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

Aortic Valve Stenosis Clinical 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

Clinical Trial 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.

Clinical Trial 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 /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04889872
Study type Interventional
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone 949-250-2500
Email THV_CT.gov@Edwards.com
Status Recruiting
Phase N/A
Start date October 12, 2021
Completion date June 2037
View Details
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