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

Locations

  • UCSF 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 accepting new patients
    San Francisco California 94109 United States
  • Stanford Univeristy accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT04889872
Study Type
Interventional
Participants
Expecting 2250 study participants
Last Updated