RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis) (RHEIA)

This is an interventional other trial for Aortic Valve Stenosis focused on measuring Research in woman, Transcatheter Aortic Valve Implantation (TAVI), surgical aortic valve replacement (SAVR), cardiovascular disease, heart disease, Sapien 3, Transcatheter Aortic Valve Replacement (TAVR) Read More

Inclusion Criteria:

1. Female patients with severe aortic stenosis as follows:

   • High gradient severe AS (Class I Indication for aortic valve replacement [AVR]): Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg with Aortic Valve Area (AVA) ≤ 1.0 cm^2 or AVA index ≤ 0.6 cm^2/m^2 OR

   • Low gradient severe aortic stenosis (Class I/IIa indication of AVR) Jet velocity < 4.0 m/s and mean gradient < 40 mmHg and AVA ≤ 1.0 cm^2 and AVA index ≤ 0.6 cm^2/m^2 with confirmation of severe AS by: mean gradient ≥40 mmHg on dobutamine stress echocardiography and/or aortic valve calcium score ≥ 1200 AU on non-contrast CT.

   AND

   • NYHA Functional Class ≥ II OR
   • Exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia
2. Age ≥ 18 years
3. The study patient 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)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

1. Patient is not a candidate for both surgical and transcatheter aortic valve replacement.
2. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV based on 3D imaging analysis
3. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
4. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization
5. Aortic valve is unicuspid, bicuspid, or is non-calcified
6. Severe aortic regurgitation (>3+)
7. Any concomitant valve disease that requires an intervention
8. Pre-existing mechanical or bioprosthetic valve in any position (mitral ring is not an exclusion).

9. Complex coronary artery disease:

   • Unprotected left main coronary artery stenosis
   • Syntax score > 32 (in the absence of prior revascularization)
   • Heart Team assessment that optimal revascularization cannot be performed.
10. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days before randomization
11. Leukopenia (WBC < 3000 cell/mcL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mcL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days before randomization
13. Hypertrophic cardiomyopathy with obstruction
14. Ventricular dysfunction with lleft ventricular ejection fraction < 30%
15. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
16. Inability to tolerate or condition precluding treatment with anti- thrombotic/anticoagulation therapy during or after the valve implant procedure
17. Stroke or transient ischemic attack within 90 days before randomization
18. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy
19. Active bacterial endocarditis within 180 days of randomization
20. Severe lung disease (FEV1 < 50%) or currently on home oxygen
21. Severe pulmonary hypertension (e.g., pulmonary arterial systolic pressure ≥ 2/3 systemic pressure)
22. History of cirrhosis or any active liver disease
23. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.
24. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or internal mammary artery to sternum, etc.)
25. Patient refuses blood products
26. BMI > 50 kg/m^2
27. Estimated life expectancy < 24 months
28. Absolute contraindications or allergy to iodinated contrast agent that cannot be adequately treated with pre-medication
29. Immobility that would prevent completion of study procedures
30. Currently participating in an investigational drug or another device study.
31. Pregnancy or lactation