Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery. This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015. Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
21
Transcatheter implantation of the IRIS
Dante Pazzanese de Cardiologia
São Paulo, Brazil
Sanatorio Italiano
Asunción, Paraguay
Acute Safety defined as incidence of adverse events
30 days defined as ability to implant, anchor and actuate without incidence of adverse events
Time frame: Procedure through 30 days post procedure
Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo
Reduction in mitral regurgitation to optimal or acceptable levels without significant mitral stenosis post procedure (defined as discharge or 48 hrs whichever comes first) and EROA \<1.5 cm2 with transmitral gradient \<5mm Hg as compared to screening echo
Time frame: Procedural through 48 hrs post procedure
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