PROGRESS CAP

Clinical Trial Title The PROGRESS Trial – Continued Access
Trial Status Open to Enrollment
Start Date 05/10/2024
Location legacy-emanuel-medical-center
Trial Type Heart Disease/Cardiology
Specific Condition Aortic Stenosis - Aortic Valve Replacement
Description

• A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement: The PROGRESS Trial.

• The objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) systems in subjects with moderate, calcific aortic stenosis (AS).

 
Eligibility Criteria
  • The continued access population will be comprised of subjects with moderate AS and appropriate anatomy for transfemoral transcatheter aortic valve replacement (TAVR) with the study devices. For the US, this study is expected to enroll subjects who qualify for Medicare coverage through age criteria (i.e., 65 years and older).
Subjects will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the study devices or clinical surveillance.
IRB Number 10901
Notes https://clinicaltrials.gov/study/NCT04889872?term=The%20PROGRESS%20Trial%20-%20Continued%20Access&viewType=Card&rank=1
Principal Investigator Amish Desai, MD
Contact Name Karla Kummer
Contact Phone 503-413-1612
Contact Fax 503-413-3543
Contact E-Mail kkummer@lhs.org