What is the Purpose of this Study?
The purpose of this study is to learn whether the SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve are beneficial for individuals with moderate, calcific aortic stenosis. Patients with moderate aortic stenosis may or may not show symptoms. Currently, only patients who have severe aortic stenosis with symptoms can have their valve replaced. This study will help researchers learn whether replacing the valve earlier can lead to health improvements by stopping or preventing further damage to the heart.
The use of SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve is considered experimental in this study. These valves are currently FDA approved for patients with severe aortic stenosis.
Eligibility
- 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement