Please select the eligibility criteria that correspond to the clinical trial below.
Title: Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
Brief Summary: Background:

- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.

Objective:

- To further study the safety and effectiveness of transcaval TAVR.

Eligibility:

- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.

Design:

* Participants will be selected by a team of heart specialists and others.
* Participants will have a computed tomography (CT) scan with or without contrast dye.
* Participants will have blood tests.
* Participants will have transcaval TAVR.
* Participants will receive the same standard care as for all patients with TAVR.
* Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
* Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.


Options:
A: 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).
B: Inclusion Criteria:

* Patients must have severe degenerative aortic valve stenosis (echocardiographic criteria: AV effective orifice area (EOA) of \< 1 cm2, mean AV gradient of \> 40 mmHg, or AV peak systolic velocity of \> 4.0 m/s)
* Patients must be symptomatic from the aortic valve stenosis (dyspnoea in NYHA-class II or greater, angina pectoris, or syncope), or asymptomatic but with echocardiographic evidence of left ventricular hypertrophy, decreased left ventricular ejection fraction, or atrial fibrillation)
* Patients must be 70 years or older
* Patients must be technical and anatomical eligible for both interventions (as specified by Medtronic CoreValve(TM) for the TAVI procedure) after a formal consult by a cardiologist and a cardiovascular surgeon
* Patients must be expected to survive more than one year after the intervention
* Patients must be able to provide written informed consent as approved by the regional ethical committee after having received adequate information about the study
* Patients must be able and agree to return to all post-procedural follow-up visits

Exclusion Criteria:

* Isolated aortic valve insufficiency
* Other significant heart valve disease requiring intervention
* Coronary artery co-morbidity requiring revascularisation
* Any previous open heart surgery
* Myocardial infarction or percutaneous coronary intervention within the last year
* Stroke or TIA within the last 30 days
* Renal insufficiency requiring hemodialysis
* Pulmonary insufficiency (FEV1 or diffusion capacity \< 40% of expected)
* Active infectious disease requiring antibiotics
* Emergency intervention (within 24 hours after the indication for intervention has been made)
* Unstable pre-interventional condition requiring inotropic support or mechanical heart assistance
* A known hypersensitivity or contraindication to heparin or nitinol
* Currently participating in an investigational drug or another device study
C: * 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.
D: Inclusion Criteria:

1. Severe aortic stenosis, defined as follows:

   1. 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 transthoracic echocardiography at rest
   2. For asymptomatic patients:

      * 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
      * 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%.
2. 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 per multidisciplinary local heart team assessment.
3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

   1. aspirin or heparin (HIT/HITTS) and bivalirudin
   2. ticlopidine and clopidogrel
   3. Nitinol (titanium or nickel)
   4. contrast media
3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
4. Ongoing sepsis, including active endocarditis.
5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
6. Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery.
7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
11. Subject refuses a blood transfusion.
12. 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).
13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
14. 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.
15. Currently participating in an investigational drug or another device trial (excluding registries).
16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
17. Need for emergency surgery for any reason.
18. Subject is pregnant or breast feeding.
19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
20. Pre-existing prosthetic heart valve in any position.
21. Severe mitral regurgitation amenable to surgical replacement or repair.
22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
26. Prohibitive left ventricular outflow tract calcification.
27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
28. Aortic annulus diameter of \<18 or \>30 mm.
29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:
30. Access vessel mean diameter \<5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter \<5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<6.0 mm for the Evolut 34R or Evolut PRO TAV.

Answer: C