For Healthcare Professionals - International

CoreValve Evolut R OUS

TAVI System

CoreValve SURTAVI Trial

Objective and Patient Population

The Medtronic CoreValve SURTAVI Trial is designed to evaluate the safety and efficacy of the Medtronic CoreValve System in the treatment of symptomatic severe AS in subjects who are at intermediate risk for aortic valve surgery.

Trial Design

Up to 2500 patients at up to 75 global sites will be included in the trial. All patients will complete a minimum of 24 months of in clinic follow-up.

Clinical endpoints will be reported and adjudicated according to Valve Academic Research Consortium (VARC) standard endpoint definitions.

Inclusion Criteria

  1. Subject must have STS mortality risk score ≥4% and ≤10%;
  2. Heart Team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
  3. Subject has severe aortic stenosis presenting with:

    a. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2

    AND

    b. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram, if subject has a left ventricular ejection fraction (LVEF) <55%];

  4. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
  5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
  6. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.

Exclusion Criteria 

  1. Subject has refused surgical aortic valve replacement (SAVR) as a treatment option;
  2. Any condition considered a contraindication for placement of a bioprosthetic valve (i.e. subject requires a mechanical valve);
  3. A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
  4. Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
  5. Ongoing sepsis, including active endocarditis;
  6. Any condition considered a contraindication to extracorporeal assistance;
  7. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization;
  8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization;
  9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
  10. Recent (within 6 months of randomization) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
  11. Active gastrointestinal (GI) bleeding within the past 3 months;
  12. Subject refuses a blood transfusion;
  13. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
  14. Multivessel coronary artery disease with a Syntax score >22;
  15. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions;
  16. 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;
  17. Currently participating in an investigational drug or another device trial (excluding registries);
  18. Evidence of an acute myocardial infarction ≤ 30 days before the index procedure;
  19. Need for emergency surgery for any reason;
  20. True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
  21. Extensive mediastinal radiation;
  22. Liver failure (Child-C);
  23. Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
  24. Uncontrolled atrial fibrillation;
  25. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
  26. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
  27. Pulmonary Hypertension (systolic pressure > 80mmHg);
  28. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
  29. Frailty assessments identify:
    • Subject is < 80 years of age and three or more of the following apply
    • Subject is ≥ 80 years of age and two or more of the following apply
      • Wheelchair bound
      • Resides in an institutional care facility (e.g. nursing home, skilled care center)
      • Body Mass Index < 20 kg/m2
      • Grip strength < 16 kg
      • Katz Index score ≤ 4
      • Albumin < 3.5 g/dL.

Anatomical Exclusion Criteria

  1. Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging;
  2. Pre-existing prosthetic heart valve in any position;
  3. Mixed aortic valve disease [aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)];
  4. Severe mitral or severe tricuspid regurgitation;
  5. Severe mitral stenosis;
  6. Hypertrophic obstructive cardiomyopathy;
  7. Echocardiographic or Multislice Computed Tomography (MSCT) evidence of new or untreated intracardiac mass, thrombus or vegetation;
  8. Ascending aorta diameter greater than maximum diameter relative to the native aortic annulus size:
    Aortic Annulus Diameter Ascending Aorta Diameter
    18 mm – 20 mm > 34 mm
    20 mm – 23 mm > 40 mm
    23 mm – 29 mm > 43 mm
  9. Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae):

    a. Femoral and left subclavian/axillary access > 70°

    OR

    b. Right subclavian/axillary access: Aortic root angulation > 30°

  10. Congenital bicuspid or unicuspid valve verified by echocardiography;
  11. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion.

Vascular Exclusion Criteria

  1. Transarterial access not able to accommodate an 18Fr sheath.

Confidence. Delivered.