Summary
The purpose of this study is to determine the safety and effectiveness of an investigational device called the ShortCut in individuals with a risk for coronary obstruction following a repeated bioprosthetic valve implantation. Coronary obstruction is the obstruction of the coronary arteries, which are the arteries that supply blood flow to the heart. During repeated implantation of a bioprosthetic valve within a failed bioprosthetic valve, the existing valve leaflets may block the coronary arteries and reduce or prevent blood supply to the heart. The Shortcut is designed to split the leaflets of the existing bioprosthetic valve, just prior to implantation of the new valve. The leaflet splitting is designed to enable blood flow through the coronary arteries supplying blood to the heart. This is intended to prevent a situation where one or two of the arteries are blocked by the existing valve leaflets. The procedure is performed under anesthesia.
Inclusion Criteria
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- 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.
Study Location(s)
Beverly
More about this Clinical Trial
Full Title
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut? device .