Participation in studies of other experimental drugs or devices within 30 days prior to enrollment in this study

Brief description of study

The purpose of this study is to gather information on how well the 3D ICE AcuNav ultrasound is able to visualize the heart during the heart disease procedure. During replacement or repair of the heart valve procedure, an ultrasound is used to visualize anatomy of the heart in order to help guide the procedure. To see the anatomy of the heart, physicians use a catheter (plastic tube) with a small ultrasound probe attached to the end of the catheter. This catheter is inserted into femoral artery to help guide the heart valve procedure. During the heart disease procedure, the treating physician will be using the ultrasound system called 3D ICE AcuNav per standard of care. The AcuNav catheters and all subcomponents that will be used during procedure are not investigational devices and have been approved by Food and Drug Administration committee for standard of care use. The AcuNav catheters will be used regardless of study participation.

Clinical Study Identifier: s17-01043
Principal Investigator: Mathew R. Williams.

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