Please select the eligibility criteria that correspond to the clinical trial below.
Title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Brief Summary: The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.


Options:
A: * INCLUSION CRITERIA:
* Adults age greater than or equal to 21 years
* Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
* Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
* Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.

EXCLUSION CRITERIA:

* Unable or unwilling to consent to participate
* Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
* Unlikely to benefit from caval-aortic TAVR
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
B: Inclusion Criteria:

1. Severe, calcific aortic stenosis
2. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) \<50%
3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 4
4. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
3. Evidence of an acute myocardial infarction ≤ 30 days before randomization
4. Aortic valve is unicuspid, bicuspid, or non-calcified
5. Severe aortic regurgitation (\>3+)
6. Severe mitral regurgitation (\>3+) ≥ moderate stenosis
7. Pre-existing mechanical or bioprosthetic valve in any position
8. Complex coronary artery disease:

   1. Unprotected left main coronary artery
   2. Syntax score \> 32
   3. Heart Team assessment that optimal revascularization cannot be performed
9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
12. Hypertrophic cardiomyopathy with obstruction
13. Ventricular dysfunction with LVEF \< 30%
14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
16. Stroke or transient ischemic attack within 90 days of randomization
17. Renal insufficiency and/or renal replacement therapy at the time of screening.
18. Active bacterial endocarditis within 180 days of randomization
19. Severe lung disease or currently on home oxygen
20. Severe pulmonary hypertension
21. History of cirrhosis or any active liver disease
22. Significant frailty as determined by the Heart Team
23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
25. Patient refuses blood products
26. Body mass index \> 50 kg/m2
27. Estimated life expectancy \< 24 months
28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
29. Immobility that would prevent completion of study procedures
30. Patient is not a candidate for both arms of the study
31. Currently participating in an investigational drug or another device study.
C: Inclusion Criteria:

* Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
* Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
* Subject has severe aortic stenosis presenting with;

  1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
  2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25;
* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:

* Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
* Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
* 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;
* Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
* Ongoing sepsis, including active endocarditis;
* Any condition considered a contraindication to extracorporeal assistance;
* Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
* Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*;
* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
* Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
* Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
* Subject refuses a blood transfusion;
* 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);
* Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
* Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid 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 index procedure;
* Need for emergency surgery for any reason;
* True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
* Extensive mediastinal radiation;
* Liver failure (Child-C);
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram;
* Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm);
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
* End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min;
* Pulmonary Hypertension (systolic pressure\> 80mmHg);
* Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc;
* Frailty assessments identify:

  1. Subject is \< 80 years of age and three or more of the following apply
  2. 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;
* Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: \* For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.
D: Inclusion Criteria

1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
6. Heart team assessment of inoperability (including examining cardiac surgeon).

Answer: C