RecruitingNot Applicable

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

United States2,250 participantsStarted 2021-10-12

Plain-language 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, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Who can participate

Age range65 Years

SexALL

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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%

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 2 years

Primary Safety Endpoint

Timeframe: 30 days

Trial details

NCT IDNCT04889872

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Edwards THV Clinical Affairs

949-250-2500 THV_CT.gov@Edwards.com

View on ClinicalTrials.gov More Aortic Stenosis, Calcific trials