Medtronic CoreValve Evolut R U.S. Clinical Study

Completed · Not applicable

Conditions studied: Aortic Stenosis

In brief

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

Key facts

Study ID

NCT02207569

Run by

Medtronic Cardiovascular

People needed

241

Starts

2014-08-01

Expected to finish

2020-10-28

Last updated by the study team

2022-11-02

Who can join

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

You may not qualify if…

• Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media
• Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
• End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
• Ongoing sepsis, including active endocarditis.
• Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure.
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• Subject refuses a blood transfusion.
• 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).
• Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
• Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.
• Currently participating in an investigational drug or another device study (excluding registries).
• Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
• Need for emergency surgery for any reason.
• Liver failure (Child-Pugh class C).
• Subject is pregnant or breast feeding.
• Anatomical exclusion criteria:
• Pre-existing prosthetic heart valve in any position.
• Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
• Severe mitral regurgitation.

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Washington Hospital Center/Medstar — Washington D.C., District of Columbia, United States
• St. Vincent Heart Center of Indiana/The Care Group, LLC — Indianapolis, Indiana, United States
• University of Kansas — Kansas City, Kansas, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Beth Israel Deaconcess 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
• Spectrum Health — Grand Rapids, Michigan, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• New York Langone Medical Center — New York, New York, United States
• The Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Riverside Methodist Hospital/Ohio Health Research Institute — Columbus, Ohio, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Pinnacle Health — Wormleysburg, Pennsylvania, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States
• The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp — Houston, Texas, United States
• Aurora Health Care/St Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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