PARTNER II Trial: S3iCAP

Inclusion Criteria

• Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted.
• Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.
• 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 3+).
• Pre-existing mechanical or bioprosthetic valve in any position.
• Complex coronary artery disease:
• Unprotected left main coronary artery
• Syntax score > 32 (in the absence of prior revascularization)
• 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 is not considered exclusion criteria.
• Any patient with a balloon valvuloplasty (BAV) 28mm as measured by echocardiogram.
• Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
• Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
• Estimated life expectancy 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
• Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral).
• Currently participating in an investigational drug or an-other device study. Note: Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• Active bacterial endocarditis within 6 months (180 days) of procedure.
• Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.
• Inability to tolerate anticoagulation/antiplatelet therapy.
• For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26 mm system and < 6.0 mm for the 29 mm system.