Brief Title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
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
Brief Summary
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.
Study Type
Interventional
Primary Outcome
A composite of death, stroke, and unplanned cardiovascular hospitalization
Secondary Outcome
Death, unplanned cardiovascular hospitalization, decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Condition
Aortic Stenosis, Calcific
Intervention
SAPIEN 3 / SAPIEN 3 Ultra
Study Arms / Comparison Groups
TAVR
Description: Transcatheter Aortic Valve Replacement (TAVR)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
750
Start Date
October 12, 2021
Completion Date
June 2037
Primary Completion Date
June 2029
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe 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
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Philippe Généreux, MD, 949-250-2500, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT04889872
Organization ID
2021-01
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Philippe Généreux, MD, Principal Investigator, Morristown Medical Center, Morristown, NJ, USA
Verification Date
June 2022