A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Sponsor: |
Edwards Lifesciences |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAT8525 |
U.S. Govt. ID: |
NCT04889872 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment Group: Doctor will use the SAPIEN 3 or SAPIEN 3 Ultra Transcatheter Heart Valve system to replace your valve. or (2) Clinical Surveillance Group: If assigned to this group, subject will not have their heart valve replaced. However, the doctor will continue to provide optimal medical therapy and will closely monitor how subject is doing (this is called Clinical Surveillance).
This study is closed
Investigator
Susheel Kodali, MD
Are you 65 years or older? |
Yes |
No |
Do you have Moderate aortic stenosis? |
Yes |
No |