What is the Purpose of this Study?
The purpose of this study to determine whether an experimental device called the ShortCut is safe and effective in people with a risk for coronary obstruction following a repeated bioprosthetic valve implantation. Coronary obstruction is the blockage of coronary arteries, which supply blood flow to the heart. ShortCut is a catheter (a long plastic tube) introduced through the groin to split the existing bioprosthetic valve leaflet/s just prior to the new bioprosthetic valve implantation to enable blood flow through the coronary arteries. This is intended to prevent a situation in which one or two of the arteries are blocked by the existing valve leaflets.
Eligibility
- 1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- 2. Patient is at risk for TAVR-induced coronary artery ostium obstruction.
- 3. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
The ShortCut Continued Access Study