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

Edwards Lifesciences · NCT04889872

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
2250
US sites recruiting
50
Study start
October 12, 2021
Record last updated
December 17, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Conditions: Aortic Stenosis, Calcific; Aortic Valve Stenosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Key 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

Recruiting US locations

Study contacts (from the official record)

  • Edwards THV Clinical Affairs · 949-250-2500 · THV_CT.gov@Edwards.com
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PROGRESS: Management of Moderate Aortic Stenosis by Clinical… (NCT04889872) | Bored Studies