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โ† Trials
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PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

RecruitingNAAges 65 Years - anyAllEdwards Lifesciences
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In plain words

What the trial is, and whether it could suit you

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF \< 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
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What it tests

  • SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
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Where

80 sites
Heart Center LLC, Huntsville
Huntsville, United States
Tucson Medical Center
Tucson, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Huntington Hospital
Pasadena, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, United States
Bay Area Structural Heart at Sutter Health
San Francisco, United States
Kaiser San Francisco Medical Center
San Francisco, United States
University of California San Francisco
San Francisco, United States

โ€ฆand 72 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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