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

Recruiting

Trial ID: NCT04889872

Purpose

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.

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

Stanford Investigator(s)

Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP

Clinical Associate Professor, Medicine - Cardiovascular Medicine

Christiane Haeffele
Christiane Haeffele

Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

Eligibility


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 transfemoral 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

Intervention(s):

device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305