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Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Description

Multi-center, international, prospective, randomized, interventional, pre-market. Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 5 years

Phase

N/A

Inclusion and Exclusion Criteria

  • Severe aortic stenosis, defined as follows:
  • For symptomatic patients: Aortic valve area ≤ 1.0 cm2 (or aortic valve area index of ≤ 0.6 cm2/m2), OR mean gradient ≥ 40 mmHg, OR Maximal aortic valve velocity ≥ 4.0 m/sec by echocardiography or cardiac catheterization
  • For asymptomatic patients: i. Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2) AND maximal aortic velocity ≥ 5.0 m/sec by echocardiography or cardiac catheterization, OR ii. Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2) by the continuity equation, AND a mean gradient ≥ 40 mmHg, or maximal aortic valve velocity ≥ 4.0 m/sec by echocardiography or cardiac catheterization, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia.
  • Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR < 3% at 30 days
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

  • 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 that cannot be adequately premedicated:
  • aspirin or heparin (HIT/HITTS) and bivalirudin
  • ticlopidine and clopidogrel
  • Nitinol (titanium or nickel)
  • contrast media
  • Leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Ongoing sepsis, including active endocarditis.
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 180 days prior to randomization.
  • Multivessel coronary artery disease with a Syntax score > 22 and/or unprotected left main coronary artery.
  • 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 2 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
  • Estimated life expectancy of less than 24 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-up exams.
  • Currently participating in an investigational drug or another device trial (excluding registries).
  • Evidence of an acute myocardial infarction ≤ 30 days before the trial procedure due to unstable coronary artery disease
  • Need for emergency surgery for any reason.
  • Subject is pregnant or breast feeding.
  • Pre-existing prosthetic heart valve in any position.
  • Severe mitral regurgitation amenable to surgical replacement or repair.
  • Severe tricuspid regurgitation amenable to surgical replacement or repair.
  • Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  • Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  • Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
  • Prohibitive left ventricular outflow tract calcification.
  • Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
  • Aortic annulus diameter of <18 or >29 mm.
  • Access vessel mean diameter < 5.0 mm for Evolut 23R, 26R, or 29R TAV, or <6.0 mm for patent LIMA, or access vessel mean diameter < 6.0 mm for CoreValve 31 mm TAV.

Sites

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