Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Stanford Investigator(s):

Intervention(s):

  • Device: SAPIEN 3 / SAPIEN 3 Ultra

Phase:

N/A

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 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

Ages Eligible for Study

65 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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