Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

Completed · Not applicable

Conditions studied: Severe Aortic Stenosis

In brief

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Key facts

Study ID

NCT01240902

Run by

Medtronic Cardiovascular

People needed

1453

Starts

2010-12-10

Expected to finish

2019-05-15

Last updated by the study team

2022-10-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Extreme Risk Only: Subject must have comorbidities 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.
• High Risk Surgical Only: Subject must have comorbidities 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.
• 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.

You may not qualify if…

• Clinical
• 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 intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)
• 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 Gastrointestinal (GI) bleeding within the past 3 months.
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
• Aspirin
• Heparin (HIT/HITTS)
• Bivalirudin (Extreme Risk Only)
• 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.

Where it is running

• Banner Good Samaritan — Phoenix, Arizona, United States
• Kaiser Permanente - Los Angeles Medical Center — Los Angeles, California, United States
• University of Southern California University Hospital — Los Angeles, California, United States
• El Camino Hospital — Mountain View, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Washington Hospital Center / Georgetown Hospital — Washington D.C., District of Columbia, United States
• University of Miami Health System / Jackson Memorial Hospital — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Saint Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Cardiovascular Institute of the South/ Terrebone General — Houma, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Detroit Medical Center Cardiovascular Institute — Detroit, Michigan, United States
• St. John Hospital and Medical Center — Detroit, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• North Shore University Hospital/ Long Island Jewish Hospital — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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