Study ID: SITRAL
SITRAL: Surgical implantation of transcatheter valve in native mitral annular calcification study
The mitral valve lets blood flow from one chamber of the heart, the left atrium, to another called the left ventricle. This trial is studying the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve in subjects with a dangerous buildup of calcification in the mitral valve, which is causing the valve to narrow (mitral stenosis, or MS) and/or allowing blood to leak backward through the valve each time the left ventricle contracts (mitral regurgitation, or MR).
Patients will have the SAPIEN 3 valve surgically implanted using a minimally invasive approach, and they must be willing to undergo follow-up care at 30 days, 6 months and 12 months post procedure.
This is a multi-center, prospective feasibility study. The study cohort will comprise all subjects undergoing mitral valve replacement with the Edwards SAPIEN 3 heart valve by a standardized, minimally invasive, surgical approach at investigational centers and will consist of up to 30 subjects at Lankenau Medical Center.
- 22 years and older
- Severe MAC with MS or MR
- NYHA ≥II
- Deemed high-risk or inoperable
- Must have been diagnosed with severe mitral annular calcification with MS and/or MR
- Must be at high-risk for mitral valve surgery or deemed inoperable due to the extent of the calcification in the mitral valve