The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. This device enables the direct measurement of the mitral valve opening. Currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. The field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.
Study Type
OBSERVATIONAL
Enrollment
22
A single time use of a novel sizing tool for mitral valve repair surgery (used ONLY in an observational capacity - this device does NOT influence decision-making during the conduct of the operation in any way).
Endeavor Health
Glenview, Illinois, United States
Mitral leaflet coaptation length.
Direct measurement of mitral leaflet coaptation length performed with the sizer in position, performed in mm using surgical (disposable) ruler.
Time frame: During surgery, immediately prior to prosthesis implantation.
Post-procedure, echocardiography measurements - mitral coaptation length.
Indirect measurement of mitral leaflet coaptation length (mm), using standard intraoperative trans-esophageal echocardiography (TEE) images (measurements performed postoperatively based on archived images).
Time frame: After separation from cardiopulmonary bypass.
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