Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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 RESILIA THV or Clinical Surveillance.

Keywords

Aortic Stenosis, Calcific, Aortic Valve Stenosis, Transcatheter aortic valve replacement (TAVR), SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA, Moderate aortic stenosis, Aortic stenosis, Transcatheter heart valve, Pathologic Constriction, SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA, TAVR

Eligibility

You can join if…

Open to people ages 65 years and up

  1. 65 years of age or older at time of randomization
  2. Moderate aortic stenosis
  3. Subject has symptoms or evidence of cardiac damage/dysfunction
  4. 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.

You CAN'T join if...

  1. Native aortic annulus size unsuitable for the THV
  2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
  3. Aortic valve is unicuspid or non-calcified
  4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
  5. Pre-existing mechanical or bioprosthetic aortic valve
  6. Severe aortic regurgitation
  7. Prior balloon aortic valvuloplasty to treat severe AS
  8. LVEF < 20%
  9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR

    10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery

    obstruction post-TAVR

Locations

  • UCSF in progress, not accepting new patients
    San Francisco California 94143 United States
  • Kaiser San Francisco Medical Center in progress, not accepting new patients
    San Francisco California 94118 United States
  • Bay Area Structural Heart at Sutter Health in progress, not accepting new patients
    San Francisco California 94109 United States
  • Stanford Univeristy in progress, not accepting new patients
    Stanford California 94305 United States
  • Allegheny Singer Research Institute accepting new patients
    Pittsburgh Pennsylvania 15212 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT04889872
Study Type
Interventional
Participants
Expecting 2250 study participants
Last Updated