Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

Completed

Conditions studied: Severe Aortic Stenosis

In brief

To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.

Key facts

Study ID

NCT01675440

Run by

Medtronic Cardiovascular

People needed

782

Starts

2012-08-01

Expected to finish

2025-04-08

Last updated by the study team

2026-05-05

Who can join

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

You may qualify if…

• 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.
• Subjects must meet all of the criteria under at least one of the sub-groups 2a-c:
• a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions:
• Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography
• Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography
• End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification) or creatinine clearance <20cc/min but not requiring renal replacement therapy
• AND
• ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%) AND iii. 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
• AND/OR
• b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization AND ii. 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 AND iii. radiographic evidence of severe aortic valve calcification AND/OR c. Failed bioprosthetic surgical aortic valve
• 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 study, 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 MCS TAVI procedure.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI 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).
• Active Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (including ability to be anticoagulated for the index procedure), nitinol, or [allergic] sensitivity to contrast media which cannot be adequately pre-medicated.
• 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 study/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 study.
• Symptomatic carotid or vertebral artery disease.
• Anatomical
• Subject has a:
• Native aortic annulus size <18 mm or >29 mm per the baseline diagnostic imaging (not applicable for TAV in SAV subjects) OR
• Surgical bioprosthetic annulus <17mm or >29mm i. Stented SAV per the manufactured labeled inner diameter OR ii. Stentless SAV per the baseline diagnostic imaging
• Subject has a pre-existing prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position:
• that could affect the implantation or function of the study valve OR
• the implantation of the study valve could affect the function of the pre-existing prosthetic heart valve

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
• 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/Terrebonne General — Houma, Louisiana, United States
• The 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 — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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