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PROGRESS CAP/2012-01-CAP: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Purpose
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.
Inclusion Criteria
Ages Eligible for Study
65 Years and older (Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Key Inclusion Criteria:
- 65 years of age or older at time of randomization
- Moderate aortic stenosis
- Subject has symptoms or evidence of cardiac damage/dysfunction
- 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.
Exclusion Criteria
- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Prior balloon aortic valvuloplasty to treat severe AS
- LVEF < 20%
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
NCT:
NCT04889872
Ramzi Khalil, MD
Interventional Cardiology
Allegheny General Hospital
Sponsor
Edwards Lifesciences
Contact
For more information about this trial, please send an email to ClinicalTrials@ahn.org.