medtronic CoreValve® Continued Access Study
Inclusion and Exclusion Criteria
- High Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days. OR Extreme Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
- Subject has senile degenerative aortic valve stenosis with: - Mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND - An initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
- Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
- The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal and drug eluting stents.
- Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Need for emergency surgery for any reason.
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
- Active GI bleeding that would preclude anticoagulation.
- A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: - Aspirin - Heparin (HIT/HITTS) and bivalirudin - Nitinol (titanium or nickel) - Ticlopidine and clopidogrel - Contrast media
- Ongoing sepsis, including active endocarditis.
- Subject refuses a blood transfusion.
- Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- Currently participating in an investigational drug or another device trial.
- Symptomatic carotid or vertebral artery disease. Anatomical
- High Risk:Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve
- University of Southern California University Hospital, Los Angeles, California, 90033
- Kaiser Permanente - Los Angeles Medical Center, Los Angeles, California, 90072
- El Camino Hospital, Mountain View, California, 94040
- VA Palo Alto Health Care System, Palo Alto, California, 94304
- Banner Good Samaritan, Phoenix, Arizona, 85006
- Providence Sacred Heart Medical Center, Spokane, Washington, 99204
- Baylor Heart and Vascular Hospital, Dallas, Texas, 75226
- The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center, Houston, Texas, 77030
- Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas, 77030
- University of Kansas Hospital, Kansas City, Kansas, 66160
- Iowa Heart Center, Des Moines, Iowa, 50314
- Cardiovascular Institute of the South/Terrebonne General, Houma, Louisiana, 70360
- Loyola University Medical Center, Maywood, Illinois, 60153
- St. Luke's Medical Center - Aurora Health Care, Milwaukee, Wisconsin, 53215
- Vanderbilt University Medical Center, Nashville, Tennessee, 37232
- St. Vincent Heart Center of Indiana, Indianapolis, Indiana, 46290
- Spectrum Health Hospitals, Grand Rapids, Michigan, 49503
- Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, 30342
- Piedmont Heart Institute, Atlanta, Georgia, 30309