The purpose of this study is to establish the safety and effectiveness of the investigational Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in patients with symptomatic, severe, calcific aortic stenosis (AS). All treatments and physician visits during this study will take place at Scripps Anderson Medical Pavilion La Jolla. Study participation will last up to 10 years.
Be 18 years or older
Have severe calcific Aortic stenosis
Have NYHA functional class II or greater
Meet all other eligibility requirements
Patients must not:
Have a pre-existing mechanical or bioprosthetic valve
Have Severe mitral regurgitation or greater than moderate mitral stenosis
Have Complex coronary artery disease (CAD) that cannot be treated by percutaneous coronary intervention (PCI)
Have BMI > 50 kg/m2
Be pregnant or lactating
Have had a stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
The Edwards SAPIEN X4 THV system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Sizes of valves are 23mm, 26mm, and 29mm based on aortic size.
Search for NCT05172960 at https://clinicaltrials.gov website for more information.