Trial Purpose and Description
The primary objective of this trial is to demonstrate that the safety and effectiveness of the Medtronic TAVR system, as measured by the rate of all-cause mortality or disabling stroke at two years, is non-inferior
to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of mortality at 30 days for SAVR.
Ages: 18 years and older
- 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:
- 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.
Dates: 07/29/2016 - 12/31/2016
Last Updated: 07/30/2016
Study HIC#: 1603017500