The FORWARD Study is a prospective, single-arm, multicenter, observational study to assess the safety and clinical performance of the Medtronic Evolut R system in patients with symptomatic native aortic stenosis or failed bioprosthesis in routine practice. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%. to other options — medications or balloon valvuloplasty. The SURTAVI Trial is a prospective, randomized, multicenter, noninferiority study to compare the safety and efficacy of the Medtronic TAVR system* to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk. All subjects will be treated with a Medtronic TAVR system. Home Talk with your doctor and family members or friends about deciding to join a study. Several clinical trials have been conducted to provide information about the chance of a risk from the Medtronic TAVR procedure. This site uses cookies to store information on your computer. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 2020 Oct 7. doi: 10.1001/jamacardio.2020.4738. Severe aortic stenosis, defined as follows: 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 transthoracic echocardiography at rest, 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, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR, Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR. The CoreValve procedure had an acceptable safety profile and was an effective alternative. Currently participating in an investigational drug or another device study (excluding registries). The Extreme Risk CoreValve Pivotal Trial evaluated the safety and efficacy of the Medtronic CoreValve system for the treatment of patients with symptomatic severe aortic stenosis in whom the predicted risk of operative mortality or serious, irreversible morbidity was 50% or greater at 30 days. The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR … The Evolut R US Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery.

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