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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement |
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| Region |
Sponsors |
| Northwest |
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| Acronym |
NCT No. |
| PROGRESS |
NCT04889872 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| Purpose |
| This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. |
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| 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 THV or Clinical Surveillance. |
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- 65 years of age or older at time of randomization
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Subject has symptoms or evidence of cardiac damage/dysfunction
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The subject or subject's legal representative has been informed of the Ceded to WIRB nature of the study, agrees to its provisions, and has provided written informed consent
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- Native aortic annulus size unsuitable for the THV
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Anatomical characteristics that would preclude safe placement of the introducer sheath or safe passage of the delivery system
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Aortic valve is unicuspid or non-calcified
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Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
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Pre-existing mechanical or bioprosthetic aortic valve
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Pathological Conditions, Anatomical
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Transcatheter heart valve
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Ventricular Outflow Obstruction
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