Millipede Feasibility Study, Study number S2436, Protocol nr 92390788
A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation Millipede Feasibility Study, S2436-92390788
Boston Scientific International SA
Duration of Study in the UK
6 years, 9 months, 31 days
Mitral regurgitation results in a backflow of blood within the heart due to the failure of the mitral valve to close properly, which requires that the patient has a procedure to correct it. The purpose of this study is to evaluate the feasibility and safety of a new device called the “Millipede Transcatheter Annuloplasty Ring System” in patients with functional mitral regurgitation. The Millipede System is an investigational device, not currently an approved treatment for mitral regurgitation.
Many patients that need mitral valve repair are treated with open-heart surgery, but for some patients, it is not a good option. The Millipede System is a form of ”transcatheter mitral valve repair” and provides a less invasive alternative without open-heart surgery. The experimental study patients are being asked to participate in a feasibility study. The Millipede System is a device that is delivered to the patient’s heart through a catheter (a long thin hollow tube) inserted into a vein in the groin. The part of the device that is left inside the heart is a crown-shaped ring made out of a metal material called nitinol.The ring is placed around the opening of the mitral valve and secured in the tissue by using metal anchors (similar to a small screw) that secure the device into the heart tissue. The device is then tightened to bring the opening of the valve back to normal size.
After the implantation of the medical device the information of the patient will be recorded through 5 years following the procedure and will be expected to visit his study doctor’s research staff for follow-up at 30 days, 90 days, 180 days, 12 months, 2 years, 3 years, 4 years, and 5 years after the valve implantation procedure and then the participation of the patients will be complete.
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
Date of REC Opinion
19 Oct 2020
Further Information Favourable Opinion