Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patients with severe aortic stenosis as follows:
✓. Age ≥ 18 years
✓. 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
✕. Patient is not a candidate for both surgical and transcatheter aortic valve replacement.
✕. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV based on 3D imaging analysis
✕. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
✕. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization
✕. Aortic valve is unicuspid, bicuspid, or is non-calcified
✕. Severe aortic regurgitation (\>3+)
What they're measuring
1
Mortality
Timeframe: through study completion, an average of 1 year
2
Stroke
Timeframe: through study completion, an average of 1 year
3
Re-hospitalization
Timeframe: through study completion, an average of 1 year