Status:
RECRUITING
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Stenosis, Calcific
Aortic Valve Stenosis
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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, calcifi...
Detailed Description
This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2037
Estimated Enrollment :
2250 Patients enrolled
Trial Details
Trial ID
NCT04889872
Start Date
October 12 2021
End Date
June 1 2037
Last Update
December 17 2025
Active Locations (80)
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1
Heart Center LLC, Huntsville
Huntsville, Alabama, United States, 35801
2
Tucson Medical Center
Tucson, Arizona, United States, 85712
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Huntington Hospital
Pasadena, California, United States, 91105