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The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
California - Northern
Edwards Lifesciences
 
Acronym NCT No.
PROGRESS NCT04889872
 
Study Type Phase
INTERVENTIONAL
n/a
 
Purpose
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.
 
Detailed 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 THV or Clinical Surveillance.
 
 
 
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
 
Exclusion Criteria
  • Native aortic annulus size unsuitable for the THV
  • Anatomical characteristics that would preclude safe 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
 
Keywords and/or Specific Medical Conditions
  • 2021-01
  • Moderate aortic stenosis
  • Aortic stenosis
  • Pathological Conditions, Anatomical
  • Aortic Valve Disease
  • SAPIEN 3
  • Aortic Valve Stenosis
  • SAPIEN 3 Ultra
  • Cardiovascular Diseases
  • Transcatheter aortic valve replacement (TAVR)
  • Constriction, Pathologic
  • Transcatheter heart valve
  • Heart Diseases
  • Ventricular Outflow Obstruction
  • Heart Valve Diseases
  • Cardiology
 
KP Clinical Facility
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Cardiology


Principal Investigator:
Jacob Mishell, MD
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-San Francisco Medical Center


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